[{"id":799,"symbol":"HRTX","drug":"CINVANTI","modality":"small_molecule","area":"oncology","event_type":"other","expect_date_from":"2026-09-10","expect_date_to":"2026-09-10","news_source_file":"documents/20260810_080042_(HRTX)_sec_0001193125-26-341301.txt","comments":"Federal Circuit oral argument (Fresenius Kabi ANDA appeal on CINVANTI 229/794 patents): \"On July 21, 2026, the Company received notice that oral argument at the Federal Circuit is scheduled for September 10, 2026.\" Separate Azurity appeal consolidated 7/31/2026, unbriefed. Resolution checked 2026-10-25: no outcome found. Only later HRTX filings are 8/14/2026 8-K (items 1.01/3.03/9.01) and 9/29/2026 8-K on a Long Grove license agreement; no appellate decision disclosed. Event left open pending decision. Resolution checked 2026-11-01: no outcome found.","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-01T21:24:15Z","company":"Heron Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-09-10","imminence":-56,"state":"overdue","overdue":true},{"id":1154,"symbol":"ATOS","drug":"(Z)-endoxifen","modality":"small_molecule","area":"womens_health","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-09-30","news_source_file":"documents/20260807_083033_(ATOS)_sec_0001193125-26-339257.txt","comments":"10-Q (Aug 7, 2026), Karisma-(Z)-endoxifen Ph2 MBD study 24-month follow-up mammographic review: \"We expect to report top-line durability data from the Karisma-(Z)-endoxifen study in the third quarter of 2026\" (also \"expected to be received before the end of the third quarter of 2026\"). Window per Q3 2026 = 2026-07-01..2026-09-30; no result disclosed in documents to date. Resolution checked 2026-11-03: no outcome found.","closed":0,"created_at":"2026-11-03 00:13:36","updated_at":"2026-11-03T23:11:54Z","company":"Atossa Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-07-01 → 2026-09-30","imminence":-36,"state":"overdue","overdue":true},{"id":832,"symbol":"GALT","drug":"belapectin","modality":"other","area":"gi_hepatology","event_type":"regulatory_submission","expect_date_from":"2026-07-01","expect_date_to":"2026-09-30","news_source_file":"documents/20260814_075546_(GALT)_sec_0001140361-26-032946-ex991.txt","comments":"\"Registrational Phase 3 trial protocol submission for belapectin in advanced MASH cirrhosis with portal hypertension is anticipated in 3Q 2026.\" 10-Q concurs: \"plans to file a Phase 3 protocol with the FDA in the third quarter of 2026.\" Resolution checked 2026-10-25: no outcome found. Later docs (2026-09-14 Investing.com headline \"belapectin nears phase III\"; 2026-10-06 AASLD presentation notice) contain no confirmation of submission. Resolution checked 2026-11-01: no outcome found.","closed":0,"created_at":"2026-10-25 11:58:15","updated_at":"2026-11-01T21:24:29Z","company":"Galectin Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-07-01 → 2026-09-30","imminence":-36,"state":"overdue","overdue":true},{"id":430,"symbol":"RGNX","drug":"RGX-202","modality":"gene_therapy","area":"rare_genetic","event_type":"regulatory_submission","expect_date_from":"2026-07-01","expect_date_to":"2026-09-30","news_source_file":"documents/20260806_071016_(RGNX)_sec_0001193125-26-336716-ex991.txt","comments":"\"on track to initiate a BLA submission in Q3 2026 under the accelerated approval pathway, supporting potential approval in 2H 2027\"; Duchenne. Reaffirmed Aug 24, 2026: \"planned submission of the Duchenne BLA this quarter\". No document through 2026-11-01 reports the actual submission (Q3 window closed unfilled). Oct 16/Oct 20, 2026 coverage (\"RGX-202 Meets Primary End Point in Phase 3 Duchenne Trial\") re-reports the AFFINITY DUCHENNE topline already announced May 2026 per the Q2 10-Q, not a BLA filing. Resolution checked 2026-11-01: no outcome found.","closed":0,"created_at":"2026-10-25 11:30:16","updated_at":"2026-11-01T21:24:37Z","company":"REGENXBIO","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-07-01 → 2026-09-30","imminence":-36,"state":"overdue","overdue":true},{"id":1138,"symbol":"SLS","drug":"galinpepimut-S","modality":"peptide","area":"hematology","event_type":"interim_analysis","expect_date_from":"2026-10-28","expect_date_to":"2026-10-28","news_source_file":"documents/20261028_083500_(SLS)_google_news_google_news-75b16ce124887a580f50c66af882f268-SLS.txt","comments":"Oct 28, 2026 GlobeNewswire: Phase 3 REGAL (AML) \"reached its pre-specified 80th event, triggering the final analysis\" — a pre-specified data-cutoff/milestone announcement, not data itself; \"Company to Report Topline Primary Endpoint Results this Quarter\" (tracked in event 1083). Checked 2026-11-04: still no topline/results disclosed.","closed":0,"created_at":"2026-11-01 21:23:55","updated_at":"2026-11-04T05:23:12Z","company":"SELLAS Life Sciences Group","tier":"Core","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-28","imminence":-8,"state":"overdue","overdue":true},{"id":736,"symbol":"IVVD","drug":"VYD2311","modality":"monoclonal_antibody","area":"infectious","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-10-31","news_source_file":"documents/20260929_072646_(IVVD)_sec_0001193125-26-406007-ex991.txt","comments":"\"DECLARATION topline data on safety and immunogenicity to support the submission are now expected in October\". Slipped from prior guidance of late Q3 2026. Blinded clinical efficacy events to be unblinded post-Accelerated Approval, no date given. Resolution checked 2026-11-01: no outcome found. October 2026 documents (10/01, 10/04) are recaps of the 2026-09-29 LIBERTY topline release and give no DECLARATION data.","closed":0,"created_at":"2026-10-25 11:51:18","updated_at":"2026-11-01T21:25:07Z","company":"Invivyd","tier":"Core","llm_prediction":"large_impact","llm_confidence":0.5,"llm_reason":"The event is the October DECLARATION topline on placebo-controlled safety and neutralizing titers. It will decide whether Invivyd can pursue its accelerated approval BLA. At about a $180M market cap, the stock is binary-sensitive to this result. A titer readout is fairly likely to be positive, but the market may 'sell the news', and FDA pathway doubts add risk in both directions.","llm_predicted_at":"2026-10-25T15:48:04Z","llm_source":"live","window":"2026-10-01 → 2026-10-31","imminence":-5,"state":"overdue","overdue":true},{"id":552,"symbol":"OSTX","drug":"OST-HER2","modality":"vaccine","area":"oncology","event_type":"other","expect_date_from":"2026-10-01","expect_date_to":"2026-10-31","news_source_file":"documents/20260814_170127_(OSTX)_sec_0001213900-26-090238.txt","comments":"10-Q: \"We also anticipate releasing additional biomarker data in October 2026 to further characterize immune pathway activation and its relationship to clinical outcomes.\" Exploratory biomarker analyses; month-long window, no specific date. Resolution checked 2026-11-01: no outcome found (no biomarker release in 8-Ks of 2026-10-05 or 2026-10-19).","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-01T21:25:20Z","company":"OS Therapies","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-10-31","imminence":-5,"state":"overdue","overdue":true},{"id":1204,"symbol":"ATNM","drug":"Actimab-A","modality":"radiopharma","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-11-04","expect_date_to":"2026-11-04","news_source_file":"documents/20261104_090500_(ATNM)_yahoo_news_yahoo-2941a65417d33f5888096c2ef7993da0-ATNM.txt","comments":"\"announced the release of an abstract for the 2026 ASH Annual Meeting ... evaluating long-term safety and tolerability of Actimab-A (lintuzumab-Ac225) in combination with CLAG-M ... in relapsed or refractory AML\". Abstract release date used as public disclosure (earliest, 2026-11-04 09:05 wire; duplicate copies at 10:00 from Traders Union / Stock Titan). Feed text truncated - no data values stated, so no result recorded; ASH meeting dates not given.","closed":0,"created_at":"2026-11-04 15:44:05","updated_at":"2026-11-05T08:24:22Z","company":"Actinium Pharmaceuticals Inc. (Delaware)","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-04","imminence":-1,"state":"overdue","overdue":true},{"id":1205,"symbol":"ATNM","drug":"Iomab-ACT","modality":"radiopharma","area":"hematology","event_type":"data_presentation","expect_date_from":"2026-11-04","expect_date_to":"2026-11-04","news_source_file":"documents/20261104_091100_(ATNM)_yahoo_news_yahoo-544ef5e4d9821bb4ba448c0edd922650-ATNM.txt","comments":"\"announced the release of three abstracts for the 68th ASH Annual Meeting ... highlight clinical findings and continued development of Iomab-ACT ... as a conditioning approach before CAR T-cell therapy\" and in sickle cell disease. Earliest disclosure 2026-11-04 09:11 (duplicated by resolution_news copy 09:11). Feed text truncated - no data values stated, so no result recorded; ASH meeting dates not given.","closed":0,"created_at":"2026-11-04 15:44:05","updated_at":"2026-11-05T08:24:22Z","company":"Actinium Pharmaceuticals Inc. (Delaware)","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-04","imminence":-1,"state":"overdue","overdue":true},{"id":1050,"symbol":"BIVI","drug":"Bezisterim","modality":"small_molecule","area":"infectious","event_type":"data_presentation","expect_date_from":"2026-11-05","expect_date_to":"2026-11-05","news_source_file":"documents/20261026_080000_(BIVI)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"GlobeNewswire 2026-10-26: invited to present ADDRESS-LC Phase 2 results at NIH/NIAID-FNIH 2026 RECOVER-TLC Hybrid Workshop (Nov 4-5, Bethesda MD), \"Panel Discussion on Thursday, November 5, being held from 9:10-10:10 a.m. ET\". Dataset already top-lined 2026-09-15; this is a conference presentation, not a new readout.","closed":0,"created_at":"2026-10-26 10:45:00","updated_at":"2026-10-26 10:45:00","company":"BioVie","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-05","imminence":0,"state":"open","overdue":false},{"id":46,"symbol":"CATX","drug":"VMT-alpha-NET","modality":"radiopharma","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-11-05","expect_date_to":"2026-11-05","news_source_file":"documents/20261023_105232_(CATX)_sec_0001193125-26-429770-ex991.txt","comments":"\"The Company will present additional data in the coming weeks: at the NANETS 2026 Multidisciplinary NET Medical Symposium, November 5, 2026\" - dataset not specified in the release.","closed":0,"created_at":"2026-10-25 10:12:41","updated_at":"2026-10-25 10:12:41","company":"Perspective Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-05","imminence":0,"state":"open","overdue":false},{"id":1109,"symbol":"IMUX","drug":null,"modality":"small_molecule","area":"cns","event_type":"other","expect_date_from":"2026-11-05","expect_date_to":"2026-11-05","news_source_file":"documents/20261029_063000_(IMUX)_yahoo_news_yahoo-bd415db37f3eb4ec1927b232a0c264e2-IMUX.txt","comments":"Company release: \"will host a virtual Research and Development (R&D) Day focused on progressive multiple sclerosis (MS) on Thursday, November 5, 2026, at 12:30 pm ET.\" Proactive adds the event \"will outline the company's plans to initiate a Phase 3 trial\" in progressive MS; no specific clinical dataset promised. Company release via Yahoo (earliest copy; later Proactive article same day).","closed":0,"created_at":"2026-10-29 23:39:18","updated_at":"2026-10-29 23:39:18","company":"Immunic","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-05","imminence":0,"state":"open","overdue":false},{"id":1126,"symbol":"MNKD","drug":null,"modality":null,"area":"other","event_type":"other","expect_date_from":"2026-11-05","expect_date_to":"2026-11-05","news_source_file":"documents/20261029_160100_(MNKD)_yahoo_news_yahoo-8956c645b3fd2f5b6cb2904c30749918-MNKD.txt","comments":"Scheduled Q3 2026 financial results and business update call: \"it will report third quarter 2026 financial results after market close on Thursday, November 5, 2026\" with a call at 4:30 p.m. ET. Company announcement (GlobeNewswire, Oct. 29, 2026); no clinical data or regulatory decision guided.","closed":0,"created_at":"2026-10-31 00:29:00","updated_at":"2026-10-31 00:29:00","company":"MannKind","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-05","imminence":0,"state":"open","overdue":false},{"id":1148,"symbol":"MNPR","drug":"ALXN1840","modality":"small_molecule","area":"rare_genetic","event_type":"data_presentation","expect_date_from":"2026-11-05","expect_date_to":"2026-11-05","news_source_file":"documents/20261102_080000_(MNPR)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","comments":"\"Professor Aftab Ala ... will present a poster on molybdenum balance in patients treated with ALXN1840\" on \"Thursday, Nov. 5, 2026, 12:00 p.m. to 1:00 p.m. MT\" at AASLD.","closed":0,"created_at":"2026-11-02 15:52:31","updated_at":"2026-11-02 15:52:31","company":"Monopar Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-05","imminence":0,"state":"open","overdue":false},{"id":1112,"symbol":"BRVE","drug":"BHB-1893","modality":"small_molecule","area":"cardiovascular","event_type":"data_presentation","expect_date_from":"2026-11-06","expect_date_to":"2026-11-06","news_source_file":"documents/20261030_073000_(BRVE)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"AHA Scientific Sessions 2026, Nov 6-9, Chicago: late-breaking oral \"Long-Term Efficacy and Safety of BHB/HRS-1893 in Patients With Obstructive HCM: Results From the 52-Week Extension Period\" presented Friday, Nov 6, 2026, 2:15-2:25 PM CT; same-day oral on nHCM diastolic function. Company webinar also Nov 6, 4:35 PM ET.","closed":0,"created_at":"2026-10-30 11:50:05","updated_at":"2026-10-30 11:50:05","company":"Braveheart Bio","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-06","imminence":1,"state":"upcoming","overdue":false},{"id":1091,"symbol":"ELTX","drug":"camupepimut (ELI-002 7P)","modality":"peptide","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-11-06","expect_date_to":"2026-11-06","news_source_file":"documents/20261029_090000_(ELTX)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","comments":"SITC 2026 (Phoenix, Nov 4-8) keynote/plenary presentation \"Updates on Clinical Results from the AMPLIFY-7P Study of a Lymph Node-Targeted KRAS Vaccine,\" Session 103 Thomas Waldmann Memorial Plenary, Friday, November 6, 2026 at 10:04 am MT. Quote: \"Presentation Date/Time: Friday, November 6, 2026, at 10:04 am MT\". Separate late-breaking poster #1186 on Nov 7 tracked as its own event; preclinical poster #824 excluded.","closed":0,"created_at":"2026-10-29 09:06:23","updated_at":"2026-11-04T13:37:55Z","company":"Elicio Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-06","imminence":1,"state":"upcoming","overdue":false},{"id":26,"symbol":"EVAX","drug":"EVX-01","modality":"peptide","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-11-06","expect_date_to":"2026-11-06","news_source_file":"documents/20261002_090505_(EVAX)_sec_0001171843-26-006353-ex991.txt","comments":"New immune/biomarker data (broad systemic immunomodulatory effects of EVX-01 + pembrolizumab) presented at SITC 2026 oral (Abstract# 502), Friday November 6, 2026, 12:30-1:30pm MT; poster Saturday November 7, 2026. \"Date/Time: Friday, November 6, 2026, 12:30-1:30pm MT\" (Nov 3, 2026 release).","closed":0,"created_at":"2026-10-25 09:53:51","updated_at":"2026-11-03T14:41:43Z","company":"Evaxion A/S American Depositary Share","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-06","imminence":1,"state":"upcoming","overdue":false},{"id":1039,"symbol":"GTBP","drug":null,"modality":"other","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-11-06","expect_date_to":"2026-11-06","news_source_file":"documents/20261026_080000_(GTBP)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"\"selected for an oral presentation at ... SITC 2026 Annual Meeting ... Presentation Date: Friday, November 6, 2026\"; abstract 655 \"Inhibition of the KRAS oncoprotein sensitizes pancreatic cancer to NK cell immunotherapy,\" presenter U. of Minnesota; no specific TriKE molecule named in the release.","closed":0,"created_at":"2026-10-26T08:36:25","updated_at":"2026-10-26T08:36:25","company":"GT Biopharma","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-06","imminence":1,"state":"upcoming","overdue":false},{"id":1092,"symbol":"CADL","drug":"aglatimagene besadenovec","modality":"gene_therapy","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-11-07","expect_date_to":"2026-11-07","news_source_file":"documents/20261029_090000_(CADL)_globenewswire_biotech_globenewswire_biotech-sha256-85e49eeb3afac0cb457.txt","comments":"PR (Oct 29, 2026): late-breaking abstract from phase 2 PrTK05 in localized intermediate-risk prostate cancer accepted for poster at SITC 41st Annual Meeting; \"Session Date: Saturday, November 7, 2026\" (Abstract 1172), presenting longitudinal immune profiling plus biodistribution/viral shedding. Presentation, not a topline readout.","closed":0,"created_at":"2026-10-29 13:07:46","updated_at":"2026-10-29 13:07:46","company":"Candel Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-07","imminence":2,"state":"upcoming","overdue":false},{"id":1193,"symbol":"ELTX","drug":"camupepimut (ELI-002 7P)","modality":"peptide","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-11-07","expect_date_to":"2026-11-07","news_source_file":"documents/20261029_090000_(ELTX)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","comments":"Late-breaking poster #1186 at SITC 2026: \"Seven valent mKRAS lymph node targeted amphiphile vaccine drives mKRAS-specific T cell responses that correlate with improved clinical outcomes in the AMPLIFY-7P randomized phase 2 trial\"; Saturday, November 7, 2026, 12:30-1:30 pm and 6:40-8:10 pm MT. Quote: \"Session Date/Time: Saturday, November 7, 2026, 12:30-1:30 pm MT and 6:40-8:10 pm MT\". Separate from Nov 6 plenary.","closed":0,"created_at":"2026-11-04 08:37:41","updated_at":"2026-11-04 08:37:41","company":"Elicio Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-07","imminence":2,"state":"upcoming","overdue":false},{"id":1121,"symbol":"HOWL","drug":"WTX-124","modality":"protein","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-11-07","expect_date_to":"2026-11-07","news_source_file":"documents/20261030_083000_(HOWL)_globenewswire_biotech_globenewswire_biotech-sha256-10cf2ff96415235ee22.txt","comments":"SITC 2026 oral presentation, Abstract 1189: \"A Phase 1/1b study of the tumor-activated IL-2 prodrug WTX-124 alone or in combination with pembrolizumab\"; \"Saturday, November 7, 2026; 2:30-2:45 p.m. MT\", Phoenix AZ. May satisfy the 2H 2026 data-update guidance (event 809).","closed":0,"created_at":"2026-10-30 16:03:16","updated_at":"2026-10-30 16:03:16","company":"Werewolf Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-07","imminence":2,"state":"upcoming","overdue":false},{"id":1122,"symbol":"HOWL","drug":"WTX-330","modality":"protein","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-11-07","expect_date_to":"2026-11-07","news_source_file":"documents/20261030_083000_(HOWL)_globenewswire_biotech_globenewswire_biotech-sha256-10cf2ff96415235ee22.txt","comments":"SITC 2026 poster, Abstract 494: \"A Phase 1b/2 study of the tumor-activated IL-12 prodrug WTX-330 in patients with relapsed/refractory solid tumors\"; \"Saturday, November 7, 2026; 9 a.m.-8:30 p.m. MT\". May satisfy the 2H 2026 data-update guidance (event 810).","closed":0,"created_at":"2026-10-30 16:03:16","updated_at":"2026-10-30 16:03:16","company":"Werewolf Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-07","imminence":2,"state":"upcoming","overdue":false},{"id":1167,"symbol":"HUMA","drug":"CTEV (coronary tissue engineered vessel)","modality":"other","area":"cardiovascular","event_type":"data_presentation","expect_date_from":"2026-11-07","expect_date_to":"2026-11-07","news_source_file":"documents/20261103_080000_(HUMA)_globenewswire_biotech_globenewswire_biotech-sha256-54d91a569ad9e05ba13.txt","comments":"AHA Scientific Sessions 2026 presentation \"First-in-Human Phase 2a Study Design of a Bioengineered Human Coronary Artery for CABG\", Saturday, November 7, 2026, 3:57 PM CT. Study design talk, not data. Separate preclinical CABG poster (Nov 8) not recorded.","closed":0,"created_at":"2026-11-03T09:42:33","updated_at":"2026-11-03T09:42:33","company":"Humacyte","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-07","imminence":2,"state":"upcoming","overdue":false},{"id":1225,"symbol":"MCRB","drug":"SER-155","modality":"other","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-11-07","expect_date_to":"2026-11-07","news_source_file":"documents/20261104_070512_(MCRB)_sec_0001193125-26-446185.txt","comments":"\"Seres and MSK will present a poster ... at the Society for Immunotherapy of Cancer (SITC) 2026 Annual Meeting in Phoenix, AZ on November 7, 2026.\" Poster of previously announced IST irEC results; not a new topline readout.","closed":0,"created_at":"2026-11-04 17:50:36","updated_at":"2026-11-04 17:50:36","company":"Seres Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-07","imminence":2,"state":"upcoming","overdue":false},{"id":1102,"symbol":"PLRX","drug":"PLN-101095","modality":"small_molecule","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-11-07","expect_date_to":"2026-11-07","news_source_file":"documents/20261029_160500_(PLRX)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"SITC 2026 poster 546 (Pliant, Decaris): \"Plasma biomarkers of immune activation predict sensitization to immune checkpoint inhibition (ICI) in patients with advanced solid tumors receiving dual αvβ8/αvβ1 integrin inhibitor PLN-101095\" — poster session Saturday, November 7, 2026. Biomarker/translational data from FORTIFY. Second poster (615, Nov 6) is NCI preclinical collaboration work; not recorded.","closed":0,"created_at":"2026-10-29","updated_at":"2026-10-29","company":"Pliant Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-07","imminence":2,"state":"upcoming","overdue":false},{"id":1257,"symbol":"XERS","drug":null,"modality":null,"area":"metabolic","event_type":"data_presentation","expect_date_from":"2026-11-04","expect_date_to":"2026-11-07","news_source_file":"documents/20261105_071245_(XERS)_sec_0001867096-26-000114.txt","comments":"\"Xeris will present, for the first time publicly, a TriNetX real-world evidence analysis at the ATA Annual Meeting, being held November 4–7, 2026, in Philadelphia, PA.\" Retrospective RWE/feasibility analysis of oral levothyroxine-treated patients (no drug asset named); window = meeting dates.","closed":0,"created_at":"2026-11-05","updated_at":"2026-11-05","company":"Xeris Biopharma Holdings","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-04 → 2026-11-07","imminence":2,"state":"open","overdue":false},{"id":1040,"symbol":"XLO","drug":"XTX501","modality":"bispecific","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-11-07","expect_date_to":"2026-11-07","news_source_file":"documents/20261026_073000_(XLO)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","comments":"Trial-in-progress poster (abstract 542) at SITC 41st Annual Meeting: \"Presentation Date: Saturday, November 7, 2026.\" Design-only poster; no data disclosed.","closed":0,"created_at":"2026-10-26","updated_at":"2026-10-26","company":"Xilio Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-07","imminence":2,"state":"upcoming","overdue":false},{"id":1022,"symbol":"AGEN","drug":"botensilimab + balstilimab","modality":"monoclonal_antibody","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-11-04","expect_date_to":"2026-11-08","news_source_file":"documents/20261002_090000_(AGEN)_yahoo_news_yahoo-55efe6fc91346b7ea917f79307afd2e1-AGEN.txt","comments":"\"two posters ... have been accepted for presentation at the Society for Immunotherapy of Cancer (SITC) 2026 Annual Meeting, taking place November 4-8, 2026, in Phoenix, Arizona\" - BOT+BAL long-term survival and agenT-797 translational research in colorectal cancer.","closed":0,"created_at":"2026-10-26 00:19:43","updated_at":"2026-10-26 00:19:43","company":"Agenus","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-04 → 2026-11-08","imminence":3,"state":"open","overdue":false},{"id":1157,"symbol":"ARWR","drug":null,"modality":null,"area":"cardiovascular","event_type":"data_presentation","expect_date_from":"2026-11-02","expect_date_to":"2026-11-08","news_source_file":"documents/20261102_073000_(ARWR)_yahoo_news_yahoo-d345300662c97493d7e92cb031f843bd-ARWR.txt","comments":"\"it will present important data at this week's American Heart Association Scientific Sessions in Chicago\" (Nov 2, 2026 release, 07:30 ET; same text via Business Wire, Yahoo Finance and Google News copies). Window = the week of publication 2026-11-02..2026-11-08; release names no drug and no exact session date.","closed":0,"created_at":"2026-11-02T19:14:16","updated_at":"2026-11-04T09:33:03Z","company":"Arrowhead Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-02 → 2026-11-08","imminence":3,"state":"open","overdue":false},{"id":276,"symbol":"CADL","drug":"linoserpaturev","modality":"gene_therapy","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-11-04","expect_date_to":"2026-11-08","news_source_file":"documents/20260813_081515_(CADL)_sec_0001193125-26-347957-ex991.txt","comments":"\"Candel will present findings on lung cancer ... and recurrent brain cancer\" at the SITC 2026 Annual Meeting (Stock Titan summary of the Oct 2, 2026 PR; Yahoo/GlobeNewswire copy of the PR is truncated after \"as well as clinical\"). Candel PR Oct 29, 2026: SITC 41st Annual Meeting \"taking place November 4-8, 2026.\" Earlier guidance: \"expects to present potential long-term survival data from arm C of its phase 1b clinical trial of linoserpaturev in rHGG in Q4 2026\" (8-K Ex. 99.1, Aug 13, 2026). Exact session day for the rHGG data not stated.","closed":0,"created_at":"2026-10-25 07:20:00","updated_at":"2026-11-02T09:42:00Z","company":"Candel Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-04 → 2026-11-08","imminence":3,"state":"open","overdue":false},{"id":1058,"symbol":"CADL","drug":"aglatimagene besadenovec","modality":"gene_therapy","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-11-04","expect_date_to":"2026-11-08","news_source_file":"documents/20261002_090000_(CADL)_yahoo_news_yahoo-34e3945cf213db4c473108470ef43f39-CADL.txt","comments":"\"PR (Oct 2, 2026): Company \"will present data from its aglatimagene besadenovec program in non-small cell lung cancer (NSCLC) in patients with progressive NSCLC despite immune checkpoint inhibitor (ICI) treatment\" at the SITC 2026 Annual Meeting; CADL copy is truncated and gives no date. Candel's own Oct 29, 2026 PR: SITC 41st Annual Meeting \"taking place November 4-8, 2026, in Phoenix, Arizona\" - hence the window. Presentation, not a topline readout.\"","closed":0,"created_at":"2026-10-26 21:03:35","updated_at":"2026-11-01T17:15:04Z","company":"Candel Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-04 → 2026-11-08","imminence":3,"state":"open","overdue":false},{"id":973,"symbol":"CGEM","drug":"velinotamig","modality":"bispecific","area":"immunology","event_type":"data_presentation","expect_date_from":"2026-11-08","expect_date_to":"2026-11-08","news_source_file":"documents/20260924_071556_(CGEM)_sec_0001193125-26-400144-ex991.txt","comments":"\"Multi-dose regimen data from the ongoing Genrix Bio Phase 1b/2a study in refractory SLE to be shared in poster session at ACR Convergence 2026 on November 8, 2026, 10:30 a.m. to 12:30 p.m. ET\"; reconfirmed in 2026-10-27 release (updated SLE results expected).","closed":0,"created_at":"2026-10-25 12:08:42","updated_at":"2026-10-27T11:25:16Z","company":"Cullinan Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-08","imminence":3,"state":"upcoming","overdue":false},{"id":1162,"symbol":"CRSP","drug":"zugocabtagene geleucel","modality":"cell_therapy","area":"immunology","event_type":"data_presentation","expect_date_from":"2026-11-08","expect_date_to":"2026-11-08","news_source_file":"documents/20261102_160100_(CRSP)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"\"Phase 1 clinical data in patients with refractory SSc will be presented in a poster presentation at the American College of Rheumatology (ACR) Convergence 2026 on November 8 at 10:30 a.m. ET.\" (Q3 2026 release, 2026-11-02).","closed":0,"created_at":"2026-11-03 04:24:02","updated_at":"2026-11-03 04:24:02","company":"CRISPR Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-08","imminence":3,"state":"upcoming","overdue":false},{"id":999,"symbol":"DTIL","drug":"PBGENE-HBV","modality":"gene_therapy","area":"infectious","event_type":"data_presentation","expect_date_from":"2026-11-05","expect_date_to":"2026-11-08","news_source_file":"documents/20261103_080930_(DTIL)_sec_0001628280-26-069092.txt","comments":"\"The embargoed abstract will become public on November 5, 2026 and the late-breaking oral presentation will occur on November 8, 2026\" (AASLD Liver Meeting 2026, 77th annual). Abstract public Nov 5, talk Nov 8 — earliest public disclosure Nov 5.","closed":0,"created_at":"2026-10-25 12:18:58","updated_at":"2026-11-04T09:31:36Z","company":"Precision BioSciences","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-05 → 2026-11-08","imminence":3,"state":"open","overdue":false},{"id":1006,"symbol":"INKT","drug":"agenT-797","modality":"cell_therapy","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-11-04","expect_date_to":"2026-11-08","news_source_file":"documents/20261002_090000_(INKT)_yahoo_news_yahoo-3646a7f294e68d7bb6fa73f302912789-INKT.txt","comments":"Oct 2, 2026 release: \"MiNK Therapeutics to Present Data on Treatment-Resistant Colorectal Cancer and Clearance of Senescent Tumor Cells and Fibroblasts at SITC 2026\" (SITC annual meeting Nov 4-8, 2026); confirmed in Nov 2, 2026 Q3 preview release highlighting \"new data released at the Society for Immunotherapy of Cancer (SITC) 2026 Annual Meeting\". Caveat: release texts in workspace are truncated; described data appear preclinical.","closed":0,"created_at":"2026-10-25 09:30:00","updated_at":"2026-11-02T22:09:51Z","company":"MiNK Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-04 → 2026-11-08","imminence":3,"state":"open","overdue":false},{"id":1147,"symbol":"MNPR","drug":"ALXN1840","modality":"small_molecule","area":"rare_genetic","event_type":"data_presentation","expect_date_from":"2026-11-08","expect_date_to":"2026-11-08","news_source_file":"documents/20261102_080000_(MNPR)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","comments":"\"Askari ... will deliver an oral presentation highlighting the baseline Wilson disease characteristics from the Phase 3 FoCus trial\" on \"Sunday, Nov. 8, 2026, 12:15 p.m. to 12:30 p.m. MT\" at AASLD (Nov 5-9, 2026). Baseline characteristics, not topline efficacy.","closed":0,"created_at":"2026-11-02 15:52:31","updated_at":"2026-11-02 15:52:31","company":"Monopar Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-08","imminence":3,"state":"upcoming","overdue":false},{"id":1008,"symbol":"OBX","drug":"OBX-115","modality":"cell_therapy","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-11-04","expect_date_to":"2026-11-08","news_source_file":"documents/20261002_090500_(OBX)_yahoo_news_yahoo-16a15f20dcb6b1942db2b276fb0ab885-OBX.txt","comments":"Obsidian announced a poster presentation of updated amsoki-cel (OBX-115) Phase 1 FIH and Phase 1/2 Agni-01 data in ICI-resistant advanced melanoma at the SITC 2026 Annual Meeting (\"November conference\"; SITC dates Nov 4-8, 2026 per conference listing). Data not yet disclosed.","closed":0,"created_at":"2026-10-25 16:01:08","updated_at":"2026-10-25 16:01:08","company":"Obsidian Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-04 → 2026-11-08","imminence":3,"state":"open","overdue":false},{"id":1079,"symbol":"PRQR","drug":"AX-0810","modality":"aso","area":"gi_hepatology","event_type":"data_presentation","expect_date_from":"2026-11-05","expect_date_to":"2026-11-08","news_source_file":"documents/20261028_080533_(PRQR)_sec_0001104659-26-119371.txt","comments":"AASLD The Liver Meeting 2026 posters: \"AX-0810 Phase 1 data to be featured in two poster presentations at AASLD, The Liver Meeting 2026, including one late-breaking poster\" — abstract 1156 on Nov 5, 2026 and late-breaking abstract 5032 on Nov 8, 2026 (formerly disclosed safety/PK/target engagement data).","closed":0,"created_at":"2026-10-28 10:22:10","updated_at":"2026-10-28 10:22:10","company":"ProQR Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-05 → 2026-11-08","imminence":3,"state":"open","overdue":false},{"id":1104,"symbol":"ASMB","drug":"ABI-6250","modality":"small_molecule","area":"infectious","event_type":"data_presentation","expect_date_from":"2026-11-05","expect_date_to":"2026-11-09","news_source_file":"documents/20261029_160000_(ASMB)_globenewswire_pharma_globenewswire_pharma-sha256-cd7ef541cf1c23642f8b.txt","comments":"Related-release listing in Oct 29, 2026 release: \"Assembly Biosciences to Present Positive Phase 1a Safety, Tolerability and Target Engagement Data for ABI-6250 at AASLD The Liver Meeting 2026\" (Oct 5, 2026); 10-Q lists AASLD Nov 5-9, 2026, Denver. Poster of Distinction.","closed":0,"created_at":"2026-10-29 21:27:47","updated_at":"2026-10-29 21:27:47","company":"Assembly Biosciences","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-05 → 2026-11-09","imminence":4,"state":"open","overdue":false},{"id":1076,"symbol":"AXGN","drug":null,"modality":null,"area":"other","event_type":"data_presentation","expect_date_from":"2026-11-09","expect_date_to":"2026-11-09","news_source_file":"documents/20261028_070429_(AXGN)_sec_0000805928-26-000106.txt","comments":"Company: \"Based on positive clinical study outcomes, we have made the decision to initiate Prostate market development beginning in 2027. Axogen management will host a prostate specific investment-community conference call and webcast on November 9, 2026 at 9:00 a.m.\" No drug named for the prostate study data.","closed":0,"created_at":"2026-10-28 12:16:56","updated_at":"2026-10-28 12:16:56","company":"Axogen","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-09","imminence":4,"state":"upcoming","overdue":false},{"id":1151,"symbol":"BCAX","drug":null,"modality":null,"area":null,"event_type":"other","expect_date_from":"2026-11-09","expect_date_to":"2026-11-09","news_source_file":"documents/20261102_083000_(BCAX)_yahoo_news_yahoo-e054ce2ed34ceb55fa6188c9b1d0a630-BCAX.txt","comments":"Q3 2026 financial results and business updates: \"it will report third quarter 2026 financial results and business updates before the market opens on Monday, November 9, 2026,\" conference call 8:30 a.m. ET. GlobeNewswire release carried via Yahoo (no primary-source copy in workspace).","closed":0,"created_at":"2026-11-02 20:04:03","updated_at":"2026-11-02 20:04:03","company":"Bicara Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-09","imminence":4,"state":"upcoming","overdue":false},{"id":1137,"symbol":"CGEN","drug":null,"modality":null,"area":null,"event_type":"other","expect_date_from":"2026-11-09","expect_date_to":"2026-11-09","news_source_file":"documents/20261026_070000_(CGEN)_yahoo_news_yahoo-b961694f5f141f2f0e8c682cca0387ac-CGEN.txt","comments":"Company release (2026-10-26): \"will release its third quarter 2026 financial results on Monday, November 9, 2026, before the U.S. financial markets open\" and host a conference call to review results and provide a corporate update at 8:30 AM ET. No specific clinical data disclosed at this call.","closed":0,"created_at":"2026-11-01 08:08:29","updated_at":"2026-11-01 08:08:29","company":"Compugen","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-09","imminence":4,"state":"upcoming","overdue":false},{"id":1033,"symbol":"CRSP","drug":"CTX310","modality":"gene_therapy","area":"cardiovascular","event_type":"data_presentation","expect_date_from":"2026-11-09","expect_date_to":"2026-11-09","news_source_file":"documents/20261102_160100_(CRSP)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"\"Phase 1b data in patients with sHTG will be presented in a late-breaking oral presentation at the American Heart Association (AHA) Scientific Sessions 2026 on November 9, 2026, at 8:00 a.m. CT.\" Q3 2026 release (2026-11-02) gives exact session date; window narrowed from AHA meeting dates 11-06..11-09 to Nov 9.","closed":0,"created_at":"2026-10-26 04:25:49","updated_at":"2026-11-03T04:24:02Z","company":"CRISPR Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-09","imminence":4,"state":"upcoming","overdue":false},{"id":1003,"symbol":"GALT","drug":null,"modality":null,"area":"gi_hepatology","event_type":"data_presentation","expect_date_from":"2026-11-05","expect_date_to":"2026-11-09","news_source_file":"documents/20261006_030000_(GALT)_resolution_news_resolution_news-f504aed2f8aaf19bbd19dbb5f6d884fa.txt","comments":"Announcement: \"Galectin Therapeutics to Present at the American Association for the Study of Liver Diseases (AASLD) Liver Meeting 2026\". AASLD The Liver Meeting 2026 runs November 5-9, 2026 in Denver, CO (dates per AASLD/other meeting releases); the GALT item itself is a headline-only wire copy naming no dataset or drug - presentation content to be confirmed.","closed":0,"created_at":"2026-10-25T09:20:10","updated_at":"2026-10-25T09:20:10","company":"Galectin Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-05 → 2026-11-09","imminence":4,"state":"open","overdue":false},{"id":1156,"symbol":"IMVT","drug":null,"modality":null,"area":null,"event_type":"other","expect_date_from":"2026-11-09","expect_date_to":"2026-11-09","news_source_file":"documents/20261021_070000_(IMVT)_yahoo_news_yahoo-d3c4f86d716eef3169e82cecec11595e-IMVT.txt","comments":"Company press release: \"Immunovant ... today announced that it will report its financial results for the second fiscal quarter ended September 30, 2026 on Monday, November 9, 2026 before the market opens\"; Roivant call/webcast at 8:00 a.m. ET \"which will include a business update for Immunovant\". Exact date stated; no drug named in the sentence. Company release carried via Yahoo (webcast/business update).","closed":0,"created_at":"2026-11-02T19:13:35Z","updated_at":"2026-11-02T19:13:35Z","company":"Immunovant","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-09","imminence":4,"state":"upcoming","overdue":false},{"id":19,"symbol":"IVA","drug":"lanifibranor","modality":"small_molecule","area":"gi_hepatology","event_type":"data_presentation","expect_date_from":"2026-11-05","expect_date_to":"2026-11-09","news_source_file":"documents/20261006_170122_(IVA)_sec_0001171843-26-006471-ex991.txt","comments":"\"presentation of three abstracts at the upcoming AASLD The Liver Meeting 2026, to be held from November 5-9, 2026, in Denver\" — lanifibranor posters (abstracts 1052 on Nov 5; 3570 and 3552 on Nov 7). Preclinical/translational data.","closed":0,"created_at":"2026-10-25 09:53:21","updated_at":"2026-10-25 09:53:21","company":"Inventiva S.A. American Depository Shares","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-05 → 2026-11-09","imminence":4,"state":"open","overdue":false},{"id":731,"symbol":"JANX","drug":"JANX011","modality":"bispecific","area":"immunology","event_type":"data_presentation","expect_date_from":"2026-11-09","expect_date_to":"2026-11-09","news_source_file":"documents/20261102_160200_(JANX)_yahoo_news_yahoo-38754d81bdfca827c67abbdb2d06965c-JANX.txt","comments":"Virtual event on \"Monday, November 9, 2026, at 8:30 a.m. ET\" to present initial Phase 1 clinical data for JANX011 in healthy volunteers. Narrows prior 2H26 guidance; data not yet disclosed (announcement only).","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-02T22:09:13Z","company":"Janux Therapeutics","tier":"","llm_prediction":"small_impact","llm_confidence":0.7,"llm_reason":"Market cap (~$1.04B) is roughly equal to cash ($971M), so investors already assign little value to the pipeline. The readout is a Phase 1 healthy-volunteer study of JANX011, a CD19 T-cell engager for autoimmune disease. Such data mainly show safety, PK and B-cell depletion, which rarely move a stock 10% or more, especially for a non-lead program.","llm_predicted_at":"2026-10-25T15:51:19Z","llm_source":"live","window":"2026-11-09","imminence":4,"state":"upcoming","overdue":false},{"id":1252,"symbol":"LXRX","drug":"sotagliflozin","modality":"small_molecule","area":"cardiovascular","event_type":"data_presentation","expect_date_from":"2026-11-06","expect_date_to":"2026-11-09","news_source_file":"documents/20261105_070000_(LXRX)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","comments":"\"Two studies of sotagliflozin will be presented at the 2026 American Heart Association (AHA) Scientific Sessions in Chicago, November 6-9\" - new insights on thrombus formation and myocardial function in HCM, including living human HCM heart tissue; abstracts/posters.","closed":0,"created_at":"2026-11-05 12:29:17","updated_at":"2026-11-05 12:29:17","company":"Lexicon Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-06 → 2026-11-09","imminence":4,"state":"upcoming","overdue":false},{"id":1164,"symbol":"MDGL","drug":"resmetirom","modality":"small_molecule","area":"gi_hepatology","event_type":"data_presentation","expect_date_from":"2026-11-05","expect_date_to":"2026-11-09","news_source_file":"documents/20261103_070000_(MDGL)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","comments":"Q3 2026 release: AASLD Liver Meeting \"taking place Nov. 5-9 in Denver, CO. Resmetirom will be featured in more abstracts than any other MASH therapy\"; 18 accepted abstracts incl. 13 real-world evidence abstracts (largest dataset ~12,000 patients). No date beyond the meeting window stated.","closed":0,"created_at":"2026-11-03 12:33:59","updated_at":"2026-11-03 12:33:59","company":"Madrigal Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-05 → 2026-11-09","imminence":4,"state":"open","overdue":false},{"id":1262,"symbol":"MIRM","drug":null,"modality":null,"area":"gi_hepatology","event_type":"data_presentation","expect_date_from":"2026-11-05","expect_date_to":"2026-11-09","news_source_file":"documents/20261102_080200_(MIRM)_gnews_businesswire_gnews_businesswire-sha256-de3749fac898a03a8fa18e.txt","comments":"Title: \"Mirum Pharmaceuticals Showcases Momentum Across Rare Liver Disease Portfolio with New Data at AASLD's The Liver Meeting® 2026.\" Meeting held Nov 5-9, 2026 in Denver (dates per peer AASLD releases); available text names no individual dataset or drug.","closed":0,"created_at":"2026-11-05 12:31:00","updated_at":"2026-11-05 12:31:00","company":"Mirum Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-05 → 2026-11-09","imminence":4,"state":"open","overdue":false},{"id":1239,"symbol":"MLYS","drug":"lorundrostat","modality":"small_molecule","area":"cardiovascular","event_type":"data_presentation","expect_date_from":"2026-11-06","expect_date_to":"2026-11-09","news_source_file":"documents/20261104_160500_(MLYS)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"\"New long-term efficacy and safety data from the ongoing Transform-HTN open-label extension trial will be featured in a late-breaking presentation at the American Heart Association Scientific Sessions 2026, taking place November 6-9 in Chicago, IL.\" Presentation of long-term OLE data; no specific session date given.","closed":0,"created_at":"2026-11-04T19:07:32","updated_at":"2026-11-04T19:07:32","company":"Mineralys Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-06 → 2026-11-09","imminence":4,"state":"upcoming","overdue":false},{"id":1165,"symbol":"NTLA","drug":"nexiguran ziclumeran","modality":"gene_therapy","area":"rare_genetic","event_type":"data_presentation","expect_date_from":"2026-11-09","expect_date_to":"2026-11-09","news_source_file":"documents/20261103_080000_(NTLA)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"\"Cardiac Outcomes Following a Single Dose of Nexiguran Ziclumeran ... A Phase 1 Analysis\" -- moderated digital poster #12, AHA Scientific Sessions 2026, Monday, November 9, 11:13 a.m. CT; in ATTRv-PN with mixed phenotype (cardiac involvement). Data made available at session start.","closed":0,"created_at":"2026-11-03T09:41:28","updated_at":"2026-11-03T09:41:28","company":"Intellia Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-09","imminence":4,"state":"upcoming","overdue":false},{"id":1025,"symbol":"VIR","drug":"elebsiran and tobevibart","modality":"other","area":"gi_hepatology","event_type":"data_presentation","expect_date_from":"2026-11-05","expect_date_to":"2026-11-09","news_source_file":"documents/20261005_160500_(VIR)_yahoo_news_yahoo-35330935433ede14f242eb1159f18e21-VIR.txt","comments":"\"the Company will present data from the Phase 2 SOLSTICE trial evaluating the combination of elebsiran and tobevibart for chronic hepatitis delta at ... AASLD The Liver Meeting 2026 in Denver, CO, November 5-9, 2026.\" Expanded SOLSTICE results including HDV RNA response through Week 96.","closed":0,"created_at":"2026-10-25 20:19:57","updated_at":"2026-10-25 20:19:57","company":"Vir Biotechnology","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-05 → 2026-11-09","imminence":4,"state":"open","overdue":false},{"id":1173,"symbol":"IMNM","drug":null,"modality":null,"area":"oncology","event_type":"data_presentation","expect_date_from":"2026-11-10","expect_date_to":"2026-11-10","news_source_file":"documents/20261102_073000_(IMNM)_yahoo_news_yahoo-0c77ec8decc0141d76c4e67a8a26e459-IMNM.txt","comments":"\"its management will present at the Guggenheim 3rd Annual Healthcare Innovation Conference on November 10, 2026, at 9 a.m. EST.\" Company release 2026-11-02 07:30 ET; no specific dataset named, management/company presentation.","closed":0,"created_at":"2026-11-03 21:04:04","updated_at":"2026-11-03 21:04:04","company":"Immunome","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-10","imminence":5,"state":"upcoming","overdue":false},{"id":1152,"symbol":"SPRB","drug":null,"modality":null,"area":"rare_genetic","event_type":"other","expect_date_from":"2026-11-10","expect_date_to":"2026-11-10","news_source_file":"documents/20261102_160500_(SPRB)_yahoo_news_yahoo-6598462fa29e9d8c6b57719820cf3287-SPRB.txt","comments":"Yahoo release 11/02/2026 (16:05 ET): CEO Javier Szwarcberg \"will participate in a fireside chat at the Guggenheim 3rd Annual Healthcare Innovation Conference on November 10, 2026 at 11:30 a.m. ET in Boston, MA.\" Company conference participation only; no dataset or guidance disclosed.","closed":0,"created_at":"2026-11-02 22:08:58","updated_at":"2026-11-02 22:08:58","company":"Spruce Biosciences","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-10","imminence":5,"state":"upcoming","overdue":false},{"id":133,"symbol":"AUTL","drug":"obe-cel","modality":"cell_therapy","area":"immunology","event_type":"data_presentation","expect_date_from":"2026-10-05","expect_date_to":"2026-11-11","news_source_file":"documents/20261005_083000_(AUTL)_yahoo_news_yahoo-8b0e32a26d37f40102f321e4687a5232-AUTL.txt","comments":"\"announced the online publication of an abstract submitted to the American College of Rheumatology (ACR) Convergence 2026 meeting being held November 6-11, 2026 in Orlando, Florida. Updated data from the ongoing Phase 1 CARLYSLE trial...\" (obe-cel in severe refractory SLE). Abstract now online; presentation at ACR Nov 6-11, 2026.","closed":0,"created_at":"2026-10-25 11:06:26","updated_at":"2026-10-25T20:15:52Z","company":"Autolus Therapeutics plc American Depositary Share","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-05 → 2026-11-11","imminence":6,"state":"open","overdue":false},{"id":1153,"symbol":"ELOX","drug":null,"modality":null,"area":null,"event_type":"data_presentation","expect_date_from":"2026-11-09","expect_date_to":"2026-11-11","news_source_file":"documents/20261102_161500_(ELOX)_yahoo_news_yahoo-f4d1a46ed7ab439e61ffe344db2b6d1d-ELOX.txt","comments":"PR Newswire 2026-11-02: CEO Sumit Aggarwal \"will present at the 3rd Annual Guggenheim Healthcare Innovation Conference, taking place November 9-11, 2026.\" Window = conference dates; no specific dataset named in the release, so drug left NULL.","closed":0,"created_at":"2026-11-02 17:09:15","updated_at":"2026-11-02 17:09:15","company":"Eloxx Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-09 → 2026-11-11","imminence":6,"state":"upcoming","overdue":false},{"id":1194,"symbol":"ELTX","drug":"camupepimut (ELI-002 7P)","modality":"peptide","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-11-11","expect_date_to":"2026-11-11","news_source_file":"documents/20261104_080000_(ELTX)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","comments":"Company-hosted virtual KOL event on camupepimut (ELI-002 7P) for metastatic and neoadjuvant PDAC, Wednesday, November 11, 2026, 2:30 PM ET, with MSKCC oncologists. Quote: \"it will host a virtual key opinion leader (\\\"KOL\\\") event on Wednesday, November 11, 2026, at 2:30 PM ET ... Key Phase 2 findings informing camupepimut's late-stage development strategy\". No new data explicitly stated.","closed":0,"created_at":"2026-11-04 08:37:41","updated_at":"2026-11-04 08:37:41","company":"Elicio Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-11","imminence":6,"state":"upcoming","overdue":false},{"id":1250,"symbol":"FATE","drug":"FT819","modality":"cell_therapy","area":"immunology","event_type":"data_presentation","expect_date_from":"2026-11-06","expect_date_to":"2026-11-11","news_source_file":"documents/20261105_070401_(FATE)_sec_0001193125-26-448530.txt","comments":"Q3 2026 8-K: \"ACR Convergence 2026, being held November 6-11 in Orlando, Florida ... Two FT819 presentations will feature updated clinical data, including administration of FT819 without conditioning chemotherapy.\" FT839 abstract at same meeting is preclinical, not recorded.","closed":0,"created_at":"2026-11-05T07:31:00","updated_at":"2026-11-05T07:31:00","company":"Fate Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-06 → 2026-11-11","imminence":6,"state":"upcoming","overdue":false},{"id":1035,"symbol":"ABSI","drug":null,"modality":null,"area":null,"event_type":"other","expect_date_from":"2026-11-12","expect_date_to":"2026-11-12","news_source_file":"documents/20261013_080000_(ABSI)_yahoo_news_yahoo-35152bfde67bde9fb04423823d2e835f-ABSI.txt","comments":"Company release: will \"report business updates and financial and operating results for the third quarter 2026 before market open on Thursday, November 12, 2026,\" with webcast at 8:00 a.m. ET. Scheduled corporate update; no clinical readout is guided to this date.","closed":0,"created_at":"2026-10-26","updated_at":"2026-10-26","company":"Absci","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-12","imminence":7,"state":"upcoming","overdue":false},{"id":1168,"symbol":"MDWD","drug":null,"modality":null,"area":null,"event_type":"other","expect_date_from":"2026-11-12","expect_date_to":"2026-11-12","news_source_file":"documents/20261029_080000_(MDWD)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"Company release (Oct 29, 2026): \"it will release its financial results for the third quarter ended September 30, 2026, on Thursday, November 12, 2026,\" with a conference call/webcast at 8:30 a.m. ET to discuss results and provide a corporate update. Exact date stated; no drug named in the sentence.","closed":0,"created_at":"2026-11-03T09:42:22","updated_at":"2026-11-03T09:42:22","company":"MediWound","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-12","imminence":7,"state":"upcoming","overdue":false},{"id":1100,"symbol":"NTLA","drug":"lonvoguran ziclumeran","modality":"gene_therapy","area":"rare_genetic","event_type":"data_presentation","expect_date_from":"2026-11-12","expect_date_to":"2026-11-12","news_source_file":"documents/20261029_080000_(NTLA)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"\"Intellia will host a live webcast on Thursday, November 12, 2026, at 8 a.m. MT / 10 a.m. ET to review data from the ACAAI presentations.\" ACAAI 2026 (Nov 12-16, Phoenix) includes oral presentations of four-year durability/safety of lonvo-z 50 mg and attack-free status (Nov 14) plus five posters (Nov 13); earliest public disclosure is the Nov 12 webcast.","closed":0,"created_at":"2026-10-29 13:18:51","updated_at":"2026-10-29 13:18:51","company":"Intellia Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-12","imminence":7,"state":"upcoming","overdue":false},{"id":1145,"symbol":"BIVI","drug":"Bezisterim","modality":"small_molecule","area":"infectious","event_type":"data_presentation","expect_date_from":"2026-11-13","expect_date_to":"2026-11-13","news_source_file":"documents/20261102_090000_(BIVI)_globenewswire_biotech_globenewswire_biotech-sha256-515b57ae0d106e27a2e.txt","comments":"GlobeNewswire 2026-11-02: selected for late-breaking oral presentation at 4th Long COVID International Conference 2026, Nice, Nov 12-13; talk \"during the 'Session 8: Clinical Trials' session, starting 3:30 p.m. on Friday, November 13\" and \"will include new biomarker data that has not been shared previously\". Conference presentation, not a new topline.","closed":0,"created_at":"2026-11-02 15:50:32","updated_at":"2026-11-02 15:50:32","company":"BioVie","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-13","imminence":8,"state":"upcoming","overdue":false},{"id":1174,"symbol":"NTHI","drug":"NEO100","modality":"small_molecule","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-11-13","expect_date_to":"2026-11-13","news_source_file":"documents/20261103_170013_(NTHI)_sec_0001829126-26-011937.txt","comments":"SNO 2026 poster CTNI-26, \"\"Durable Radiographic Remission and Prolonged Survival with Intranasal NEO100 in Recurrent WHO Grade III/IV IDH1-Mutant Astrocytoma: Updated Results from a Phase 1/2a Study and Compassionate Use Experience\"\" — \"\"Friday, November 13, 2026, 7:30 to 9:30 p.m. EST\"\"; poster date is public date, not a topline readout.","closed":0,"created_at":"2026-11-03 23:09:31","updated_at":"2026-11-03 23:09:31","company":"NeOnc Technologies Holdings","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-13","imminence":8,"state":"upcoming","overdue":false},{"id":1175,"symbol":"NTHI","drug":"NEO212","modality":"small_molecule","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-11-13","expect_date_to":"2026-11-13","news_source_file":"documents/20261103_170013_(NTHI)_sec_0001829126-26-011937.txt","comments":"SNO 2026 poster CTNI-27, \"\"Oral NEO212 in TMZ-Resistant Recurrent GBM and Brain Metastases: Phase 1 Safety, PK, and Early Signals of Activity\"\" — \"\"Friday, November 13, 2026, 7:30 to 9:30 p.m. EST\"\"; poster presentation, not a topline readout. Nov 17 FDA End-of-Phase 1 meeting (event 600) still separate.","closed":0,"created_at":"2026-11-03 23:09:31","updated_at":"2026-11-03 23:09:31","company":"NeOnc Technologies Holdings","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-13","imminence":8,"state":"upcoming","overdue":false},{"id":899,"symbol":"CYTK","drug":"aficamten","modality":"small_molecule","area":"cardiovascular","event_type":"pdufa","expect_date_from":"2026-11-14","expect_date_to":"2026-11-14","news_source_file":"documents/20260806_163046_(CYTK)_sec_0001193125-26-338217.txt","comments":"10-Q: \"the FDA assigned a standard review classification to the sNDA with a PDUFA date of November 14, 2026\" — sNDA to add MAPLE-HCM (aficamten monotherapy vs metoprolol in oHCM) results to MYQORZO label; submitted January 2026.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Cytokinetics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-14","imminence":9,"state":"upcoming","overdue":false},{"id":1097,"symbol":"VKTX","drug":"VK2735","modality":"peptide","area":"metabolic","event_type":"data_presentation","expect_date_from":"2026-11-15","expect_date_to":"2026-11-15","news_source_file":"documents/20261028_161009_(VKTX)_sec_0001193125-26-436145-ex991.txt","comments":"ObesityWeek (Nov 14-17, 2026, Washington DC): poster \"Impact of SC VK2735 on Obesity Severity and Cardiometabolic Parameters in the VENTURE Study\", Sunday, November 15, 2026, 2:30-3:30 pm ET. Poster presentation, not a topline readout.","closed":0,"created_at":"2026-10-29","updated_at":"2026-10-29","company":"Viking Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-15","imminence":10,"state":"upcoming","overdue":false},{"id":1099,"symbol":"BCRX","drug":"ORLADEYO (berotralstat)","modality":"small_molecule","area":"immunology","event_type":"data_presentation","expect_date_from":"2026-11-12","expect_date_to":"2026-11-16","news_source_file":"documents/20261029_070000_(BCRX)_yahoo_news_yahoo-62592f9df21625797f349c26c7b791a8-BCRX.txt","comments":"2026-10-29 company release: four HAE abstracts \"accepted for presentation at the American College of Allergy, Asthma & Immunology (ACAAI) 2026 Annual Scientific Meeting taking place in Phoenix, Arizona, November 12-16\"; headline names \"New Data for ORLADEYO (berotralstat) and Navenibart\". ORLADEYO abstracts only; no per-abstract date so full meeting window used.","closed":0,"created_at":"2026-10-29T13:17:54","updated_at":"2026-11-03T00:14:04Z","company":"BioCryst Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-12 → 2026-11-16","imminence":11,"state":"upcoming","overdue":false},{"id":1155,"symbol":"BCRX","drug":"navenibart","modality":"monoclonal_antibody","area":"immunology","event_type":"data_presentation","expect_date_from":"2026-11-12","expect_date_to":"2026-11-16","news_source_file":"documents/20261029_070000_(BCRX)_yahoo_news_yahoo-62592f9df21625797f349c26c7b791a8-BCRX.txt","comments":"2026-10-29 company release: four HAE abstracts \"accepted for presentation at the American College of Allergy, Asthma & Immunology (ACAAI) 2026 Annual Scientific Meeting taking place in Phoenix, Arizona, November 12-16\"; headline cites \"New Data for ORLADEYO (berotralstat) and Navenibart\". No per-abstract date, so full meeting window.","closed":0,"created_at":"2026-11-02T19:13:28","updated_at":"2026-11-02T19:13:28","company":"BioCryst Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-12 → 2026-11-16","imminence":11,"state":"upcoming","overdue":false},{"id":938,"symbol":"CRBP","drug":"CRB-913","modality":"small_molecule","area":"metabolic","event_type":"data_presentation","expect_date_from":"2026-11-14","expect_date_to":"2026-11-17","news_source_file":"documents/20260914_070627_(CRBP)_sec_0001193125-26-389829-ex991.txt","comments":"\"CANYON-1 ... data will be detailed in a late-breaking presentation at ObesityWeek 2026, to be held November 14 - 17, 2026\" (topline already released Sep 14, 2026).","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Corbus Pharmaceuticals Holdings","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-14 → 2026-11-17","imminence":12,"state":"upcoming","overdue":false},{"id":600,"symbol":"NTHI","drug":"NEO212","modality":"small_molecule","area":"oncology","event_type":"other","expect_date_from":"2026-11-17","expect_date_to":"2026-11-17","news_source_file":"documents/20260928_170022_(NTHI)_sec_0001829126-26-010493-ex991.txt","comments":"\"scheduled to meet with the U.S. Food and Drug Administration (FDA) on November 17, 2026, for an in-person End-of-Phase 1 Type B meeting concerning NEO212\" (Phase 2 design/regulatory path); meeting may be rescheduled.","closed":0,"created_at":"2026-10-25 11:41:23","updated_at":"2026-10-25 11:41:23","company":"NeOnc Technologies Holdings","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-17","imminence":12,"state":"upcoming","overdue":false},{"id":1260,"symbol":"PMN","drug":"PMN310","modality":"monoclonal_antibody","area":"cns","event_type":"data_presentation","expect_date_from":"2026-11-16","expect_date_to":"2026-11-17","news_source_file":"documents/20261105_070000_(PMN)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"CTAD 2026 poster # P047: \"Interim Safety and Biomarker Analysis of PRECISE-AD\" — \"Poster presentation: Monday, Nov 16-Tues Nov 17th\". Caveat: (*data previously presented on July 28, 2026); re-presentation of PRECISE-AD blinded 6-month interim data, not a new topline readout.","closed":0,"created_at":"2026-11-05 12:30:40","updated_at":"2026-11-05 12:30:40","company":"ProMIS Neurosciences","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-16 → 2026-11-17","imminence":12,"state":"upcoming","overdue":false},{"id":1217,"symbol":"RYTM","drug":"setmelanotide","modality":"peptide","area":"metabolic","event_type":"data_presentation","expect_date_from":"2026-11-14","expect_date_to":"2026-11-17","news_source_file":"documents/20261103_160836_(RYTM)_sec_0001628280-26-069485.txt","comments":"10-Q: \"five presentations have been accepted for presentation at ObesityWeek 2026, taking place November 14-17, 2026,\" including \"Efficacy and Safety of Setmelanotide in Acquired Hypothalamic Obesity: Final Phase 3 Trial Results\" and two-year Phase 3 TRANSCEND results","closed":0,"created_at":"2026-11-04 17:49:44","updated_at":"2026-11-04 17:49:44","company":"Rhythm Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-14 → 2026-11-17","imminence":12,"state":"upcoming","overdue":false},{"id":1068,"symbol":"VYGR","drug":"VY7523","modality":"monoclonal_antibody","area":"cns","event_type":"data_presentation","expect_date_from":"2026-11-16","expect_date_to":"2026-11-17","news_source_file":"documents/20261027_080100_(VYGR)_globenewswire_biotech_globenewswire_biotech-sha256-f5af01a8de2d3b4a925.txt","comments":"CTAD 2026 poster #P054 \"Baseline characteristics of participants enrolled in a multiple ascending dose study of ... VY7523\"; poster session Mon Nov 16, 2026 2:00 p.m. - Tue Nov 17, 2026 5:30 p.m. ET (conference Nov 16-19). Baseline demographics, not tau PET efficacy data; Q4 2026 tau PET readout remains separate.","closed":0,"created_at":"2026-10-27T09:31:51","updated_at":"2026-10-27T09:31:51","company":"Voyager Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-16 → 2026-11-17","imminence":12,"state":"upcoming","overdue":false},{"id":1069,"symbol":"VYGR","drug":"VY1706","modality":"gene_therapy","area":"cns","event_type":"data_presentation","expect_date_from":"2026-11-16","expect_date_to":"2026-11-17","news_source_file":"documents/20261027_080100_(VYGR)_globenewswire_biotech_globenewswire_biotech-sha256-f5af01a8de2d3b4a925.txt","comments":"CTAD 2026 poster #P055 \"First-in-human study design of VY1706, a systemically administered BBB-penetrant tau lowering gene therapy in early Alzheimer's disease\"; poster session Mon Nov 16, 2026 2:00 p.m. - Tue Nov 17, 2026 5:30 p.m. ET (conference Nov 16-19). Study design only; initial acute safety data still guided to early 2027.","closed":0,"created_at":"2026-10-27T09:31:51","updated_at":"2026-10-27T09:31:51","company":"Voyager Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-16 → 2026-11-17","imminence":12,"state":"upcoming","overdue":false},{"id":754,"symbol":"IPHA","drug":"IPH4502","modality":"adc","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-11-18","expect_date_to":"2026-11-18","news_source_file":"documents/20260917_063338_(IPHA)_sec_0001628280-26-062360-ex991.txt","comments":"\"Initial Phase 1 dose-escalation data will be presented at the 38th EORTC-NCI-AACR Symposium (ENA 2026) on November 18, 2026.\" Earlier guidance (21-Jul-2026 PR) said preliminary data \"expected by year-end\".","closed":0,"created_at":"2026-10-25 11:52:30","updated_at":"2026-10-25 11:52:30","company":"Innate Pharma","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-18","imminence":13,"state":"upcoming","overdue":false},{"id":1166,"symbol":"NTLA","drug":"nexiguran ziclumeran","modality":"gene_therapy","area":"rare_genetic","event_type":"data_presentation","expect_date_from":"2026-11-18","expect_date_to":"2026-11-18","news_source_file":"documents/20261103_080000_(NTLA)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"\"Long-Term Durability, Outcomes, and Safety of Nexiguran Ziclumeran ... in ATTRv-PN\" -- E-Poster #156, International Society of Amyloidosis 2026 Symposium, Wednesday, November 18, 10:04 a.m. UYT (up to four years of follow-up).","closed":0,"created_at":"2026-11-03T09:41:28","updated_at":"2026-11-03T09:41:28","company":"Intellia Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-18","imminence":13,"state":"upcoming","overdue":false},{"id":2,"symbol":"ACAD","drug":"remlifanserin","modality":"small_molecule","area":"cns","event_type":"data_presentation","expect_date_from":"2026-11-16","expect_date_to":"2026-11-19","news_source_file":"documents/20260924_171107_(ACAD)_sec_0001193125-26-401157-ex991.txt","comments":"\"Acadia plans to present detailed safety and efficacy results from the RADIANT Phase 2 study in an oral presentation at the upcoming Clinical Trials on Alzheimer's Disease (CTAD) conference, taking place November 16-19, 2026 in Boston.\"","closed":0,"created_at":"2026-10-25 05:52:00","updated_at":"2026-10-25 05:52:00","company":"ACADIA Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-16 → 2026-11-19","imminence":14,"state":"upcoming","overdue":false},{"id":1172,"symbol":"AVXL","drug":null,"modality":null,"area":"cns","event_type":"data_presentation","expect_date_from":"2026-11-16","expect_date_to":"2026-11-19","news_source_file":"documents/20260825_083104_(AVXL)_sec_0001731122-26-001143-ex991.txt","comments":"Anavex \"19th Clinical Trials on Alzheimer's Disease Conference as a Silver Sponsor with one poster presentation taking place on November 16-19 in Boston, MA\". Poster dataset not specified in the release; no separate date given.","closed":0,"created_at":"2026-11-03 21:01:59","updated_at":"2026-11-03 21:01:59","company":"Anavex Life Sciences","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-16 → 2026-11-19","imminence":14,"state":"upcoming","overdue":false},{"id":1107,"symbol":"BHVN","drug":"BHV-1530","modality":"adc","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-11-19","expect_date_to":"2026-11-19","news_source_file":"documents/20261029_160503_(BHVN)_sec_0001935979-26-000093-ex991.txt","comments":"\"Phase 1 data for BHV-1530 ... selected for an oral presentation at the 38th EORTC-NCI-AACR Symposium (ENA 2026), to be held November 18 to 20, 2026, in Barcelona, Spain (presentation scheduled for November 19)\"; earlier 2H guidance referenced ESMO October 2026, no data disclosed there. Presentation, not a topline readout.","closed":0,"created_at":"2026-10-29T17:28:38-04:00","updated_at":"2026-10-30T20:14:57Z","company":"Biohaven","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-19","imminence":14,"state":"upcoming","overdue":false},{"id":1238,"symbol":"CBLL","drug":"Ceribell System","modality":"other","area":"cns","event_type":"other","expect_date_from":"2026-11-03","expect_date_to":"2026-11-19","news_source_file":"documents/20261103_165057_(CBLL)_sec_0001193125-26-445555.txt","comments":"Q3 2026 10-Q (legal proceedings): \"Trial proceedings in the USITC investigation concluded as of June 12, 2026... An initial determination is expected by November 19, 2026, and a final determination by March 2027.\" Patent case vs Natus; not an FDA action.","closed":0,"created_at":"2026-11-05 00:07:28","updated_at":"2026-11-05 00:07:28","company":"CeriBell","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-03 → 2026-11-19","imminence":14,"state":"open","overdue":false},{"id":1195,"symbol":"IMRX","drug":"atebimetinib (IMM-1-104)","modality":"small_molecule","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-11-18","expect_date_to":"2026-11-19","news_source_file":"documents/20261104_073000_(IMRX)_globenewswire_biotech_globenewswire_biotech-sha256-31afad14976a39c5c51.txt","comments":"Two abstracts accepted at 2026 EORTC-NCI-AACR (Nov 17-19, 2026): PDAC combination strategies abstract 22, Poster Spotlight PB-003, \"Date: November 19, 2026\"; preclinical ATC poster abstract 144, PB-144 presented November 18, 2026. Preclinical/translational data.","closed":0,"created_at":"2026-11-04 13:38:17","updated_at":"2026-11-04 13:38:17","company":"Immuneering","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-18 → 2026-11-19","imminence":14,"state":"upcoming","overdue":false},{"id":48,"symbol":"CATX","drug":"VMT-alpha-NET","modality":"radiopharma","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-11-20","expect_date_to":"2026-11-20","news_source_file":"documents/20261023_105232_(CATX)_sec_0001193125-26-429770-ex991.txt","comments":"\"and the EORTC-NCI-AACR (ENA) Symposium, November 20, 2026\" - additional data to be presented; dataset not specified in the release.","closed":0,"created_at":"2026-10-25 10:12:42","updated_at":"2026-10-25 10:12:42","company":"Perspective Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-20","imminence":15,"state":"upcoming","overdue":false},{"id":1002,"symbol":"ERAS","drug":"ERAS-0015","modality":"small_molecule","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-11-18","expect_date_to":"2026-11-20","news_source_file":"documents/20260910_080000_(ERAS)_yahoo_news_yahoo-6184304dd65c41e540447c2aa0d92caf-ERAS.txt","comments":"\"Oral presentation to share updated monotherapy clinical data for ERAS-0015 including additional patients and longer follow-up\" at the 38th EORTC-NCI-AACR (ENA) Symposium 2026. Release says only \"upcoming\" symposium; window reflects ENA 2026 dates (Nov 18-20, 2026). Yahoo copy of GlobeNewswire release; full text truncated. Poster there is nonclinical combo data (not recorded).","closed":0,"created_at":"2026-10-25 12:19:30","updated_at":"2026-10-25 12:19:30","company":"Erasca","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-18 → 2026-11-20","imminence":15,"state":"upcoming","overdue":false},{"id":1227,"symbol":"PMVP","drug":"rezatapopt","modality":"small_molecule","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-11-17","expect_date_to":"2026-11-20","news_source_file":"documents/20261104_080000_(PMVP)_yahoo_news_yahoo-46ea7163b8e53f18d297dc96b98adf7f-PMVP.txt","comments":"\"updated results from the pivotal Phase 2 portion of the PYNNACLE clinical trial of rezatapopt will be featured\" in a \"late-breaking oral presentation\" at ENA 2026, \"to highlight efficacy data across tumor types and in the ovarian cancer primary analysis population\" (2026-11-04). PMVP release gives no presentation date; ENA 2026 held November 17-20, 2026. Supersedes 2026-08-31 guidance of an update on all PYNNACLE Phase 2 cohorts at a Q4 2026 medical conference.","closed":0,"created_at":"2026-11-04 12:50:10","updated_at":"2026-11-04T17:50:52Z","company":"PMV Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-17 → 2026-11-20","imminence":15,"state":"upcoming","overdue":false},{"id":1135,"symbol":"PYXS","drug":"micvotabart pelidotin (MICVO)","modality":"adc","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-11-18","expect_date_to":"2026-11-21","news_source_file":"documents/20261027_084500_(PYXS)_yahoo_news_yahoo-76005ff063a4907bacd7a5f555ded5e8-PYXS.txt","comments":"\"late-breaking oral presentation on micvotabart pelidotin (MICVO) monotherapy in previously treated recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) at the 38th EORTC-NCI-AACR Symposium ... in Barcelona, Spain, November 18 - No[vember ...]\". Two posters also at the meeting; event covers the monotherapy dataset only. Source text truncated at the meeting end date; window set to Nov 18-21.","closed":0,"created_at":"2026-11-01 13:08:25","updated_at":"2026-11-01 13:08:25","company":"Pyxis Oncology","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-18 → 2026-11-21","imminence":16,"state":"upcoming","overdue":false},{"id":90,"symbol":"CAPR","drug":"Deramiocel","modality":"cell_therapy","area":"rare_genetic","event_type":"pdufa","expect_date_from":"2026-11-22","expect_date_to":"2026-11-22","news_source_file":"documents/20260824_092530_(CAPR)_sec_0001104659-26-100071-ex991.txt","comments":"\"extended the Prescription Drug User Fee Act (PDUFA) target action date ... from August 22, 2026 to November 22, 2026\"; BLA classified as major amendment after 24-month HOPE-3 OLE data submitted for refined upper limb function indication.","closed":0,"created_at":"2026-10-25 07:05:00","updated_at":"2026-10-25 07:05:00","company":"Capricor Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-22","imminence":17,"state":"upcoming","overdue":false},{"id":312,"symbol":"SVRA","drug":"molgramostim","modality":"protein","area":"respiratory","event_type":"pdufa","expect_date_from":"2026-11-22","expect_date_to":"2026-11-22","news_source_file":"documents/20260811_160548_(SVRA)_sec_0001193125-26-344585.txt","comments":"10-Q: FDA extended BLA review; \"resulting in a three-month extension of the Prescription Drug User Fee Act (\"PDUFA\") target action date to November 22, 2026.\" MOLBREEVI for autoimmune PAP.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Savara","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-22","imminence":17,"state":"upcoming","overdue":false},{"id":173,"symbol":"ADMA","drug":"ASCENIV","modality":"protein","area":"immunology","event_type":"data_presentation","expect_date_from":"2026-11-01","expect_date_to":"2026-11-30","news_source_file":"documents/20261104_160500_(ADMA)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"Real-world outcomes analysis in 127 medically complex PI patients treated with ASCENIV; Q3 2026 release (Nov 4, 2026): \"ADMA plans to present an analysis of 127 medically complex primary immunodeficiency (\"PI\") patients treated with ASCENIV ... in mid-November at the American College of Allergy, Asthma and Immunology (ACAAI) annual conference.\" Exact dates not stated; full month used.","closed":0,"created_at":"2026-10-25 11:10:12","updated_at":"2026-11-04T22:02:35Z","company":"ADMA Biologics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-01 → 2026-11-30","imminence":25,"state":"open","overdue":false},{"id":70,"symbol":"AMLX","drug":"avexitide","modality":"peptide","area":"metabolic","event_type":"data_presentation","expect_date_from":"2026-11-01","expect_date_to":"2026-11-30","news_source_file":"documents/20261006_080000_(AMLX)_yahoo_news_yahoo-cd80a40c9794c16d2ef1fcf3f183373e-AMLX.txt","comments":"Press release dated 2026-10-06: \"Amylyx Pharmaceuticals to Present Topline Data from Phase 3 LUCIDITY Clinical Trial of Avexitide in Post-Bariatric Hypoglycemia at ObesityWeek 2026 Annual Meeting.\" Copies only (Business Wire/Yahoo/Google News); no exact congress dates given, so window kept to November 2026. Topline was already reported 2026-08-18 (event 112); this is the conference presentation of that data.","closed":0,"created_at":"2026-10-25 10:34:58","updated_at":"2026-10-26T04:24:48Z","company":"Amylyx Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-01 → 2026-11-30","imminence":25,"state":"open","overdue":false},{"id":66,"symbol":"AVXL","drug":"blarcamesine","modality":"small_molecule","area":"cns","event_type":"other","expect_date_from":"2026-11-01","expect_date_to":"2026-11-30","news_source_file":"documents/20261020_161606_(AVXL)_sec_0001731122-26-001351-ex991.txt","comments":"FDA meeting in November 2026 to discuss adding pediatric participants to the Phase 3 Rett syndrome protocol (ANAVEX2-73-RS-005): \"the FDA granted the Company a meeting to discuss adding pediatric participants to the Phase 3 protocol for November\". No specific day stated; previously announced Sept 9, 2026.","closed":0,"created_at":"2026-10-25 10:13:57","updated_at":"2026-10-25 10:13:57","company":"Anavex Life Sciences","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-01 → 2026-11-30","imminence":25,"state":"open","overdue":false},{"id":944,"symbol":"COGT","drug":"bezuclastinib","modality":"small_molecule","area":"oncology","event_type":"pdufa","expect_date_from":"2026-11-30","expect_date_to":"2026-11-30","news_source_file":"documents/20260810_080621_(COGT)_sec_0001193125-26-341315-ex991.txt","comments":"\"Potential FDA approval of bezuclastinib in GIST – PDUFA date of November 30, 2026\"; 10-Q confirms \"FDA assigned a PDUFA target action date of November 30, 2026\" for bezuclastinib + sunitinib in imatinib-pretreated GIST.","closed":0,"created_at":"2026-10-25 12:07:01","updated_at":"2026-10-25 12:07:01","company":"Cogent Biosciences","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-30","imminence":25,"state":"upcoming","overdue":false},{"id":880,"symbol":"DWTX","drug":"Halneuron","modality":"small_molecule","area":"pain_anesthesia","event_type":"topline_results","expect_date_from":"2026-11-01","expect_date_to":"2026-11-30","news_source_file":"documents/20261019_084526_(DWTX)_sec_0001104659-26-116748-ex991.txt","comments":"\"advance the ongoing Halneuron Phase 2b Chemotherapy Induced Neuropathic Pain (CINP) trial toward topline data readout in November 2026\"; earlier 8-K (2026-08-13) guided only \"fall of 2026\" - narrowed to November 2026 per the later filing. 217/220+ patients enrolled.","closed":0,"created_at":"2026-10-25 12:02:21","updated_at":"2026-10-25 12:02:21","company":"Dogwood Therapeutics","tier":"Core","llm_prediction":"large_impact","llm_confidence":0.8,"llm_reason":"Microcap (~$38M) with runway only to March 2027 and a binary Phase 2b readout for its lead asset. A move of at least 10% is very likely either way. Direction is uncertain: Nav1.7 and tetrodotoxin agents have mixed histories in pain trials, while the largest holder adding shares is supportive.","llm_predicted_at":"2026-10-25T15:48:16Z","llm_source":"live","window":"2026-11-01 → 2026-11-30","imminence":25,"state":"open","overdue":false},{"id":1001,"symbol":"IBRX","drug":"ANKTIVA","modality":"protein","area":"oncology","event_type":"topline_results","expect_date_from":"2026-11-01","expect_date_to":"2026-11-30","news_source_file":"documents/20261021_093522_(IBRX)_yahoo_news_yahoo-e67ef4d21eb99cb48ff51dc0d96a7799-IBRX.txt","comments":"\"ImmunityBio announced completion of the database lock for Cohort A of the registrational QUILT-2.005 trial in BCG-naive NMIBC (company release 2026-10-21); topline results expected in November 2026 per \"ImmunityBio Locks Anktiva Trial Database, Eyes November Results As FDA Filing Nears\". Month only, so window covers November 2026.","closed":0,"created_at":"2026-10-25 12:19:26","updated_at":"2026-10-26T04:26:04Z","company":"ImmunityBio","tier":"Core","llm_prediction":"large_impact","llm_confidence":0.45,"llm_reason":"The BCG-naive NMIBC randomized trial (QUILT-2.005) is a major label-expansion readout for ImmunityBio's core asset, and the volatile stock (~$8.8B cap) could move sharply either way. With papillary approval in hand, BCG-naive would expand the market substantially, while a miss or ambiguous data would hit hard. Direction is uncertain.","llm_predicted_at":"2026-10-25T15:48:15Z","llm_source":"live","window":"2026-11-01 → 2026-11-30","imminence":25,"state":"open","overdue":false},{"id":1159,"symbol":"LYEL","drug":null,"modality":"cell_therapy","area":"hematology","event_type":"data_presentation","expect_date_from":"2026-11-01","expect_date_to":"2026-11-30","news_source_file":"documents/20261102_080000_(LYEL)_yahoo_news_yahoo-0ecfbbc30cd73da1b3f38e6c1d49407c-LYEL.txt","comments":"GlobeNewswire release (Nov 2, 2026): management \"will participate in the following investor events: Goldman Sachs' RxChange Series: Framing Lyell's next-generation lymphoma CAR-T data in 4Q\" - Fireside Chat. Stock Titan headline calls it \"A November talk\". Only month is stated, so window set to all of November 2026.","closed":0,"created_at":"2026-11-02T23:21:18","updated_at":"2026-11-02T23:21:18","company":"Lyell Immunopharma","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-01 → 2026-11-30","imminence":25,"state":"open","overdue":false},{"id":631,"symbol":"MLTX","drug":"sonelokimab","modality":"bispecific","area":"dermatology","event_type":"other","expect_date_from":"2026-11-01","expect_date_to":"2026-11-30","news_source_file":"documents/20260810_071514_(MLTX)_sec_0001213900-26-086939-ex991.txt","comments":"BLA submitted Sep 30, 2026 for HS (adults and pediatric patients 12+). Nov 4, 2026 release: \"Expected to receive a decision on BLA filing acceptance by the end of November 2026 and a Prescription Drug User Fee Act (PDUFA) goal date by mid December 2026\"; within ~60 days of submission. Event open pending FDA filing-acceptance decision.","closed":0,"created_at":"2026-10-25 11:44:58","updated_at":"2026-11-04T15:44:51Z","company":"MoonLake Immunotherapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-01 → 2026-11-30","imminence":25,"state":"open","overdue":false},{"id":1004,"symbol":"NKTX","drug":"NKX019","modality":"cell_therapy","area":"immunology","event_type":"data_presentation","expect_date_from":"2026-11-01","expect_date_to":"2026-11-30","news_source_file":"documents/20260927_150204_(NKTX)_yahoo_news_yahoo-c5f99c57554f30019f628caff0cc795f-NKTX.txt","comments":"Nkarta \"expects to present initial clinical data from its autoimmune disease programs at the American College of Rheumatology's 2026 Convergence meeting in November, including presentations in myositis, scleroderma and program-wide safety.\" Month-level guidance only (Nov 2026); no exact ACR dates stated. Source is a Yahoo/Marketbeat alert of company guidance; no primary release in workspace.","closed":0,"created_at":"2026-10-25 09:21:43","updated_at":"2026-10-25 09:21:43","company":"Nkarta","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-01 → 2026-11-30","imminence":25,"state":"open","overdue":false},{"id":528,"symbol":"PEPG","drug":"PGN-EDODM1","modality":"aso","area":"cns","event_type":"topline_results","expect_date_from":"2026-11-01","expect_date_to":"2026-11-30","news_source_file":"documents/20260806_074021_(PEPG)_sec_0001193125-26-336767-ex991.txt","comments":"\"10 mg/kg FREEDOM2-DM1 cohort fully enrolled, with 7 of 8 participants having completed dosing; data expected in November\" (10-Q: \"we expect to report data from this cohort in November, 2026\").","closed":0,"created_at":"2026-10-25 11:36:32","updated_at":"2026-10-25 11:36:32","company":"PepGen","tier":"Core","llm_prediction":"large_impact","llm_confidence":0.6,"llm_reason":"Small-cap ($187M) single-asset company whose 10 mg/kg MAD splicing data are a binary-like catalyst. Prior DM1 readouts from PepGen and peers have moved shares sharply in both directions. Competition from Avidity and Dyne makes the bar high, so direction is uncertain.","llm_predicted_at":"2026-10-25T15:48:12Z","llm_source":"live","window":"2026-11-01 → 2026-11-30","imminence":25,"state":"open","overdue":false},{"id":524,"symbol":"PHAR","drug":"leniolisib","modality":"small_molecule","area":"immunology","event_type":"topline_results","expect_date_from":"2026-11-01","expect_date_to":"2026-11-30","news_source_file":"documents/20261022_070613_(PHAR)_sec_0001828316-26-000047.txt","comments":"\"Pharming expects topline Phase II results from its separate trial in CVID patients with immune dysregulation ... in November 2026\" (narrowed from prior Q4 2026 guidance).","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Pharming Group","tier":"Core","llm_prediction":"small_impact","llm_confidence":0.72,"llm_reason":"Pharming is a commercial-stage company with about $390M in revenue from RUCONEST and Joenja, so its value does not hinge on this readout. The November readout is a Phase II CVID expansion study for an already approved drug. A positive genetic-PID Phase II has already de-risked the mechanism, making a 10%+ first-session move unlikely.","llm_predicted_at":"2026-10-25T15:48:11Z","llm_source":"live","window":"2026-11-01 → 2026-11-30","imminence":25,"state":"open","overdue":false},{"id":361,"symbol":"SLGL","drug":"SGT-610 (patidegib gel, 2%)","modality":"small_molecule","area":"oncology","event_type":"topline_results","expect_date_from":"2026-11-01","expect_date_to":"2026-11-30","news_source_file":"documents/20260820_083046_(SLGL)_sec_0001178913-26-004205-ex991.txt","comments":"Q2 2026 release: \"Last patient last visit is expected in September 2026, and top-line results are scheduled for late November 2026.\" Reaffirmed in 2026-09-17 6-K after LPLV (\"Top-line results remain on track for late November 2026\"). Pivotal Phase 3 (SGT-610-01) in Gorlin syndrome; no day-level date given.","closed":0,"created_at":"2026-10-25T07:24:22","updated_at":"2026-10-25T07:24:22","company":"Sol-Gel Technologies","tier":"Core","llm_prediction":"large_impact","llm_confidence":0.8,"llm_reason":"This is a binary pivotal Phase 3 readout for the lead asset, which management calls the most important milestone in the company's history. The market cap is about $220M against roughly $49M in cash, so the value rests mostly on SGT-610. Either success or failure should move the stock well over 10%. An earlier patidegib Phase 3 missed its primary endpoint, which raises the downside risk, but low dropout and a powered design make the direction uncertain.","llm_predicted_at":"2026-10-25T15:48:07Z","llm_source":"live","window":"2026-11-01 → 2026-11-30","imminence":25,"state":"open","overdue":false},{"id":236,"symbol":"VANI","drug":"NPM-139","modality":"peptide","area":"metabolic","event_type":"topline_results","expect_date_from":"2026-11-01","expect_date_to":"2026-11-30","news_source_file":"documents/20260806_081517_(VANI)_sec_0001753926-26-001349-ex991.txt","comments":"\"Top-line data from the 20-participant trial is expected in November of 2026\" (SLIM-1 Phase 1, NPM-139 semaglutide implant vs Wegovy). Month given only; restated in the Aug 13, 2026 business update and 10-Q.","closed":0,"created_at":"2026-10-25 11:15:19","updated_at":"2026-10-25 11:15:19","company":"Vivani Medical","tier":"Core","llm_prediction":"large_impact","llm_confidence":0.55,"llm_reason":"VANI is a ~$100M microcap, so a first-in-human readout on its lead implant is a binary event, made more visible by the Novo Nordisk evaluation agreement. The 4-week low-dose PK and safety readout could swing either way: clean PK supports a rally, while an implant-related issue or poor release would hit the stock. Microcaps often move more than 10% on such readouts.","llm_predicted_at":"2026-10-25T15:48:08Z","llm_source":"live","window":"2026-11-01 → 2026-11-30","imminence":25,"state":"open","overdue":false},{"id":1228,"symbol":"BLSM","drug":"BH-30236","modality":"small_molecule","area":"hematology","event_type":"data_presentation","expect_date_from":"2026-12-05","expect_date_to":"2026-12-08","news_source_file":"documents/20261104_070000_(BLSM)_yahoo_news_yahoo-a9db32f2c17a75019e11e993a70b749d-BLSM.txt","comments":"2026-11-04 release: \"announced an upcoming poster presentation highlighting preclinical and clinical data\" for oral macrocyclic CLK inhibitor BH-30236 at the 68th ASH Annual Meeting (Dec 5-8, 2026): \"Clinical data demonstrate target engagement and support the potential for BH-30236 to address therapeutic resistance in relapsed/refractory AML and HR-MDS.\" Poster, not a topline readout; specific session date not stated in retrieved (truncated) text.","closed":0,"created_at":"2026-11-04T12:51:00-05:00","updated_at":"2026-11-05T08:22:40Z","company":"BlossomHill Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-05 → 2026-12-08","imminence":33,"state":"upcoming","overdue":false},{"id":1080,"symbol":"PRQR","drug":"AX-0810","modality":"aso","area":"gi_hepatology","event_type":"data_presentation","expect_date_from":"2026-12-09","expect_date_to":"2026-12-09","news_source_file":"documents/20261028_080533_(PRQR)_sec_0001104659-26-119371.txt","comments":"\"Cohort 3 data and the 12 week follow up from the AX-0810 Phase 1 study ... will be presented at Nature's RNA at the Bench and Bedside V in December 2026\" — presentation on December 9, 2026, 2:30-3:00pm PT, La Jolla, CA. Also preclinical AX-0811 PoC data (preclinical, not tracked).","closed":0,"created_at":"2026-10-28 10:22:10","updated_at":"2026-10-28 10:22:10","company":"ProQR Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-09","imminence":34,"state":"upcoming","overdue":false},{"id":1244,"symbol":"AGIO","drug":"mitapivat","modality":"small_molecule","area":"hematology","event_type":"data_presentation","expect_date_from":"2026-12-01","expect_date_to":"2026-12-10","news_source_file":"documents/20261104_090100_(AGIO)_yahoo_news_yahoo-fd50104dc6bc946f91db2b28f0eba43d-AGIO.txt","comments":"Company release (via Yahoo, 2026-11-04 09:01 ET): \"14 abstracts accepted at ASH 2026, including three oral presentations featuring new data across mitapivat clinical programs\"; \"New analyses from RISE UP Phase 3 trial of mitapivat in sickle cell disease show durable hemoglobin improvements for up to two years\". Same release also covers first AG-236 Phase 1 data in PV. Meeting dates not stated in the truncated release; window set to the ASH 2026 annual meeting period.","closed":0,"created_at":"2026-11-05 04:14:46","updated_at":"2026-11-05 04:14:46","company":"Agios Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-01 → 2026-12-10","imminence":35,"state":"upcoming","overdue":false},{"id":35,"symbol":"ANAB","drug":"imsidolimab","modality":"monoclonal_antibody","area":"dermatology","event_type":"pdufa","expect_date_from":"2026-12-12","expect_date_to":"2026-12-12","news_source_file":"documents/20260921_162000_(ANAB)_sec_0001193125-26-396690-ex991.txt","comments":"\"FDA target action date (PDUFA) of Dec. 12, 2026, for Quimilza (imsidolimab) in generalized pustular psoriasis (GPP)\". CEO also guided \"FDA approval of Quimilza in GPP in December 2026\". Vanda holds/announces the decision; Anaptys records royalties.","closed":0,"created_at":"2026-10-25 10:04:43","updated_at":"2026-10-25 10:04:43","company":"AnaptysBio","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-12","imminence":37,"state":"upcoming","overdue":false},{"id":1259,"symbol":"CCCC","drug":"cemsidomide","modality":"small_molecule","area":"hematology","event_type":"data_presentation","expect_date_from":"2026-12-12","expect_date_to":"2026-12-12","news_source_file":"documents/20261105_071501_(CCCC)_sec_0001628280-26-070560.txt","comments":"Trial-in-progress poster at 68th ASH Annual Meeting: \"Date/Time: December 12, 2026 from 5:30 – 7:30 PM CT\" (cemsidomide + elranatamab Phase 1b design in RRMM). Poster presents trial design, no new efficacy data stated.","closed":0,"created_at":"2026-11-05 12:30:16","updated_at":"2026-11-05 12:30:16","company":"C4 Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-12","imminence":37,"state":"upcoming","overdue":false},{"id":1202,"symbol":"CLRB","drug":"iopofosine I 131","modality":"radiopharma","area":"hematology","event_type":"data_presentation","expect_date_from":"2026-12-12","expect_date_to":"2026-12-12","news_source_file":"documents/20261104_090000_(CLRB)_globenewswire_pharma_globenewswire_pharma-sha256-a2d2ca1b3938bb36b966.txt","comments":"ASH 2026 Poster I (Pub #1790) \"Duration of Response to Iopofosine I 131 ... by Prior Lines of Therapy: Results from the Pivotal Phase 2b CLOVER WaM Study\" - \"December 12, 2026, 5:30:00 PM - 7:30:00 PM\", New Orleans. Updated 12-month follow-up analysis.","closed":0,"created_at":"2026-11-04 15:43:41","updated_at":"2026-11-04 15:43:41","company":"Cellectar Biosciences","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-12","imminence":37,"state":"upcoming","overdue":false},{"id":1229,"symbol":"CTY","drug":"CITY-FXI","modality":"sirna","area":"hematology","event_type":"data_presentation","expect_date_from":"2026-12-12","expect_date_to":"2026-12-12","news_source_file":"documents/20261104_090100_(CTY)_globenewswire_biotech_globenewswire_biotech-sha256-bf0216b180c28bb75fa.txt","comments":"Oral presentation (Abstract 189) at ASH 68th Annual Meeting, Dec 12, 2026, 2:30-2:45 p.m. CT: Phase 1 SAD data in healthy volunteers (Part A) and initial data from first SAD cohort in Factor V Leiden / prothrombin G20210A adults (Part B).","closed":0,"created_at":"2026-11-04 19:54:44","updated_at":"2026-11-04 19:54:44","company":"City Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-12","imminence":37,"state":"upcoming","overdue":false},{"id":1224,"symbol":"GERN","drug":"imetelstat","modality":"aso","area":"hematology","event_type":"data_presentation","expect_date_from":"2026-12-12","expect_date_to":"2026-12-12","news_source_file":"documents/20261104_090000_(GERN)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"ASH 2026 poster (abstract #2013): \"Imetelstat plus ruxolitinib in patients with intermediate-1/2 or high-risk myelofibrosis: updated results from the IMproveMF trial\" - presented Dec. 12, 2026, 5:30-7:30pm ET at the 68th ASH Annual Meeting (Dec 12-16, 2026, New Orleans). One of six imetelstat abstracts; only clinical dataset event created.","closed":0,"created_at":"2026-11-04 17:50:22","updated_at":"2026-11-04 17:50:22","company":"Geron","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-12","imminence":37,"state":"upcoming","overdue":false},{"id":744,"symbol":"IRON","drug":"DISC-3405","modality":"monoclonal_antibody","area":"hematology","event_type":"data_presentation","expect_date_from":"2026-12-12","expect_date_to":"2026-12-12","news_source_file":"documents/20261104_090500_(IRON)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"ASH 2026 poster #1180 \"Preliminary results from DISC-3405-102: A phase 1b study ... in participants with sickle cell disease,\" Saturday, December 12, 5:30-7:30pm EST. Initial data now pinned to conference.","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-04T15:44:21Z","company":"Disc Medicine","tier":"","llm_prediction":"small_impact","llm_confidence":0.72,"llm_reason":"The Q4 2026 DISC-3405 readout is initial Phase 1b data in sickle cell disease, an early-stage pipeline asset. Disc's ~$2.9B valuation is driven mainly by bitopertin, whose Phase 3 APOLLO topline also lands in Q4, so early SCD data alone is unlikely to move the stock 10% or more.","llm_predicted_at":"2026-10-25T15:51:20Z","llm_source":"live","window":"2026-12-12","imminence":37,"state":"upcoming","overdue":false},{"id":747,"symbol":"IRON","drug":"selcodebart (DISC-0974)","modality":"monoclonal_antibody","area":"hematology","event_type":"data_presentation","expect_date_from":"2026-12-12","expect_date_to":"2026-12-12","news_source_file":"documents/20261104_090500_(IRON)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"ASH 2026 oral #242 \"RALLY-MF: Efficacy of a Phase 2 study of selcodebart (DISC-0974) ... to treat anemia in myelofibrosis,\" Saturday, December 12, 2:15-2:30pm EST. Additional RALLY-MF data now pinned to conference.","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-04T15:44:21Z","company":"Disc Medicine","tier":"","llm_prediction":"small_impact","llm_confidence":0.8,"llm_reason":"Additional RALLY-MF Phase 2 data is an incremental update to an open-label study that has already shown strong responses. Stock value hinges on bitopertin's APOLLO readout, so the selcodebart update is unlikely to move the stock 10%.","llm_predicted_at":"2026-10-25T15:51:23Z","llm_source":"live","window":"2026-12-12","imminence":37,"state":"upcoming","overdue":false},{"id":1241,"symbol":"SNDX","drug":"revumenib","modality":"small_molecule","area":"hematology","event_type":"data_presentation","expect_date_from":"2026-12-12","expect_date_to":"2026-12-12","news_source_file":"documents/20261104_090000_(SNDX)_globenewswire_pharma_globenewswire_pharma-sha256-56a1f1b832d908b40c4a.txt","comments":"ASH 2026: \"Revumenib as pre-emptive therapy for measurable residual disease in NPM1 mutated or KMT2A rearranged AML: the ALLG AMLM26 INTERCEPT platform trial\" Oral Presentation Publication No. 388, Saturday, December 12, Session Time 4:00-5:30 PM CT. 3Q26 release had guided 4Q26.","closed":0,"created_at":"2026-11-05 00:09:04","updated_at":"2026-11-05 00:09:04","company":"Syndax Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-12","imminence":37,"state":"upcoming","overdue":false},{"id":471,"symbol":"VNDA","drug":"Quimilza (imsidolimab)","modality":"monoclonal_antibody","area":"dermatology","event_type":"pdufa","expect_date_from":"2026-12-12","expect_date_to":"2026-12-12","news_source_file":"documents/20260805_160448_(VNDA)_sec_0001628280-26-053308-ex991.txt","comments":"\"The Biologics License Application (BLA) for Quimilza (imsidolimab) in Generalized Pustular Psoriasis (GPP) is under review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of December 12, 2026.\"","closed":0,"created_at":"2026-10-25 11:32:56","updated_at":"2026-10-25 11:32:56","company":"Vanda Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-12","imminence":37,"state":"upcoming","overdue":false},{"id":975,"symbol":"CGEM","drug":"CLN-049","modality":"bispecific","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-12-13","expect_date_to":"2026-12-13","news_source_file":"documents/20261104_091707_(CGEM)_sec_0001193125-26-446348.txt","comments":"\"Updated anti-leukemia activity from a Phase 1 study of CLN-049 ... in R/R AML and MDS\" — ASH 2026 Poster II #3385, session December 13, 2026, 6:00-8:00 p.m. (ASH held Dec 12-15, New Orleans). Confirms December 2026 guided window; updated dose escalation results (selected Phase 2 regimens 6 and 12 µg/kg) in poster.","closed":0,"created_at":"2026-10-25 12:08:42","updated_at":"2026-11-04T15:43:05Z","company":"Cullinan Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-13","imminence":38,"state":"upcoming","overdue":false},{"id":1206,"symbol":"CLYM","drug":"budoprutug","modality":"monoclonal_antibody","area":"hematology","event_type":"data_presentation","expect_date_from":"2026-12-13","expect_date_to":"2026-12-13","news_source_file":"documents/20261104_090000_(CLYM)_globenewswire_biotech_globenewswire_biotech-sha256-51d97498855181c12da.txt","comments":"ASH 2026 poster #3003 \"Budoprutug, a low-fucosylated anti-CD19 monoclonal antibody, in adults with primary immune thrombocytopenia: Preliminary phase 1b study results\"; session date/time \"December 13, 2026, from 6:00 - 8:00 pm CT\" (meeting Dec 12-15). Data from all three dose cohorts. Presentation, not a topline readout.","closed":0,"created_at":"2026-11-04T10:43:53","updated_at":"2026-11-04T10:43:53","company":"Climb Bio","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-13","imminence":38,"state":"upcoming","overdue":false},{"id":1231,"symbol":"CRSP","drug":"zugocabtagene geleucel","modality":"cell_therapy","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-12-13","expect_date_to":"2026-12-13","news_source_file":"documents/20261104_090100_(CRSP)_globenewswire_biotech_globenewswire_biotech-sha256-ab81e282c0918a77099.txt","comments":"\"clinical data in patients with relapsed or refractory large B-cell lymphoma from the ongoing Phase 1/2 trial of zugo-cel ... will be presented in an oral presentation at the 68th ASH Annual Meeting\"; \"Session Date and Time: Sunday, December 13, 2026, 5:15 p.m. CST\" (Abstract 706). Not yet a result.","closed":0,"created_at":"2026-11-04 19:55:16","updated_at":"2026-11-04 19:55:16","company":"CRISPR Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-13","imminence":38,"state":"upcoming","overdue":false},{"id":1219,"symbol":"EVAX","drug":"EVX-04","modality":"vaccine","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-12-13","expect_date_to":"2026-12-13","news_source_file":"documents/20261104_090000_(EVAX)_globenewswire_biotech_globenewswire_biotech-sha256-6db48f15203a4f696f3.txt","comments":"Target-validation data for EVX-04 in AML presented at ASH 2026 poster# 4310: \"Date/Time: Sunday, December 13, 2026, 6:00-8:00pm ET\". Data described as preclinical (conserved ERV target expression, ERV-specific T-cell responses in humanized mice). Duplicate releases Nov 4, 2026 09:00 ET (GlobeNewswire/Yahoo) and 6-K 09:05 ET.","closed":0,"created_at":"2026-11-04 17:49:51","updated_at":"2026-11-04 17:49:51","company":"Evaxion A/S American Depositary Share","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-13","imminence":38,"state":"upcoming","overdue":false},{"id":1246,"symbol":"GERN","drug":"imetelstat","modality":"aso","area":"hematology","event_type":"data_presentation","expect_date_from":"2026-12-13","expect_date_to":"2026-12-13","news_source_file":"documents/20261104_090000_(GERN)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"ASH 2026 poster (abstract #3402): \"Phase 1/1b trial of imetelstat and azacitidine with or without venetoclax in relapsed acute myeloid leukemia (IMAGINE trial)\" - presented Dec. 13, 2026, 6:00-8:00pm ET at the 68th ASH Annual Meeting (Dec 12-16, 2026, New Orleans). Separate dataset from IMproveMF poster (event #1224); other ASH abstracts are PK/PD or mechanistic/preclinical and not recorded.","closed":0,"created_at":"2026-11-05T03:22:19Z","updated_at":"2026-11-05T03:22:19Z","company":"Geron","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-13","imminence":38,"state":"upcoming","overdue":false},{"id":1170,"symbol":"SNDX","drug":"revumenib + venetoclax/azacitidine","modality":"small_molecule","area":"hematology","event_type":"data_presentation","expect_date_from":"2026-12-13","expect_date_to":"2026-12-13","news_source_file":"documents/20261104_090000_(SNDX)_globenewswire_pharma_globenewswire_pharma-sha256-56a1f1b832d908b40c4a.txt","comments":"ASH 2026: \"Azacitidine, venetoclax, and revumenib ... final analysis of Beat AML phase 1b study\" Oral Presentation Publication No. 662, Sunday, December 13, Session Time 4:30–6:00 PM CT. (3Q26 release had guided 4Q26; exact date now stated.)","closed":0,"created_at":"2026-11-03 13:57:01","updated_at":"2026-11-05T00:09:01Z","company":"Syndax Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-13","imminence":38,"state":"upcoming","overdue":false},{"id":1183,"symbol":"SNDX","drug":"revumenib + intensive chemotherapy","modality":"small_molecule","area":"hematology","event_type":"data_presentation","expect_date_from":"2026-12-13","expect_date_to":"2026-12-13","news_source_file":"documents/20261104_090000_(SNDX)_globenewswire_pharma_globenewswire_pharma-sha256-56a1f1b832d908b40c4a.txt","comments":"ASH 2026: \"Revumenib + intensive chemotherapy ... updated phase 1/2 and pharmacokinetic results from SNDX-5613-0708\" Poster Presentation Publication No. 3406, Sunday, December 13, Session Time 6:00–8:00 PM CT. (3Q26 release had guided 4Q26.)","closed":0,"created_at":"2026-11-04 05:23:52","updated_at":"2026-11-05T00:09:01Z","company":"Syndax Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-13","imminence":38,"state":"upcoming","overdue":false},{"id":1240,"symbol":"SNDX","drug":"revumenib","modality":"small_molecule","area":"hematology","event_type":"data_presentation","expect_date_from":"2026-12-13","expect_date_to":"2026-12-13","news_source_file":"documents/20261104_090000_(SNDX)_globenewswire_pharma_globenewswire_pharma-sha256-56a1f1b832d908b40c4a.txt","comments":"ASH 2026: \"A multicenter phase 1 trial of revumenib as post-transplant maintenance after allogeneic stem cell transplant in patients with KMT2A-rearranged or NPM1-mutated acute leukemia\" Oral Presentation Publication No. 715, Sunday, December 13, Session Time 4:30-6:00 PM CT. First results; 3Q26 release had guided 4Q26.","closed":0,"created_at":"2026-11-05 00:09:04","updated_at":"2026-11-05 00:09:04","company":"Syndax Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-13","imminence":38,"state":"upcoming","overdue":false},{"id":1203,"symbol":"CLRB","drug":"iopofosine I 131","modality":"radiopharma","area":"hematology","event_type":"data_presentation","expect_date_from":"2026-12-14","expect_date_to":"2026-12-14","news_source_file":"documents/20261104_090000_(CLRB)_globenewswire_pharma_globenewswire_pharma-sha256-a2d2ca1b3938bb36b966.txt","comments":"ASH 2026 Poster III (Pub #5325) \"Iopofosine I 131 in Waldenstrom macroglobulinemia: 12-month follow up data from the CLOVER-WaM trial\" - \"December 14, 2026, 6:00:00 PM - 8:00:00 PM\". Separate dataset from the Dec 12 DOR-by-prior-lines poster.","closed":0,"created_at":"2026-11-04 15:43:41","updated_at":"2026-11-04 15:43:41","company":"Cellectar Biosciences","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-14","imminence":39,"state":"upcoming","overdue":false},{"id":1218,"symbol":"COAG","drug":"sutacimig","modality":"bispecific","area":"hematology","event_type":"data_presentation","expect_date_from":"2026-12-14","expect_date_to":"2026-12-14","news_source_file":"documents/20261104_090500_(COAG)_globenewswire_biotech_globenewswire_biotech-sha256-44fbb5cd77e70d200df.txt","comments":"ASH 2026 poster (abs26-10755), MCCNO Hall F: \"Date and Time: December 14, 2026, 6:00 PM – 8:00 PM CT\" — first PK/PD results from single ascending dose cohort of Phase 2b HMB-001-201 in congenital FVII deficiency; \"Updated data for all dosed participants will be presented at the meeting.\"","closed":0,"created_at":"2026-11-04 17:49:46","updated_at":"2026-11-04 17:49:46","company":"Hemab Therapeutics Holdings","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-14","imminence":39,"state":"upcoming","overdue":false},{"id":1200,"symbol":"IMMX","drug":"NXC-201","modality":"cell_therapy","area":"hematology","event_type":"data_presentation","expect_date_from":"2026-12-14","expect_date_to":"2026-12-14","news_source_file":"documents/20261104_091500_(IMMX)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"ASH 2026 oral presentation (Publication #826) of \"45-patient safety and efficacy data for NXC-201 from Nexicart-2\": \"Data will be presented on Monday, December 14, 2026 at 11:15 AM CDT.\" Same 45-patient dataset as the Sept 29, 2026 interim update.","closed":0,"created_at":"2026-11-04","updated_at":"2026-11-04","company":"Immix Biopharma","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-14","imminence":39,"state":"upcoming","overdue":false},{"id":745,"symbol":"IRON","drug":"DISC-3405","modality":"monoclonal_antibody","area":"hematology","event_type":"data_presentation","expect_date_from":"2026-12-14","expect_date_to":"2026-12-14","news_source_file":"documents/20261104_090500_(IRON)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"ASH 2026 oral #929 \"Results from RESTORE-PV ... DISC-3405 ... in participants with polycythemia vera,\" Monday, December 14, 3:45-4:00pm EST. Additional RESTORE-PV data update now pinned to conference.","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-04T15:44:21Z","company":"Disc Medicine","tier":"","llm_prediction":"small_impact","llm_confidence":0.72,"llm_reason":"The upcoming readout is an update of RESTORE-PV plus initial sickle cell data. Initial PV data, showing strong phlebotomy reduction, were already public. The $2.9B company has a broader pipeline, so an incremental Phase 2 update is unlikely to move the stock 10% or more.","llm_predicted_at":"2026-10-25T15:51:22Z","llm_source":"live","window":"2026-12-14","imminence":39,"state":"upcoming","overdue":false},{"id":1171,"symbol":"SNDX","drug":"revumenib + decitabine/cedazuridine + venetoclax","modality":"small_molecule","area":"hematology","event_type":"data_presentation","expect_date_from":"2026-12-14","expect_date_to":"2026-12-14","news_source_file":"documents/20261104_090000_(SNDX)_globenewswire_pharma_globenewswire_pharma-sha256-56a1f1b832d908b40c4a.txt","comments":"ASH 2026: \"Update on the phase II study of the all-oral combination of revumenib ... with decitabine/cedazuridine (ASTX727) and venetoclax (SAVE)\" Oral Presentation Publication No. 904, Monday, December 14, Session Time 2:45–4:15 PM CT. (3Q26 release had guided 4Q26.)","closed":0,"created_at":"2026-11-03 13:57:01","updated_at":"2026-11-05T00:09:01Z","company":"Syndax Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-14","imminence":39,"state":"upcoming","overdue":false},{"id":39,"symbol":"ADCT","drug":"ZYNLONTA + glofitamab","modality":"adc","area":"hematology","event_type":"data_presentation","expect_date_from":"2026-11-01","expect_date_to":"2026-12-15","news_source_file":"documents/20261104_090000_(ADCT)_yahoo_news_yahoo-9a6d8a65714c76a922486cc4649dcb84-ADCT.txt","comments":"LOTIS-7 (ZYNLONTA + glofitamab) data: \"new and updated data from the ZYNLONTA clinical program will be shared across multiple abstracts, including five oral presentations, at the 68th ASH Annual Meeting taking place December 12-15, 2026\" (Nov 4, 2026). Oct 8 release: \"much anticipated LOTIS-7 and MZL data abstracts in early November with presentations in December.\" Window spans abstract (early Nov) to ASH orals.","closed":0,"created_at":"2026-10-25 10:05:10","updated_at":"2026-11-04T17:51:07Z","company":"ADC Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-01 → 2026-12-15","imminence":40,"state":"open","overdue":false},{"id":43,"symbol":"ADCT","drug":"ZYNLONTA","modality":"adc","area":"hematology","event_type":"data_presentation","expect_date_from":"2026-11-01","expect_date_to":"2026-12-15","news_source_file":"documents/20261104_090000_(ADCT)_yahoo_news_yahoo-9a6d8a65714c76a922486cc4649dcb84-ADCT.txt","comments":"MZL (ZYNLONTA monotherapy) data: ZYNLONTA data \"across multiple abstracts, including five oral presentations, at the 68th ASH Annual Meeting taking place December 12-15, 2026\" (Nov 4, 2026). Oct 8 release: MZL data abstracts in early November with presentations in December. Window spans abstract to ASH presentations.","closed":0,"created_at":"2026-10-25 10:05:25","updated_at":"2026-11-04T17:51:07Z","company":"ADC Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-01 → 2026-12-15","imminence":40,"state":"open","overdue":false},{"id":1234,"symbol":"AUTL","drug":null,"modality":"cell_therapy","area":"hematology","event_type":"data_presentation","expect_date_from":"2026-12-12","expect_date_to":"2026-12-15","news_source_file":"documents/20261104_091500_(AUTL)_yahoo_news_yahoo-72759925aa13e92d768dbc78698028fd-AUTL.txt","comments":"\"announced the online publication of abstracts submitted to the American Society of Hematology (ASH) Annual Meeting, to be held December 12-15, 2026, in New Orleans, Louisiana. Abstract 4498 - Oral Presentation\" Caveat: only Yahoo wire copy available (truncated); no drug or dataset named in the visible text, so drug left NULL.","closed":0,"created_at":"2026-11-04T14:56:27","updated_at":"2026-11-04T14:56:27","company":"Autolus Therapeutics plc American Depositary Share","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-12 → 2026-12-15","imminence":40,"state":"upcoming","overdue":false},{"id":1248,"symbol":"BEAM","drug":"risto-cel","modality":"cell_therapy","area":"hematology","event_type":"data_presentation","expect_date_from":"2026-12-12","expect_date_to":"2026-12-15","news_source_file":"documents/20261104_090000_(BEAM)_yahoo_news_yahoo-f76273a4711e49200564f567e63522bc-BEAM.txt","comments":"GlobeNewswire 2026-11-04: \"Beam Therapeutics to Present Updated Clinical Data from BEACON Phase 1/2 Trial of Risto-cel in Sickle Cell Disease in an Oral Presentation at ... ASH\"; \"BEACON Trial Results Selected for Official ASH Press Program\". 68th ASH Annual Meeting = Dec 12-15, 2026 (meeting dates; release copy truncated, exact session day not stated).","closed":0,"created_at":"2026-11-05T03:24:36","updated_at":"2026-11-05T03:24:36","company":"Beam Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-12 → 2026-12-15","imminence":40,"state":"upcoming","overdue":false},{"id":774,"symbol":"IMNM","drug":"IM-1021","modality":"adc","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-12-12","expect_date_to":"2026-12-15","news_source_file":"documents/20261104_090100_(IMNM)_yahoo_news_yahoo-c169910cc1ab7d3b744ca53497c6776c-IMNM.txt","comments":"Original guidance (2026-08-11 release/10-Q): \"Immunome expects to present initial lymphoma data for IM-1021 in 2026.\" Dated by company release 2026-11-04 09:01 ET: \"today announced the presentation of initial first-in-human clinical data from the ongoing Phase 1 study of IM-1021, an investigational ROR1-targeted antibody-drug conjugate (ADC), at the 68th ASH Annual Meeting.\" Meeting dates 2026-12-12..2026-12-15; no specific session date stated.","closed":0,"created_at":"2026-10-25 11:53:51","updated_at":"2026-11-05T08:24:10Z","company":"Immunome","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-12 → 2026-12-15","imminence":40,"state":"upcoming","overdue":false},{"id":1233,"symbol":"KPTI","drug":"selinexor","modality":"small_molecule","area":"hematology","event_type":"data_presentation","expect_date_from":"2026-12-12","expect_date_to":"2026-12-15","news_source_file":"documents/20261104_090100_(KPTI)_yahoo_news_yahoo-a90bd3d6e405c120dab08cfe3f3c37be-KPTI.txt","comments":"\"abstracts from two of its clinical trials evaluating selinexor in patients with myelofibrosis were selected for oral presentations at ASH 2026... an abstract... in multiple myeloma was selected for a poster.\" ASH 2026 meeting dates Dec 12-15, 2026.","closed":0,"created_at":"2026-11-04 19:56:34","updated_at":"2026-11-04 19:56:34","company":"Karyopharm Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-12 → 2026-12-15","imminence":40,"state":"upcoming","overdue":false},{"id":1215,"symbol":"KURA","drug":"ziftomenib","modality":"small_molecule","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-12-12","expect_date_to":"2026-12-15","news_source_file":"documents/20261104_090200_(KURA)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","comments":"\"eight abstracts related to ziftomenib... accepted for presentation at the 2026 American Society of Hematology (ASH) Annual Meeting, taking place December 12-15 in New Orleans\" - KOMET-008 zif+gilteritinib oral Dec 12; KOMET-007 zif+7+3+quizartinib oral Dec 14; KOMET-007 zif+ven/aza long-term poster Dec 14; KOMET-001 MEIS1 exploratory poster Dec 14. Data not yet disclosed.","closed":0,"created_at":"2026-11-04T12:55:00","updated_at":"2026-11-04T12:55:00","company":"Kura Oncology","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-12 → 2026-12-15","imminence":40,"state":"upcoming","overdue":false},{"id":1212,"symbol":"MLTX","drug":"sonelokimab","modality":"bispecific","area":"dermatology","event_type":"other","expect_date_from":"2026-11-04","expect_date_to":"2026-12-15","news_source_file":"documents/20261104_070000_(MLTX)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"Nov 4, 2026 release: \"Expected to receive a decision on BLA filing acceptance by the end of November 2026 and a Prescription Drug User Fee Act (PDUFA) goal date by mid December 2026.\" Milestone is receipt of the PDUFA goal date (not the FDA action date).","closed":0,"created_at":"2026-11-04T10:46:00","updated_at":"2026-11-04T10:46:00","company":"MoonLake Immunotherapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-04 → 2026-12-15","imminence":40,"state":"open","overdue":false},{"id":1207,"symbol":"RIGL","drug":"R289","modality":"small_molecule","area":"hematology","event_type":"data_presentation","expect_date_from":"2026-12-12","expect_date_to":"2026-12-15","news_source_file":"documents/20261104_091500_(RIGL)_yahoo_news_yahoo-a1363eab914f84d1829143b719dc98f7-RIGL.txt","comments":"PR 2026-11-04: Phase 1b data for R289 (IRAK1/4 inhibitor) in R/R lower-risk MDS \"will be presented in an oral session at the 68th American Society of Hematology\" Annual Meeting. ASH 68th Annual Meeting runs December 12-15, 2026 (New Orleans). Caveat: feed copy is truncated before the session date; window is the meeting dates.","closed":0,"created_at":"2026-11-04","updated_at":"2026-11-05T08:24:53Z","company":"Rigel Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-12 → 2026-12-15","imminence":40,"state":"upcoming","overdue":false},{"id":1201,"symbol":"SLN","drug":"divesiran","modality":"sirna","area":"hematology","event_type":"data_presentation","expect_date_from":"2026-12-12","expect_date_to":"2026-12-15","news_source_file":"documents/20261104_090000_(SLN)_gnews_businesswire_gnews_businesswire-sha256-664449b9d1ef19c39b03ae.txt","comments":"Title: \"Oral Presentation on SANRECO Phase 2 Study of Divesiran in Polycythemia Vera at ASH 2026\". Only an aggregator (Google News/Business Wire) stub available; no individual talk date stated, so window = ASH 2026 Annual Meeting dates (Dec 12-15, 2026, New Orleans). Abstract may post earlier; data at talk = data_presentation, not topline.","closed":0,"created_at":"2026-11-04 15:43:18","updated_at":"2026-11-04 15:43:18","company":"Silence Therapeutics Plc American Depository Share","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-12 → 2026-12-15","imminence":40,"state":"upcoming","overdue":false},{"id":948,"symbol":"CORT","drug":"relacorilant","modality":"small_molecule","area":"metabolic","event_type":"pdufa","expect_date_from":"2026-12-17","expect_date_to":"2026-12-17","news_source_file":"documents/20260729_160719_(CORT)_sec_0001628280-26-050607-ex991.txt","comments":"\"We expect a decision on our NDA by December 17, 2026\"; 10-Q: \"FDA has assigned a Prescription Drug User Fee Act target date of December 17, 2026\". NDA for Cushing's syndrome resubmitted June 17, 2026 after Dec 2025 CRL.","closed":0,"created_at":"2026-10-25T08:06:32","updated_at":"2026-10-25T08:06:32","company":"Corcept Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-17","imminence":42,"state":"upcoming","overdue":false},{"id":476,"symbol":"VNDA","drug":"tasimelteon (HETLIOZ)","modality":"small_molecule","area":"cns","event_type":"other","expect_date_from":"2026-12-14","expect_date_to":"2026-12-18","news_source_file":"documents/20260806_073920_(VNDA)_sec_0001628280-26-053855.txt","comments":"FDA formal hearing on HETLIOZ sNDA for jet lag disorder: \"In July 2026, the presiding judge scheduled a hearing to begin on December 14, 2026\" (10-Q); 8-K: \"five-day hearing before the Administrative Law Judge in December 2026.\" Hearing dates, not an adcom.","closed":0,"created_at":"2026-10-25 11:32:56","updated_at":"2026-10-25 11:32:56","company":"Vanda Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-14 → 2026-12-18","imminence":43,"state":"upcoming","overdue":false},{"id":161,"symbol":"ANNX","drug":"ANX1502","modality":"small_molecule","area":"hematology","event_type":"topline_results","expect_date_from":"2026-09-22","expect_date_to":"2026-12-21","news_source_file":"documents/20260812_063026_(ANNX)_sec_0001193125-26-345672-ex991.txt","comments":"\"POC Data for ANX1502 ... Expected in Fall 2026\" (Q2 2026 release, 2026-08-12); 10-Q: \"Dosing is complete and we plan to provide an update on the POC study in the second half of 2026.\" Window covers Fall 2026 (2026-09-22..2026-12-21).","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-27T11:26:57Z","company":"Annexon","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.8,"llm_reason":"ANX1502 CAD POC readout is a minor pipeline event. It covers PK/PD and biomarkers in a small study, and the valuation of the $720M company rests on the GA Phase 3 and GBS BLA. The update may also coincide with other news, so a large move from this readout alone is unlikely.","llm_predicted_at":"2026-10-25T15:48:04Z","llm_source":"live","window":"2026-09-22 → 2026-12-21","imminence":46,"state":"open","overdue":false},{"id":624,"symbol":"MLYS","drug":"lorundrostat","modality":"small_molecule","area":"cardiovascular","event_type":"pdufa","expect_date_from":"2026-12-22","expect_date_to":"2026-12-22","news_source_file":"documents/20260811_160844_(MLYS)_sec_0001933414-26-000112-ex991.txt","comments":"\"Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026\" for the lorundrostat NDA (hypertension in combination with other antihypertensive drugs); body of 10-Q confirms same exact date. PDUFA target date, not a guaranteed action date.","closed":0,"created_at":"2026-10-25T07:44:21","updated_at":"2026-10-25T07:44:21","company":"Mineralys Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-22","imminence":47,"state":"upcoming","overdue":false},{"id":509,"symbol":"PRAX","drug":"relutrigine","modality":"small_molecule","area":"cns","event_type":"pdufa","expect_date_from":"2026-12-27","expect_date_to":"2026-12-27","news_source_file":"documents/20260629_164034_(PRAX)_sec_0001689548-26-000069.txt","comments":"8-K: FDA \"extended by three months the review period for its New Drug Application (NDA) for relutrigine... setting an updated PDUFA target action date from September 27, 2026 to December 27, 2026.\" Major amendment (sensitivity analyses); no new studies requested.","closed":0,"created_at":"2026-10-25 11:35:05","updated_at":"2026-10-25 11:35:05","company":"Praxis Precision Medicines","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-27","imminence":52,"state":"upcoming","overdue":false},{"id":1114,"symbol":"RFL","drug":"Trappsol Cyclo","modality":"other","area":"rare_genetic","event_type":"other","expect_date_from":"2026-10-28","expect_date_to":"2026-12-27","news_source_file":"documents/20261029_113520_(RFL)_sec_0001213900-26-113659.txt","comments":"FDA filing decision on the remibetadex NDA submitted 2026-10-28: \"Within 60 days of receipt, the FDA will determine whether the application is complete and acceptable for filing and, if accepted, whether Priority Review will be granted. If the application is accepted, the FDA will assign a PDUFA target action date.\" Window derived from 60 days after the stated October 28, 2026 submission; no PDUFA date assigned yet.","closed":0,"created_at":"2026-10-30 13:56:22","updated_at":"2026-10-30 13:56:22","company":"Rafael Holdings","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-28 → 2026-12-27","imminence":52,"state":"open","overdue":false},{"id":284,"symbol":"TLSA","drug":"foralumab","modality":"monoclonal_antibody","area":"cns","event_type":"regulatory_submission","expect_date_from":"2026-09-30","expect_date_to":"2026-12-29","news_source_file":"documents/20260930_070001_(TLSA)_sec_0001213900-26-104868-ex991.txt","comments":"Orphan Drug Designation request submitted to FDA for MSA on 2026-09-30. \"The FDA's Office of Orphan Products Development (OOPD) aims to complete its review of an orphan drug designation (ODD) request within 90 days of receipt.\" Decision window inferred from 90-day review aim.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Tiziana Life Sciences","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-09-30 → 2026-12-29","imminence":54,"state":"open","overdue":false},{"id":945,"symbol":"COGT","drug":"bezuclastinib","modality":"small_molecule","area":"hematology","event_type":"pdufa","expect_date_from":"2026-12-30","expect_date_to":"2026-12-30","news_source_file":"documents/20260810_080621_(COGT)_sec_0001193125-26-341315-ex991.txt","comments":"\"Potential FDA approval of bezuclastinib in NonAdvSM – PDUFA date of December 30, 2026\"; NDA accepted March 2026. AdvSM NDA PDUFA (June 29, 2027) tracked separately.","closed":0,"created_at":"2026-10-25 12:07:01","updated_at":"2026-10-25T12:17:33Z","company":"Cogent Biosciences","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-30","imminence":55,"state":"upcoming","overdue":false},{"id":416,"symbol":"ABCL","drug":"ABCL575","modality":"monoclonal_antibody","area":"immunology","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260805_162815_(ABCL)_sec_0001703057-26-000046.txt","comments":"10-Q (Aug 5, 2026): \"Dosing for the Phase 1 study has been completed with the top-line data readout expected in Q4 2026\" for ABCL575. Company states no plans to pursue development past Phase 1.","closed":0,"created_at":"2026-10-25T07:28:08","updated_at":"2026-10-25T07:28:08","company":"AbCellera Biologics","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.88,"llm_reason":"ABCL575 is a Phase 1 healthy-volunteer safety study, and the company says it has no plans to develop it past Phase 1. ABCL635 is the value driver, and the $540M cash pile is a large share of the $3.7B market cap, so the readout is unlikely to move the stock 10% or more.","llm_predicted_at":"2026-10-25T15:50:01Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":181,"symbol":"ABSI","drug":"ABS-201","modality":"monoclonal_antibody","area":"dermatology","event_type":"interim_analysis","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260811_160614_(ABSI)_sec_0001672688-26-000134-ex991.txt","comments":"\"Absci anticipates reporting interim proof-of-concept data from this study in the second half of 2026\" (MAD portion of HEADLINE Phase 1/2a in pattern hair loss).","closed":0,"created_at":"2026-10-25 11:11:09","updated_at":"2026-10-25 11:11:09","company":"Absci","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.6,"llm_reason":"The interim proof-of-concept efficacy readout for ABS-201 in pattern hair loss is the defining catalyst for a $1.6B company valued largely on this one asset. A novel-mechanism hair-regrowth readout is likely to be binary, with a big move either way, and the direction is uncertain given early, small-cohort data.","llm_predicted_at":"2026-10-25T15:49:00Z","llm_source":"live","window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":412,"symbol":"ACHV","drug":"cytisinicline","modality":"small_molecule","area":"cns","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260811_160440_(ACHV)_sec_0001193125-26-344571-ex991.txt","comments":"\"We intend to resubmit the NDA naming Adare as our finished drug product manufacturer for commercial supply in the fourth quarter of 2026\" (Q2 2026 release, Aug 11, 2026). Resubmission follows June 2026 CRL on cGMP/labeling.","closed":0,"created_at":"2026-10-25 07:27:48","updated_at":"2026-10-25 07:27:48","company":"Achieve Life Sciences","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":1208,"symbol":"ACIU","drug":"ACI-7104","modality":"vaccine","area":"cns","event_type":"interim_analysis","expect_date_from":"2026-11-04","expect_date_to":"2026-12-31","news_source_file":"documents/20261104_070004_(ACIU)_sec_0001651625-26-000027.txt","comments":"\"Data will be available before year-end on the characterization of ACI-7104-induced antibodies including their a-syn binding properties\"; additional clinical data from VacSYn Part 1 expected before year-end. Window from release date to 2026-12-31.","closed":0,"created_at":"2026-11-04T10:44:48","updated_at":"2026-11-04T10:44:48","company":"AC Immune","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.72,"llm_reason":"The pending readout is an antibody characterization (a-syn binding properties) from an already-reported Part 1 interim. This is incremental mechanistic data with low binary risk and unlikely to move a $241M cap stock by 10% or more.","llm_predicted_at":"2026-11-04T15:45:41Z","llm_source":"live","window":"2026-11-04 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":185,"symbol":"ACRS","drug":"bosakitug (ATI-045)","modality":"monoclonal_antibody","area":"dermatology","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261105_065900_(ACRS)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","comments":"\"Readout of Top Line Results from Phase 2 Trial of Investigational Anti-TSLP Monoclonal Antibody Bosakitug Expected in the Fourth Quarter 2026\"; 109-patient ADMIRATION trial fully enrolled; CEO: \"Phase 2 results in AD from bosakitug ... in the coming few weeks\" (no specific date stated). Timeline reaffirmed 2026-11-05.","closed":0,"created_at":"2026-10-25 11:11:13","updated_at":"2026-11-05T12:30:57Z","company":"Aclaris Therapeutics","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.5,"llm_reason":"Bosakitug is a secondary anti-TSLP asset; the company's value is driven mainly by bispecific ATI-052. The Phase 2 AD readout in 109 patients carries moderate weight, and anti-TSLP in AD has a modest prior bar. The market cap is about $564M, so a modest move is likely unless the data are a clear failure.","llm_predicted_at":"2026-10-25T15:49:03Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":186,"symbol":"ACRS","drug":"ATI-9494","modality":"small_molecule","area":"immunology","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261105_065900_(ACRS)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","comments":"\"Filing of Investigational New Drug (IND) Application for ... ATI-9494 On Track for Fourth Quarter 2026\"; 10-Q: \"We expect to file an IND application for ATI-9494 in the fourth quarter of 2026.\" Reaffirmed 2026-11-05.","closed":0,"created_at":"2026-10-25 11:11:13","updated_at":"2026-11-05T12:30:57Z","company":"Aclaris Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":178,"symbol":"ACRV","drug":"ACR-368","modality":"small_molecule","area":"oncology","event_type":"interim_analysis","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260812_161020_(ACRV)_sec_0001193125-26-346859-ex991.txt","comments":"\"A prespecified simultaneous interim analysis and data update from both all-comer (biopsy-independent) serous EC arms of the ACR-368 Phase 2b study in second half of 2026\" (8-K Ex-99.1; same wording in 10-Q). Window per \"second half of 2026\".","closed":0,"created_at":"2026-10-25T07:10:27","updated_at":"2026-10-25T07:10:27","company":"Acrivon Therapeutics","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.55,"llm_reason":"A $75M company trading below its $90M cash is a binary setup. The ACR-368 registrational-intent interim in all-comer serous endometrial cancer is the key value driver, so a strong or weak readout is likely to move the stock more than 10%. Direction is unclear: prexasertib has a mixed history, but expectations are low.","llm_predicted_at":"2026-10-25T15:48:59Z","llm_source":"live","window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":180,"symbol":"ADCT","drug":"ZYNLONTA + glofitamab","modality":"adc","area":"hematology","event_type":"regulatory_submission","expect_date_from":"2026-08-13","expect_date_to":"2026-12-31","news_source_file":"documents/20260813_091434_(ADCT)_sec_0000950103-26-012287-ex991.txt","comments":"LOTIS-7 Breakthrough Therapy designation submission: \"We are also evaluating a regulatory pathway for this combination and plan to submit for Breakthrough Therapy designation ('BTD') this year.\" Window = from document date (2026-08-13) through end of 2026.","closed":0,"created_at":"2026-10-25 11:22:00","updated_at":"2026-10-25 11:22:00","company":"ADC Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-08-13 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":1133,"symbol":"AEON","drug":"ABP-450","modality":"protein","area":"cns","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260930_080024_(AEON)_sec_0001837607-26-000064-ex991.txt","comments":"IND submission for the two-stage CMAP pharmacodynamic study of ABP-450; company guided Q4 2026: \"Filing an IND for CMAP PD study in Q4 2026\" / \"expects to submit in the fourth quarter of 2026\"; reaffirmed in Oct 2026 corporate presentation (\"IND Filing for CMAP Study Q4 2026\"). Not yet filed as of 2026-11-03.","closed":0,"created_at":"2026-11-01 13:08:14","updated_at":"2026-11-03T23:10:38Z","company":"AEON Biopharma","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":375,"symbol":"AGEN","drug":"botensilimab + balstilimab","modality":"monoclonal_antibody","area":"oncology","event_type":"regulatory_submission","expect_date_from":"2026-01-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260807_163047_(AGEN)_sec_0001193125-26-340363.txt","comments":"10-Q: \"we intend during 2026 to seek Accelerated Approval in the United States and Conditional Marketing Authorization in the European Union for BOT/BAL\" in refractory MSS mCRC without active liver metastases; company cautions no assurance submission will be made on this timeline.","closed":0,"created_at":"2026-10-25 11:25:29","updated_at":"2026-10-25 11:25:29","company":"Agenus","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-01-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":176,"symbol":"AGIO","drug":"AG-181","modality":"small_molecule","area":"rare_genetic","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260730_063237_(AGIO)_sec_0001439222-26-000115-ex991.txt","comments":"8-K: \"Agios dosed the first patient in the Phase 1b trial evaluating the safety and tolerability of AG-181 in adults with PKU. Data from this trial are expected in the second half of 2026.\" 10-Q: expect to \"confirm proof of mechanism in the second half of 2026\" (PKU, PAH stabilizer).","closed":0,"created_at":"2026-10-25 11:10:13","updated_at":"2026-10-25 11:10:13","company":"Agios Pharmaceuticals","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.8,"llm_reason":"AG-181 is an early Phase 1b safety readout in PKU at a $2.2B commercial-stage company. Value is driven mainly by mitapivat and the sickle cell PDUFA, so the readout is unlikely to move the stock 10% or more.","llm_predicted_at":"2026-10-25T15:48:56Z","llm_source":"live","window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":38,"symbol":"ALDX","drug":"reproxalap","modality":"small_molecule","area":"ophthalmology","event_type":"other","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260929_070115_(ALDX)_sec_0001193125-26-405954-ex991.txt","comments":"Formal Dispute Resolution Request (FDRR) submission and meeting with FDA Office of New Drugs expected Q4 2026: \"Aldeyra expects to meet with OND in the fourth quarter of 2026.\" Decision timing uncertain (interim response/advisory panel possible).","closed":0,"created_at":"2026-10-25 10:04:54","updated_at":"2026-10-25 10:04:54","company":"Aldeyra Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":480,"symbol":"ALKS","drug":"alixorexton","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2026-11-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260728_070518_(ALKS)_sec_0001193125-26-318844-ex991.txt","comments":"Q2 2026 release: \"topline results from our alixorexton phase 2 idiopathic hypersomnia study expected toward year-end\" (Vibrance-3). Window interpreted as late 2026.","closed":0,"created_at":"2026-10-25 07:32:56","updated_at":"2026-10-25 07:32:56","company":"Alkermes","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.68,"llm_reason":"The Phase 2 idiopathic hypersomnia readout is an indication expansion for alixorexton, whose NT1/NT2 data are already known. ALKS is a $7.4B company with roughly $1.8B in diversified commercial revenue, which dampens the impact of a single readout. Orexin class efficacy is also largely de-risked, so a move of 10% or more seems unlikely.","llm_predicted_at":"2026-10-25T15:50:25Z","llm_source":"live","window":"2026-11-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":168,"symbol":"ALLO","drug":"ALLO-329","modality":"cell_therapy","area":"immunology","event_type":"interim_analysis","expect_date_from":"2026-11-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260812_161718_(ALLO)_sec_0001628280-26-056213.txt","comments":"\"Dose escalation and lymphodepletion optimization are ongoing, and we expect to provide a clinical and translational data update in late 2026.\" (RESOLUTION Phase 1, SLE/IIM/SSc); window per \"late 2026\".","closed":0,"created_at":"2026-10-25 11:09:51","updated_at":"2026-10-25 11:09:51","company":"Allogene Therapeutics","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.5,"llm_reason":"ALLO-329 is the first clinical update for an allogeneic CAR T in autoimmune disease, a high-interest space. Investors will weigh it on B-cell depletion and on any efficacy without lymphodepletion. At a ~$430M market cap the stock is volatile, so a 10%+ move either way is plausible, but whether the data will impress is uncertain.","llm_predicted_at":"2026-10-25T15:48:56Z","llm_source":"live","window":"2026-11-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":166,"symbol":"ALMS","drug":"envudeucitinib","modality":"small_molecule","area":"dermatology","event_type":"data_presentation","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260813_160736_(ALMS)_sec_0001847367-26-000016-ex991.txt","comments":"Anticipated 2026 milestones: \"Long-term data: Phase 2, two-year safety data (2H 2026)\"; no specific conference or date stated.","closed":0,"created_at":"2026-10-25 11:09:29","updated_at":"2026-10-25 11:09:29","company":"Alumis","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":165,"symbol":"ALMS","drug":"envudeucitinib","modality":"small_molecule","area":"dermatology","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260901_083046_(ALMS)_sec_0001104659-26-104145-ex991.txt","comments":"\"Alumis remains on track to submit an NDA for envudeucitinib in moderate-to-severe plaque psoriasis in 4Q 2026\"; reaffirmed in Oct 9, 2026 release (\"On track to submit an NDA ... in 4Q 2026\") and Oct 15 headline (\"ahead of filing\").","closed":0,"created_at":"2026-10-25 11:09:29","updated_at":"2026-10-25T16:09:02Z","company":"Alumis","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":380,"symbol":"ALXO","drug":"ALX2004","modality":"adc","area":"oncology","event_type":"interim_analysis","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260806_080522_(ALXO)_sec_0001193125-26-336843-ex991.txt","comments":"\"Enrollment continues in the dose-escalation portion of the Phase 1 trial of ALX2004 ... on track to report safety data in the second half of 2026\"; 2H 2026=2026-07-01..2026-12-31","closed":0,"created_at":"2026-10-25 11:25:51","updated_at":"2026-10-25 11:25:51","company":"ALX Oncology Holdings","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.55,"llm_reason":"The event is initial Phase 1 dose-escalation safety data for ALX2004, an early, low-information readout that rarely moves a stock decisively. The market cap of about $149M is roughly equal to the $153M cash balance, so downside is cushioned. Still, early ADC data (e.g., first responses) can surprise either way, and small caps are volatile, so a 10%+ move is plausible.","llm_predicted_at":"2026-10-25T15:49:54Z","llm_source":"live","window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":113,"symbol":"AMLX","drug":"avexitide","modality":"peptide","area":"metabolic","event_type":"regulatory_submission","expect_date_from":"2026-08-18","expect_date_to":"2026-12-31","news_source_file":"documents/20260818_070958_(AMLX)_sec_0001193125-26-354716-ex991.txt","comments":"\"Amylyx plans to submit a New Drug Application (NDA) to the FDA by the end of 2026\" (8-K Ex-99.1 dated 2026-08-18); avexitide has Breakthrough Therapy and Orphan Drug designations for PBH.","closed":0,"created_at":"2026-10-25 11:05:00","updated_at":"2026-10-25 11:05:00","company":"Amylyx Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-08-18 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":1051,"symbol":"ANNX","drug":"tanruprubart","modality":"monoclonal_antibody","area":"immunology","event_type":"interim_analysis","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260812_160038_(ANNX)_sec_0001193125-26-346779.txt","comments":"10-Q: \"we anticipate initial PK, PD, biomarker and functional data in the second half of 2026 to supplement our comprehensive data package for tanruprubart in GBS\" from the ongoing open-label U.S./Europe FORWARD study; data to precede FDA engagement and Q4 2026 BLA submission. Distinct from the Aug 2026 initial-cohort (n=10) clinical response results.","closed":0,"created_at":"2026-10-26","updated_at":"2026-10-26","company":"Annexon","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.55,"llm_reason":"The interim readout is likely the open-label FORWARD PK/PD/functional data. An initial cohort was already reported as positive, so the readout is largely supportive and partly priced in. The bigger stock drivers are FDA alignment on the BLA and the vonaprument Phase 3 readout, not this update.","llm_predicted_at":"2026-10-26T14:45:04Z","llm_source":"live","window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":158,"symbol":"ANNX","drug":"tanruprubart","modality":"monoclonal_antibody","area":"immunology","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260812_063026_(ANNX)_sec_0001193125-26-345672-ex991.txt","comments":"\"Next Milestone: Biologics License Application (BLA) submission with U.S./European data from FORWARD trial expected in fourth quarter of 2026.\"","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Annexon","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":159,"symbol":"ANNX","drug":"vonaprument","modality":"monoclonal_antibody","area":"ophthalmology","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260812_160038_(ANNX)_sec_0001193125-26-346779.txt","comments":"\"The Month 15 primary endpoint remains on track for the fourth quarter of 2026\" (10-Q, 2026-08-12); reiterated in the 2026-10-28 investor-event release (\"anticipated 15-month and 24-month results beginning in Q4 2026\") and the 2026-11-04 recap. Guidance only - no data disclosed as of 2026-11-04; full Q4 2026 window.","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-05T04:15:49Z","company":"Annexon","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.72,"llm_reason":"Vonaprument is the main value driver for this $720M company, and the Phase 3 GA Month 15 readout is binary, so a move of 10% or more either way is likely. Adding a Month 24 dual primary endpoint suggests some hedging on the Month 15 result, which raises downside risk. A clear win could still produce a large rally, so direction is uncertain.","llm_predicted_at":"2026-10-25T15:48:53Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":87,"symbol":"AQST","drug":"Anaphylm (dibutepinephrine)","modality":"small_molecule","area":"immunology","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261103_160100_(AQST)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","comments":"\"Outside the U.S., the Company expects to submit a New Drug Submission to Health Canada in Q4 2026 and plans to file in the European Union in Q1 2027.\" (Q3 2026 release, Nov 3, 2026) -> Q4 2026 window for Canadian NDS; company-guided, subject to change.","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-04T19:55:30Z","company":"Aquestive Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":363,"symbol":"ARCT","drug":"ARCT-032","modality":"other","area":"respiratory","event_type":"other","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260806_160601_(ARCT)_sec_0001193805-26-001039-ex991.txt","comments":"\"The decision to advance ARCT-032 into Phase 3 is expected in Q4 2026, triggering significant resources and support from Thermo Fisher.\" Q4 2026 mapped to 2026-10-01..2026-12-31. Company-guided decision on Phase 2 CF program (10 mg cohort, 12 weeks).","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Arcturus Therapeutics Holdings","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":141,"symbol":"ARQT","drug":"ZORYVE (roflumilast) foam 0.3%","modality":"small_molecule","area":"dermatology","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260805_161424_(ARQT)_sec_0001787306-26-000049-ex991.txt","comments":"Phase 2 proof-of-concept vitiligo study enrollment complete; \"expects to report results, as well as decisions on program advancement ... in the fourth quarter of 2026\".","closed":0,"created_at":"2026-10-25 11:06:59","updated_at":"2026-10-25 11:06:59","company":"Arcutis Biotherapeutics","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.78,"llm_reason":"This is a Phase 2 proof-of-concept readout in vitiligo for an already-approved drug, at a $4B commercial-stage company whose valuation rests on growing ZORYVE sales (2026 guidance raised to $525–540M). A vitiligo result either way is unlikely to move the stock 10% or more in one session.","llm_predicted_at":"2026-10-25T15:48:51Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":147,"symbol":"ARVN","drug":"ARV-806","modality":"small_molecule","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260804_160823_(ARVN)_sec_0001628280-26-052554.txt","comments":"\"We are planning to complete this Phase 1 monotherapy dose escalation clinical trial and share clinical data in the second half of 2026\" (Q2 2026 10-Q) for ARV-806 in KRAS G12D solid tumors. Caveat: ARV-806 does not appear in the Nov 2026 corporate presentation (8-K 11/3/26) pipeline or milestone slides, which cover only ARV-393, ARV-6723, ARV-027 and ARV-102; no discontinuation stated.","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-04T05:24:49Z","company":"Arvinas","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":1245,"symbol":"ARVN","drug":"ARV-102","modality":"small_molecule","area":"cns","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261103_160438_(ARVN)_sec_0001628280-26-069464.txt","comments":"Q3 2026 10-Q: \"We plan to submit a CTA in the European Union, or EU, in the fourth quarter of 2026\" for the ARV-102 Phase 1b trial in patients with PSP; UK CTA planned 1Q 2027, trial initiation in EU/UK in 2027. U.S. Phase 1b remains on hold pending FDA information request.","closed":0,"created_at":"2026-11-04 23:15:04","updated_at":"2026-11-04 23:15:04","company":"Arvinas","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":146,"symbol":"ARVN","drug":"ARV-393","modality":"small_molecule","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-12-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261103_160438_(ARVN)_sec_0001628280-26-069464.txt","comments":"\"Submitted our initial monotherapy dose escalation data ... for presentation at the 68th American Society of Hematology (ASH) Annual Meeting in December 2026\" (Q3 2026 10-Q); Nov 4 release: safety/PK/PD from all early-cohort patients plus preliminary efficacy in T-cell lymphomas. ASH dates not stated in available text.","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-05T04:15:36Z","company":"Arvinas","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-01 → 2026-12-31","imminence":56,"state":"upcoming","overdue":false},{"id":143,"symbol":"ARWR","drug":"plozasiran","modality":"sirna","area":"metabolic","event_type":"regulatory_submission","expect_date_from":"2026-08-04","expect_date_to":"2026-12-31","news_source_file":"documents/20260804_160302_(ARWR)_sec_0000879407-26-000058-ex991.txt","comments":"\"upcoming plozasiran sNDA submission, anticipated before the end of 2026, to potentially expand the approved indication to include patients with severe hypertriglyceridemia (sHTG)\" - window runs from Aug 4, 2026 release to end of 2026. Oct 7, 2026: FDA granted plozasiran entry in the STAR pilot program for this sNDA (see event 1127).","closed":0,"created_at":"2026-10-25 11:06:59","updated_at":"2026-10-31T12:40:42Z","company":"Arrowhead Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-08-04 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":215,"symbol":"ATOS","drug":"(Z)-endoxifen","modality":"small_molecule","area":"rare_genetic","event_type":"other","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260918_170021_(ATOS)_sec_0001193125-26-395694-ex991.txt","comments":"(Z)-endoxifen IND clearances in MAS and DMD: \"IND clearance in MAS and DMD anticipated in 2H26, with study initiations in 1H27\" (Sept 2026 corporate presentation; RPD for both, ODD for DMD). Window per 2H26 = 2026-07-01..2026-12-31. Phase 2 initiation guided for 1H27.","closed":0,"created_at":"2026-10-25 11:14:13","updated_at":"2026-10-25T11:14:18Z","company":"Atossa Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":1063,"symbol":"ATOS","drug":"(Z)-endoxifen","modality":"small_molecule","area":"oncology","event_type":"interim_analysis","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260807_083033_(ATOS)_sec_0001193125-26-339257.txt","comments":"10-Q (Aug 7, 2026): I-SPY2 EOP expanded combination arms ((Z)-endoxifen + abemaciclib or elagolix): \"Enrollment for all arms of this expanded study using (Z)-endoxifen as a combination therapy is complete, and we expect to begin receiving data throughout the second half of 2026.\" Window per 2H26 = 2026-07-01..2026-12-31; data timing only, not stated as topline.","closed":0,"created_at":"2026-10-26T23:13:28","updated_at":"2026-10-26T23:13:28","company":"Atossa Therapeutics","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.55,"llm_reason":"The likely readout is Karisma 24-month durability or interim I-SPY/EVANGELINE neoadjuvant data, all incremental to the existing endoxifen story. That favors a sub-10% move. The risk is a large swing given the ~$27M micro-cap, going-concern doubt and warrant overhang.","llm_predicted_at":"2026-10-27T03:16:38Z","llm_source":"live","window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":67,"symbol":"ATOS","drug":"(Z)-endoxifen","modality":"small_molecule","area":"oncology","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260918_170021_(ATOS)_sec_0001193125-26-395694-ex991.txt","comments":"EVANGELINE Phase 2 (neoadjuvant, premenopausal ER+/HER2- breast cancer): \"Enrollment completed, top line data anticipated in 4Q26\". Slide also notes final Ph2 data anticipated in 1H27; 4Q26 is the first/topline readout.","closed":0,"created_at":"2026-10-25 10:34:07","updated_at":"2026-10-25 10:34:07","company":"Atossa Therapeutics","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.45,"llm_reason":"EVANGELINE topline is a small Phase 2 neoadjuvant study using Ki-67 endpoints, and prior interim data already showed Ki-67 response rates above 85%, so the readout is largely de-risked. At a ~$27M micro-cap, volatility is high, but these readouts have historically produced muted or dilution-driven moves. A ≥10% move in either direction is still plausible.","llm_predicted_at":"2026-10-25T15:48:32Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":1136,"symbol":"ATYR","drug":"efzofitimod","modality":"protein","area":"respiratory","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260924_074735_(ATYR)_sec_0001339970-26-000065.txt","comments":"\"expects to focus on regulatory submissions in the U.S. and Europe as it initiates study-related activities in the fourth quarter of 2026\" - no specific submission date or filing type given; tied to planned Phase 3 in pulmonary sarcoidosis and requires additional capital.","closed":0,"created_at":"2026-11-01 08:07:53","updated_at":"2026-11-01 08:07:53","company":"aTyr Pharma","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":134,"symbol":"AUTL","drug":"AUTO8","modality":"cell_therapy","area":"hematology","event_type":"data_presentation","expect_date_from":"2026-08-11","expect_date_to":"2026-12-31","news_source_file":"documents/20260811_073342_(AUTL)_sec_0001730463-26-000119-ex991.txt","comments":"\"Phase 1 ALARIC trial evaluating AUTO8 in light-chain amyloidosis is ongoing and initial data are expected to be reported at the end of 2026\" (summary: By year-end 2026).","closed":0,"created_at":"2026-10-25 11:06:26","updated_at":"2026-10-25 11:06:26","company":"Autolus Therapeutics plc American Depositary Share","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-08-11 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":1258,"symbol":"AVTX","drug":"abdakibart","modality":"monoclonal_antibody","area":"immunology","event_type":"other","expect_date_from":"2026-11-05","expect_date_to":"2026-12-31","news_source_file":"documents/20261105_070000_(AVTX)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"\"Avalo expects feedback from the U.S. Food and Drug Administration on its proposed development plan by year-end 2026 and plans to initiate the Phase 3 program in the first half of 2027.\" FDA feedback on proposed registrational Phase 3 development plan in hidradenitis suppurativa; window runs from release date through year-end 2026.","closed":0,"created_at":"2026-11-05 12:30:04","updated_at":"2026-11-05 12:30:04","company":"Avalo Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-05 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":117,"symbol":"BBOT","drug":"BBO-11818","modality":"small_molecule","area":"oncology","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260908_161906_(BBOT)_sec_0001193125-26-385225-ex991.txt","comments":"\"BBO-11818 and BBO-10203 monotherapy data update in the fourth quarter of 2026.\" Q4 as defined = Oct 1-Dec 31, 2026.","closed":0,"created_at":"2026-10-25 11:05:09","updated_at":"2026-10-25 11:05:09","company":"BridgeBio Oncology Therapeutics","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.45,"llm_reason":"Market cap of $228M sits well below the $344M cash balance, so the stock is pessimistically priced and highly sensitive to news. The Q4 BBO-11818 monotherapy update is a key pan-KRAS readout that could swing the stock sharply either way. The deprioritization of BBO-8520 monotherapy adds uncertainty about direction.","llm_predicted_at":"2026-10-25T15:48:46Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":118,"symbol":"BBOT","drug":"BBO-10203","modality":"small_molecule","area":"oncology","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260908_161906_(BBOT)_sec_0001193125-26-385225-ex991.txt","comments":"\"BBO-11818 and BBO-10203 monotherapy data update in the fourth quarter of 2026.\" Q4 as defined = Oct 1-Dec 31, 2026.","closed":0,"created_at":"2026-10-25 11:05:09","updated_at":"2026-10-25 11:05:09","company":"BridgeBio Oncology Therapeutics","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.45,"llm_reason":"Market cap (~$228M) sits well below cash ($344M), so the market is assigning negative value to the pipeline. The Q4 2026 BBO-10203 monotherapy update is a key catalyst for a small, volatile stock, which favors a large move. Direction is unclear: PI3K-RAS breaker data could re-rate the stock, but the cash floor limits downside, and the shift toward combinations hints monotherapy may be modest.","llm_predicted_at":"2026-10-25T15:48:48Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":115,"symbol":"BCAX","drug":"ficerafusp alfa","modality":"bispecific","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260811_164602_(BCAX)_sec_0001628280-26-055765.txt","comments":"10-Q: Phase 1b expansion cohorts of ficerafusp alfa mono/combo pembrolizumab in 3L MSS RAS/BRAF wild-type metastatic colorectal cancer — \"We expect to present data from these cohorts in the second half of 2026.\"","closed":0,"created_at":"2026-10-25 11:05:02","updated_at":"2026-10-25 11:05:02","company":"Bicara Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":213,"symbol":"BCDA","drug":"CardiAMP Cell Therapy","modality":"cell_therapy","area":"cardiovascular","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260923_091500_(BCDA)_yahoo_news_yahoo-7d6be274efebd7cc42967415bb87c55b-BCDA.txt","comments":"GlobeNewswire Sep 23 2026: \"BioCardia is working towards a Shonin pre-market regulatory submission to Japan's Pharmaceutical and Medical Device Agency (PMDA) in Q4 2026.\" Window = Q4 2026. No later update yet.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"BioCardia","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":1158,"symbol":"BCDA","drug":"Helix Catheter","modality":"other","area":"cardiovascular","event_type":"other","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261019_091523_(BCDA)_sec_0001437749-26-032887.txt","comments":"8-K/GlobeNewswire Oct 19 2026: \"FDA Substantive Review and Meeting Expected this Quarter\" on the Helix De Novo pre-submission package accepted Oct 19 2026. Window = Q4 2026 (\"this quarter\", 2026-10-01..2026-12-31). Acceptance of the package itself is result #527 under event #64; this row tracks the pending substantive review/FDA meeting.","closed":0,"created_at":"2026-11-02 23:20:23","updated_at":"2026-11-03T04:21:14Z","company":"BioCardia","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":108,"symbol":"BCRX","drug":"BCX17725","modality":"protein","area":"dermatology","event_type":"topline_results","expect_date_from":"2026-08-05","expect_date_to":"2026-12-31","news_source_file":"documents/20260805_070239_(BCRX)_sec_0001171843-26-005223-ex991.txt","comments":"\"expects to report data from this part by the end of 2026\"; Phase 1 Part 4 in Netherton syndrome, up to 12 patients. Window starts at the Aug 5, 2026 disclosure date.","closed":0,"created_at":"2026-10-25 11:04:49","updated_at":"2026-10-25 11:04:49","company":"BioCryst Pharmaceuticals","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.8,"llm_reason":"BCX17725 is an early Phase 1 readout in a small rare dermatology indication (Netherton syndrome, up to 12 patients). Valuation of the ~$2B company is driven by ORLADEYO revenue and navenibart, so a move of 10% or more is unlikely.","llm_predicted_at":"2026-10-25T15:48:43Z","llm_source":"live","window":"2026-08-05 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":109,"symbol":"BDTX","drug":"silevertinib","modality":"small_molecule","area":"oncology","event_type":"interim_analysis","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260805_160217_(BDTX)_sec_0001701541-26-000023-ex991.txt","comments":"\"The Company plans to provide an update on the Phase 2 trial of silevertinib in frontline patients with non-classical EGFR-mutant (EGFRm) NSCLC in the fourth quarter of 2026.\" Q4 2026 guidance; prior cut was ASCO 2026 (Apr 11, 2026 data cutoff).","closed":0,"created_at":"2026-10-25 11:04:50","updated_at":"2026-10-25 11:04:50","company":"Black Diamond Therapeutics","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.4,"llm_reason":"BDTX trades near cash (~$120M market cap vs $110.5M cash), so the Q4 2026 Phase 2 update paired with FDA feedback on a pivotal path is a binary-ish catalyst that could move the stock sharply. Most efficacy data was already shown at ASCO, which tempers the update itself, but FDA pivotal-path clarity (or a disappointing path) adds risk in either direction.","llm_predicted_at":"2026-10-25T15:48:43Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":110,"symbol":"BDTX","drug":"silevertinib","modality":"small_molecule","area":"oncology","event_type":"other","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260805_160217_(BDTX)_sec_0001701541-26-000023-ex991.txt","comments":"FDA feedback on pivotal development path in frontline non-classical EGFRm NSCLC: \"expects to provide an update in the fourth quarter of 2026.\" Regulatory interaction/feedback, no submission stated.","closed":0,"created_at":"2026-10-25 11:04:50","updated_at":"2026-10-25 11:04:50","company":"Black Diamond Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":104,"symbol":"BEAM","drug":"risto-cel","modality":"cell_therapy","area":"hematology","event_type":"topline_results","expect_date_from":"2026-08-04","expect_date_to":"2026-12-31","news_source_file":"documents/20260804_070908_(BEAM)_sec_0001193125-26-331522-ex991.txt","comments":"\"Beam expects to report updated clinical data by year-end 2026 and submit a U.S. BLA for risto-cel as early as year-end 2026\" (Q3 2026 release, 2026-11-03; same guidance as 2026-08-04 10-Q; BEACON dosing complete in all adult and adolescent patients). Window = document date..2026-12-31.","closed":0,"created_at":"2026-10-25 07:04:17","updated_at":"2026-11-03T18:57:45Z","company":"Beam Therapeutics","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.75,"llm_reason":"Risto-cel BEACON update is an incremental read from an open-label Phase 1/2 trial with largely de-risked efficacy, ahead of the BLA. Investor attention centers on BEAM-302 and the pipeline, so a large first-session move from this readout is unlikely.","llm_predicted_at":"2026-10-25T15:48:36Z","llm_source":"live","window":"2026-08-04 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":56,"symbol":"BHVN","drug":"BHV-7000","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260909_215518_(BHVN)_sec_0001935979-26-000077.txt","comments":"\"No impact to RISE 3 timelines. The study is fully enrolled and randomized, dosing is ongoing, and topline data remains on track for the second half of 2026\" (2H 2026 = 2026-07-01..2026-12-31). Reaffirmed in Q3 2026 release/10-Q on 2026-10-29 despite Sept 4, 2026 partial clinical hold on new enrollment.","closed":0,"created_at":"2026-10-25 10:13:21","updated_at":"2026-11-02T20:05:09Z","company":"Biohaven","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.45,"llm_reason":"BHV-7000 has been licensed worldwide to SK Biopharmaceuticals, so Biohaven's economics are likely limited to milestones and royalties. That should dampen the stock reaction. Kv7 is already validated in focal epilepsy, which lowers the risk of a surprise result. The partial hold adds noise, but a large move is less likely.","llm_predicted_at":"2026-10-25T15:48:29Z","llm_source":"live","window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":102,"symbol":"BIOA","drug":"BGE-102","modality":"small_molecule","area":"metabolic","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260805_165514_(BIOA)_sec_0001193125-26-335368-ex991.txt","comments":"Q2 2026 release: QUELL-CV Phase 2 (oral BGE-102, NLRP3 inhibitor) in obesity with elevated inflammation/CV risk; \"topline data anticipated in the second half of 2026\".","closed":0,"created_at":"2026-10-25 07:04:07","updated_at":"2026-10-25 07:04:07","company":"BioAge Labs","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.5,"llm_reason":"The company trades below its $381M cash, so its value rests heavily on BGE-102. The Phase 2 hsCRP endpoint is likely to be met given the 86% Phase 1 reductions. But the dose-response and safety picture in about 160 patients could move the stock sharply either way.","llm_predicted_at":"2026-10-25T15:48:40Z","llm_source":"live","window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":57,"symbol":"BLSM","drug":"BH-30643","modality":"small_molecule","area":"oncology","event_type":"other","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260918_073032_(BLSM)_sec_0001193125-26-395043.txt","comments":"End-of-Phase 1 meeting with FDA on recommended Phase 2 dose and potential accelerated approval pathway in EGFR C797S-positive NSCLC: \"is planned in the fourth quarter of 2026\" (10-Q); 8-K says \"later this year\". Outcome/caveat: whether accelerated pathway is available is uncertain.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"BlossomHill Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":50,"symbol":"CADL","drug":"aglatimagene besadenovec","modality":"gene_therapy","area":"oncology","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260910_081611_(CADL)_sec_0001193125-26-387310-ex991.txt","comments":"\"we prepare for the planned submission of the BLA for aglatimagene besadenovec in the fourth quarter of 2026\" (CEO quote, 8-K Ex. 99.1). Board-appointment PR; no expected day given, so full Q4 2026 window.","closed":0,"created_at":"2026-10-25 10:12:44","updated_at":"2026-10-25 10:12:44","company":"Candel Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":972,"symbol":"CGEM","drug":"zipalertinib","modality":"small_molecule","area":"oncology","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261001_193544_(CGEM)_sec_0001193125-26-411011-ex991.txt","comments":"\"After agreement with the U.S. FDA, Real-Time Oncology Review program submission process initiated; completion of NDA submission expected by year-end 2026.\" 1L EGFR ex20ins NSCLC combo with chemotherapy; window = doc date..2026-12-31.","closed":0,"created_at":"2026-10-25 12:08:42","updated_at":"2026-10-25 12:08:42","company":"Cullinan Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":974,"symbol":"CGEM","drug":"CLN-978","modality":"bispecific","area":"immunology","event_type":"data_presentation","expect_date_from":"2026-12-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260924_071556_(CGEM)_sec_0001193125-26-400144-ex991.txt","comments":"\"Multi-dose and single target dose regimen data in SLE, RA, and SjD in December\" (CD19xCD3 T cell engager); December 2026 per press release of 2026-09-24.","closed":0,"created_at":"2026-10-25 12:08:42","updated_at":"2026-10-25 12:08:42","company":"Cullinan Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-01 → 2026-12-31","imminence":56,"state":"upcoming","overdue":false},{"id":970,"symbol":"CGON","drug":"cretostimogene grenadenorepvec","modality":"gene_therapy","area":"oncology","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260806_083016_(CGON)_sec_0001193125-26-336886-ex991.txt","comments":"\"Completion of BLA submission in initial indication of HR BCG-unresponsive NMIBC with CIS with or without Ta/T1 disease in 4Q'26\"; 10-Q: BLA \"expected to complete in the fourth quarter of 2026\". Submission, not approval.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"CG Oncology","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":968,"symbol":"CHRS","drug":"casdozokitug","modality":"monoclonal_antibody","area":"oncology","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260805_164314_(CHRS)_sec_0001104659-26-091188-ex991.txt","comments":"\"Enrollment is complete in the randomized Phase 2 trial of casdozokitug/toripalimab/bevacizumab in 1L uHCC and the first data readout is expected 2H 2026.\" Release also projects public disclosure of data sets with sufficient maturity in early October 2026.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Coherus Oncology","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.5,"llm_reason":"At a $162M market cap, a randomized Phase 2 1L HCC readout for a first-in-class IL-27 antibody is a major catalyst, and cash is limited. The release spotlights tagmokitug activity rather than casdozokitug, which hints at caution. Even so, either a clear win or a miss could move the stock 10% or more, so direction is uncertain.","llm_predicted_at":"2026-10-25T15:52:15Z","llm_source":"live","window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":25,"symbol":"CLDX","drug":"barzolvolimab","modality":"monoclonal_antibody","area":"dermatology","event_type":"topline_results","expect_date_from":"2026-11-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260806_160121_(CLDX)_sec_0001171843-26-005316-ex991.txt","comments":"Phase 2 atopic dermatitis study: \"Topline data from this study are expected to be presented in late 2026.\" Window = late 2026 (2026-11-01 to 2026-12-31).","closed":0,"created_at":"2026-10-25 09:53:51","updated_at":"2026-10-25 09:53:51","company":"Celldex Therapeutics","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.55,"llm_reason":"The Nov–Dec window most likely matches the Phase 2 atopic dermatitis topline, not the Sept/Oct Phase 3 CSU data. AD is a secondary indication for a $2.3B company holding $718M cash, so value rests mainly on CSU. The July prurigo nodularis failure has likely already lowered expectations for non-urticaria indications.","llm_predicted_at":"2026-10-25T15:48:32Z","llm_source":"live","window":"2026-11-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":1236,"symbol":"CLNN","drug":"CNM-Au8","modality":"other","area":"cns","event_type":"other","expect_date_from":"2026-11-04","expect_date_to":"2026-12-31","news_source_file":"documents/20261104_083623_(CLNN)_sec_0001437749-26-034776.txt","comments":"Q3 2026 10-Q: \"We expect a response from the FDA before the end of 2026 regarding whether it will accept and review our NDA based on the existing regulatory framework.\" NDA for CNM-Au8 in ALS (accelerated approval) submitted October 2026; this tracks the FDA filing-acceptance decision, not the action date.","closed":0,"created_at":"2026-11-05 00:06:56","updated_at":"2026-11-05 00:06:56","company":"Clene","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-04 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":1048,"symbol":"CLYM","drug":"budoprutug","modality":"monoclonal_antibody","area":"immunology","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260806_073516_(CLYM)_sec_0001193125-26-336762-ex991.txt","comments":"Guided budoprutug Q4 2026 readouts: ITP \"additional data from the 500 mg and 1000 mg cohorts in the fourth quarter of 2026\" and SLE \"data, including safety and biomarker data from the Global study in the fourth quarter of 2026.\" Window = Q4 2026 (2026-10-01..2026-12-31). Neither reported as of 2026-10-26. | ITP data now guided to ASH 2026 poster #3003 on 2026-12-13 (event 1206); SLE Global study data still expected Q4 2026.","closed":0,"created_at":"2026-10-26 12:38:20","updated_at":"2026-11-04T15:44:09Z","company":"Climb Bio","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.6,"llm_reason":"Q4 budoprutug readouts are early, open-label PD/biomarker data (pMN low-dose B-cell and anti-PLA2R, ITP cohorts, SLE safety) presented at medical meetings and partly derisked by prior data. The cash runway into 2H 2028 removes financing pressure. A move under 10% is most likely.","llm_predicted_at":"2026-10-26T12:39:01Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":963,"symbol":"CMPS","drug":"COMP360","modality":"small_molecule","area":"cns","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260707_063323_(CMPS)_sec_0001816590-26-000047-ex991.txt","comments":"\"Rolling NDA submission and initial review underway with final submission expected to be completed in Q4\"; timeline slide: \"Anticipated completion of rolling NDA submission Q4 2026\" (NDA for COMP360 in TRD).","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"COMPASS Pathways Plc American Depository Shares","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":960,"symbol":"CMPX","drug":"CTX-8371","modality":"bispecific","area":"oncology","event_type":"interim_analysis","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260806_073020_(CMPX)_sec_0001171843-26-005292-ex991.txt","comments":"\"Additional data from the cohort expansions are expected in Q4 2026\" (PD-1 x PD-L1 Phase 1 expansions in TNBC, NSCLC, HL).","closed":0,"created_at":"2026-10-25 12:07:44","updated_at":"2026-10-25 12:07:44","company":"Compass Therapeutics","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.6,"llm_reason":"The CTX-8371 interim update is a Phase 1 expansion-cohort readout following the dose-escalation data already shown at ASCO, so it is incremental. Tovecimig's FDA feedback and BLA path likely dominate the stock. The low market cap, below cash, adds volatility risk, but the readout is unlikely to be the main driver.","llm_predicted_at":"2026-10-25T15:52:11Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":961,"symbol":"CMPX","drug":"CTX-10726","modality":"bispecific","area":"oncology","event_type":"interim_analysis","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260806_073020_(CMPX)_sec_0001171843-26-005292-ex991.txt","comments":"\"initial clinical data expected in Q4 2026\" from the Phase 1 dose-escalation study of CTX-10726 (PD-1 x VEGF-A).","closed":0,"created_at":"2026-10-25 12:07:44","updated_at":"2026-10-25 12:07:44","company":"Compass Therapeutics","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.6,"llm_reason":"Initial Phase 1 dose-escalation data for CTX-10726 in Q4 will likely be early safety/PK data from small cohorts, and it could be bundled with tovecimig news (FDA feedback, ESMO, BLA). The market cap (~$144M) sits below cash (~$180M), which suggests the company is valued mainly on tovecimig. The PD-1xVEGF class is hot, but a first look at a 3+3 study rarely moves the stock decisively.","llm_predicted_at":"2026-10-25T15:52:13Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":962,"symbol":"CMPX","drug":"tovecimig","modality":"bispecific","area":"oncology","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260701_170022_(CMPX)_sec_0001171843-26-004428-ex991.txt","comments":"July 2026 corporate presentation: \"Q4 26: Submit BLA\"; \"BLA filing initiating in late 2026\". Caveat: on 2026-09-22 FDA recommended a survival trial before BLA submission; company says it intends to continue preparing a BLA submission.","closed":0,"created_at":"2026-10-25 12:07:44","updated_at":"2026-10-25 12:07:44","company":"Compass Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":946,"symbol":"COGT","drug":"bezuclastinib","modality":"small_molecule","area":"hematology","event_type":"interim_analysis","expect_date_from":"2026-08-10","expect_date_to":"2026-12-31","news_source_file":"documents/20260810_080621_(COGT)_sec_0001193125-26-341315-ex991.txt","comments":"\"Announced completion of enrollment in the 'avapritinib switch' SUMMIT extension trial with preliminary results expected by end of 2026.\" Window starts at the Aug 10, 2026 release date; enrollment completion alone is not a readout.","closed":0,"created_at":"2026-10-25 12:07:04","updated_at":"2026-10-25 12:07:04","company":"Cogent Biosciences","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.7,"llm_reason":"The interim readout is most likely the preliminary SUMMIT 'avapritinib switch' extension data in a $5.4B company that is already de-risked by three positive pivotal trials and has PDUFA dates set. These supplementary data are unlikely to move the stock 10% or more.","llm_predicted_at":"2026-10-25T15:52:10Z","llm_source":"live","window":"2026-08-10 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":1232,"symbol":"CORT","drug":"relacorilant","modality":"small_molecule","area":"oncology","event_type":"other","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261103_160908_(CORT)_sec_0001628280-26-069494-ex991.txt","comments":"European Commission final decision on EU marketing authorization for Lifyorli (relacorilant) + nab-paclitaxel in platinum-resistant ovarian cancer after CHMP positive opinion (Sep 2026). 8-K 2026-11-03: \"Approval expected by the end of this year\"; 10-Q: EC \"will ... issue a final decision regarding approval in the fourth quarter of 2026\".","closed":0,"created_at":"2026-11-04 19:55:34","updated_at":"2026-11-04 19:55:34","company":"Corcept Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":942,"symbol":"COYA","drug":null,"modality":"protein","area":"cns","event_type":"data_presentation","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260811_080341_(COYA)_sec_0001193125-26-343473-ex991.txt","comments":"\"2H 2026: Announce biomarker data from the completed investigator-initiated study in patients with FTD\" (Q2 2026 release, Aug 11, 2026); same milestone list adds \"2H 2026: Report additional single-cell proteomics data from the completed ALS and AD investigator-initiated trials\" — both IIS datasets, one window, bullet names no drug so drug LEFT NULL. Unchanged by Oct 14, 2026 8-K, which only moved the separate FTD Phase 2 trial start from 2H 2026 to 2027.","closed":0,"created_at":"2026-10-25T08:06:00","updated_at":"2026-10-29T00:50:03Z","company":"Coya Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":918,"symbol":"CRSP","drug":"CTX310","modality":"gene_therapy","area":"cardiovascular","event_type":"interim_analysis","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260803_162423_(CRSP)_sec_0001193125-26-330644-ex991.txt","comments":"\"The Company also expects to provide a Phase 1b clinical update in the second half of 2026.\" Window per rule: 2026-07-01..2026-12-31.","closed":0,"created_at":"2026-10-25 12:05:19","updated_at":"2026-10-26T04:25:47Z","company":"CRISPR Therapeutics","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.72,"llm_reason":"The CTX310 Phase 1a durability update at ESC follows earlier positive ANGPTL3 data and is largely expected. CRISPR is a ~$4.8B company with $2.4B cash and a diversified pipeline including CASGEVY, so a single-program interim update is unlikely to move the stock 10% or more.","llm_predicted_at":"2026-10-25T15:52:05Z","llm_source":"live","window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":919,"symbol":"CRSP","drug":"CTX611","modality":"sirna","area":"cardiovascular","event_type":"interim_analysis","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260803_162423_(CRSP)_sec_0001193125-26-330644-ex991.txt","comments":"\"CTX611 (SRSD107) ... is advancing through a Phase 2 clinical trial in patients undergoing total knee arthroplasty (TKA). The Company expects to provide an update in the second half of 2026.\" Q3 2026 release (2026-11-02): enrollment now complete, \"with an update expected in the second half of 2026.\" Window unchanged.","closed":0,"created_at":"2026-10-25 12:05:19","updated_at":"2026-11-04T05:24:55Z","company":"CRISPR Therapeutics","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.8,"llm_reason":"CTX611 Phase 2 TKA interim is a partnered siRNA asset in a validated FXI class. CRSP is a ~$4.8B company with $2.4B cash, CASGEVY revenue and many other programs, so a single interim readout is unlikely to move the stock 10% or more.","llm_predicted_at":"2026-10-25T15:52:06Z","llm_source":"live","window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":920,"symbol":"CRSP","drug":"zugocabtagene geleucel","modality":"cell_therapy","area":"immunology","event_type":"interim_analysis","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260803_162423_(CRSP)_sec_0001193125-26-330644-ex991.txt","comments":"Autoimmune: \"Enrollment across the zugo-cel autoimmune clinical program continues ... The Company expects to provide further updates in the second half of 2026.\" Immuno-oncology B-cell malignancies: \"updates anticipated in the second half of 2026.\" Both updates guided to H2 2026 (2026-07-01..2026-12-31).","closed":0,"created_at":"2026-10-25 12:05:19","updated_at":"2026-10-25 12:05:19","company":"CRISPR Therapeutics","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.7,"llm_reason":"CRSP is a ~$4.8B company with $2.4B in cash, a growing CASGEVY revenue stream and a broad pipeline. An interim Phase 1 update on allogeneic CD19 CAR-T zugo-cel in autoimmune disease is early-stage and only one of several programs, so a first-session move under 10% is most likely.","llm_predicted_at":"2026-10-25T15:52:08Z","llm_source":"live","window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":912,"symbol":"CTMX","drug":"varsetatug masetecan","modality":"adc","area":"oncology","event_type":"interim_analysis","expect_date_from":"2026-08-06","expect_date_to":"2026-12-31","news_source_file":"documents/20260806_161058_(CTMX)_sec_0001193125-26-338009-ex991.txt","comments":"\"A Phase 1 data update is expected by the end of 2026 with a focus on dose selection for late phase development\" (monotherapy, advanced CRC; enrollment complete, 113 pts). Window per \"by the end of 2026\" from document date. 10-Q: \"anticipated to be presented by the end of 2026\".","closed":0,"created_at":"2026-10-25 12:04:36","updated_at":"2026-10-25 12:04:36","company":"CytomX Therapeutics","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.55,"llm_reason":"Varseta-M is CytomX's lead asset and drives a $530M valuation, so the year-end Phase 1 CRC dose-selection update is binary in either direction. CTMX has a history of large moves on prior Varseta-M data. Efficacy at the optimized doses and the safety profile (e.g., GI toxicity) could swing the stock sharply either way.","llm_predicted_at":"2026-10-25T15:52:03Z","llm_source":"live","window":"2026-08-06 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":910,"symbol":"CV","drug":"CapsoCam Colon","modality":"other","area":"gi_hepatology","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260813_160715_(CV)_sec_0001378325-26-000035-ex991.txt","comments":"\"Pipeline continues to advance with CapsoCam Colon(TM) on track for 510(k) submission in the fourth quarter of 2026\"; 10-Q adds \"subject to any further requests from the FDA\". Second-generation capsule; enrollment of 801 patients completed.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"CapsoVision","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":900,"symbol":"CYTK","drug":"aficamten","modality":"small_molecule","area":"cardiovascular","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260828_092149_(CYTK)_sec_0001193125-26-372456-ex991.txt","comments":"\"plans to submit a supplemental New Drug Application to the FDA for aficamten ... in the fourth quarter of 2026\" for symptomatic nHCM; reiterated in Q3 2026 release (\"We expect to file a Supplemental NDA (NDA) for nHCM in Q4 2026\") and 10-Q.","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-05T04:14:05Z","company":"Cytokinetics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":893,"symbol":"DFTX","drug":"DT120 ODT","modality":"small_molecule","area":"cns","event_type":"other","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260914_080240_(DFTX)_sec_0001104659-26-107275-ex991.txt","comments":"\"Pre-NDA meeting scheduled in 4Q 2026\" for DT120 ODT in GAD.","closed":0,"created_at":"2026-10-25 12:02:58","updated_at":"2026-10-25 12:02:58","company":"Definium Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":898,"symbol":"DMRA","drug":"DMR-001","modality":"monoclonal_antibody","area":"hematology","event_type":"regulatory_submission","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260810_160042_(DMRA)_sec_0001193125-26-342307.txt","comments":"\"We plan to complete additional regulatory submissions for DMR-001 in the second half of 2026 to expand the Phase 1/1b trial globally\" (10-Q, filed 2026-08-10).","closed":0,"created_at":"2026-10-25 12:03:02","updated_at":"2026-10-25 12:03:02","company":"Damora Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":896,"symbol":"DMRA","drug":"DMR-002","modality":"monoclonal_antibody","area":"hematology","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261104_160600_(DMRA)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"\"Complete the first regulatory submission for DMR-002 in the fourth quarter of 2026\" (Q3 2026 results release, 2026-11-04). Narrowed from prior \"second half of 2026\" guidance; Q4 2026 = 2026-10-01..2026-12-31.","closed":0,"created_at":"2026-10-25 12:03:02","updated_at":"2026-11-05T00:08:33Z","company":"Damora Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":883,"symbol":"DNTH","drug":"DNTH212","modality":"bispecific","area":"immunology","event_type":"other","expect_date_from":"2026-08-04","expect_date_to":"2026-12-31","news_source_file":"documents/20260804_160521_(DNTH)_sec_0001690585-26-000033-ex991.txt","comments":"\"Phase 1 healthy volunteer data anticipated by year end\" (two-part Phase 1 in China, Part A healthy volunteers); window = document date to 2026-12-31 per \"by YE'26\".","closed":0,"created_at":"2026-10-25 12:02:41","updated_at":"2026-10-25 12:02:41","company":"Dianthus Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-08-04 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":881,"symbol":"DNTH","drug":"claseprubart","modality":"monoclonal_antibody","area":"immunology","event_type":"topline_results","expect_date_from":"2026-12-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260804_160521_(DNTH)_sec_0001690585-26-000033-ex991.txt","comments":"\"top-line results with 46 patients on track for December '26\" (Phase 2 MoMeNtum in MMN); enrollment completed above 36-patient target.","closed":0,"created_at":"2026-10-25 12:02:38","updated_at":"2026-10-25 12:02:38","company":"Dianthus Therapeutics","tier":"Core","llm_prediction":"small_impact","llm_confidence":0.6,"llm_reason":"The December event is the Phase 2 MMN readout, a small indication. At a $4.4B market cap the company is valued mainly on gMG and CIDP, and $1.2B in cash cushions the downside. Positive CIDP interim data and the validated C1s mechanism (riliprubart in MMN) make success fairly expected, so a move under 10% is most likely.","llm_predicted_at":"2026-10-25T15:51:57Z","llm_source":"live","window":"2026-12-01 → 2026-12-31","imminence":56,"state":"upcoming","overdue":false},{"id":989,"symbol":"DSGN","drug":"DT-216P2","modality":"small_molecule","area":"rare_genetic","event_type":"other","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260803_080340_(DSGN)_sec_0001193125-26-329570-ex991.txt","comments":"\"Design expects to provide an update on its registrational plans in the fourth quarter of 2026\" (RESTORE-FA); reconfirmed in Q3 2026 release of 2026-11-04: \"Registrational Plan Update in Q4 2026\". No exact date stated.","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-04T22:02:23Z","company":"Design Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":986,"symbol":"DTIL","drug":"PBGENE-HBV","modality":"gene_therapy","area":"infectious","event_type":"interim_analysis","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260701_071708_(DTIL)_sec_0001628280-26-046340.txt","comments":"\"The Company is targeting year-end 2026 for the next program update\" for the ELIMINATE-B study in chronic hepatitis B (also 10-Q: \"expect to provide additional updates on the ELIMINATE-B trial progress by the end of 2026\").","closed":0,"created_at":"2026-10-25 12:09:44","updated_at":"2026-10-25 12:09:44","company":"Precision BioSciences","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.5,"llm_reason":"The year-end 2026 PBGENE-HBV update is the key value driver for a ~$187M gene-editing company. Prior HBV readouts moved DTIL sharply in both directions, and functional-cure signals such as HBsAg loss are binary-like, so a move of at least 10% is likely but the direction is uncertain.","llm_predicted_at":"2026-10-25T15:52:18Z","llm_source":"live","window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":987,"symbol":"DTIL","drug":"PBGENE-DMD","modality":"gene_therapy","area":"rare_genetic","event_type":"interim_analysis","expect_date_from":"2026-11-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261103_080930_(DTIL)_sec_0001628280-26-069092.txt","comments":"\"Initial safety data are targeted for year-end 2026, with efficacy data at distinct timepoints expected to follow in the first and second half of 2027.\" (Q3 2026 10-Q, FUNCTION-DMD) Year-end 2026 = late 2026 window.","closed":0,"created_at":"2026-10-25 12:09:44","updated_at":"2026-11-04T09:31:36Z","company":"Precision BioSciences","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.45,"llm_reason":"A ~$187M micro-cap whose PBGENE-DMD excision approach is a key value driver for Duchenne. The year-end 2026 readout is initial safety data, possibly with early dystrophin signals. In DMD gene therapy, such early data often move small caps sharply in either direction.","llm_predicted_at":"2026-10-25T15:52:21Z","llm_source":"live","window":"2026-11-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":868,"symbol":"ELUT","drug":"NXT-41","modality":"other","area":"other","event_type":"pdufa","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260813_161524_(ELUT)_sec_0001104659-26-095934-ex991.txt","comments":"Company guided window: \"The Company continues to expect FDA clearance for NXT-41 in the fourth quarter of 2026.\" Q2 2026 business update; no specific PDUFA date disclosed.","closed":0,"created_at":"2026-10-25 08:00:46","updated_at":"2026-10-25 08:00:46","company":"Elutia","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":863,"symbol":"ENGN","drug":"detalimogene","modality":"gene_therapy","area":"oncology","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260908_073318_(ENGN)_sec_0001193125-26-384380-ex991.txt","comments":"\"enGene expects to report updated data on key primary and secondary regulatory endpoints (CR at any time and Duration of Response (DOR) >= 12 months), as well as additional durability datapoints, from Cohort 1 ... in 4Q 2026.\" Landmark CR rates from pivotal cohort also guided to 4Q 2026.","closed":0,"created_at":"2026-10-25 12:01:03","updated_at":"2026-10-25 12:01:03","company":"enGene Therapeutics","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.45,"llm_reason":"The market cap (~$106M) sits far below cash ($266M), so the market is deeply skeptical of detalimogene. The 4Q update on pivotal CR rates and durability is a binary-like event for this low-priced stock. Weak 12-month durability could push it down sharply, while solid landmark CR data could trigger a large rerating toward cash.","llm_predicted_at":"2026-10-25T15:52:00Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":864,"symbol":"ENGN","drug":"detalimogene","modality":"gene_therapy","area":"oncology","event_type":"other","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260908_073318_(ENGN)_sec_0001193125-26-384380-ex991.txt","comments":"\"Pre-Biologics License Application (BLA) meeting with the FDA on track for 4Q 2026\" / \"conduct a pre-BLA meeting with the FDA in 4Q 2026\". Regulatory meeting date not specified beyond quarter.","closed":0,"created_at":"2026-10-25 12:01:03","updated_at":"2026-10-25 12:01:03","company":"enGene Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":865,"symbol":"ENGN","drug":"detalimogene","modality":"gene_therapy","area":"oncology","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260908_073318_(ENGN)_sec_0001193125-26-384380-ex991.txt","comments":"\"Initiation of BLA submission for detalimogene planned for 4Q 2026\"; 10-Q: \"initiate the submission of our planned BLA in the fourth quarter of calendar year 2026\".","closed":0,"created_at":"2026-10-25 12:01:03","updated_at":"2026-10-25 12:01:03","company":"enGene Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":862,"symbol":"ENTA","drug":"EPS-3903","modality":"small_molecule","area":"immunology","event_type":"regulatory_submission","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260810_160518_(ENTA)_sec_0001193125-26-342336-ex991.txt","comments":"\"targeting an IND filing in the second half of 2026\" for EPS-3903, oral STAT6 inhibitor; window per \"second half of 2026\" = 2026-07-01..2026-12-31.","closed":0,"created_at":"2026-10-25 12:01:02","updated_at":"2026-10-25 12:01:02","company":"Enanta Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":859,"symbol":"ENTA","drug":"EDP-978","modality":"small_molecule","area":"immunology","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260810_160518_(ENTA)_sec_0001193125-26-342336-ex991.txt","comments":"\"The Company expects to report topline data from the trial in the fourth quarter of 2026\" (Phase 1 trial of EDP-978, oral once-daily KIT inhibitor in urticaria). 10-Q of 2026-08-12 repeats 4Q 2026 guidance.","closed":0,"created_at":"2026-10-25 12:01:02","updated_at":"2026-10-25 12:01:02","company":"Enanta Pharmaceuticals","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.68,"llm_reason":"The EDP-978 readout is a Phase 1 trial in healthy volunteers measuring safety, PK and tryptase. That design limits how much it can surprise. Market cap is about $338M against roughly $211M in cash, and RSV is the main value driver. KIT tryptase data could move the stock somewhat, but a move under 10% is most likely.","llm_predicted_at":"2026-10-25T15:51:53Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":853,"symbol":"EOLS","drug":"Evolysse Sculpt","modality":"other","area":"dermatology","event_type":"pdufa","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260805_165642_(EOLS)_sec_0001628280-26-053468.txt","comments":"Q3-26 10-Q: Evolysse Sculpt \"to be approved in the United States in the fourth quarter of 2026\"; Nov 4, 2026 release: \"anticipated to receive U.S. approval in the fourth quarter of 2026\". Approval dependent on Symatese FDA submission; no specific PDUFA day stated.","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-05T08:21:46Z","company":"Evolus","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":855,"symbol":"EPRX","drug":"EP-104GI","modality":"small_molecule","area":"gi_hepatology","event_type":"interim_analysis","expect_date_from":"2026-12-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261015_101310_(EPRX)_sec_0001171843-26-006648-ex991.txt","comments":"\"Interim analysis of the Phase 2b portion of the study is on track for December 2026\"; \"we will be reporting on symptoms, histologic findings and safety in the first 60 patients in Phase 2b to reach 6 months\". Earlier guidance was Q4 2026; narrower December 2026 window stated here. Phase 2b enrollment target (120 pts) reached Oct 12, 2026.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Eupraxia Pharmaceuticals","tier":"Core","llm_prediction":"large_impact","llm_confidence":0.62,"llm_reason":"The first placebo-controlled Phase 2b interim for EP-104GI, the company's lead asset, is binary for a ~$500M single-asset company. The open-label data built expectations and the company signals confidence via the sample-size review, so either a clear win or a miss could move the stock 10%+. Direction is uncertain.","llm_predicted_at":"2026-10-25T15:51:54Z","llm_source":"live","window":"2026-12-01 → 2026-12-31","imminence":56,"state":"upcoming","overdue":false},{"id":851,"symbol":"ERAS","drug":"ERAS-4001","modality":"small_molecule","area":"oncology","event_type":"interim_analysis","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260811_160519_(ERAS)_sec_0001193125-26-344584-ex991.txt","comments":"\"Preliminary Phase 1 monotherapy data expected in the second half of 2026\" (BOREALIS-1, Ph1); CEO: \"upcoming ERAS-4001 clinical data readout expected later this year\"","closed":0,"created_at":"2026-10-25 12:00:13","updated_at":"2026-10-25 12:00:13","company":"Erasca","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.6,"llm_reason":"Valuation (~$4.9B) is driven mainly by ERAS-0015. ERAS-4001 preliminary Phase 1 monotherapy data is a secondary catalyst, and the company just raised $632M, so a first-session move under 10% is most likely.","llm_predicted_at":"2026-10-25T15:51:49Z","llm_source":"live","window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":30,"symbol":"EVAX","drug":"EVX-04","modality":"vaccine","area":"oncology","event_type":"regulatory_submission","expect_date_from":"2026-08-20","expect_date_to":"2026-12-31","news_source_file":"documents/20260820_073505_(EVAX)_sec_0001171843-26-005672-ex991.txt","comments":"Company guided regulatory filing for first-in-human clinical testing of EVX-04 (AML off-the-shelf cancer vaccine). \"preparing the regulatory filing for clinical testing of EVX-04, which is expected to be submitted before the end of the year.\" Window = document date..2026-12-31.","closed":0,"created_at":"2026-10-25 09:53:55","updated_at":"2026-10-25 09:53:55","company":"Evaxion A/S American Depositary Share","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-08-20 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":836,"symbol":"FBIO","drug":"Triplex","modality":"vaccine","area":"infectious","event_type":"topline_results","expect_date_from":"2026-08-13","expect_date_to":"2026-12-31","news_source_file":"documents/20260813_161521_(FBIO)_sec_0001104659-26-095931-ex991.txt","comments":"Q2 2026 release (Aug 13, 2026): \"a potential data readout by the end of 2026 for prevention and control of CMV in patients co-infected with HIV and CMV.\" Window runs from the release date to year-end; company calls it \"potential\".","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Fortress Biotech","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.8,"llm_reason":"Triplex is a minor, investigator-sponsored CMV vaccine program within Fortress's diversified portfolio. FBIO has substantial cash and revenue, so a small HIV/CMV readout is unlikely to move the stock 10%.","llm_predicted_at":"2026-10-25T15:51:46Z","llm_source":"live","window":"2026-08-13 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":841,"symbol":"FDMT","drug":"4D-710","modality":"gene_therapy","area":"respiratory","event_type":"interim_analysis","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260813_160644_(FDMT)_sec_0001193125-26-349160-ex991.txt","comments":"\"AEROW Phase 1/2 clinical trial and program update expected in Q4 2026\" (Q2 2026 earnings release).","closed":0,"created_at":"2026-10-25 11:59:01","updated_at":"2026-10-25 11:59:01","company":"4D Molecular Therapeutics","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.8,"llm_reason":"4D-710 is a secondary, deprioritized CF program, and its 'program update' is expected in Q4 2026. The company's valuation is driven by 4D-150. The market cap of about $655M is close to cash of $431M, so the CF update is unlikely to move the stock 10% in either direction.","llm_predicted_at":"2026-10-25T15:51:48Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":977,"symbol":"FTH","drug":"PIKTOR","modality":"small_molecule","area":"oncology","event_type":"topline_results","expect_date_from":"2026-08-04","expect_date_to":"2026-12-31","news_source_file":"documents/20260804_074027_(FTH)_sec_0001193125-26-331563-ex991.txt","comments":"Phase 2 PIK-201 (endometrial cancer) topline results expected \"by year-end 2026\" (3Q26 release 2026-11-03: \"look forward to reading out topline data from our Phase 2 PIK-201 trial in endometrial cancer by year-end\"); confirmed in 10-Q filed 2026-11-03. Window runs from Aug 2026 guidance to end of 2026.","closed":0,"created_at":"2026-10-25 12:09:09","updated_at":"2026-11-04T19:56:19Z","company":"Faeth Therapeutics","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.55,"llm_reason":"The Phase 2 PIK-201 endometrial readout is the first major catalyst for a single-asset company (~$519M market cap) after a reverse merger. Few shares trade, and the result could move the stock sharply either way. PI3K/mTOR combinations carry tolerability risk, which leaves the direction uncertain.","llm_predicted_at":"2026-10-25T15:52:17Z","llm_source":"live","window":"2026-08-04 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":826,"symbol":"GLUE","drug":"NEK7-directed MGD (second generation)","modality":"small_molecule","area":"other","event_type":"regulatory_submission","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260806_070402_(GLUE)_sec_0001193125-26-336681-ex991.txt","comments":"\"Submit an IND application for a second-generation NEK7-directed MGD in H2 2026.\" CNS-penetrant NEK7-directed molecular glue degrader.","closed":0,"created_at":"2026-10-25T07:57:04","updated_at":"2026-10-25T07:57:04","company":"Monte Rosa Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":824,"symbol":"GLUE","drug":"MRT-2359","modality":"small_molecule","area":"oncology","event_type":"interim_analysis","expect_date_from":"2026-08-06","expect_date_to":"2026-12-31","news_source_file":"documents/20260806_070402_(GLUE)_sec_0001193125-26-336681-ex991.txt","comments":"\"We will update data from the initial Phase 1/2 arm exploring MRT-2359 in advanced CRPC by the end of the year\"; enrollment of the 6-patient AR-mutant expansion arm completed.","closed":0,"created_at":"2026-10-25T07:57:04","updated_at":"2026-10-25T07:57:04","company":"Monte Rosa Therapeutics","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.8,"llm_reason":"The MRT-2359 update covers only 6 AR-mutant CRPC patients and follows interim data already shown at ASCO GU. Valuation hinges on MRT-8102 and the Novartis-partnered VAV1 program, with $626M cash against a ~$950M market cap. A large first-session move from this readout is unlikely.","llm_predicted_at":"2026-10-25T15:51:43Z","llm_source":"live","window":"2026-08-06 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":821,"symbol":"GOSS","drug":"seralutinib","modality":"small_molecule","area":"cardiovascular","event_type":"other","expect_date_from":"2026-09-23","expect_date_to":"2026-12-31","news_source_file":"documents/20260923_160541_(GOSS)_sec_0001728117-26-000104.txt","comments":"FDA decision on acceptance of the seralutinib NDA for filing: \"will determine whether to accept the NDA for filing ... which the Company anticipates could occur later this year.\" Window runs from filing date through year-end 2026; not yet occurred.","closed":0,"created_at":"2026-10-25 11:57:18","updated_at":"2026-10-25 11:57:18","company":"Gossamer Bio","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-09-23 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":811,"symbol":"HELP","drug":"HLP003","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261021_163350_(HELP)_sec_0001062993-26-005468-ex991.txt","comments":"\"Topline data readout from APPROACH Phase 3 study of HLP003 ... on track for Q4 2026\"; reaffirmed Oct 27, 2026: \"continues to anticipate reporting topline data ... in Q4 2026.\" Enrollment complete (223 participants); EMBRACE still enrolling.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-27T17:43:37Z","company":"Helus Pharma","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.72,"llm_reason":"Helus Pharma's HLP003 APPROACH readout is a binary, value-defining Phase 3 for its lead asset, at roughly a $770M market cap. A move of at least 10% is very likely. Direction is uncertain: the prior Phase 2 was strong and the drug has Breakthrough designation, but psychedelic-class Phase 3 trials carry functional-unblinding and durability risk, and expectations are high.","llm_predicted_at":"2026-10-25T15:51:38Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":809,"symbol":"HOWL","drug":"WTX-124","modality":"protein","area":"oncology","event_type":"interim_analysis","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260731_070621_(HOWL)_sec_0001785530-26-000018-ex991.txt","comments":"Q2 2026 release: \"In the second half of the year, we expect to provide ... data updates on our clinical trials of WTX-124 and WTX-330.\" Window = 2H 2026 (broad, no specific date). 10-Q notes Phase 1/1b trial of WTX-124 expected to be completed in Q4 2026. Aug-2026 merger with Ambros adds uncertainty.","closed":0,"created_at":"2026-10-25 11:55:59","updated_at":"2026-10-25 11:55:59","company":"Werewolf Therapeutics","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.45,"llm_reason":"Micro-cap ($49M) in a strategic alternatives process with limited cash, so a WTX-124 interim data update could move the stock sharply either way. Data could support a deal or confirm the program's demise.","llm_predicted_at":"2026-10-25T15:51:35Z","llm_source":"live","window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":810,"symbol":"HOWL","drug":"WTX-330","modality":"protein","area":"oncology","event_type":"interim_analysis","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260731_070621_(HOWL)_sec_0001785530-26-000018-ex991.txt","comments":"Q2 2026 release: \"In the second half of the year, we expect to provide ... data updates on our clinical trials of WTX-124 and WTX-330.\" Window = 2H 2026 (broad, no specific date). 10-Q: dose/regimen-determining Part A of Phase 1b/2 expected to complete Q4 2026.","closed":0,"created_at":"2026-10-25 11:55:59","updated_at":"2026-10-25 11:55:59","company":"Werewolf Therapeutics","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.45,"llm_reason":"Werewolf is a ~$49M microcap running a strategic alternatives process, with about $22M cash and runway only into Q2 2027. That makes the stock highly sensitive to any WTX-330 IL-12 interim data, in either direction. The update would likely be small and early-stage, so the direction is hard to call, but a move of 10% or more is plausible.","llm_predicted_at":"2026-10-25T15:51:37Z","llm_source":"live","window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":1196,"symbol":"HRMY","drug":"EPX-100","modality":"small_molecule","area":"cns","event_type":"data_presentation","expect_date_from":"2026-12-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261104_073000_(HRMY)_globenewswire_biotech_globenewswire_biotech-sha256-786e675a8731ca50e45.txt","comments":"\"Updated 18-month data from the open-label extension part of the ARGUS study to be presented at the American Epilepsy Society (AES) Annual Meeting in December 2026\" - month only; window covers all of December 2026. Conference presentation, not a topline readout.","closed":0,"created_at":"2026-11-04 13:38:25","updated_at":"2026-11-04 13:38:25","company":"Harmony Biosciences Holdings","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-01 → 2026-12-31","imminence":56,"state":"upcoming","overdue":false},{"id":800,"symbol":"HROW","drug":"IHEEZO","modality":"small_molecule","area":"ophthalmology","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260810_161055_(HROW)_sec_0001493152-26-036865-ex991.txt","comments":"\"IHEEZO (QUELL): Topline data from QUELL, a prospective, randomized, multi-center clinical trial evaluating IHEEZO in patients undergoing intravitreal injections, are expected in the fourth quarter of 2026.\" Q4 2026 = 2026-10-01..2026-12-31.","closed":0,"created_at":"2026-10-25 11:55:30","updated_at":"2026-10-25 11:55:30","company":"Harrow","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.8,"llm_reason":"QUELL is a label-expansion study of an already-marketed anesthetic gel that contributes only a modest share of a diversified ~$350M revenue base. Topline results are unlikely to move a $1B commercial company 10% or more in one session.","llm_predicted_at":"2026-10-25T15:51:29Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":802,"symbol":"HROW","drug":"NATACYN","modality":"small_molecule","area":"ophthalmology","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260810_161055_(HROW)_sec_0001493152-26-036865-ex991.txt","comments":"\"NATACYN: The first patients were enrolled in an investigator-initiated clinical study during the second quarter, with topline data expected in the fourth quarter of 2026.\" Investigator-initiated study; Q4 2026 = 2026-10-01..2026-12-31.","closed":0,"created_at":"2026-10-25 11:55:30","updated_at":"2026-10-25 11:55:30","company":"Harrow","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.85,"llm_reason":"The NATACYN readout comes from a small investigator-initiated study of an already-marketed antifungal. Harrow is a ~$1B diversified commercial company whose valuation rests on VEVYE, IHEEZO and TRIESENCE, so this topline result is unlikely to move the stock 10% in either direction.","llm_predicted_at":"2026-10-25T15:51:32Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":81,"symbol":"HUMA","drug":"ATEV (Symvess)","modality":"other","area":"renal","event_type":"regulatory_submission","expect_date_from":"2026-10-23","expect_date_to":"2026-12-31","news_source_file":"documents/20261023_080000_(HUMA)_globenewswire_biotech_globenewswire_biotech-sha256-88967b8bba8a88094c5.txt","comments":"sBLA to expand Symvess label to AV access for hemodialysis: \"targeted for submission to the FDA this quarter\" (Oct 23, 2026 release); reaffirmed Oct 28, 2026: \"plans to submit a supplemental BLA this year.\" Window from first document date. Submission, not an approval.","closed":0,"created_at":"2026-10-25 06:37:06","updated_at":"2026-10-28T12:16:43Z","company":"Humacyte","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-23 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":790,"symbol":"IBIO","drug":"IBIO-610","modality":"monoclonal_antibody","area":"metabolic","event_type":"regulatory_submission","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260914_161645_(IBIO)_sec_0001420720-26-000028-ex991.txt","comments":"\"IBIO-610 IND equivalent filing expected in 2H 2026\" (Sept 2026 corporate presentation); reaffirmed 2026-10-13 8-K press release: \"iBio expects to start first-in-human trials of IBIO-610 in first half of 2027\". 2H 2026 = 2026-07-01..2026-12-31.","closed":0,"created_at":"2026-10-25 11:54:49","updated_at":"2026-10-27T03:14:43Z","company":"iBio","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":794,"symbol":"IBRX","drug":"ANKTIVA","modality":"protein","area":"oncology","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260804_073613_(IBRX)_sec_0001326110-26-000077-ex991.txt","comments":"\"a planned 2026 sBLA submission for the Phase 2B QUILT-2.005 trial in BCG-naive NMIBC carcinoma in situ (with or without papillary disease)\" (2026-08-04 8-K). Timing refined by later coverage: ANKTIVA \"plans a fourth-quarter FDA filing\" (Stocktwits via Yahoo, 2026-10-27), so window is Q4 2026. Month/day not stated.","closed":0,"created_at":"2026-10-25 11:54:49","updated_at":"2026-10-27T11:26:44Z","company":"ImmunityBio","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":1032,"symbol":"IMNM","drug":"IM-1335","modality":"adc","area":"oncology","event_type":"regulatory_submission","expect_date_from":"2026-11-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260811_161039_(IMNM)_sec_0001193125-26-344636.txt","comments":"\"IND-enabling work for IM-1335 is ongoing and we expect to submit an IND for this program to the FDA in late 2026.\" (10-Q filed 2026-08-11; same guidance in 2026-08-11 release: INDs for IM-1340 and IM-1335 in mid- and late 2026). Window = late 2026.","closed":0,"created_at":"2026-10-26 04:24:44","updated_at":"2026-10-26 04:24:44","company":"Immunome","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":761,"symbol":"IMUX","drug":"vidofludimus calcium","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2026-08-11","expect_date_to":"2026-12-31","news_source_file":"documents/20260811_070536_(IMUX)_sec_0001193805-26-001071-ex991.txt","comments":"\"top-line data from our Phase 3 ENSURE trials of vidofludimus calcium in relapsing multiple sclerosis (MS) expected by year-end\"/\"expected to be available by the end of 2026\"; window runs from document date. Twin ENSURE-1/ENSURE-2 trials, enrollment complete June 2025, 1,121 and 1,100 patients. If positive, NDA submission targeted mid-2027. Reaffirmed by CMO interview 2026-10-30 (\"Phase 3 ENSURE programme in relapsing MS, with results expected by the end of 2026\").","closed":0,"created_at":"2026-10-25 11:53:30","updated_at":"2026-11-02T17:57:31Z","company":"Immunic","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.8,"llm_reason":"The ENSURE Phase 3 readout in relapsing MS is binary and company-defining for a roughly $98M company whose value rests almost entirely on vidofludimus. A move of at least 10% is very likely. Direction is uncertain: the active teriflunomide comparator and a high bar for showing superior relapse reduction cut against a clean win, while success could re-rate the stock sharply.","llm_predicted_at":"2026-10-25T15:51:25Z","llm_source":"live","window":"2026-08-11 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":768,"symbol":"IMVT","drug":"IMVT-1402","modality":"monoclonal_antibody","area":"immunology","event_type":"topline_results","expect_date_from":"2026-08-06","expect_date_to":"2026-12-31","news_source_file":"documents/20260806_072920_(IMVT)_sec_0001764013-26-000101.txt","comments":"D2T RA Period 2 (primary endpoint at Week 28, NCT06754462): 8-K PR (2026-08-06) says the company expects to \"provide further updates on its potentially registrational IMVT-1402 D2T RA program ... in the second half of calendar year 2026\"; 10-Q: \"Further updates on this program are expected in the second half of calendar year 2026.\" Guidance = 2H 2026; window starts at filing date to keep a unique key distinct from the CLE event.","closed":0,"created_at":"2026-10-25 11:53:39","updated_at":"2026-11-03T00:14:05Z","company":"Immunovant","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.45,"llm_reason":"The expected window (2H 2026) matches two pending IMVT-1402 readouts: D2T RA Period 2, the primary endpoint, and the CLE proof-of-concept. D2T RA is the key value driver for a $6B company after the batoclimab TED failures. Period 2 is likely a randomized withdrawal after strong open-label data, so results could swing either way by 10% or more. Large caps sometimes move less, but RA drives much of the valuation.","llm_predicted_at":"2026-10-25T15:51:29Z","llm_source":"live","window":"2026-08-06 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":765,"symbol":"INBX","drug":"ozekibart (INBRX-109)","modality":"monoclonal_antibody","area":"oncology","event_type":"other","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260813_161015_(INBX)_sec_0002007919-26-000044-ex991.txt","comments":"\"The Company plans to meet with the FDA in the fourth quarter of 2026 to discuss plans to initiate a first-line registrational trial in CRC as well as the potential for an accelerated regulatory pathway for ozekibart in fourth-line CRC.\"","closed":0,"created_at":"2026-10-25T07:53:09","updated_at":"2026-10-25T07:53:09","company":"Inhibrx Biosciences","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":1124,"symbol":"INO","drug":"INO-3107","modality":"dna_vaccine","area":"rare_genetic","event_type":"regulatory_submission","expect_date_from":"2026-10-30","expect_date_to":"2026-12-31","news_source_file":"documents/20261030_180100_(INO)_prnewswire_biotech_prnewswire_biotech-sha256-21ff4c0ca1ae8928d91759.txt","comments":"\"The FDA requires INOVIO to submit a draft protocol for the study by the end of 2026 with the expectation of aligning on a final protocol by mid-2027\" (confirmatory study for VOCERYQ). Window per \"by the end of 2026\".","closed":0,"created_at":"2026-10-30","updated_at":"2026-10-30","company":"Inovio Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-30 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":752,"symbol":"IPSC","drug":"CNTY-813","modality":"cell_therapy","area":"metabolic","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261002_081825_(IPSC)_sec_0001104659-26-113055-ex991.txt","comments":"\"We remain on track to submit the CNTY-813 IND in the fourth quarter of this year\" — reaffirmed 2026-10-02 EASD 2026 release (\"CNTY-813 IND submission remains on track for Q4 2026\"). Also in 2026-08-12 8-K/10-Q. iPSC-derived islet replacement for T1D; subject to completion of remaining IND-enabling studies.","closed":0,"created_at":"2026-10-25 11:52:23","updated_at":"2026-10-26T14:42:03Z","company":"Century Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":746,"symbol":"IRON","drug":"selcodebart (DISC-0974)","modality":"monoclonal_antibody","area":"hematology","event_type":"other","expect_date_from":"2026-07-30","expect_date_to":"2026-12-31","news_source_file":"documents/20260730_083249_(IRON)_sec_0001193125-26-325031-ex991.txt","comments":"End-of-Phase 2 FDA meeting in anemia of myelofibrosis: \"an end-of-Phase 2 meeting with the FDA expected to occur by year-end\"; 2026-09-10 release says feedback and pivotal plans expected by end of year.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Disc Medicine","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-07-30 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":742,"symbol":"IRON","drug":"bitopertin","modality":"small_molecule","area":"rare_genetic","event_type":"regulatory_submission","expect_date_from":"2026-10-19","expect_date_to":"2026-12-31","news_source_file":"documents/20261019_070808_(IRON)_sec_0001193125-26-424649-ex991.txt","comments":"\"Disc plans to resubmit an NDA to the U.S. FDA by the end of 2026\" (CRL response for bitopertin in EPP); window runs from the 2026-10-19 disclosure date.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25T11:52:02Z","company":"Disc Medicine","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-19 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":18,"symbol":"IVA","drug":"lanifibranor","modality":"small_molecule","area":"gi_hepatology","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260903_060009_(IVA)_sec_0001171843-26-005860-ex991.txt","comments":"\"Inventiva expects to report topline results from NATiV3 in the fourth quarter of 2026, as previously communicated.\" Phase 3 NATiV3 in MASH F2/F3; last patient completed final 72-week visit. Repeated in 2026-09-28 and 2026-10-06 releases.","closed":0,"created_at":"2026-10-25 09:53:21","updated_at":"2026-10-25 09:53:21","company":"Inventiva S.A. American Depository Shares","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.8,"llm_reason":"NATiV3 is a binary pivotal Phase 3 readout for Inventiva's single-asset company (~$850M cap), so a move of 10% or more is very likely either way. Direction is uncertain: the Phase 2b NATIVE data were positive, but Phase 3 MASH biopsy endpoints are risky and Rezdiffra and GLP-1 competition sets a high bar.","llm_predicted_at":"2026-10-25T15:48:22Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":724,"symbol":"JSPR","drug":"vensobafusp alfa","modality":"bispecific","area":"renal","event_type":"interim_analysis","expect_date_from":"2026-10-15","expect_date_to":"2026-12-31","news_source_file":"documents/20261015_080017_(JSPR)_sec_0001213900-26-109587-ex991.txt","comments":"\"The Company expects to report initial interim data from the IgAN basket study by year-end 2026.\" Stage 1 IgAN cohort (n=18) enrollment complete; window is document date through 2026-12-31.","closed":0,"created_at":"2026-10-25 07:50:14","updated_at":"2026-10-25 07:50:14","company":"Jasper Therapeutics","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.6,"llm_reason":"Micro-cap ($16M) with the merged pipeline now centered on vensobafusp alfa. Initial IgAN interim data from 18 patients in China is likely to drive a large move. Direction is uncertain: proteinuria results could spark a rally, but a financing overhang risks a drop.","llm_predicted_at":"2026-10-25T15:51:17Z","llm_source":"live","window":"2026-10-15 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":705,"symbol":"KOD","drug":"tarcocimab tedromer","modality":"monoclonal_antibody","area":"ophthalmology","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260928_085356_(KOD)_sec_0001193125-26-403481-ex991.txt","comments":"\"Zenkuda multi-indication biologics license application (BLA) planned for the fourth quarter of 2026\" covering wAMD, DR and RVO (five Phase 3 studies).","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Kodiak Sciences","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":704,"symbol":"KOD","drug":"KSI-101","modality":"bispecific","area":"ophthalmology","event_type":"topline_results","expect_date_from":"2026-12-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260928_085356_(KOD)_sec_0001193125-26-403481-ex991.txt","comments":"\"we remain on track to announce topline data in December 2026 for KSI-101 in the Phase 3 PEAK study in patients with macular edema secondary to inflammation (MESI)\" (Pivotal Analysis 1).","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Kodiak Sciences","tier":"Core","llm_prediction":"small_impact","llm_confidence":0.45,"llm_reason":"The PEAK Phase 3 readout for KSI-101 in MESI compares the drug against sham, which gives it a high probability of success. Earlier data suggested strong efficacy. With a ~$5.4B market cap driven mainly by Zenkuda, a positive result is likely priced in. Only a failure would probably move the stock 10% or more.","llm_predicted_at":"2026-10-25T15:51:12Z","llm_source":"live","window":"2026-12-01 → 2026-12-31","imminence":56,"state":"upcoming","overdue":false},{"id":708,"symbol":"KPTI","drug":"selinexor","modality":"small_molecule","area":"hematology","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260813_073730_(KPTI)_sec_0001193125-26-347897-ex991.txt","comments":"\"Topline data from the Phase 2 SENTRY-2 60 mg cohort expected in the second half of 2026.\" Selinexor monotherapy in JAKi-naive myelofibrosis with moderate thrombocytopenia; 60 mg cohort fully enrolled. Window per \"second half of 2026\".","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Karyopharm Therapeutics","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.6,"llm_reason":"The ~$12M market cap, going-concern doubt and a looming debt default make any readout highly volatile. The pending topline is most likely EMN29 or SENTRY-2. A positive result could spark a squeeze and a negative one could drive the stock toward zero, so the direction is uncertain.","llm_predicted_at":"2026-10-25T15:51:14Z","llm_source":"live","window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":710,"symbol":"KPTI","drug":"selinexor + pomalidomide + dexamethasone","modality":"small_molecule","area":"hematology","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260813_073730_(KPTI)_sec_0001193125-26-347897-ex991.txt","comments":"\"Announce topline data from the event-driven Phase 3 XPORT-MM-031 (EMN29) trial expected in the second half of 2026.\" All-oral selinexor 40 mg + pomalidomide + dexamethasone vs elotuzumab + pomalidomide + dexamethasone in previously treated myeloma; trial sponsored by the European Myeloma Network, KPTI guides the readout. Window per \"second half of 2026\".","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Karyopharm Therapeutics","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.6,"llm_reason":"Micro-cap (~$12M) with going-concern risk and an imminent debt covenant default. A Phase 3 SPd readout in myeloma would supports XPOVIO's core revenue, so either a positive or a negative result could plausibly move the stock 10% or more. Direction is uncertain given the competitive myeloma market and the overhang from financing and restructuring.","llm_predicted_at":"2026-10-25T15:51:15Z","llm_source":"live","window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":711,"symbol":"KPTI","drug":"selinexor","modality":"small_molecule","area":"hematology","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260831_080849_(KPTI)_sec_0001193125-26-375495.txt","comments":"sNDA (selinexor + ruxolitinib, myelofibrosis, accelerated approval) submitted Aug 31, 2026 with Priority Review request; \"expects to receive notice of the FDA's decision on sNDA filing acceptance and, if accepted, the anticipated review timelines in the fourth quarter of 2026\". Window = Q4 2026.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Karyopharm Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":689,"symbol":"KRYS","drug":"KB111","modality":"gene_therapy","area":"dermatology","event_type":"interim_analysis","expect_date_from":"2026-08-03","expect_date_to":"2026-12-31","news_source_file":"documents/20261102_070715_(KRYS)_sec_0001711279-26-000072.txt","comments":"Q3 2026 release (Nov 2, 2026) reaffirms: \"The Company expects to report interim study results before the end of the year\" (HALITE-1, KB111 in HHD; enrollment complete at 5 patients, dosing ongoing; window runs from the Aug 3, 2026 guidance date). 10-Q: \"We expect to report HALITE-1 interim study results before the end of the year.\"","closed":0,"created_at":"2026-10-25 11:49:21","updated_at":"2026-11-04T19:55:46Z","company":"Krystal Biotech","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.88,"llm_reason":"KB111 interim data comes from a small, open-label, safety-focused study of about seven patients in Hailey-Hailey disease, a niche indication. Krystal is a profitable ~$9.5B company with strong VYJUVEK revenue and many other catalysts, so this readout is unlikely to move the stock 10%.","llm_predicted_at":"2026-10-25T15:51:06Z","llm_source":"live","window":"2026-08-03 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":693,"symbol":"KRYS","drug":"KB707","modality":"gene_therapy","area":"oncology","event_type":"interim_analysis","expect_date_from":"2026-08-03","expect_date_to":"2026-12-31","news_source_file":"documents/20260803_070402_(KRYS)_sec_0001711279-26-000058-ex991.txt","comments":"\"expects to provide an interim clinical update on these patients as well as outline potential development plans for intratumoral KB707 for the treatment of Gorlin syndrome later this year\" (3 patients enrolled in OPAL-1, NCT05970497). \"Later this year\" from Aug 3, 2026 release. | Caveat: the Q3 2026 release (Nov 2, 2026) did not reaffirm this intratumoral KB707 update; no newer timing given.","closed":0,"created_at":"2026-10-25 11:49:24","updated_at":"2026-11-04T19:55:46Z","company":"Krystal Biotech","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.8,"llm_reason":"The KB707 interim update is most likely the small Gorlin syndrome cohort (3 patients) for intratumoral dosing, a niche program. Krystal is a ~$9.5B profitable company whose value rests on VYJUVEK, so this readout is unlikely to move the stock 10% either way.","llm_predicted_at":"2026-10-25T15:51:09Z","llm_source":"live","window":"2026-08-03 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":690,"symbol":"KURA","drug":"ziftomenib","modality":"small_molecule","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261104_090200_(KURA)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","comments":"2H 2026 \"anticipated presentation of\": (1) updated long-term KOMET-007 Ph1b ziftomenib+venetoclax/azacitidine data; (2) initial KOMET-007 ziftomenib+7+3+quizartinib data; (3) initial KOMET-008 ziftomenib+gilteritinib data; (4) KOMET-001 MEIS1-associated exploratory analysis. Guided window preserved; specific ASH 2026 dates tracked in separate event.","closed":0,"created_at":"2026-10-25 11:49:22","updated_at":"2026-11-04T17:49:24Z","company":"Kura Oncology","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":677,"symbol":"KYNB","drug":"FG-3246","modality":"adc","area":"oncology","event_type":"interim_analysis","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260813_160516_(KYNB)_sec_0001193125-26-349141-ex991.txt","comments":"\"Interim analysis is on track for the fourth quarter of 2026\" (Phase 2 monotherapy trial in mCRPC); reconfirmed \"on track for the fourth quarter of this year\" in Aug 31, 2026 release. 4Q 2026 = 2026-10-01..2026-12-31.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Kyntra Bio","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.55,"llm_reason":"At a ~$21M market cap with ~$96M in cash, KYNB trades well below cash, and FG-3246 is its main value driver. An interim readout in mCRPC could move the stock sharply either way. Phase 2 interim data from a CD46 ADC is uncertain.","llm_predicted_at":"2026-10-25T15:50:59Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":683,"symbol":"KYTX","drug":"mivocabtagene autoleucel","modality":"cell_therapy","area":"cns","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260924_060027_(KYTX)_sec_0001193125-26-400062-ex991.txt","comments":"\"rolling BLA submission on track for completion in Q4 2026\" for miv-cel in SPS; one-year KYSA-8 data to be included. Window = Q4 2026 (per accuracy rules).","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Kyverna Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":684,"symbol":"KYTX","drug":"mivocabtagene autoleucel","modality":"cell_therapy","area":"cns","event_type":"data_presentation","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260811_160443_(KYTX)_sec_0001193125-26-344572-ex991.txt","comments":"\"additional data from the Stanford Phase 1 IIT in Q4 2026\" in progressive MS (investigator-initiated). Window = Q4 2026.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Kyverna Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":1116,"symbol":"LGND","drug":"ersodetug","modality":"monoclonal_antibody","area":"metabolic","event_type":"topline_results","expect_date_from":"2026-12-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261029_071444_(LGND)_sec_0000886163-26-000058.txt","comments":"Q3 2026 release: \"On October 14, 2026, Rezolute announced completion of enrollment in the Phase 3 study of ersodetug in tumor HI and topline data is expected mid-December 2026.\" \"mid-December 2026\" widened to the full month.","closed":0,"created_at":"2026-10-30 13:57:02","updated_at":"2026-10-30 13:57:02","company":"Ligand Pharmaceuticals","tier":"Core","llm_prediction":"small_impact","llm_confidence":0.9,"llm_reason":"Ligand is a $6B diversified royalty aggregator with over 200 assets. Ersodetug is a single Rezolute-partnered royalty asset, and the tumor HI Phase 3 readout is unlikely to move LGND 10% in either direction.","llm_predicted_at":"2026-10-30T13:57:57Z","llm_source":"live","window":"2026-12-01 → 2026-12-31","imminence":56,"state":"upcoming","overdue":false},{"id":669,"symbol":"LRMR","drug":"nomlabofusp","modality":"protein","area":"rare_genetic","event_type":"regulatory_submission","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260804_070252_(LRMR)_sec_0001193125-26-331516-ex991.txt","comments":"\"Rolling BLA submission seeking accelerated approval underway, with the first module submitted and completion expected 2H 2026\" (Q2 2026 release; first module submitted June 2026).","closed":0,"created_at":"2026-10-25 07:46:30","updated_at":"2026-10-25 07:46:30","company":"Larimar Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":663,"symbol":"LXEO","drug":"LX2020","modality":"gene_therapy","area":"cardiovascular","event_type":"interim_analysis","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260812_070257_(LXEO)_sec_0001193125-26-345722-ex991.txt","comments":"\"12-month data update for all high dose participants in Q4 2026\" from ongoing Phase I/II HEROIC-PKP2 trial in PKP2-ACM. Interim update, not topline.","closed":0,"created_at":"2026-10-25 11:46:39","updated_at":"2026-10-25 11:46:39","company":"Lexeo Therapeutics","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.42,"llm_reason":"Market cap (~$237M) roughly equals cash (~$234M), so LX2020 is being priced near zero. A Q4 2026 12-month update on all high-dose PKP2-ACM patients is a key value driver for a small-cap gene therapy company, and such readouts often move the stock more than 10%. The direction is uncertain: RMAT designation suggests the interim signal was positive, but past Lexeo data readouts have drawn mixed or sell-the-news reactions.","llm_predicted_at":"2026-10-25T15:50:57Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":1013,"symbol":"LYEL","drug":"ronde-cel","modality":"cell_therapy","area":"hematology","event_type":"interim_analysis","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260806_162705_(LYEL)_sec_0001628280-26-054367.txt","comments":"10-Q (Aug 6, 2026): \"A progress update from the PiNACLE-H2H trial is expected in the second half of 2026.\" Phase 3 head-to-head ronde-cel vs axi-cel/liso-cel in 2L LBCL; progress update, not pivotal data (pivotal PiNACLE 3L+ data guided to mid-2027).","closed":0,"created_at":"2026-10-25 16:08:06","updated_at":"2026-10-25 16:08:06","company":"Lyell Immunopharma","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.55,"llm_reason":"The 2H26 event is an interim update from the PiNACLE 3L+ single-arm trial, following strong ASH 2025 data (93% ORR, 76% CR). Such updates are usually confirmatory and partly priced in. The market cap is roughly equal to cash (~$228M), which limits downside, and a durability readout in a CAR-T trial rarely moves the stock 10%. Small-cap volatility still leaves some tail risk.","llm_predicted_at":"2026-10-25T16:10:11Z","llm_source":"live","window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":815,"symbol":"MANE","drug":"VDPHL01","modality":"small_molecule","area":"dermatology","event_type":"topline_results","expect_date_from":"2026-10-19","expect_date_to":"2026-12-31","news_source_file":"documents/20261019_090614_(MANE)_sec_0001827635-26-000036-ex991.txt","comments":"12-month (Part B) data from Phase 2/3 Study '302' in male pattern hair loss. Oct 19, 2026: \"Later this year, we also anticipate reporting the longer-term data from Part B of Study '302', further extending the safety findings of VDPHL01 in males through 12 months\"; Aug 11, 2026 8-K said 12-month data anticipated in 2H26.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Veradermics","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.62,"llm_reason":"At a ~$5.8B valuation, success was largely priced in after the positive Study 302. Study 304 replicates 302 efficacy with clean safety, so a confirmatory result is likely to move the stock modestly, under 10%.","llm_predicted_at":"2026-10-25T15:51:40Z","llm_source":"live","window":"2026-10-19 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":656,"symbol":"MBX","drug":"MBX 4291","modality":"peptide","area":"metabolic","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260806_080359_(MBX)_sec_0001193125-26-336841-ex991.txt","comments":"Q2 2026 release: \"The Company remains on track to report data from the first cohort of the 12-week MAD (Part C) in Q4 2026.\" Cohort C1 evaluates a 30 mg (once-weekly x 4) + 120 mg and 180 mg (once-monthly) titration regimen in adults with obesity (BMI >= 30). Window = Q4 2026.","closed":0,"created_at":"2026-10-25 07:45:57","updated_at":"2026-10-25 07:45:57","company":"MBX Biosciences","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.55,"llm_reason":"MBX is a ~$2.4B company whose valuation rests heavily on the once-monthly obesity asset. Early obesity MAD readouts are binary-ish catalysts, and the bar is high after blinded 7% weight loss at 8 weeks. Cohort-level weight loss and tolerability versus monthly competitors could move the stock sharply either way.","llm_predicted_at":"2026-10-25T15:50:55Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":649,"symbol":"MGNX","drug":"MGC028","modality":"adc","area":"oncology","event_type":"topline_results","expect_date_from":"2026-11-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260813_160752_(MGNX)_sec_0001125345-26-000054-ex991.txt","comments":"\"The dose escalation study of MGC028 is ongoing and the Company anticipates providing an update with preliminary clinical results in late 2026.\" Late 2026 = Nov 1-Dec 31, 2026.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"MacroGenics","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.55,"llm_reason":"Market cap ~$231M against pro forma cash of $327M, so the stock trades below cash. The readout is preliminary Phase 1 dose-escalation data for a first-in-class ADAM9 ADC, which tends to be modest and ambiguous. The stock could still move sharply on a microcap with a cash floor, but a sub-10% reaction seems likeliest.","llm_predicted_at":"2026-10-25T15:50:52Z","llm_source":"live","window":"2026-11-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":642,"symbol":"MGTX","drug":"botaretigene sparoparvovec (bota-vec)","modality":"gene_therapy","area":"ophthalmology","event_type":"regulatory_submission","expect_date_from":"2026-08-13","expect_date_to":"2026-12-31","news_source_file":"documents/20260813_080559_(MGTX)_sec_0001104659-26-095491-ex991.txt","comments":"Q2 2026 PR: \"Anticipate submission of global regulatory filings for approval of bota-vec in 2026\"; CEO: \"working expeditiously to submit regulatory filings for bota-vec this year\". Global (US/EU) filings for XLRP; window = document date..2026-12-31.","closed":0,"created_at":"2026-10-25 11:45:28","updated_at":"2026-10-25 11:45:28","company":"MeiraGTx Holdings","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-08-13 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":626,"symbol":"MGX","drug":"MGX-001","modality":"gene_therapy","area":"hematology","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260810_161039_(MGX)_sec_0001193125-26-342388-ex991.txt","comments":"\"Remains on track to submit an investigational new drug (IND) application in 4Q 2026 for the global clinical program of MGX-001 for the treatment of hemophilia A\" (Q2 2026 release, 2026-08-10); reaffirmed in Sept 2026 deck (\"IND Filing Q4 26\") and in the Nov 4, 2026 release (\"subject to regulatory clearance, the Company plans to initiate a global clinical trial in 2027\").","closed":0,"created_at":"2026-10-25T07:44:47","updated_at":"2026-11-05T04:16:12Z","company":"Metagenomi Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":635,"symbol":"MIRM","drug":"brelovitug","modality":"monoclonal_antibody","area":"infectious","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260928_080247_(MIRM)_sec_0001759425-26-000049.txt","comments":"8-K: \"Topline results from the Phase 3 AZURE-4 study ... are expected in the fourth quarter of 2026.\"","closed":0,"created_at":"2026-10-25 11:45:03","updated_at":"2026-10-25 11:45:03","company":"Mirum Pharmaceuticals","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.68,"llm_reason":"The event being predicted is AZURE-4 topline in Q4 2026. AZURE-1 Phase 3 already met its primary endpoint with strong data, so the mechanism is largely de-risked and AZURE-4 is expected to confirm it. For a $5.4B company with multiple commercial products, a confirmatory success likely moves the stock less than 10%.","llm_predicted_at":"2026-10-25T15:50:48Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":623,"symbol":"MNKD","drug":"Ralinepag DPI (MNKD-1501)","modality":"small_molecule","area":"cardiovascular","event_type":"regulatory_submission","expect_date_from":"2026-08-05","expect_date_to":"2026-12-31","news_source_file":"documents/20260805_160326_(MNKD)_sec_0001193125-26-335016-ex991.txt","comments":"\"On track for IND filing by year end\" (Q2 2026 release dated August 5, 2026). Window = document date through end of 2026; no specific month stated.","closed":0,"created_at":"2026-10-25 11:44:37","updated_at":"2026-10-25 11:44:37","company":"MannKind","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-08-05 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":622,"symbol":"MNPR","drug":"ALXN1840","modality":"small_molecule","area":"rare_genetic","event_type":"regulatory_submission","expect_date_from":"2026-08-12","expect_date_to":"2026-12-31","news_source_file":"documents/20260812_093034_(MNPR)_sec_0001437749-26-027164.txt","comments":"\"We announced on July 22, 2026, that we have initiated a rolling submission of our NDA for ALXN1840, and we anticipate completing the submission within the next few months\" (10-Q, Aug 12, 2026). Caveat: no assurance FDA will accept the NDA for filing or approve it.","closed":0,"created_at":"2026-10-25 11:44:31","updated_at":"2026-10-25 11:44:31","company":"Monopar Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-08-12 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":617,"symbol":"NAMS","drug":"obicetrapib","modality":"small_molecule","area":"metabolic","event_type":"topline_results","expect_date_from":"2026-08-05","expect_date_to":"2026-12-31","news_source_file":"documents/20260805_070816_(NAMS)_sec_0001193125-26-333827-ex991.txt","comments":"\"Topline data from RUBENS Phase 3 expected around year-end 2026\" (Q3 2026 release, Nov 4 2026); RUBENS evaluates obicetrapib alone or with ezetimibe in T2D/metabolic syndrome; enrollment completed Aug 2026 (n=347).","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-04T17:50:07Z","company":"NewAmsterdam Pharma","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.8,"llm_reason":"The event is most likely the RUBENS Phase 3 topline, expected by year-end 2026. RUBENS is a ~300-patient LDL-C trial in diabetes or metabolic syndrome, and obicetrapib's LDL-lowering is already well established across several Phase 3 trials. A positive result is largely expected, and the PREVAIL outcomes interim is the real value driver, so the move should stay under 10%.","llm_predicted_at":"2026-10-25T15:50:45Z","llm_source":"live","window":"2026-08-05 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":1220,"symbol":"NAMS","drug":"obicetrapib","modality":"small_molecule","area":"metabolic","event_type":"other","expect_date_from":"2026-11-04","expect_date_to":"2026-12-31","news_source_file":"documents/20261104_074034_(NAMS)_sec_0001193125-26-446228.txt","comments":"10-Q: \"We anticipate that Menarini will receive decisions from regulators in Switzerland and the UK later this year.\" Regulatory decisions on Ubeslo/Evlarco MAAs under Menarini in Menarini territory; Swiss and UK decisions covered together.","closed":0,"created_at":"2026-11-04 17:50:05","updated_at":"2026-11-04 17:50:05","company":"NewAmsterdam Pharma","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-04 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":609,"symbol":"NKTX","drug":"NKX019","modality":"cell_therapy","area":"immunology","event_type":"data_presentation","expect_date_from":"2026-08-10","expect_date_to":"2026-12-31","news_source_file":"documents/20260810_161221_(NKTX)_sec_0001193125-26-342402-ex991.txt","comments":"\"Initial clinical data from Ntrust-1 and Ntrust-2 are planned for presentation at a medical conference in 2026.\" Exact conference/date not disclosed; window starts at 8-K date (2026-08-10). Q2 2026 8-K/10-Q. Superseded in specificity by the ACR Convergence 2026 guidance (Nov 2026).","closed":0,"created_at":"2026-10-25 11:42:17","updated_at":"2026-10-25T13:22:12Z","company":"Nkarta","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-08-10 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":607,"symbol":"NMRA","drug":"NMRA-898","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260814_071322_(NMRA)_sec_0001193125-26-350349-ex991.txt","comments":"\"Neumora is conducting a MAD study with NMRA-898 in healthy volunteers and patients with stable schizophrenia and expects to report data from the study in the second half of 2026.\" Window per stated \"second half of 2026\".","closed":0,"created_at":"2026-10-25 11:41:51","updated_at":"2026-10-25 11:41:51","company":"Neumora Therapeutics","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.5,"llm_reason":"Neumora has a $76M market cap, which is below its $117M cash, so the stock reacts strongly to catalysts. NMRA-898 is an M4 PAM in a hot space that is read against emraclidine and other M4 programs. Its Phase 1 MAD readout in schizophrenia patients could move the stock sharply either way, depending on PANSS signals and tolerability.","llm_predicted_at":"2026-10-25T15:50:43Z","llm_source":"live","window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":606,"symbol":"NMRA","drug":"NMRA-511","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260814_071322_(NMRA)_sec_0001193125-26-350349-ex991.txt","comments":"\"Neumora plans to report data from a MAD expansion cohort evaluating higher doses of NMRA-511 in healthy elderly participants in the fourth quarter of 2026\" (Q2 2026 8-K, Aug 14 2026).","closed":0,"created_at":"2026-10-25 11:41:51","updated_at":"2026-10-25 11:41:51","company":"Neumora Therapeutics","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.5,"llm_reason":"The NMRA-511 readout is a MAD expansion cohort of higher doses in healthy elderly volunteers. That is a safety and PK update rather than an efficacy readout, so a modest move is most likely. The ~$76M market cap, below the $117M cash balance, leaves room for volatility, but the low information content of the data argues against a 10%+ move.","llm_predicted_at":"2026-10-25T15:50:42Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":608,"symbol":"NMRA","drug":"NMRA-215","modality":"small_molecule","area":"metabolic","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260727_070730_(NMRA)_sec_0001193125-26-316819-ex991.txt","comments":"\"plans to submit an IND application for NMRA-215 in the fourth quarter of 2026\"; reaffirmed in Aug 14 2026 8-K (\"expects to submit an IND in the fourth quarter of 2026\").","closed":0,"created_at":"2026-10-25 11:41:54","updated_at":"2026-10-25 11:41:54","company":"Neumora Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":589,"symbol":"NVCT","drug":"ciprocopan (NXP100)","modality":"small_molecule","area":"hematology","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261104_070000_(NVCT)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","comments":"\"We plan to submit a U.S. IND for NXP100 by year-end\" (Q3 2026 release, Nov 4, 2026) and \"an IND submission, for an indication beyond PNH, is expected by year-end.\" Window kept from the original Q4 2026 guidance; reaffirmed Nov 4, 2026.","closed":0,"created_at":"2026-10-25 11:40:47","updated_at":"2026-11-05T08:23:36Z","company":"Nuvectis Pharma","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":590,"symbol":"NVCT","drug":"NXP200","modality":"small_molecule","area":"oncology","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261104_070000_(NVCT)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","comments":"\"We expect to submit a U.S. IND for NXP200 by year-end\" (Q3 2026 release, Nov 4, 2026) and \"A U.S. IND submission is expected by year-end.\" 4Q2026 = 2026-10-01..2026-12-31.","closed":0,"created_at":"2026-10-25 11:40:47","updated_at":"2026-11-04T17:50:21Z","company":"Nuvectis Pharma","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":1222,"symbol":"NVCT","drug":"ciprocopan (NXP100)","modality":"small_molecule","area":"hematology","event_type":"other","expect_date_from":"2026-11-04","expect_date_to":"2026-12-31","news_source_file":"documents/20261104_070000_(NVCT)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","comments":"FDA discussions on U.S. regulatory path for ciprocopan in PNH: \"an update is expected by year-end.\" By-end-2026 window measured from Nov 4, 2026 release. Regulatory update, not a data readout.","closed":0,"created_at":"2026-11-04T12:50:00Z","updated_at":"2026-11-04T12:50:00Z","company":"Nuvectis Pharma","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-04 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":577,"symbol":"OCS","drug":"Privosegtor","modality":"small_molecule","area":"cns","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260810_080002_(OCS)_sec_0001193125-26-341298-ex991.txt","comments":"Planned IND submission for Privosegtor in acute MS relapses: \"a planned IND submission in the fourth quarter of 2026\" (Aug 10, 2026 6-K). Q3 2026 release (Nov 3, 2026) now says \"IND clearance to initiate trials in acute MS relapses is expected in Q4 2026\", consistent with submission already made. Window unchanged: 2026-10-01..2026-12-31.","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-04T19:55:02Z","company":"Oculis Holding","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":575,"symbol":"OCUL","drug":"AXPAXLI","modality":"small_molecule","area":"ophthalmology","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260803_070736_(OCUL)_sec_0001104659-26-089443-ex991.txt","comments":"\"New Drug Application (NDA) submission for AXPAXLI in wet AMD planned for Q4 2026\" under 505(b)(2) pathway; pre-NDA meeting was scheduled for Q3 2026. NDA based on SOL-1 Week 52 data, interim SOL-R safety, confirmatory evidence.","closed":0,"created_at":"2026-10-25 11:39:44","updated_at":"2026-10-25 11:39:44","company":"Ocular Therapeutix","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":739,"symbol":"ODTX","drug":"OD-002","modality":"small_molecule","area":"immunology","event_type":"regulatory_submission","expect_date_from":"2026-08-04","expect_date_to":"2026-12-31","news_source_file":"documents/20260804_070016_(ODTX)_sec_0001193125-26-331512-ex991.txt","comments":"OD-002 (oral SLC15A4 inhibitor) CTA filing: \"we plan to file a CTA for our second clinical program, OD-002 ... by the end of this year.\" \"By the end of 2026\" = document date..2026-12-31; Sept 2026 deck states only \"H2 2026: CTA filing\". Preclinical program - no clinical data implied.","closed":0,"created_at":"2026-10-25 08:02:00","updated_at":"2026-10-25 08:02:00","company":"Odyssey Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-08-04 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":559,"symbol":"ORKA","drug":"ORKA-001","modality":"monoclonal_antibody","area":"dermatology","event_type":"interim_analysis","expect_date_from":"2026-12-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260810_070041_(ORKA)_sec_0001213900-26-086933-ex991.txt","comments":"\"The Company also expects to report 52-week data from EVERLAST-A for all participants in December 2026.\" 10-Q phrases it as \"by the end of 2026\".","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Oruka Therapeutics","tier":"Core","llm_prediction":"small_impact","llm_confidence":0.62,"llm_reason":"The December event is the EVERLAST-A 52-week durability update, following strong Week 16 data and an earlier Week 28 look, so much of the efficacy is already known and priced in. The company is large ($5.4B) and well funded. EVERLAST-B Week 16 data may land in the same window and could add volatility, but the most likely outcome is a modest move.","llm_predicted_at":"2026-10-25T15:50:32Z","llm_source":"live","window":"2026-12-01 → 2026-12-31","imminence":56,"state":"upcoming","overdue":false},{"id":551,"symbol":"OSTX","drug":"OST-HER2","modality":"vaccine","area":"oncology","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261019_084716_(OSTX)_sec_0001213900-26-110497-ex991.txt","comments":"\"reiterates its intention to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) under the Accelerated Approval Program ... and Conditional Marketing Authorisation Applications ... to the U.K. MHRA, EMA and Australian TGA in the fourth quarter of 2026\"; headline: \"early market access regulatory approval submissions ... in the fourth quarter of 2026\". Guidance window only, no fixed filing date. Earlier 10-Q guided MHRA/EMA MAAs to Q1 2027.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"OS Therapies","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":550,"symbol":"OVID","drug":"OV329","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2026-11-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260813_083209_(OVID)_sec_0001628280-26-056497-ex991.txt","comments":"Q2 2026 release: photo stimulation proof-of-mechanism study of OV329 (5, 7, 9 mg) initiated; \"anticipates results near year end 2026\" -> late 2026 window. Not otherwise dated.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Ovid Therapeutics","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.55,"llm_reason":"The year-end OV329 readout is an exploratory photosensitivity proof-of-mechanism study. This model is well validated, and the GABA-AT mechanism already has precedent with vigabatrin, so a positive result is largely expected. The larger value driver is the 2027 FOS Phase 2 and the KCC2 program. A $463M market cap with $170M cash also cushions the stock. A modest move is most likely, though a clear miss could still cause a sharp drop.","llm_predicted_at":"2026-10-25T15:50:34Z","llm_source":"live","window":"2026-11-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":527,"symbol":"PGEN","drug":"PRGN-2009","modality":"other","area":"oncology","event_type":"other","expect_date_from":"2026-08-04","expect_date_to":"2026-12-31","news_source_file":"documents/20260804_160536_(PGEN)_sec_0000950103-26-011876-ex991.txt","comments":"\"The Company plans to provide an update on progress across the AdenoVerse portfolio, including PRGN-2009, by the end of the year.\" Broad pipeline update (PRGN-2009 Ph2 in HPV+ oropharyngeal and cervic Q3 2026 results/business update call set for 2026-11-04 (Yahoo 2026-10-28); no specific PRGN-2009 data date given.","closed":0,"created_at":"2026-10-25 11:36:29","updated_at":"2026-11-02T09:39:58Z","company":"Precigen","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-08-04 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":645,"symbol":"PHAT","drug":"vonoprazan","modality":"small_molecule","area":"gi_hepatology","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261029_070000_(PHAT)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","comments":"\"Phathom expects to report topline results during the fourth quarter 2026 for the 12-week blinded treatment portion of its Phase 2 pHalcon-EoE-201 trial evaluating VOQUEZNA in patients with EoE\" (Q3 2026 release; window unchanged).","closed":0,"created_at":"2026-10-25 11:45:28","updated_at":"2026-10-29T13:07:39Z","company":"Phathom Pharmaceuticals","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.72,"llm_reason":"The Q4 2026 catalyst is the Phase 2 EoE topline readout for vonoprazan, an already-approved, revenue-generating drug. The company's value rests mainly on VOQUEZNA GERD sales, and EoE is a modest label expansion, so the stock will likely move less than 10% either way.","llm_predicted_at":"2026-10-25T15:50:53Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":510,"symbol":"PRAX","drug":"relutrigine","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260806_083228_(PRAX)_sec_0001689548-26-000083.txt","comments":"10-Q: EMERALD study in broad DEEs \"has completed recruitment, with topline results anticipated in the fourth quarter of 2026.\"","closed":0,"created_at":"2026-10-25 11:35:05","updated_at":"2026-10-25 11:35:05","company":"Praxis Precision Medicines","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.62,"llm_reason":"EMERALD broad-DEE topline is a label-expansion readout for relutrigine, which already has an NDA under review. At a ~$7.2B cap, value is spread across a diversified pipeline, including ulixacaltamide with a PDUFA date in January 2027, which likely limits the first-session move.","llm_predicted_at":"2026-10-25T15:50:28Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":492,"symbol":"PRQR","drug":"AX-0810","modality":"aso","area":"gi_hepatology","event_type":"data_presentation","expect_date_from":"2026-08-13","expect_date_to":"2026-12-31","news_source_file":"documents/20260813_070008_(PRQR)_sec_0001104659-26-095422-ex991.txt","comments":"Q2 2026 release: \"ProQR plans to present the full dataset from the Phase 1 study of AX-0810, including Cohort 3, at a medical or scientific conference later this year\". Now specified by the Oct 28, 2026 6-K: AASLD posters Nov 5 and Nov 8, 2026 (#1079) and Cohort 3 + 12-week follow-up at Nature RNA at the Bench and Bedside V on Dec 9, 2026 (#1080). Kept open; outcomes recorded against those dated events.","closed":0,"created_at":"2026-10-25 11:34:31","updated_at":"2026-11-03T08:29:45Z","company":"ProQR Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-08-13 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":490,"symbol":"PTCT","drug":"ST-920","modality":"gene_therapy","area":"rare_genetic","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261029_161020_(PTCT)_sec_0001104659-26-120200-ex991.txt","comments":"8-K Ex-99.1 (Oct 29 2026): \"ST-920 Fabry disease BLA submission expected to be completed in Q4 2026\"; \"Potential FDA accelerated approval and commercial launch in 2027.\" Completion of rolling BLA submission (not an approval). Q4 2026 = 2026-10-01..2026-12-31.","closed":0,"created_at":"2026-10-25 11:34:24","updated_at":"2026-10-30T16:02:46Z","company":"PTC Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":482,"symbol":"PYXS","drug":"micvotabart pelidotin (MICVO) + pembrolizumab","modality":"adc","area":"oncology","event_type":"interim_analysis","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260702_162052_(PYXS)_sec_0001193125-26-294613-ex991.txt","comments":"\"also expects to report updated data from the ongoing Phase 1/2 dose-escalation study evaluating MICVO in combination with pembrolizumab for first-line (1L) R/M HNSCC in the fourth quarter of 2026\"","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Pyxis Oncology","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.45,"llm_reason":"PYXS is a ~$200M small-cap whose value rests almost entirely on MICVO. The Q4 2026 1L HNSCC combination update with pembrolizumab is a key readout, so a move of 10% or more is likely. Direction is uncertain: the monotherapy update in the fall may already have set expectations, and dose-cap and safety questions remain.","llm_predicted_at":"2026-10-25T15:50:21Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":1191,"symbol":"QTTB","drug":"bempikibart","modality":"monoclonal_antibody","area":"dermatology","event_type":"other","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261104_070352_(QTTB)_sec_0001193125-26-446183.txt","comments":"Q3 2026 8-K: registration-directed program in severe/very severe AA \"expected to initiate in the first half of 2027 subject to planned regulatory discussions in the fourth quarter of 2026.\" Regulatory interaction window only; no FDA decision or data outcome guided.","closed":0,"created_at":"2026-11-04T08:37:02Z","updated_at":"2026-11-04T08:37:02Z","company":"Q32 Bio","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":467,"symbol":"RANI","drug":"RT-114","modality":"peptide","area":"metabolic","event_type":"interim_analysis","expect_date_from":"2026-08-13","expect_date_to":"2026-12-31","news_source_file":"documents/20260813_161112_(RANI)_sec_0001193125-26-349197-ex991.txt","comments":"\"additional data from the dose expansion cohort expected by the end of 2026\"; first participants in Phase 1a expansion cohort (15 healthy volunteers) dosed. Positive initial Phase 1a single-dose data (>150% oral bioavailability vs SC) were first reported July 2026 (recap only in this filing).","closed":0,"created_at":"2026-10-25 11:32:50","updated_at":"2026-10-25 11:32:50","company":"Rani Therapeutics Holdings","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.55,"llm_reason":"The upcoming readout is additional PK data from a 15-subject healthy-volunteer expansion cohort. The initial Phase 1a data, showing bioavailability above 150% of subcutaneous dosing, are already public, so a confirmatory PK update is likely low surprise. Microcaps can be volatile, but a modest move is the most probable outcome.","llm_predicted_at":"2026-10-25T15:50:13Z","llm_source":"live","window":"2026-08-13 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":463,"symbol":"RAPP","drug":"RAP-219","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261104_071215_(RAPP)_sec_0001193125-26-446202.txt","comments":"FOS open-label long-term safety trial: \"Initial data from the open-label long-term safety trial in patients from the Phase 2a trial in FOS are expected in the fourth quarter of 2026\" (Q3 2026 8-K EX-99.1, Nov 4, 2026; first guided Oct 20, 2026).","closed":0,"created_at":"2026-10-25 11:32:36","updated_at":"2026-11-04T15:45:07Z","company":"Rapport Therapeutics","tier":"Watch","llm_prediction":"large_downside","llm_confidence":0.6,"llm_reason":"The trial technically hit its endpoint, but the 3.1-point placebo-adjusted YMRS gain (p=0.045) is weaker than typical mania benchmarks, and agitation was higher on drug. The market will likely read this as underwhelming.","llm_predicted_at":"2026-10-25T15:50:14Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":444,"symbol":"RCKT","drug":"RP-A601","modality":"gene_therapy","area":"cardiovascular","event_type":"other","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260810_161718_(RCKT)_sec_0001140361-26-032028-ex991.txt","comments":"\"Rocket continues to engage with the FDA regarding alignment on the design of a potential pivotal study of RP-A601 in PKP2-ACM with regulatory update expected in the second half of 2026\"","closed":0,"created_at":"2026-10-25 11:31:46","updated_at":"2026-10-25 11:31:46","company":"Rocket Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":431,"symbol":"RGNX","drug":"surabgene lomparvovec","modality":"gene_therapy","area":"ophthalmology","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260806_071016_(RGNX)_sec_0001193125-26-336716-ex991.txt","comments":"\"Topline data from pivotal subretinal wet AMD studies, ATMOSPHERE and ASCENT, expected in Q4 2026\"; Q4 2026 = 2026-10-01..2026-12-31. With AbbVie (ABBV-RGX-314). Reaffirmed Oct 12, 2026: \"topline pivotal data anticipated in the fourth quarter of 2026\". | Reaffirmed Oct 21, 2026 (Oct 20 investor event): \"the company said it ex[pects]... Q4 pivotal readout\" for sura-vec in wet AMD.","closed":0,"created_at":"2026-10-25 11:30:16","updated_at":"2026-10-29T23:35:12Z","company":"REGENXBIO","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.6,"llm_reason":"Market cap is about $473M. Pivotal wet AMD topline data from ATMOSPHERE and ASCENT is the key value driver for the AbbVie-partnered asset. A binary readout like this likely moves the stock at least 10%, but the direction is uncertain: noninferiority to anti-VEGF is plausible, while safety and durability remain risks.","llm_predicted_at":"2026-10-25T15:50:08Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":428,"symbol":"RIGL","drug":"R289","modality":"small_molecule","area":"hematology","event_type":"interim_analysis","expect_date_from":"2026-08-04","expect_date_to":"2026-12-31","news_source_file":"documents/20260804_161016_(RIGL)_sec_0001034842-26-000053-ex991.txt","comments":"Q2 2026 release: dose expansion of Phase 1b in R/R lower-risk MDS \"on track to be completed in the second half of 2026 ... and share preliminary data by year end.\" Window = document date to 2026-12-31 (by year end). Preliminary, not topline. ASH 2026 oral session (PR 2026-11-04) is the announced venue for these Phase 1b data; no data disclosed yet.","closed":0,"created_at":"2026-10-25 11:30:07","updated_at":"2026-11-04T15:44:47Z","company":"Rigel Pharmaceuticals","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.72,"llm_reason":"Rigel is a profitable commercial company valued near $900M on roughly $290M of revenue. The R289 Phase 1b readout in lower-risk MDS is preliminary, and the pipeline asset is a modest share of valuation, so a first-session move under 10% is most likely.","llm_predicted_at":"2026-10-25T15:50:05Z","llm_source":"live","window":"2026-08-04 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":426,"symbol":"RLMD","drug":"NDV-01","modality":"small_molecule","area":"oncology","event_type":"regulatory_submission","expect_date_from":"2026-08-06","expect_date_to":"2026-12-31","news_source_file":"documents/20260806_164040_(RLMD)_sec_0001213900-26-086190-ex991.txt","comments":"\"NDV-01 United States IND filing – By YE26\"; Q2 2026 release dated 2026-08-06. Phase 3 RESCUE initiation has no stated date (only \"upon IND clearance\"), so not dated.","closed":0,"created_at":"2026-10-25 11:29:27","updated_at":"2026-10-25 11:29:27","company":"Relmada Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-08-06 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":427,"symbol":"RLMD","drug":"sepranolone","modality":"small_molecule","area":"rare_genetic","event_type":"regulatory_submission","expect_date_from":"2026-08-06","expect_date_to":"2026-12-31","news_source_file":"documents/20260806_164040_(RLMD)_sec_0001213900-26-086190-ex991.txt","comments":"\"Sepranolone United States IND filing – By YE26\"; formulation development complete, finalizing pre-filled syringe. Phase 2 PWS initiation only \"upon IND clearance\" (no date).","closed":0,"created_at":"2026-10-25 11:29:27","updated_at":"2026-10-25 11:29:27","company":"Relmada Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-08-06 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":414,"symbol":"RNTX","drug":"LTI-03","modality":"peptide","area":"respiratory","event_type":"interim_analysis","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260814_063423_(RNTX)_sec_0001193125-26-350270.txt","comments":"10-Q: \"We expect to report initial interim data on some proportion of patients in the fourth quarter of 2026\" for the RENEW Phase 2 trial (NCT06968845) in IPF. Sept 4, 2026 science deck refers more broadly to Phase 2 data \"in the second half of 2026\"; Q4 window is the stated guidance.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Rein Therapeutics","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.55,"llm_reason":"A ~$52M single-asset micro-cap (cash ~$43.6M, so it trades near cash) is reporting interim Phase 2 IPF data on a subset of patients. Readouts like this typically cause big moves for such stocks. Direction is uncertain: the primary endpoint is safety, and interim FVC/biomarker data could be read either way. Positive biomarker or FVC signals could spark a rally, while noisy or weak efficacy data could drive the stock down.","llm_predicted_at":"2026-10-25T15:50:01Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":396,"symbol":"RXRX","drug":"REC-4881","modality":"small_molecule","area":"gi_hepatology","event_type":"other","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260805_063136_(RXRX)_sec_0001601830-26-000097-ex991.txt","comments":"REC-4881 (MEK1/2, FAP): FDA discussions ongoing; company guided (Nov 2, 2026 8-K) that it \"anticipates initiating a registrational trial in the second half of 2027, pending ongoing FDA discussions, and will provide additional details later this year.\" An update defining the registrational path was expected in 2H26 (=2026-07-01..2026-12-31); not yet resolved.","closed":0,"created_at":"2026-10-25 11:27:18","updated_at":"2026-11-03T04:22:25Z","company":"Recursion Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":392,"symbol":"RZLT","drug":"ersodetug","modality":"monoclonal_antibody","area":"oncology","event_type":"topline_results","expect_date_from":"2026-12-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261014_171148_(RZLT)_sec_0001104659-26-115874-ex991.txt","comments":"\"the open-label Phase 3 study of ersodetug in tumor HI (upLIFT) is now fully enrolled and topline data are expected mid-December 2026\". Enrollment complete per 10/14/26 8-K; earlier guidance (9/24/26 8-K/10-K) said before end of 2026.","closed":0,"created_at":"2026-10-25 11:27:11","updated_at":"2026-10-25 11:27:11","company":"Rezolute","tier":"Core","llm_prediction":"small_impact","llm_confidence":0.45,"llm_reason":"Interim data (7 of 8 responders) means only 2 of the remaining 8 patients must respond to clear the 9/16 threshold. Success is therefore largely expected and priced in, and tumor HI is a small market, which limits upside surprise.","llm_predicted_at":"2026-10-25T15:49:57Z","llm_source":"live","window":"2026-12-01 → 2026-12-31","imminence":56,"state":"upcoming","overdue":false},{"id":389,"symbol":"SANA","drug":"SC451","modality":"cell_therapy","area":"metabolic","event_type":"regulatory_submission","expect_date_from":"2026-01-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260908_080008_(SANA)_sec_0001193125-26-384405-ex991.txt","comments":"\"2026 goal of filing SC451 IND and starting Phase 1/2 trial\" / \"Goal is to file IND and begin Phase 1/2 trial this year\"; HIP iPSC-derived islet cells for type 1 diabetes.","closed":0,"created_at":"2026-10-25 11:26:36","updated_at":"2026-10-25 11:26:36","company":"Sana Biotechnology","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-01-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":1254,"symbol":"SEER","drug":null,"modality":"other","area":"other","event_type":"other","expect_date_from":"2026-11-05","expect_date_to":"2026-12-31","news_source_file":"documents/20261105_070000_(SEER)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"ITC final determination in Seer's patent action vs Nanomics: \"The Commission is expected to reach a final determination by year's end.\" OUII on Oct 30 recommended all remedies sought (exclusion + cease-and-desist); Nanomics defaulted in Sept. Patent/IP regulatory decision, not an FDA action.","closed":0,"created_at":"2026-11-05T07:29:20","updated_at":"2026-11-05T07:29:20","company":"Seer","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-05 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":372,"symbol":"SGMT","drug":"TVB-3567","modality":"small_molecule","area":"dermatology","event_type":"topline_results","expect_date_from":"2026-01-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260930_060956_(SGMT)_sec_0001193125-26-408224-ex991.txt","comments":"\"Phase 1 clinical trial results anticipated in 2026, Phase 2 proof of concept clinical trial anticipated to begin before the end of 2026, subject to regulatory feedback\". Oct 2026 deck notes SAD/MAD/food-effect dosing complete and Phase 2 doses identified; Part D ongoing.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Sagimet Biosciences Inc. Series A","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.85,"llm_reason":"TVB-3567 is a follow-on FASN inhibitor, and this readout is Phase 1 data from healthy volunteers: safety, PK and sebum PD. Denifanstat already validates the mechanism and is the main value driver. The company has ample cash, so a large move on this readout is unlikely.","llm_predicted_at":"2026-10-25T15:49:48Z","llm_source":"live","window":"2026-01-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":571,"symbol":"SLDB","drug":"SGT-003","modality":"gene_therapy","area":"rare_genetic","event_type":"other","expect_date_from":"2026-11-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260806_160410_(SLDB)_sec_0001193125-26-337935.txt","comments":"10-Q: \"We plan to meet with the FDA late in the fourth quarter of 2026 to discuss the INSPIRE DUCHENNE SGT-003 data package and to seek guidance on a potential accelerated approval pathway.\" Timing is company guidance; no specific date given.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Solid Biosciences","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":16,"symbol":"SLS","drug":"SLS009","modality":"small_molecule","area":"hematology","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260811_160748_(SLS)_sec_0001390478-26-000013-ex991.txt","comments":"Phase 2 trial in newly diagnosed first-line AML: \"Topline data expected in Q4 2026.\" 28 patients enrolled as of Aug 10, 2026; enrollment/dosing ongoing. Window = Q4 2026.","closed":0,"created_at":"2026-10-25 09:53:08","updated_at":"2026-10-25 09:53:08","company":"SELLAS Life Sciences Group","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.55,"llm_reason":"The $2.3B valuation is driven mainly by the pending REGAL Phase 3 readout for GPS. SLS009 topline in frontline AML is an early open-label Phase 2 readout with partial enrollment (28 of 80), so data are likely incremental and the move modest, though volatility is high.","llm_predicted_at":"2026-10-25T15:48:18Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":1083,"symbol":"SLS","drug":"galinpepimut-S","modality":"peptide","area":"hematology","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261028_083500_(SLS)_google_news_google_news-75b16ce124887a580f50c66af882f268-SLS.txt","comments":"Phase 3 REGAL trial in AML: Oct 28, 2026 GlobeNewswire release \"announced that the pivotal Phase 3 REGAL trial ... reached its pre-specified 80th event, triggering the final analysis\"; \"Company to Report Topline Primary Endpoint Results this Quarter.\" Window = Q4 2026 (topline primary endpoint, overall survival). 80th-event trigger recorded separately as event 1138.","closed":0,"created_at":"2026-10-28 18:33:04","updated_at":"2026-11-01T21:23:56Z","company":"SELLAS Life Sciences Group","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.85,"llm_reason":"The REGAL Phase 3 final analysis is binary for SLS. GPS is the company's lead asset and the stock carries a $2.3B valuation on a high retail, speculative base, so the topline result should move it more than 10% either way. Success could still disappoint if the effect is modest, and failure would be catastrophic, which leaves the direction uncertain.","llm_predicted_at":"2026-10-28T18:34:30Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":17,"symbol":"SLXN","drug":"SIL204","modality":"sirna","area":"oncology","event_type":"interim_analysis","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260810_061608_(SLXN)_sec_0001178913-26-003966-ex991.txt","comments":"Company guidance in Aug 2026 investor deck: \"Early human data regarding SIL-204 expected Q4, 2026\"; also lists secondary-endpoint \"ctDNA biomarker data (expected early Q4, 2026)\". Safety run-in of Phase 2/3 LAPC trial; Q4 2026 window as stated. Sept 30, 2026 release (first patient dosed) reaffirmed \"preliminary clinical readouts in the near term\"; no change to Q4 2026 window.","closed":0,"created_at":"2026-10-25 09:53:12","updated_at":"2026-10-27T11:27:22Z","company":"Silexion Therapeutics Corp","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.55,"llm_reason":"SLXN is a micro-cap whose value rests almost entirely on SIL204. The Q4 2026 interim is early ctDNA data from a small dose-escalation safety run-in in LAPC, given with chemotherapy. Readouts like this at tiny caps usually move the stock 10% or more, but the direction is uncertain: a pop on positive biomarker signals, or a drop on ambiguity or financing overhang.","llm_predicted_at":"2026-10-25T15:48:22Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":347,"symbol":"SNDX","drug":"revumenib","modality":"small_molecule","area":"hematology","event_type":"data_presentation","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260804_160218_(SNDX)_sec_0001193125-26-332736-ex991.txt","comments":"\"The Company expects to publish safety and efficacy data from R/R NUP98r acute leukemia patients treated with revumenib in the fourth quarter of 2026.\" 3Q26 release (Nov 2, 2026) also lists, for 4Q26: post-transplant maintenance data and INTERCEPT Phase 1 (MRD/early relapse, NPM1m/KMT2Ar) data — all to be presented at upcoming medical meetings with no meeting date stated.","closed":0,"created_at":"2026-10-25 11:23:40","updated_at":"2026-11-04T05:23:54Z","company":"Syndax Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":340,"symbol":"SPRB","drug":"TA-ERT","modality":"protein","area":"rare_genetic","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260812_090517_(SPRB)_sec_0001193125-26-345874-ex991.txt","comments":"BLA submission for TA-ERT in MPS IIIB \"anticipated in the fourth quarter of 2026\", seeking accelerated approval based on CSF HS-NRE; 10-Q (same day) reaffirms \"fourth quarter of 2026\". TrAnsform confirmatory study and EAP initiation also guided Q4 2026 but are trial starts, not catalysts.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Spruce Biosciences","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":336,"symbol":"SRPT","drug":"SRP-1003","modality":"sirna","area":"rare_genetic","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260805_160623_(SRPT)_sec_0001193125-26-335056-ex991.txt","comments":"\"Readouts from our MAD cohorts of our ongoing phase 1/2 studies in DM1 and FSHD remain on track for 2H 2026.\" 10-Q: SRP-1003 (DM1) \"expect to share further data in the second half of 2026.\" Date is the half-year window; no specific date stated.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Sarepta Therapeutics","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.5,"llm_reason":"SRP-1003 is an Arrowhead-licensed siRNA, likely for DM1 or FSHD, with MAD cohort data due in 2H 2026. With a market cap near $1.9B and the Duchenne franchise declining, the siRNA pipeline is now a key value driver, so a readout could move the stock 10% or more in either direction. Comparable DM1 readouts at peers such as Avidity and Dyne have produced large moves, but the direction is hard to call.","llm_predicted_at":"2026-10-25T15:49:42Z","llm_source":"live","window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":337,"symbol":"SRPT","drug":"SRP-1001","modality":"sirna","area":"rare_genetic","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260805_160623_(SRPT)_sec_0001193125-26-335056-ex991.txt","comments":"\"Readouts from our MAD cohorts of our ongoing phase 1/2 studies in DM1 and FSHD remain on track for 2H 2026.\" 10-Q: SRP-1001 (FSHD) \"expect to share further data in the second half of 2026.\" Window is the stated half-year; no specific date.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Sarepta Therapeutics","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.5,"llm_reason":"SRP-1001 is the DM1 siRNA from Arrowhead, and its MAD cohort readout is a key value driver for Sarepta. At roughly a $1.9B market cap, with sentiment depressed after the ELEVIDYS label cut, the stock is likely to move 10%+ either way. DM1 peers (Avidity, Dyne) show high sensitivity to splicing and DMPK knockdown data, but the direction is uncertain.","llm_predicted_at":"2026-10-25T15:49:43Z","llm_source":"live","window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":328,"symbol":"SRRK","drug":"SRK-439","modality":"monoclonal_antibody","area":"rare_genetic","event_type":"topline_results","expect_date_from":"2026-11-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260806_071015_(SRRK)_sec_0001193125-26-336715-ex991.txt","comments":"\"A Phase 1 study evaluating SRK-439 in healthy volunteers is progressing well with topline data anticipated in late 2026.\" Late 2026 = 2026-11-01..2026-12-31.","closed":0,"created_at":"2026-10-25 07:21:55","updated_at":"2026-10-25 07:21:55","company":"Scholar Rock Holding","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.82,"llm_reason":"SRK-439 Phase 1 healthy-volunteer topline is a minor, early-stage catalyst for a $5B company whose value is driven by apitegromab's approval and launch; a big move is unlikely.","llm_predicted_at":"2026-10-25T15:49:37Z","llm_source":"live","window":"2026-11-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":323,"symbol":"STRO","drug":"STRO-227","modality":"adc","area":"oncology","event_type":"regulatory_submission","expect_date_from":"2026-11-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260812_073050_(STRO)_sec_0001193125-26-345748.txt","comments":"10-Q: \"anticipate submitting an IND in connection with this program in late 2026\" (press release: \"IND submission later this year\"). Dual-payload PTK7 ADC; preclinical, no clinical data.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Sutro Biopharma","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":305,"symbol":"TARA","drug":"IV Choline Chloride","modality":"small_molecule","area":"metabolic","event_type":"interim_analysis","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260811_080536_(TARA)_sec_0001213900-26-087506-ex991.txt","comments":"\"Company remains on track to report interim results from Phase 2b cohort in 4Q 2026\" (Oct 15, 2026 release completing enrollment of the 2b open-label dose-confirmation phase of THRIVE-3); 10-Q: \"We anticipate reporting interim results from the dose-confirmation portion of the trial in the fourth quarter of 2026.\"","closed":0,"created_at":"2026-10-25 07:20:46","updated_at":"2026-10-28T16:26:19Z","company":"Protara Therapeutics","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.68,"llm_reason":"The company trades below its $162M cash, and the stock is valued mainly on TARA-002. IV choline for parenteral nutrition is a niche, low-risk substrate-replacement program, so an interim THRIVE-3 readout is unlikely to move the stock 10% or more.","llm_predicted_at":"2026-10-25T15:49:32Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":306,"symbol":"TARA","drug":"TARA-002","modality":"cell_therapy","area":"rare_genetic","event_type":"interim_analysis","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260811_080536_(TARA)_sec_0001213900-26-087506-ex991.txt","comments":"\"Expect to provide an update and complete enrollment of the STARBORN-1 trial in LMs in 4Q 2026\". Enrollment completion itself is not a catalyst; the guided STARBORN-1 data update is.","closed":0,"created_at":"2026-10-25 07:20:46","updated_at":"2026-10-25 07:20:46","company":"Protara Therapeutics","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.6,"llm_reason":"Market cap (~$144M) is below cash (~$162M), so expectations are low. The interim event is the STARBORN-1 LM update, where prior data were already strong, so further confirmation is unlikely to move the stock much. The ADVANCED-3 redesign does not add binary risk to this event.","llm_predicted_at":"2026-10-25T15:49:35Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":280,"symbol":"TNGX","drug":"vopimetostat","modality":"small_molecule","area":"oncology","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260811_072034_(TNGX)_sec_0001193125-26-343434-ex991.txt","comments":"\"Disclose vopimetostat lung cancer monotherapy data in 2H 2026\"; 10-Q: \"we anticipate providing a safety and efficacy update in 2026\" (lung cancer cohort of vopimetostat monotherapy trial). Window = second half of 2026.","closed":0,"created_at":"2026-10-25 11:18:27","updated_at":"2026-10-25 11:18:27","company":"Tango Therapeutics","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.55,"llm_reason":"The $4.7B valuation already reflects the June combo data (92% ORR). The 2H26 readout is probably either the ESMO update of known data or lung monotherapy data, so it is less likely to be a surprise. Downside risk exists if lung data disappoint, but a move under 10% is most likely.","llm_predicted_at":"2026-10-25T15:49:27Z","llm_source":"live","window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":281,"symbol":"TNGX","drug":"TNG456","modality":"small_molecule","area":"oncology","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260811_072034_(TNGX)_sec_0001193125-26-343434-ex991.txt","comments":"\"Release initial TNG456 data in glioblastoma and other cancers in 2H 2026\"; 10-Q: \"We anticipate providing initial clinical data from this trial in the second half of 2026.\" Window = second half of 2026.","closed":0,"created_at":"2026-10-25 11:18:27","updated_at":"2026-10-25 11:18:27","company":"Tango Therapeutics","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.68,"llm_reason":"Tango is a $4.7B company whose valuation rests mainly on vopimetostat, backed by strong pancreatic cancer data and $1.0B in cash. Initial TNG456 Phase 1/2 data in glioblastoma is a secondary pipeline readout, so a first-session move of 10% or more is less likely.","llm_predicted_at":"2026-10-25T15:49:28Z","llm_source":"live","window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":272,"symbol":"TNYA","drug":"TN-201","modality":"gene_therapy","area":"cardiovascular","event_type":"interim_analysis","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260805_161533_(TNYA)_sec_0001193125-26-335140.txt","comments":"10-Q: \"We expect to present one-year Cohort 2 data and two-year Cohort 1 data from MyPEAK-1 in the fourth quarter of 2026.\" 8-K of same date says \"additional interim data from the MyPEAK-1 clinical trial in the fourth quarter of 2026.\" Exact date not stated.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Tenaya Therapeutics","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.5,"llm_reason":"Micro-cap ($88M) whose value rests mainly on TN-201. The Q4 2026 update combines longer-term MyPEAK-1 follow-up with regulatory feedback on pivotal plans, so a 10%+ move either way is plausible. The modest 4% MyBP-C protein increase and past selloffs on Tenaya data releases make the direction uncertain.","llm_predicted_at":"2026-10-25T15:49:24Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":273,"symbol":"TNYA","drug":"TN-401","modality":"gene_therapy","area":"cardiovascular","event_type":"interim_analysis","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260805_161533_(TNYA)_sec_0001193125-26-335140.txt","comments":"10-Q: \"We expect to present interim Cohort 2 results in the fourth quarter of the year.\" 8-K: \"Tenaya expects to report additional interim data from the RIDGE-1 clinical trial in the fourth quarter of 2026.\" Exact date not stated.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Tenaya Therapeutics","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.5,"llm_reason":"TN-401 interim Cohort 2 update follows positive May 2026 data, so it is an incremental readout. It is likely bundled with TN-201 data and regulatory updates. The microcap is volatile, but continuity of prior results points to a modest move unless the regulatory news surprises.","llm_predicted_at":"2026-10-25T15:49:25Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":277,"symbol":"TNYA","drug":"TN-201","modality":"gene_therapy","area":"cardiovascular","event_type":"other","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260805_161533_(TNYA)_sec_0001193125-26-335140.txt","comments":"Regulatory update on late-stage pivotal trial plans: \"We are also engaging with regulatory authorities to obtain feedback on pivotal trial plans for TN-201 and plan to provide an update on progress in the fourth quarter of 2026.\" Timing only; no decision date stated.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Tenaya Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":278,"symbol":"TNYA","drug":"TN-401","modality":"gene_therapy","area":"cardiovascular","event_type":"other","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260805_161533_(TNYA)_sec_0001193125-26-335140.txt","comments":"Regulatory update on late-stage pivotal trial planning: \"We are also engaging with regulators on late-stage pivotal trial planning for TN-401 and plan to provide an update on the status of our discussions in the fourth quarter of 2026.\"","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Tenaya Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":7,"symbol":"TRDA","drug":"ENTR-601-44","modality":"aso","area":"rare_genetic","event_type":"topline_results","expect_date_from":"2026-08-05","expect_date_to":"2026-12-31","news_source_file":"documents/20261014_070000_(TRDA)_yahoo_news_yahoo-894cc11cb92cd49135547d22d405178f-TRDA.txt","comments":"\"Company to receive ELEVATE-44-201 data from Cohort 1 open-label period by year-end 2026\" (Oct 14, 2026 GlobeNewswire release, reaffirming Aug 5, 2026 guidance). Window per \"by the end of 2026\" rule from original guidance date.","closed":0,"created_at":"2026-10-25 09:52:36","updated_at":"2026-11-02T05:35:20Z","company":"Entrada Therapeutics","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.4,"llm_reason":"Small-cap ($184M) DMD exon 44 readout of open-label Cohort 1 dystrophin data is pivotal for valuation. Peer exon-skipping readouts (Dyne, Avidity) have moved stocks sharply, but the direction depends on dystrophin levels relative to competitors.","llm_predicted_at":"2026-10-25T15:48:18Z","llm_source":"live","window":"2026-08-05 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":269,"symbol":"TRVI","drug":"Haduvio (nalbuphine ER) / LAKE","modality":"small_molecule","area":"respiratory","event_type":"interim_analysis","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260806_160820_(TRVI)_sec_0001193125-26-337974-ex991.txt","comments":"Phase 2b LAKE (RCC) sample size re-estimation: \"once 50% of the participants complete treatment which is expected to occur in the fourth quarter of 2026. The Company will report the outcome of the SSRE once available.\"","closed":0,"created_at":"2026-10-25 11:17:39","updated_at":"2026-10-25 11:17:39","company":"Trevi Therapeutics","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.75,"llm_reason":"The event is a blinded sample size re-estimation in the RCC Phase 2b LAKE trial, not an efficacy readout. The outcome (keep or increase enrollment) is unlikely to move a $1.8B company focused mainly on IPF cough by 10%.","llm_predicted_at":"2026-10-25T15:49:21Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":263,"symbol":"TTRX","drug":"GX-03","modality":"other","area":"dermatology","event_type":"other","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261006_193052_(TTRX)_sec_0001213900-26-107329-ex991.txt","comments":"\"Q4 2026: FDA Type B Meeting\" listed as upcoming milestone for GX-03 in AD; company said in Aug 2026 it had \"advanced our FDA Type B meeting package\".","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Turn Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":256,"symbol":"TVRD","drug":"TTI-101","modality":"small_molecule","area":"oncology","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260814_070524_(TVRD)_sec_0001104659-26-096417-ex991.txt","comments":"\"4Q 2026: TTI-101 Phase 1b/2 HCC topline data\" (8-K business update, Aug 14, 2026). 10-Q: topline data across the three cohorts of the REVERT LIVER CANCER Phase 1b/2 trial in HCC expected in Q4 2026.","closed":0,"created_at":"2026-10-25 11:16:55","updated_at":"2026-10-25 11:16:55","company":"Tvardi Therapeutics","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.6,"llm_reason":"The company is a $13M microcap trading below its cash, so the TTI-101 HCC topline is its main near-term catalyst and the stock is likely to move sharply either way. Prior TTI-101 failures in IPF lean slightly negative, but low expectations could also produce a large upside move.","llm_predicted_at":"2026-10-25T15:49:20Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":234,"symbol":"VERA","drug":"atacicept","modality":"protein","area":"renal","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260915_064534_(VERA)_sec_0001193125-26-391280-ex991.txt","comments":"\"Plan to submit supplemental BLA to the U.S. Food and Drug Administration (FDA) for full approval in Q4 2026\" (2026-09-15 SEC EX-99.1); reaffirmed 2026-10-22 release: \"Plan to submit supplemental BLA to the U.S. FDA in Q4 2026 for full approval expected in 2027.\"","closed":0,"created_at":"2026-10-25 07:14:56","updated_at":"2026-10-25T16:07:25Z","company":"Vera Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":232,"symbol":"VERU","drug":"sabizabulin","modality":"small_molecule","area":"oncology","event_type":"other","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260908_081706_(VERU)_sec_0001193125-26-384430-ex991.txt","comments":"\"We will first seek regulatory clarity from the FDA through a preIND meeting in calendar Q4 2026\" for planned Phase 2b in KRAS-driven metastatic pancreatic cancer resistant to daraxonrasib. Meeting date per company guidance, not an FDA decision.","closed":0,"created_at":"2026-10-25 11:15:05","updated_at":"2026-10-25 11:15:05","company":"Veru","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":229,"symbol":"VIR","drug":"VIR-5818","modality":"bispecific","area":"oncology","event_type":"interim_analysis","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260805_160955_(VIR)_sec_0001628280-26-053351-ex991.txt","comments":"\"The Company expects to report updated dose-escalation data from its Phase 1 trial evaluating VIR-5818 ... in the second half of 2026.\" HER2-targeted PRO-XTEN dual-masked T-cell engager, monotherapy and with pembrolizumab.","closed":0,"created_at":"2026-10-25 11:14:59","updated_at":"2026-10-25 11:14:59","company":"Vir Biotechnology","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.72,"llm_reason":"VIR-5818 is an update to Phase 1 dose-escalation basket data and a secondary asset. The stock is driven mainly by the CHD Phase 3 program and VIR-5500. With about $1B in cash, a large first-session move on this readout is unlikely.","llm_predicted_at":"2026-10-25T15:49:16Z","llm_source":"live","window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":227,"symbol":"VIR","drug":"elebsiran and tobevibart","modality":"other","area":"gi_hepatology","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260805_160955_(VIR)_sec_0001628280-26-053351-ex991.txt","comments":"\"Topline data from the Phase 3 ECLIPSE 1 trial are expected in the fourth quarter of 2026.\" Combo of siRNA elebsiran + anti-HBsAg mAb tobevibart in chronic hepatitis delta.","closed":0,"created_at":"2026-10-25 11:14:56","updated_at":"2026-10-25 11:14:56","company":"Vir Biotechnology","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.5,"llm_reason":"ECLIPSE 1 compares the combination against deferred treatment, and strong Phase 2 data (88% undetectable HDV RNA at Week 96) make a positive readout highly likely and largely priced in. Much of the ~$1.8B valuation rests on cash (~$1B) and oncology, which dampens the move. Risk is mainly on the downside, but a large miss is unlikely.","llm_predicted_at":"2026-10-25T15:49:15Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":1096,"symbol":"VKTX","drug":"VK3019","modality":"peptide","area":"metabolic","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261028_161009_(VKTX)_sec_0001193125-26-436145-ex991.txt","comments":"Phase 1 SAD study of DACRA VK3019 in healthy adults: \"The company expects to complete the SAD study later this quarter\"; 4-week MAD study guided to start 1Q27.","closed":0,"created_at":"2026-10-29","updated_at":"2026-10-29","company":"Viking Therapeutics","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.72,"llm_reason":"VK3019 Phase 1 SAD data is early-stage and small relative to the VK2735 Phase 3 franchise. Single-dose safety and PK results rarely move a $3B company by 10% or more.","llm_predicted_at":"2026-10-29T15:14:26Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":216,"symbol":"VRDN","drug":"VRDN-008","modality":"bispecific","area":"immunology","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261104_071125_(VRDN)_sec_0001193125-26-446200.txt","comments":"\"Viridian expects to announce VRDN-008 phase 1 healthy volunteer data and development plans for the FcRn portfolio in Q4 2026\" (Q3 2026 release, 2026-11-04; 10-Q same day: \"data on track for the fourth quarter of 2026\"). Window narrowed from earlier 2H 2026 guidance. Half-life extended bispecific FcRn inhibitor.","closed":0,"created_at":"2026-10-25 11:14:25","updated_at":"2026-11-04T19:54:50Z","company":"Viridian Therapeutics","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.8,"llm_reason":"VRDN-008 phase 1 healthy volunteer PK/IgG data is an early pipeline readout for a $2.6B commercial-stage company whose value is driven by Lumvoa and elegrobart in TED. Such data typically moves the stock modestly.","llm_predicted_at":"2026-10-25T15:49:11Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":219,"symbol":"VRDN","drug":"VRDN-292","modality":"monoclonal_antibody","area":"ophthalmology","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261104_071125_(VRDN)_sec_0001193125-26-446200.txt","comments":"\"VRDN-292 IND on track to support phase 1 clinical trial initiation in Q4 2026, starting in patients with Graves' disease.\" Q3 2026 release of 2026-11-04; candidate is now named (anti-TSHR mAb). Note: guided milestone is trial initiation, not a data readout.","closed":0,"created_at":"2026-10-25 11:14:28","updated_at":"2026-11-04T19:55:04Z","company":"Viridian Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":210,"symbol":"VYGR","drug":"VY7523","modality":"monoclonal_antibody","area":"cns","event_type":"interim_analysis","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260806_160323_(VYGR)_sec_0001640266-26-000007-ex991.txt","comments":"\"Voyager expects tau positron emission tomography (PET) imaging efficacy data in Q4 2026 from the ongoing multiple ascending dose (MAD) clinical trial in participants with Alzheimer's disease\"; 10-Q: initial tau PET imaging efficacy data, enrollment completed Q4 2025.","closed":0,"created_at":"2026-10-25 11:13:35","updated_at":"2026-10-25 11:13:35","company":"Voyager Therapeutics","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.55,"llm_reason":"Market cap is about $115M, below the $149M cash position, and the VY7523 tau PET efficacy readout in Q4 2026 is a binary catalyst. A positive signal could drive a large rally, while a null result could still knock the stock down sharply. The direction is uncertain.","llm_predicted_at":"2026-10-25T15:49:11Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":205,"symbol":"WVE","drug":"WVE-007","modality":"sirna","area":"metabolic","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261027_073000_(WVE)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"Q3 2026 release (2026-10-27): \"Wave expects to share data from the Phase 1 600 mg SAD cohort in the fourth quarter of 2026.\" Narrowed from prior H2 2026 guidance; INLIGHT Phase 1 SAD 600 mg cohort.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-27T13:32:13Z","company":"Wave Life Sciences","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.5,"llm_reason":"WVE trades at a $660M market cap with $490M cash, so WVE-007 obesity data drives most of the valuation. The upcoming readout (600mg SAD cohort and further INLIGHT data in 2H26) is likely to move the stock at least 10%. The direction is uncertain because prior INLIGHT data drew mixed reactions and fat loss without weight loss is debated.","llm_predicted_at":"2026-10-25T15:49:08Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":206,"symbol":"WVE","drug":"WVE-006","modality":"aso","area":"rare_genetic","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261027_073000_(WVE)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"Q3 2026 release (2026-10-27): \"Wave expects to share data from the 600 mg (monthly) multidose cohort in the fourth quarter of 2026.\" RestorAATion-2 600 mg monthly multidose cohort; narrowed from prior H2 2026 guidance. Earlier single-dose data disclosed May 2026.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-27T13:32:13Z","company":"Wave Life Sciences","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.6,"llm_reason":"The upcoming WVE-006 readout is the 600 mg monthly multidose cohort, an incremental update after the May 2026 data that already showed AATD proof of concept. The stock's valuation is driven mainly by the obesity program WVE-007, and with a market cap near cash, the AATD update is unlikely to move shares 10%.","llm_predicted_at":"2026-10-25T15:49:09Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":1070,"symbol":"WVE","drug":"WVE-008","modality":"other","area":"gi_hepatology","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261027_073000_(WVE)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"Q3 2026 release (2026-10-27): \"A clinical trial application (CTA) filing for WVE-008 is on track for the fourth quarter of 2026.\" WVE-008 = GalNAc-conjugated AIMer (RNA editing) for PNPLA3 I148M liver disease.","closed":0,"created_at":"2026-10-27T09:32:01","updated_at":"2026-10-27T09:32:01","company":"Wave Life Sciences","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":1044,"symbol":"XNCR","drug":"plamotamab","modality":"bispecific","area":"immunology","event_type":"data_presentation","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261026_075027_(XNCR)_sec_0001213900-26-112279.txt","comments":"Pipeline slide: \"Initial dose-escalation data from ongoing Phase 1b in RA at ACR\" in the 2H2026 column; ACR Convergence 2026. Exact presentation date not stated in the document, so the 2H2026 window is used.","closed":0,"created_at":"2026-10-26 08:41:00","updated_at":"2026-10-26 08:41:00","company":"Xencor","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":1061,"symbol":"XNCR","drug":"XmAb541","modality":"bispecific","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261026_075027_(XNCR)_sec_0001213900-26-112279.txt","comments":"2026-10-26 pipeline slide lists XmAb541 (CLDN6 x CD3) monotherapy, and with XmAb808, in CLDN6+ HGSOC with \"Safety and early assessment of efficacy\" in the 2H2026 column; no specific date given, so the 2H2026 window is used.","closed":0,"created_at":"2026-10-26T23:20:00Z","updated_at":"2026-10-26T23:20:00Z","company":"Xencor","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":1074,"symbol":"XNCR","drug":"XmAb942","modality":"monoclonal_antibody","area":"immunology","event_type":"interim_analysis","expect_date_from":"2026-10-26","expect_date_to":"2026-12-31","news_source_file":"documents/20261026_075027_(XNCR)_sec_0001213900-26-112279.txt","comments":"2026-10-26 company presentation timeline: XmAb942 (Xtend TL1A, IBD+) in IBD+ ... \"Update on progress achieved in Phase 2b XENITH-UC study ~YE26\"; approximate year-end 2026 window (document date to 2026-12-31). Separate from the ~2H27 primary endpoint analysis.","closed":0,"created_at":"2026-10-27 17:56:25","updated_at":"2026-10-27 17:56:25","company":"Xencor","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.68,"llm_reason":"The event for XmAb942 is only a progress update on the Phase 2b XENITH-UC study, around YE26. The primary endpoint analysis is not until about 2H27, so the update is likely enrollment or status rather than efficacy data. That makes a 10% or larger first-session move on a ~$1.9B company unlikely.","llm_predicted_at":"2026-10-27T21:57:23Z","llm_source":"live","window":"2026-10-26 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":195,"symbol":"ZBIO","drug":"obexelimab","modality":"monoclonal_antibody","area":"immunology","event_type":"regulatory_submission","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","news_source_file":"documents/20260813_070549_(ZBIO)_sec_0001104659-26-095437-ex991.txt","comments":"\"Zenas expects to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the second half of 2026\" for obexelimab in IgG4-RD.","closed":0,"created_at":"2026-10-25 11:12:19","updated_at":"2026-10-25 11:12:19","company":"Zenas BioPharma","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-07-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":196,"symbol":"ZBIO","drug":"ZB021","modality":"small_molecule","area":"immunology","event_type":"other","expect_date_from":"2026-08-13","expect_date_to":"2026-12-31","news_source_file":"documents/20260813_070549_(ZBIO)_sec_0001104659-26-095437-ex991.txt","comments":"\"Dosing is ongoing in the single ascending dose (SAD) and now, the multiple ascending dose (MAD) parts of the Phase 1 trial ... These data are expected by year-end 2026\" (initial Phase 1 clinical data).","closed":0,"created_at":"2026-10-25 11:12:19","updated_at":"2026-10-25 11:12:19","company":"Zenas BioPharma","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-08-13 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":194,"symbol":"ZBIO","drug":"obexelimab","modality":"monoclonal_antibody","area":"immunology","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261013_060128_(ZBIO)_sec_0001104659-26-115151-ex991.txt","comments":"\"Phase 2 SunStone trial in Systemic Lupus Erythematosus (SLE) topline results expected in 4Q 2026\"; 10-Q adds \"topline results, including biomarker data, in the fourth quarter of 2026\".","closed":0,"created_at":"2026-10-25 11:12:19","updated_at":"2026-10-25 11:12:19","company":"Zenas BioPharma","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.6,"llm_reason":"The 4Q26 readout is most likely the Phase 2 SunStone topline in SLE, a large-market indication that could expand obexelimab well beyond IgG4-RD. SLE trials often fail, and ZBIO is a $1.8B company whose lead asset is obexelimab, so either a clear win or a miss could plausibly move the stock 10% or more. The direction is hard to call.","llm_predicted_at":"2026-10-25T15:49:06Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":189,"symbol":"ZURA","drug":"tibulizumab","modality":"bispecific","area":"dermatology","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261027_074036_(ZURA)_sec_0001855644-26-000012.txt","comments":"TibuSHIELD Phase 2 in hidradenitis suppurativa enrollment complete (247 participants). Q3 2026 8-K (2026-10-27): \"Topline data remains on track for the fourth quarter of 2026\"; 8-K dated 2026-07-01/2026-08-17 said \"fourth quarter of 2026.\"","closed":0,"created_at":"2026-10-25 11:11:39","updated_at":"2026-10-28T00:01:05Z","company":"Zura Bio","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.72,"llm_reason":"The Phase 2 TibuSHIELD HS readout is the first efficacy data for Zura's lead asset, and the company is small (~$338M cap, ~$205M cash). HS is a competitive field (bimekizumab, sonelokimab), so the result will be judged on differentiation. A clear benefit or a miss would likely move the stock well over 10%, but the direction is hard to call.","llm_predicted_at":"2026-10-25T15:49:05Z","llm_source":"live","window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":192,"symbol":"ZVRA","drug":"celiprolol","modality":"small_molecule","area":"cardiovascular","event_type":"other","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261103_171626_(ZVRA)_sec_0001434647-26-000087.txt","comments":"Q3 2026 Form 10-Q: after a Q1 2026 Type C meeting, \"we ... plan to continue the dialogue with regulators going forward with a follow-up meeting in the fourth quarter of 2026\" (DiSCOVER Phase 3 in VEDS). Window = Q4 2026 (2026-10-01..2026-12-31), updated from prior \"second half of 2026\" guidance.","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-05T08:24:31Z","company":"Zevra Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":1189,"symbol":"ZVRA","drug":"arimoclomol","modality":"small_molecule","area":"rare_genetic","event_type":"other","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","news_source_file":"documents/20261104_021022_(ZVRA)_yahoo_news_yahoo-a9001427aa5b99f3235ebb8dd8b9ab96-ZVRA.txt","comments":"Q3 2026 earnings call summary: company \"outlined plans for an infant label expansion and a Q4 European decision on arimoclomol.\" Window = Q4 2026 (2026-10-01..2026-12-31); this is the re-examination outcome after the July 2026 CHMP negative opinion. Aggregator summary; no full primary Q3 release text in workspace.","closed":0,"created_at":"2026-11-04 09:33:22","updated_at":"2026-11-04 09:33:22","company":"Zevra Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2026-12-31","imminence":56,"state":"open","overdue":false},{"id":591,"symbol":"NUVB","drug":"taletrectinib","modality":"small_molecule","area":"oncology","event_type":"pdufa","expect_date_from":"2027-01-04","expect_date_to":"2027-01-04","news_source_file":"documents/20260806_073008_(NUVB)_sec_0001193125-26-336751-ex991.txt","comments":"\"the U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for IBTROZI with updated efficacy data in TKI-naive and TKI-pretreated advanced ROS1+ NSCLC, with a target action date of January 4, 2027.\" sNDA submitted May 2026; date unchanged in 10-Q.","closed":0,"created_at":"2026-10-25 11:41:02","updated_at":"2026-10-25 11:41:02","company":"Nuvation Bio","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-04","imminence":60,"state":"upcoming","overdue":false},{"id":1192,"symbol":"OCGN","drug":"OCU400","modality":"gene_therapy","area":"ophthalmology","event_type":"regulatory_submission","expect_date_from":"2026-10-15","expect_date_to":"2027-01-13","news_source_file":"documents/20261015_080105_(OCGN)_sec_0001104659-26-115970-ex991.txt","comments":"Bahamas LARTA full approval after the 2026-10-15 provisional approval/priority designation. Oct-15 deck: \"Full LARTA approval, focused on logistics ... and patient dosing expected within 90 days under a regulated EAP.\" Nov-4-2026 update: \"Advancing toward full approval and potential patient enrollment as early as year-end.\"","closed":0,"created_at":"2026-11-04 13:37:53","updated_at":"2026-11-04 13:37:53","company":"Ocugen","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-15 → 2027-01-13","imminence":69,"state":"open","overdue":false},{"id":493,"symbol":"PRQR","drug":"AX-0811","modality":"aso","area":"gi_hepatology","event_type":"data_presentation","expect_date_from":"2027-01-01","expect_date_to":"2027-01-15","news_source_file":"documents/20260909_080020_(PRQR)_sec_0001104659-26-106138-ex991.txt","comments":"AX-0811 Phase 1 target engagement data for the first two cohorts \"expected in early January 2027\" (Sept 9, 2026 release; reiterated in the Oct 28, 2026 6-K: \"initial data expected in early January 2027\"). Supersedes Aug 13, 2026 guidance of \"by year-end 2026, pending CTA authorization\".","closed":0,"created_at":"2026-10-25 11:34:31","updated_at":"2026-10-29T09:01:30Z","company":"ProQR Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-01-15","imminence":71,"state":"upcoming","overdue":false},{"id":877,"symbol":"DYN","drug":"z-rostudirsen (DYNE-251)","modality":"aso","area":"rare_genetic","event_type":"pdufa","expect_date_from":"2027-01-21","expect_date_to":"2027-01-21","news_source_file":"documents/20260720_073514_(DYN)_sec_0001193125-26-308343.txt","comments":"\"FDA has granted the BLA Priority Review and assigned a Prescription Drug User Fee Act target action date of January 21, 2027\" for exon 51 DMD BLA; BLA accepted for review July 2026. First disclosed in the July 20, 2026 8-K.","closed":0,"created_at":"2026-10-25 08:02:00","updated_at":"2026-10-25 08:02:00","company":"Dyne Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-21","imminence":77,"state":"upcoming","overdue":false},{"id":508,"symbol":"PRAX","drug":"ulixacaltamide","modality":"small_molecule","area":"cns","event_type":"pdufa","expect_date_from":"2027-01-29","expect_date_to":"2027-01-29","news_source_file":"documents/20260806_083228_(PRAX)_sec_0001689548-26-000083.txt","comments":"10-Q: NDA for ulixacaltamide HCl in essential tremor \"accepted for review with a target action date under the Prescription Drug User Fee Act, or PDUFA, of January 29, 2027.\" Mid-cycle meeting complete; no adcom planned.","closed":0,"created_at":"2026-10-25 11:35:05","updated_at":"2026-10-25 11:35:05","company":"Praxis Precision Medicines","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-29","imminence":85,"state":"upcoming","overdue":false},{"id":523,"symbol":"PHAR","drug":"leniolisib","modality":"small_molecule","area":"immunology","event_type":"pdufa","expect_date_from":"2027-01-30","expect_date_to":"2027-01-30","news_source_file":"documents/20260925_111229_(PHAR)_sec_0001828316-26-000041.txt","comments":"\"assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2027\" for sNDA of lower doses of Joenja in children 4+ years with APDS weighing 13 to <27 kg; Priority Review.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Pharming Group","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-30","imminence":86,"state":"upcoming","overdue":false},{"id":1230,"symbol":"OCS","drug":"Licaminlimab","modality":"monoclonal_antibody","area":"ophthalmology","event_type":"topline_results","expect_date_from":"2026-11-01","expect_date_to":"2027-01-31","news_source_file":"documents/20261103_160500_(OCS)_yahoo_news_yahoo-de03e240e5b6ffc72195993e3534a929-OCS.txt","comments":"Q3 2026 release on PREDICT-1 registrational symptoms trial in TNFR1-mediated dry eye disease: \"Patient randomization is now complete ... Topline results are anticipated around year-end 2026.\" No month/day given; window covers late 2026 through January 2027. Same guidance in the Oct 7, 2026 release (\"around year-end\").","closed":0,"created_at":"2026-11-04 19:55:02","updated_at":"2026-11-04 19:55:02","company":"Oculis Holding","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.5,"llm_reason":"PREDICT-1 is a registrational dry eye trial of licaminlimab. Dry eye readouts are binary and historically volatile, and symptom endpoints often miss. For a ~$500M company this asset is a meaningful value driver, so a move of 10% or more is likely. The direction is uncertain because the enriched genetic-variant design is untested at registrational scale.","llm_predicted_at":"2026-11-04T19:57:45Z","llm_source":"live","window":"2026-11-01 → 2027-01-31","imminence":87,"state":"open","overdue":false},{"id":530,"symbol":"PEPG","drug":"PGN-EDODM1","modality":"aso","area":"cns","event_type":"interim_analysis","expect_date_from":"2026-08-06","expect_date_to":"2027-01-31","news_source_file":"documents/20260806_074021_(PEPG)_sec_0001193125-26-336767-ex991.txt","comments":"\"Update from the OLE study is expected by early January.\" OLE enrollment totals 16 participants after DSMB approved escalation from 5 mg/kg to 10 mg/kg; exact date not stated.","closed":0,"created_at":"2026-10-25 11:36:34","updated_at":"2026-10-25 11:36:34","company":"PepGen","tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.6,"llm_reason":"PepGen is a small-cap ($167M) company with essentially one asset. The November readout of the 10 mg/kg FREEDOM2 cohort, measuring splicing correction, is a binary event likely to move the stock at least 10%. Direction is uncertain given competing DM1 programs and the mixed history of EDO data, so no clear upside or downside call.","llm_predicted_at":"2026-11-02T05:36:49Z","llm_source":"live","window":"2026-08-06 → 2027-01-31","imminence":87,"state":"open","overdue":false},{"id":10,"symbol":"SXTP","drug":"tafenoquine","modality":"small_molecule","area":"infectious","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-01-31","news_source_file":"documents/20261023_080023_(SXTP)_sec_0001213900-26-111864-ex991.txt","comments":"\"30 Hospital subjects randomized... Blinded follow-up completes in early January 2027; unblinding follows.\" Study remains blinded; no efficacy data yet. Earlier release: plans to report hospitalized babesiosis study results in January 2027.","closed":0,"created_at":"2026-10-25 09:52:49","updated_at":"2026-10-25 09:52:49","company":"60 DEGREES PHARMACEUTICALS, INC","tier":"Core","llm_prediction":"large_impact","llm_confidence":0.55,"llm_reason":"SXTP is a microcap with going-concern doubt, and the January 2027 unblinding of the N=30 randomized hospital babesiosis study is its key value driver. A positive or negative result should move the stock more than 10% either way, and the small trial makes the direction hard to call.","llm_predicted_at":"2026-11-02T05:36:49Z","llm_source":"live","window":"2027-01-01 → 2027-01-31","imminence":87,"state":"upcoming","overdue":false},{"id":12,"symbol":"SXTP","drug":"tafenoquine","modality":"small_molecule","area":"infectious","event_type":"other","expect_date_from":"2027-01-16","expect_date_to":"2027-01-31","news_source_file":"documents/20261023_080023_(SXTP)_sec_0001213900-26-111864-ex991.txt","comments":"\"A pre-sNDA meeting is planned for late January 2027 after the hospital study unblinds and the expanded-access package is updated.\" No FDA meeting date confirmed by the agency.","closed":0,"created_at":"2026-10-25 09:52:52","updated_at":"2026-10-25 09:52:52","company":"60 DEGREES PHARMACEUTICALS, INC","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-16 → 2027-01-31","imminence":87,"state":"upcoming","overdue":false},{"id":175,"symbol":"AGIO","drug":"mitapivat","modality":"small_molecule","area":"hematology","event_type":"pdufa","expect_date_from":"2027-02-01","expect_date_to":"2027-02-01","news_source_file":"documents/20261030_070000_(AGIO)_yahoo_news_yahoo-e1448eed5a2a574ecaf0022db147c9dc-AGIO.txt","comments":"Company release (via Yahoo, 2026-10-30 07:00 ET): \"FDA classified Agios' response to the information request as a major amendment to the mitapivat sNDA, resulting in a three-month review extension\"; \"New PDUFA Goal Date of February 1, 2027\". Original goal date was November 1, 2026. FDA requested additional information to evaluate whether a REMS is necessary for mitapivat in sickle cell disease. Source is the company release via Yahoo (no SEC/wire copy in run); timing update only, no decision yet.","closed":0,"created_at":"2026-10-25 11:10:13","updated_at":"2026-10-31T00:24:43Z","company":"Agios Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-02-01","imminence":88,"state":"upcoming","overdue":false},{"id":757,"symbol":"INMB","drug":"pobistrocel","modality":"cell_therapy","area":"rare_genetic","event_type":"regulatory_submission","expect_date_from":"2027-02-01","expect_date_to":"2027-02-14","news_source_file":"documents/20261021_071500_(INMB)_yahoo_news_yahoo-709d54e925f0e03efc8ad404289f7405-INMB.txt","comments":"Revised strategy: \"Full MAA submission targeted for early February 2027, under a revised strategy that could bring potential UK approval forward by approximately six weeks\"; final pre-MAA package submitted to MHRA Oct 20, 2026. Supersedes earlier \"end of Q3 or early Q4 of 2026\" guidance (10-Q). Window reflects \"early February 2027\".","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25T12:18:40Z","company":"INmune Bio","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-02-01 → 2027-02-14","imminence":101,"state":"upcoming","overdue":false},{"id":140,"symbol":"ARQT","drug":"ZORYVE (roflumilast) cream 0.05%","modality":"small_molecule","area":"dermatology","event_type":"pdufa","expect_date_from":"2027-02-23","expect_date_to":"2027-02-23","news_source_file":"documents/20260805_161424_(ARQT)_sec_0001787306-26-000049-ex991.txt","comments":"FDA accepted sNDA for ZORYVE cream 0.05% in infants 3 to 24 months with mild to moderate atopic dermatitis; \"PDUFA target action date of February 23, 2027\". 10-Q states infants down to 3 months.","closed":0,"created_at":"2026-10-25 11:06:59","updated_at":"2026-10-25 11:06:59","company":"Arcutis Biotherapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-02-23","imminence":110,"state":"upcoming","overdue":false},{"id":971,"symbol":"CGEM","drug":"zipalertinib","modality":"small_molecule","area":"oncology","event_type":"pdufa","expect_date_from":"2027-02-27","expect_date_to":"2027-02-27","news_source_file":"documents/20261001_193544_(CGEM)_sec_0001193125-26-411011-ex991.txt","comments":"\"An NDA seeking accelerated approval for zipalertinib monotherapy in this indication remains under FDA review, with a Prescription Drug User Fee Act (PDUFA) target action date of February 27, 2027.\" 2L EGFR ex20ins NSCLC; NDA accepted April 2026.","closed":0,"created_at":"2026-10-25 12:08:42","updated_at":"2026-10-25 12:08:42","company":"Cullinan Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-02-27","imminence":114,"state":"upcoming","overdue":false},{"id":152,"symbol":"APMD","drug":"AD109 (Oxnimbi)","modality":"small_molecule","area":"respiratory","event_type":"pdufa","expect_date_from":"2027-02-28","expect_date_to":"2027-02-28","news_source_file":"documents/20260908_171053_(APMD)_sec_0001193125-26-385355-ex991.txt","comments":"\"FDA accepted for review the New Drug Application (NDA) for AD109 (proposed proprietary name Oxnimbi)... assigned a PDUFA target action date of February 28, 2027.\" NDA for adults with OSA; oral fixed-dose aroxybutynin/atomoxetine. No assurances of approval by that date.","closed":0,"created_at":"2026-10-25 11:07:23","updated_at":"2026-10-25 11:07:23","company":"Apnimed","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-02-28","imminence":115,"state":"upcoming","overdue":false},{"id":1115,"symbol":"LGND","drug":"Qtorin rapamycin","modality":"small_molecule","area":"rare_genetic","event_type":"pdufa","expect_date_from":"2027-02-28","expect_date_to":"2027-02-28","news_source_file":"documents/20261029_071444_(LGND)_sec_0000886163-26-000058.txt","comments":"Q3 2026 release (2026-10-29): \"On October 28, 2026, Palvella announced the FDA accepted for filing and granted Priority Review of the NDA for Qtorin rapamycin for the treatment of microcystic lymphatic malformations... The FDA has assigned a PDUFA target action date of February 28, 2027.\" Ligand holds a royalty interest; action date is Palvella-reported.","closed":0,"created_at":"2026-10-30 13:57:02","updated_at":"2026-10-30 13:57:02","company":"Ligand Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-02-28","imminence":115,"state":"upcoming","overdue":false},{"id":654,"symbol":"MAZE","drug":"MZE829","modality":"small_molecule","area":"renal","event_type":"topline_results","expect_date_from":"2026-11-01","expect_date_to":"2027-02-28","news_source_file":"documents/20260811_164516_(MAZE)_sec_0001193125-26-344878-ex991.txt","comments":"\"expects to announce updated data in late 2026 or early 2027 on three 10-15 patient cohorts: AMKD without diabetes, AMKD with diabetes and AMKD with severe FSGS\" (also cited in Aug 17 release). Updated Phase 2 HORIZON data.","closed":0,"created_at":"2026-10-25 11:46:12","updated_at":"2026-10-25 11:46:12","company":"Maze Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-01 → 2027-02-28","imminence":115,"state":"open","overdue":false},{"id":1077,"symbol":"PVLA","drug":"QTORIN rapamycin","modality":"small_molecule","area":"dermatology","event_type":"pdufa","expect_date_from":"2027-02-28","expect_date_to":"2027-02-28","news_source_file":"documents/20261028_073013_(PVLA)_sec_0001193125-26-435113.txt","comments":"\"The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2027.\" NDA for microcystic lymphatic malformations accepted for filing with Priority Review; first FDA-approved therapy if approved.","closed":0,"created_at":"2026-10-28 12:17:08","updated_at":"2026-10-28 12:17:08","company":"Palvella Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-02-28","imminence":115,"state":"upcoming","overdue":false},{"id":592,"symbol":"NTLA","drug":"lonvoguran ziclumeran","modality":"gene_therapy","area":"rare_genetic","event_type":"pdufa","expect_date_from":"2027-03-10","expect_date_to":"2027-03-10","news_source_file":"documents/20260908_160515_(NTLA)_sec_0001193125-26-385194-ex991.txt","comments":"\"FDA has accepted the Biologics License Application (BLA) for lonvo-z and granted the BLA Priority Review with a PDUFA target action date of March 10, 2027.\" FDA \"is not currently planning to hold an advisory committee\" for the HAE BLA.","closed":0,"created_at":"2026-10-25 11:41:07","updated_at":"2026-10-25 11:41:07","company":"Intellia Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-03-10","imminence":125,"state":"upcoming","overdue":false},{"id":34,"symbol":"AQST","drug":"Anaphylm (dibutepinephrine)","modality":"small_molecule","area":"immunology","event_type":"pdufa","expect_date_from":"2027-03-16","expect_date_to":"2027-03-16","news_source_file":"documents/20261015_072116_(AQST)_sec_0001398733-26-000058.txt","comments":"\"FDA ... has acknowledged its resubmission of the NDA for Anaphylm (dibutepinephrine) sublingual film ... as complete and has assigned a PDUFA goal date of March 16, 2027.\" Resubmission accepted as complete, classified Class 2 response (Oct 15, 2026 PR). Resubmitted Sept 17, 2026.","closed":0,"created_at":"2026-10-25 10:04:24","updated_at":"2026-10-25T10:37:54Z","company":"Aquestive Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-03-16","imminence":131,"state":"upcoming","overdue":false},{"id":1179,"symbol":"AQST","drug":"Libervant (diazepam)","modality":"small_molecule","area":"cns","event_type":"pdufa","expect_date_from":"2027-03-23","expect_date_to":"2027-03-23","news_source_file":"documents/20261103_160100_(AQST)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","comments":"Q3 2026 release: \"Final FDA approval for patients twelve years of age and older is subject to expiration of the orphan drug exclusivity for Valtoco on January 10, 2027, and final FDA action, with a PDUFA goal date of March 23, 2027.\" Final approval of existing tentative approval; U.S. commercialization licensed to Eton.","closed":0,"created_at":"2026-11-04 01:16:29","updated_at":"2026-11-04 01:16:29","company":"Aquestive Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-03-23","imminence":138,"state":"upcoming","overdue":false},{"id":1180,"symbol":"AQST","drug":"Libervant (diazepam)","modality":"small_molecule","area":"cns","event_type":"pdufa","expect_date_from":"2027-03-29","expect_date_to":"2027-03-29","news_source_file":"documents/20261103_160100_(AQST)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","comments":"Q3 2026 release: \"The Company has also submitted a Type 9 NDA seeking to add patients six to eleven years of age to the label, with a PDUFA goal date of March 29, 2027.\" Label-expansion PDUFA (ages 6-11).","closed":0,"created_at":"2026-11-04 01:16:29","updated_at":"2026-11-04 01:16:29","company":"Aquestive Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-03-29","imminence":144,"state":"upcoming","overdue":false},{"id":247,"symbol":"UNCY","drug":"oxylanthanum carbonate","modality":"small_molecule","area":"renal","event_type":"pdufa","expect_date_from":"2027-03-29","expect_date_to":"2027-03-29","news_source_file":"documents/20260929_074632_(UNCY)_sec_0001213900-26-104314-ex991.txt","comments":"\"Company anticipates FDA acceptance of the NDA within 30 days of resubmission; new assigned PDUFA date expected to be 6 months from resubmission.\" NDA resubmitted Sept 29, 2026, so expected PDUFA ~2027-03-29; date not yet formally assigned by FDA.","closed":0,"created_at":"2026-10-25 11:16:21","updated_at":"2026-10-25 11:16:21","company":"Unicycive Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-03-29","imminence":144,"state":"upcoming","overdue":false},{"id":182,"symbol":"ABSI","drug":"ABS-201","modality":"monoclonal_antibody","area":"dermatology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260811_160614_(ABSI)_sec_0001672688-26-000134-ex991.txt","comments":"\"full 26-week readout in early 2027\"; 10-Q: \"full proof-of-concept data in early 2027\" from HEADLINE Phase 1/2a in pattern hair loss.","closed":0,"created_at":"2026-10-25 11:11:11","updated_at":"2026-10-25 11:11:11","company":"Absci","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":40,"symbol":"ACIU","drug":"ACI-7104","modality":"vaccine","area":"cns","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260923_070005_(ACIU)_sec_0001651625-26-000020-ex991.txt","comments":"\"The final design of Part 2 is being consolidated and will be submitted to the FDA for review, with meetings expected early in 2027\" - FDA meeting on future development path/Part 2 design; exact date not stated.","closed":0,"created_at":"2026-10-25 10:05:10","updated_at":"2026-10-25 10:05:10","company":"AC Immune","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":513,"symbol":"ACIU","drug":"ACI-19764","modality":"small_molecule","area":"cns","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261104_070004_(ACIU)_sec_0001651625-26-000027.txt","comments":"\"initial results expected early in 2027\" (Phase 1b anti-inflammatory/hsCRP cohort); earlier guidance was \"by year end\" on 2026-08-20, now pushed to early 2027. Table also lists H1 2027.","closed":0,"created_at":"2026-10-25 10:30:00","updated_at":"2026-11-04T15:45:04Z","company":"AC Immune","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.62,"llm_reason":"Upcoming event is the Phase 1b hsCRP cohort interim readout. It is a small, early biomarker result in a crowded NLRP3 field, and the safety and PK data are already disclosed. Even with ACIU's small cap, a move under 10% is the more likely outcome, though a clear hsCRP reduction could spark a larger rally.","llm_predicted_at":"2026-10-25T15:50:28Z","llm_source":"live","window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":171,"symbol":"AKTS","drug":"AKY-1189","modality":"radiopharma","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260813_160416_(AKTS)_sec_0001193125-26-349133-ex991.txt","comments":"\"Expect preliminary data from the ongoing Phase 1b NECTINIUM-2 clinical trial in the first quarter of 2027.\" Phase 1b in locally advanced/metastatic urothelial and other Nectin-4 expressing tumors.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Aktis Oncology","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":390,"symbol":"ALEC","drug":"AL137","modality":"monoclonal_antibody","area":"cns","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260806_161049_(ALEC)_sec_0001193125-26-338008-ex991.txt","comments":"\"The company is targeting an IND submission in Q1 2027 and first-in-human dosing in Australia no later than April 2027.\" 10-Q repeats \"targeted for the first quarter of 2027\". IND timing is company-guided; FIH dosing (trial start) not tracked.","closed":0,"created_at":"2026-10-25 11:26:46","updated_at":"2026-10-25 11:26:46","company":"Alector","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":365,"symbol":"ANVS","drug":"buntanetap","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260814_160542_(ANVS)_sec_0001104659-26-097091-ex991.txt","comments":"Q2 2026 release (Aug 14, 2026): \"The Company plans a database lock for the 6-month analysis in Q1 2027, with the top-line symptomatic data readout anticipated in the same quarter.\" Phase 3 AD study (850 patients, pTau217+), 6-month symptomatic readout; ADAS-Cog13 and ADCS-iADL co-primary endpoints. Originally guided in the 2026-07-09 release: \"Q1 2027: 6-month symptomatic top-line data readout.\"","closed":0,"created_at":"2026-10-25 11:24:51","updated_at":"2026-10-25 11:24:51","company":"Annovis Bio","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":285,"symbol":"AQST","drug":"Anaphylm (dibutepinephrine)","modality":"small_molecule","area":"immunology","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260811_160607_(AQST)_sec_0001398733-26-000041-ex991.txt","comments":"Q2 2026 release: \"remains on track to submit regulatory applications ... in the European Union in the first quarter of 2027.\" EU MAA submission, company-guided timing, subject to change.","closed":0,"created_at":"2026-10-25 11:18:57","updated_at":"2026-10-25 11:18:57","company":"Aquestive Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":142,"symbol":"ARQT","drug":"ZORYVE (roflumilast) foam 0.3%","modality":"small_molecule","area":"dermatology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260805_161424_(ARQT)_sec_0001787306-26-000049-ex991.txt","comments":"Phase 2 proof-of-concept hidradenitis suppurativa study still enrolling; results and program advancement decisions expected \"first quarter of 2027\".","closed":0,"created_at":"2026-10-25 11:06:59","updated_at":"2026-10-25 11:06:59","company":"Arcutis Biotherapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":135,"symbol":"AUTL","drug":"obe-cel","modality":"cell_therapy","area":"cns","event_type":"data_presentation","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260811_073342_(AUTL)_sec_0001730463-26-000119-ex991.txt","comments":"\"first preliminary results, including safety, PK/PD and biomarker data are planned to be presented at the ACTRIMS Forum in the first quarter of 2027\" (BOBCAT Phase 1, progressive MS).","closed":0,"created_at":"2026-10-25 11:06:26","updated_at":"2026-10-25 11:06:26","company":"Autolus Therapeutics plc American Depositary Share","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":129,"symbol":"AVIR","drug":"bemnifosbuvir/ruzasvir (BEM/RZR)","modality":"small_molecule","area":"gi_hepatology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260812_161536_(AVIR)_sec_0001193125-26-346888-ex991.txt","comments":"\"Topline results are expected in early Q1 2027\" for C-FORWARD Phase 3 (ex-North America, >880 patients enrolled June 2026); 10-Q: \"expects to report topline results from C-FORWARD early in the first quarter 2027\".","closed":0,"created_at":"2026-10-25 11:06:00","updated_at":"2026-10-25 11:06:00","company":"Atea Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":123,"symbol":"AXSM","drug":"solriamfetol","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261102_070522_(AXSM)_sec_0001193125-26-442628.txt","comments":"\"The Company anticipates topline results in the first quarter of 2027\" (solriamfetol in binge eating disorder, ENGAGE Phase 3); target enrollment reached. Window narrowed from 4Q 2026 (prior guidance) per 3Q 2026 business update.","closed":0,"created_at":"2026-10-25 11:05:34","updated_at":"2026-11-02T17:56:28Z","company":"Axsome Therapeutics","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.8,"llm_reason":"The 4Q26 ENGAGE readout of solriamfetol in binge eating disorder is a label expansion for an already-approved drug. At an ~$8B market cap, value rests mainly on Auvelity's ~$180M quarterly sales and growth, so BED is a modest share of valuation and a move under 10% is likely either way.","llm_predicted_at":"2026-10-25T15:48:50Z","llm_source":"live","window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":58,"symbol":"BHVN","drug":"troriluzole","modality":"small_molecule","area":"cns","event_type":"pdufa","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261022_070007_(BHVN)_sec_0001935979-26-000083.txt","comments":"\"FDA informed Biohaven that the company's NDA resubmission for Vyglxia (troriluzole) in SCA has been accepted for review... and has assigned a user fee goal date in the first quarter of 2027\" (Q1 2027 = 2027-01-01..2027-03-31). No more precise PDUFA day stated. FDA plans to convene a PCNS advisory committee; anticipated date \"forthcoming in the near term\" (no date given).","closed":0,"created_at":"2026-10-25 10:13:23","updated_at":"2026-11-03T14:43:05Z","company":"Biohaven","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":1024,"symbol":"BLSM","drug":"BH-501284","modality":"small_molecule","area":"oncology","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260928_070000_(BLSM)_yahoo_news_yahoo-1cb291bc755a59c8b0a3ee32770772aa-BLSM.txt","comments":"Pan-KRAS inhibitor BH-501284 IND submission guided for Q1 2027: \"supporting the continued advancement of BH-501284 toward an IND submission in Q1 2027\" (release dated 2026-09-28). Company-guided timing; preclinical-stage asset.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"BlossomHill Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":28,"symbol":"BMEA","drug":"icovamenib","modality":"small_molecule","area":"metabolic","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260824_070000_(BMEA)_yahoo_news_yahoo-418a8ca54a6d2f29a23d00381d39bca9-BMEA.txt","comments":"\"The Company anticipates reporting topline results for the Week 26 primary endpoint in the first quarter of 2027\" (COVALENT-211, insulin-deficient T2D; enrollment complete, n=64). Also repeated in Q2 release \"26-week primary endpoint data expected in the first quarter of 2027\".","closed":0,"created_at":"2026-10-25 05:53:24","updated_at":"2026-10-25 05:53:24","company":"Biomea Fusion","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":54,"symbol":"BNTC","drug":"BB-301","modality":"gene_therapy","area":"rare_genetic","event_type":"other","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261005_080808_(BNTC)_sec_0001193125-26-413177-ex991.txt","comments":"\"Final pivotal study design expected to be confirmed in 1Q 2027\"; FDA to review additional data including OPMD Natural History Study data. Pivotal trial initiation (mid-2027) not recorded as a catalyst.","closed":0,"created_at":"2026-10-25 10:13:11","updated_at":"2026-10-25 10:13:11","company":"Benitec Biopharma","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":45,"symbol":"CBIO","drug":"CR-001","modality":"bispecific","area":"oncology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261015_162610_(CBIO)_sec_0001628280-26-066006.txt","comments":"\"on track to report initial monotherapy data from ASCEND in the first quarter of 2027\" - ORR from 1L NSCLC cohort (up to 12 pts) plus safety/PK/PD in >125 patients. Phase 1/2 ASCEND monotherapy.","closed":0,"created_at":"2026-10-25 10:12:40","updated_at":"2026-10-25 10:12:40","company":"Crescent Biopharma","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":51,"symbol":"CBIO","drug":"CR-003","modality":"adc","area":"oncology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261015_162610_(CBIO)_sec_0001628280-26-066006.txt","comments":"\"A Phase 1/2 trial of CR-003 (SKB105) in participants with advanced solid tumors conducted by Kelun-Biotech in China is ongoing and proof-of-concept data are expected in the first quarter of 2027.\"","closed":0,"created_at":"2026-10-25 10:12:45","updated_at":"2026-10-25 10:12:45","company":"Crescent Biopharma","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":969,"symbol":"CGEN","drug":"COM701","modality":"monoclonal_antibody","area":"oncology","event_type":"interim_analysis","expect_date_from":"2026-08-03","expect_date_to":"2027-03-31","news_source_file":"documents/20260803_070228_(CGEN)_sec_0001178913-26-003754-ex991.txt","comments":"Q2 2026 release: \"Compugen anticipates the interim analysis with median progression-free survival data by the first quarter of 2027\" (MAIA-ovarian, randomized placebo-controlled, platinum-sensitive ovarian cancer). Window spans from release date to end of Q1 2027.","closed":0,"created_at":"2026-10-25 12:08:27","updated_at":"2026-10-25 12:08:27","company":"Compugen","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-08-03 → 2027-03-31","imminence":146,"state":"open","overdue":false},{"id":955,"symbol":"COAG","drug":"HMB-002","modality":"monoclonal_antibody","area":"hematology","event_type":"interim_analysis","expect_date_from":"2026-11-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260811_160045_(COAG)_sec_0001193125-26-344533.txt","comments":"8-K/10-Q: \"The Company expects to report additional data from the trial in late 2026 or early 2027.\" Refers to the ongoing VELORA Pioneer Phase 1/2 trial of HMB-002 in VWD; multiple-dose assessment underway.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Hemab Therapeutics Holdings","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-01 → 2027-03-31","imminence":146,"state":"open","overdue":false},{"id":947,"symbol":"COCP","drug":"CDI-988","modality":"small_molecule","area":"infectious","event_type":"topline_results","expect_date_from":"2026-11-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260909_080019_(COCP)_sec_0001493152-26-041877-ex991.txt","comments":"\"Preliminary efficacy results expected in late 2026 or early 2027\"; CEO: \"look forward to reporting preliminary results near the end of 2026 or early 2027\" for Phase 1b norovirus challenge study (NCT07198139), last subject dosed 2026-09-09. Earlier (2026-08-03 8-K) guided topline data by end of Q4 2026.","closed":0,"created_at":"2026-10-25 12:07:07","updated_at":"2026-10-25 12:07:07","company":"Cocrystal Pharma","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-01 → 2027-03-31","imminence":146,"state":"open","overdue":false},{"id":939,"symbol":"CRBP","drug":"CRB-701","modality":"adc","area":"oncology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261015_102748_(CRBP)_sec_0001193125-26-422437-ex991.txt","comments":"\"CRB-701 + pembrolizumab data in 1L OPSCC in Q1 2027 / Topline ORR data expected in Q1 2027\" (Oct 15, 2026 corporate presentation).","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Corbus Pharmaceuticals Holdings","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":935,"symbol":"CRMD","drug":"rezafungin","modality":"peptide","area":"infectious","event_type":"pdufa","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261019_080028_(CRMD)_sec_0001213900-26-110477-ex991.txt","comments":"\"FDA has granted Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date in Q1 2027\" (sNDA for prophylaxis of invasive fungal disease, submitted by partner Mundipharma; only quarter-level date given). Acceptance for filing does not assure approval.","closed":0,"created_at":"2026-10-25 12:05:30","updated_at":"2026-10-25 12:05:30","company":"CorMedix","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":915,"symbol":"CRVS","drug":"soquelitinib","modality":"small_molecule","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260806_160422_(CRVS)_sec_0001104659-26-091975.txt","comments":"10-Q: Phase 3 relapsed/refractory PTCL \"interim futility analysis is planned after a defined number of progression events occurs. It is anticipated that this will occur sometime in early 2027.\" Window = Q1 2027 for \"early 2027\".","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Corvus Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":1242,"symbol":"CYTK","drug":"aficamten","modality":"small_molecule","area":"cardiovascular","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261104_160516_(CYTK)_sec_0001193125-26-447198-ex991.txt","comments":"Q3 2026 release: \"We expect to file a Supplemental New Drug Application (NDA) for nHCM in Q4 2026 and a Type II Variation in the European Union in early 2027.\" Date = early 2027.","closed":0,"created_at":"2026-11-04T23:13:49","updated_at":"2026-11-04T23:13:49","company":"Cytokinetics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":1243,"symbol":"CYTK","drug":"aficamten","modality":"small_molecule","area":"cardiovascular","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261104_160516_(CYTK)_sec_0001193125-26-447198-ex991.txt","comments":"Q3 2026 release: \"Recently completed conduct of the adolescent cohort of CEDAR-HCM ... We expect to present topline data in early 2027.\" 10-Q: \"We recently completed cohort 1 of CEDAR-HCM in the third quarter of 2026.\"","closed":0,"created_at":"2026-11-04T23:13:49","updated_at":"2026-11-04T23:13:49","company":"Cytokinetics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":992,"symbol":"DMAC","drug":"DM199","modality":"protein","area":"cns","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260810_163706_(DMAC)_sec_0001437749-26-026792.txt","comments":"\"As we approach enrollment of the 200th participant, we estimate that the interim analysis will be completed in the first quarter of 2027.\" ReMEDy2 Phase 2/3 in acute ischemic stroke; DSMB interim analysis after first 200 participants complete the trial; may stop for futility or set final sample size (300-728).","closed":0,"created_at":"2026-10-25 12:10:02","updated_at":"2026-10-25 12:10:02","company":"DiaMedica Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":1176,"symbol":"DNLI","drug":"zafinofusp alfa (DNL126)","modality":"protein","area":"rare_genetic","event_type":"data_presentation","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261103_160310_(DNLI)_sec_0001714899-26-000107-ex991.txt","comments":"\"Denali plans to present additional data from the Phase 1/2 study at a medical congress in the first quarter of 2027.\" Phase 1/2 in MPS IIIA; treatment duration for primary endpoint completed in Q3 2026 (n=20). Congress not named.","closed":0,"created_at":"2026-11-03T18:10:09","updated_at":"2026-11-03T18:10:09","company":"Denali Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":988,"symbol":"DSGN","drug":"DT-216P2","modality":"small_molecule","area":"rare_genetic","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260803_080340_(DSGN)_sec_0001193125-26-329570-ex991.txt","comments":"\"data following 12 weeks of treatment expected in the first quarter of 2027\" (RESTORE-FA, Friedreich ataxia); reconfirmed 2026-11-04: \"12-Week RESTORE-FA Data in Q1 2027\".","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-04T22:02:23Z","company":"Design Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":878,"symbol":"DYN","drug":"z-basivarsen (DYNE-101)","modality":"aso","area":"rare_genetic","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260929_161018_(DYN)_sec_0001818794-26-000009-ex991.txt","comments":"\"Dyne continues to expect topline data in Q1 2027 from the ACHIEVE registrational expansion cohort (REC), with a primary endpoint of change from baseline in vHOT at 6 months\". Q1 2027 window.","closed":0,"created_at":"2026-10-25 08:02:00","updated_at":"2026-10-25 08:02:00","company":"Dyne Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":875,"symbol":"EDIT","drug":"EDIT-401","modality":"gene_therapy","area":"metabolic","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261008_070433_(EDIT)_sec_0001650664-26-000093.txt","comments":"Initial safety/tolerability data update from the Phase 1/2 Strive trial: \"The Company expects to report initial safety and tolerability data in the first quarter of 2027.\" 10-Q (2026-08-05) similarly guided \"a data update in the first quarter of 2027\".","closed":0,"created_at":"2026-10-25 08:01:28","updated_at":"2026-10-25 08:01:28","company":"Editas Medicine","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":816,"symbol":"GYRE","drug":"CG923308","modality":"small_molecule","area":"oncology","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260901_090028_(GYRE)_sec_0001140361-26-035189-ex991.txt","comments":"\"CDK2 / Cyclin E Degrader CG923308 ... Q1'27 IND-application submission in U.S. and/or China\" (Upcoming Catalysts slide). IND submission only; Phase 1 start guided for 2027.","closed":0,"created_at":"2026-10-25 11:56:56","updated_at":"2026-10-25 11:56:56","company":"Gyre Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":817,"symbol":"GYRE","drug":"CG620953","modality":"small_molecule","area":"immunology","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260901_090028_(GYRE)_sec_0001140361-26-035189-ex991.txt","comments":"\"TYK2 / JAK 1 Degrader CG620953 ... Q1'27 IND-application submission in U.S. and/or China\" (Upcoming Catalysts slide). IND submission only; Phase 1 start guided for 2027.","closed":0,"created_at":"2026-10-25 11:56:56","updated_at":"2026-10-25 11:56:56","company":"Gyre Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":818,"symbol":"GYRE","drug":"F351","modality":"small_molecule","area":"gi_hepatology","event_type":"other","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260901_090028_(GYRE)_sec_0001140361-26-035189-ex991.txt","comments":"\"F351 potential launch in early 27'\" and \"NDA-filing accepted by China NMPA in May 2026; Potential launch post-NMPA decision in early 2027\". Represents the NMPA approval decision/launch timing.","closed":0,"created_at":"2026-10-25 11:56:56","updated_at":"2026-10-25 11:56:56","company":"Gyre Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":804,"symbol":"HRMY","drug":"BP-205","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260804_080512_(HRMY)_sec_0001104659-26-090086-ex991.txt","comments":"Nov 4, 2026: \"Phase 1b study in sleep-deprived healthy volunteers initiated in Q3 in the US; data expected in Q1 2027\" (earlier: \"data expected in early 2027\"). Q1 2027 = Jan-Mar 2027.","closed":0,"created_at":"2026-10-25 11:55:45","updated_at":"2026-11-04T13:38:27Z","company":"Harmony Biosciences Holdings","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":801,"symbol":"HROW","drug":"TRIESENCE","modality":"small_molecule","area":"ophthalmology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260810_161055_(HROW)_sec_0001493152-26-036865-ex991.txt","comments":"\"The Company's Phase 3 trial evaluating TRIESENCE for the treatment of ocular inflammation and pain following cataract surgery is on track to fully enroll in 2026, with topline data expected in early 2027.\" Early 2027 = 2027-01-01..2027-03-31.","closed":0,"created_at":"2026-10-25 11:55:30","updated_at":"2026-10-25 11:55:30","company":"Harrow","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":791,"symbol":"IBIO","drug":"IBIO-600","modality":"monoclonal_antibody","area":"metabolic","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260914_161645_(IBIO)_sec_0001420720-26-000028-ex991.txt","comments":"\"IBIO-600 Interim Phase 1 data anticipated in 1Q 2027\" (Sept 2026 corporate presentation, slide \"Anticipated Near Term Catalysts\"); Phase 1 SAD study of anti-myostatin antibody. 1Q 2027 = 2027-01-01..2027-03-31.","closed":0,"created_at":"2026-10-25 11:54:49","updated_at":"2026-10-25 11:54:49","company":"iBio","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":788,"symbol":"IDYA","drug":"IDE849","modality":"adc","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-11-03","expect_date_to":"2027-03-31","news_source_file":"documents/20261103_080427_(IDYA)_sec_0001193125-26-444225-ex991.txt","comments":"\"IDEAYA plans to provide the first clinical data from its global Phase 1/2 trial of IDE849 monotherapy in extensive-stage SCLC (ES-SCLC) and NEC by the end of 2026 or early in 2027\"; 10-Q same. Window widened from prior \"second half of 2026\".","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-04T09:31:18Z","company":"IDEAYA Biosciences","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-03 → 2027-03-31","imminence":146,"state":"open","overdue":false},{"id":764,"symbol":"INBX","drug":"ozekibart (INBRX-109)","modality":"monoclonal_antibody","area":"oncology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260813_161015_(INBX)_sec_0002007919-26-000044-ex991.txt","comments":"\"The Company expects to announce interim results from these cohorts during the first quarter of 2027.\" Two new Phase 1 CRC cohorts (FOLFIRI+Avastin 2L; Lonsurf+Avastin 3L/4L).","closed":0,"created_at":"2026-10-25T07:53:09","updated_at":"2026-10-25T07:53:09","company":"Inhibrx Biosciences","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":760,"symbol":"INKT","drug":"agenT-797","modality":"cell_therapy","area":"respiratory","event_type":"interim_analysis","expect_date_from":"2026-07-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260813_163035_(INKT)_sec_0001193125-26-349309.txt","comments":"10-Q: \"U.S. sites enrolling in parallel and preliminary data expected in the second half of 2026\" for randomized Phase 2 C-1300-02 in acute lung injury/AHRF; same-day 8-K says \"Additional data are expected in early 2027\" - window spans both statements. Preliminary, not company-confirmed topline.","closed":0,"created_at":"2026-10-25 11:53:05","updated_at":"2026-10-25 11:53:05","company":"MiNK Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-07-01 → 2027-03-31","imminence":146,"state":"open","overdue":false},{"id":759,"symbol":"INMB","drug":"pobistrocel","modality":"cell_therapy","area":"rare_genetic","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260806_160746_(INMB)_sec_0001213900-26-086135.txt","comments":"10-Q: MAA intended in the \"European Union in early 2027\"; Oct 21, 2026 release states \"EU EMA in 2027\". Window reflects \"early 2027\". Followed by a planned U.S. BLA (no date stated).","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"INmune Bio","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":1255,"symbol":"IOVA","drug":"lifileucel","modality":"cell_therapy","area":"oncology","event_type":"other","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261105_070000_(IOVA)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"Ex-US Amtagvi/lifileucel MAA approval decisions in advanced melanoma, both guided to 1Q27: UK MHRA \"for potential approval by 1Q27\"; \"A potential MAA approval by Swissmedic is expected in 1Q27.\" One row for both approvals (same drug/window); no exact dates stated.","closed":0,"created_at":"2026-11-05 12:29:40","updated_at":"2026-11-05 12:29:40","company":"Iovance Biotherapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":749,"symbol":"IRLA","drug":"LAM-001","modality":"small_molecule","area":"respiratory","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261009_075932_(IRLA)_sec_0001193125-26-418538-ex991.txt","comments":"\"LAM-001 is currently being evaluated in an ongoing Phase 2 trial in BOS, with data anticipated in the first quarter of 2027.\" Trial fully enrolled Jan 2026; reiterated in Oct 19 2026 corporate presentation (1Q27 BOS Phase 2 data).","closed":0,"created_at":"2026-10-25 11:52:10","updated_at":"2026-10-25 11:52:10","company":"IRulya Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":728,"symbol":"JSPR","drug":"briquilimab","modality":"monoclonal_antibody","area":"rare_genetic","event_type":"other","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260814_110039_(JSPR)_sec_0001213900-26-089592.txt","comments":"10-Q: \"progressing our efforts towards a pre-Biologics License Application (BLA) meeting with the FDA and expect to announce next steps in the first quarter of 2027\" (SCID).","closed":0,"created_at":"2026-10-25 07:50:14","updated_at":"2026-10-25 07:50:14","company":"Jasper Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":729,"symbol":"JSPR","drug":"KP-701","modality":"monoclonal_antibody","area":"immunology","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260814_110039_(JSPR)_sec_0001213900-26-089592.txt","comments":"10-Q: \"In the first quarter of 2027, we expect to file a clinical trial application (CTA) or an investigational new drug application (IND) for Phase 1 testing.\"","closed":0,"created_at":"2026-10-25 07:50:14","updated_at":"2026-10-25 07:50:14","company":"Jasper Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":1161,"symbol":"KRYS","drug":"KB111","modality":"gene_therapy","area":"dermatology","event_type":"other","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261102_070000_(KRYS)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"\"The Company expects to meet with the FDA in the first quarter of 2027, following completion of scale validation, to discuss study results, the scale, and study designs to enable a registrational study start in 2027\" (HHD severity scale validation must complete first)","closed":0,"created_at":"2026-11-02T23:22:36","updated_at":"2026-11-02T23:22:36","company":"Krystal Biotech","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":1117,"symbol":"LGND","drug":"volixibat","modality":"small_molecule","area":"gi_hepatology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261029_071444_(LGND)_sec_0000886163-26-000058.txt","comments":"Q3 2026 release: \"enrollment was completed in the VANTAGE Phase 2b study of volixibat in cholestatic pruritus due to primary biliary cholangitis (PBC) with topline results expected in the first quarter of 2027\" (Mirum-reported).","closed":0,"created_at":"2026-10-30 13:57:02","updated_at":"2026-10-30 13:57:02","company":"Ligand Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":78,"symbol":"LXRX","drug":"sotagliflozin","modality":"small_molecule","area":"cardiovascular","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261023_083000_(LXRX)_globenewswire_pharma_globenewswire_pharma-sha256-0c32ba11685bfc9772e6.txt","comments":"\"Topline results are anticipated in the first quarter of 2027.\" Phase 3 SONATA-HCM in nHCM and oHCM; primary endpoint change from baseline in KCCQ-CSS at Week 26","closed":0,"created_at":"2026-10-25T06:36:37","updated_at":"2026-10-25T06:36:37","company":"Lexicon Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":1251,"symbol":"LXRX","drug":"sotagliflozin","modality":"small_molecule","area":"metabolic","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261105_070000_(LXRX)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","comments":"\"Data preparation and administrative work is now being completed to support a high-quality NDA resubmission, anticipated in the first quarter of 2027.\" ZYNQUISTA (sotagliflozin) NDA resubmission for glycemic control in adults with T1D; supported by positive STENO1 safety data.","closed":0,"created_at":"2026-11-05 12:29:17","updated_at":"2026-11-05 12:29:17","company":"Lexicon Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":1226,"symbol":"MCRB","drug":"SER-155","modality":"other","area":"oncology","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261104_070512_(MCRB)_sec_0001193125-26-446185.txt","comments":"\"Seres expects to submit plans for the next irEC study design to the FDA in Q1 2027\" / \"anticipates submitting the study design to the FDA in the first quarter of 2027.\" Dependent on funding.","closed":0,"created_at":"2026-11-04 17:50:36","updated_at":"2026-11-04 17:50:36","company":"Seres Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":651,"symbol":"MDWD","drug":"EscharEx","modality":"protein","area":"other","event_type":"interim_analysis","expect_date_from":"2026-08-13","expect_date_to":"2027-03-31","news_source_file":"documents/20260813_070543_(MDWD)_sec_0001178913-26-004097-ex991.txt","comments":"Q2 2026 release: \"The pre-specified interim sample size reassessment and completion of enrollment are expected by the end of the first quarter of 2027\" in the Phase III VALUE trial in venous leg ulcers (216 patients). Window runs from the release date to 2027-03-31. Enrollment completion itself is not a separate catalyst. Sep 14, 2026 DSMB pre-specified review found no safety concerns and recommended continuation without modification; timeline unchanged.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25T12:19:49Z","company":"MediWound","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-08-13 → 2027-03-31","imminence":146,"state":"open","overdue":false},{"id":641,"symbol":"MIRA","drug":"MIRA-55","modality":"small_molecule","area":"pain_anesthesia","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260901_080025_(MIRA)_sec_0001493152-26-040930-ex991.txt","comments":"Company is \"targeting submission of an Investigational New Drug application for MIRA-55 to the U.S. Food and Drug Administration in the first quarter of 2027,\" subject to completion of remaining IND-enabling studies and regulatory requirements.","closed":0,"created_at":"2026-10-25 11:45:06","updated_at":"2026-10-25 11:45:06","company":"MIRA Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":638,"symbol":"MIRM","drug":"volixibat","modality":"small_molecule","area":"gi_hepatology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260805_160656_(MIRM)_sec_0001759425-26-000045.txt","comments":"10-Q: \"recently completed enrollment and expect topline data in the first quarter of 2027\" (volixibat, cholestatic pruritus in PBC).","closed":0,"created_at":"2026-10-25 11:45:03","updated_at":"2026-10-25 11:45:03","company":"Mirum Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":628,"symbol":"MLTX","drug":"sonelokimab","modality":"bispecific","area":"immunology","event_type":"topline_results","expect_date_from":"2026-11-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260810_074628_(MLTX)_sec_0001821586-26-000010.txt","comments":"Nov 4, 2026 release: \"MoonLake expects results of the P-OLARIS trial to become available in early 2027\" (narrowed from Aug 10, 2026 guidance of \"end of 2026 or early 2027\"; window retained to span the original guidance). Phase 2 imaging study in PsA/axSpA.","closed":0,"created_at":"2026-10-25 11:44:58","updated_at":"2026-11-04T15:45:05Z","company":"MoonLake Immunotherapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-01 → 2027-03-31","imminence":146,"state":"open","overdue":false},{"id":627,"symbol":"MLTX","drug":"sonelokimab","modality":"bispecific","area":"dermatology","event_type":"data_presentation","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261104_070000_(MLTX)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"Nov 4, 2026 release: \"The Company expects to complete the VELA-TEEN clinical trial in the fourth quarter of 2026 and plans to submit final results for presentation at a scientific conference in the first quarter of 2027\"; 10-Q: \"announce final topline results in the first quarter of 2027.\" Conference presentation, so data_presentation; timing moved from H2 2026 to Q1 2027.","closed":0,"created_at":"2026-10-25 11:44:58","updated_at":"2026-11-04T15:45:05Z","company":"MoonLake Immunotherapeutics","tier":"","llm_prediction":"small_impact","llm_confidence":0.62,"llm_reason":"The likely remaining dermatology readout is the final VELA-TEEN adolescent HS topline (2H26). The ~22-patient interim already showed strong, consistent responses, and adult VELA 52-week data are out, so this readout is incremental and largely de-risked. The company is well funded through mid-2028, which further limits downside from financing fears.","llm_predicted_at":"2026-10-25T15:50:47Z","llm_source":"live","window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":1209,"symbol":"MLTX","drug":"sonelokimab","modality":"bispecific","area":"immunology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261104_070000_(MLTX)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"Nov 4, 2026 release: \"Enrollment completed in the Phase 3 IZAR-2 trial in psoriatic arthritis, with initial topline results expected in Q1 2027\"; milestones list: \"Expected to announce Week 16 topline results in Q1 2027\". IZAR-2 Week 16 readout in TNF-IR PsA (with risankizumab active reference).","closed":0,"created_at":"2026-11-04T10:46:00","updated_at":"2026-11-04T10:46:00","company":"MoonLake Immunotherapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":620,"symbol":"MSLE","drug":"forazapadin","modality":"small_molecule","area":"rare_genetic","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260930_070006_(MSLE)_sec_0001171843-26-006303-ex991.txt","comments":"Sep 30, 2026 release: \"we now intend to share topline clinical data in the first quarter of 2027\" for BASECAMP Phase 2 in DMD; company says it is \"adjusting our previous plan for releasing data\" (prior guidance was Q4 2026).","closed":0,"created_at":"2026-10-25 11:44:24","updated_at":"2026-10-25 11:44:24","company":"Satellos Bioscience","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":616,"symbol":"NAMS","drug":"obicetrapib","modality":"small_molecule","area":"cardiovascular","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260805_070816_(NAMS)_sec_0001193125-26-333827-ex991.txt","comments":"\"PREVAIL interim analysis planned for 4Q2026 with result expected in 1Q2027\"; DSMB-run interim (blinded to company), recommendation may stop trial for efficacy/futility or continue to end 2027. 10-Q adds \"We expect to receive the DSMB's recommendation ... in the first quarter of 2027.\"","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"NewAmsterdam Pharma","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":601,"symbol":"NSRX","drug":"NS002","modality":"small_molecule","area":"immunology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260728_083427_(NSRX)_sec_0001493152-26-034938-ex991.txt","comments":"Guidance first given 7/28/2026: \"advancing NS002 toward a pivotal trial in the fourth quarter of 2026 and topline data readout the first quarter of 2027\"; reaffirmed in the 9/14/2026 6-K (\"anticipates topline data readout from the study in the first quarter of 2027\"). Pivotal study planned to start Q4 2026.","closed":0,"created_at":"2026-10-25 07:41:06","updated_at":"2026-10-25 07:41:06","company":"Nasus Pharma","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":1221,"symbol":"NVCT","drug":"NXP200","modality":"small_molecule","area":"oncology","event_type":"data_presentation","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261104_070000_(NVCT)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","comments":"\"Updates from the ongoing Phase 1b study in China, including in additional tumor types, are expected in early 2027.\" Early 2027 = 2027-01-01..2027-03-31.","closed":0,"created_at":"2026-11-04T12:50:00Z","updated_at":"2026-11-04T12:50:00Z","company":"Nuvectis Pharma","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":1223,"symbol":"NVCT","drug":"ciprocopan (NXP100)","modality":"small_molecule","area":"hematology","event_type":"other","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261104_070000_(NVCT)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","comments":"Second China marketing application for ciprocopan in PNH patients previously treated with anti-C5 therapy is under review, \"with approval expected in 1Q27.\" 1Q27 = 2027-01-01..2027-03-31. Approval decision by partner Haisco in China.","closed":0,"created_at":"2026-11-04T12:50:00Z","updated_at":"2026-11-04T12:50:00Z","company":"Nuvectis Pharma","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":581,"symbol":"OCGN","drug":"OCU400","modality":"gene_therapy","area":"ophthalmology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261014_212206_(OCGN)_sec_0001104659-26-115921-ex991.txt","comments":"\"Ocugen continues to advance OCU400 through its Phase 3 liMeliGhT clinical trial with a topline data readout expected in the first quarter of 2027.\" Phase 3 in retinitis pigmentosa; enrollment complete (N=140).","closed":0,"created_at":"2026-10-25 07:39:42","updated_at":"2026-10-25 07:39:42","company":"Ocugen","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":565,"symbol":"OLMA","drug":"palazestrant","modality":"small_molecule","area":"oncology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260810_160519_(OLMA)_sec_0001193125-26-342334-ex991.txt","comments":"Q2 2026 release: \"we now expect to report top-line data in the first quarter of 2027\" from pivotal Phase 3 OPERA-01 (monotherapy, 2L/3L ER+/HER2- MBC); enrollment complete.","closed":0,"created_at":"2026-10-25 11:39:03","updated_at":"2026-10-25 11:39:03","company":"Olema Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":563,"symbol":"OPK","drug":"MDX2301","modality":"bispecific","area":"infectious","event_type":"data_presentation","expect_date_from":"2026-11-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260727_160803_(OPK)_sec_0001193125-26-318069-ex991.txt","comments":"Q3 2026 release (Nov 4, 2026): ModeX \"completes enrollment in MDX2301 Phase 1 clinical trial\"; \"Early data is expected to be presented in late 2026 or early 2027.\" Window = late 2026 to early 2027; enrollment completion is not itself a listed catalyst.","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-04T22:00:42Z","company":"OPKO Health","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-01 → 2027-03-31","imminence":146,"state":"open","overdue":false},{"id":561,"symbol":"ORKA","drug":"ORKA-002","modality":"monoclonal_antibody","area":"dermatology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260810_070041_(ORKA)_sec_0001213900-26-086933-ex991.txt","comments":"\"The Company now expects to report Week 16 data from ORCA-SURGE, a Phase 2 trial in moderate-to-severe PsO, in the first quarter of 2027.\" Timing accelerated from prior guidance.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Oruka Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":545,"symbol":"PBLS","drug":"zolucatetide","modality":"peptide","area":"oncology","event_type":"data_presentation","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260813_071904_(PBLS)_sec_0001193125-26-347869-ex991.txt","comments":"FAP: \"Anticipate disclosing additional FAP data in the first quarter of 2027.\"","closed":0,"created_at":"2026-10-25 11:37:24","updated_at":"2026-10-25 11:37:24","company":"Parabilis Medicines","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":535,"symbol":"PDSB","drug":"PDS0301","modality":"protein","area":"oncology","event_type":"interim_analysis","expect_date_from":"2026-10-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261020_195906_(PDSB)_sec_0001140361-26-040283-ex991.txt","comments":"\"Q4-2026/Q1-2027 Biochemically recurrent prostate cancer (Interim readout)\" — NCI-partnered PDS0301 + enzalutamide study; first of five guided PDS0301 readouts.","closed":0,"created_at":"2026-10-25 11:37:04","updated_at":"2026-10-25 11:37:04","company":"PDS Biotechnology","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-01 → 2027-03-31","imminence":146,"state":"open","overdue":false},{"id":519,"symbol":"PHVS","drug":"deucrictibant XR","modality":"small_molecule","area":"immunology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260908_065109_(PHVS)_sec_0001193125-26-384339-ex991.txt","comments":"\"Topline data from Part 1 of CREAATE (NCT07266805) ... are anticipated in the first quarter of 2027.\" CREAATE: prophylaxis of AAE-C1INH attacks.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Pharvaris","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":515,"symbol":"PMN","drug":"PMN310","modality":"monoclonal_antibody","area":"cns","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260813_160703_(PMN)_sec_0001104659-26-095905-ex991.txt","comments":"\"unblinded 12-month topline data, including the full safety dataset, an expanded biomarker panel, and clinical cognitive outcome measures, in the first quarter of 2027\" — after database lock, following completion of 12-month dosing in Q4 2026.","closed":0,"created_at":"2026-10-25 11:35:19","updated_at":"2026-10-25 11:35:19","company":"ProMIS Neurosciences","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":507,"symbol":"PMVP","drug":"rezatapopt","modality":"small_molecule","area":"oncology","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261005_090006_(PMVP)_sec_0001193125-26-413254-ex991.txt","comments":"\"Company planning NDA submission for accelerated approval of rezatapopt in patients with platinum-resistant/refractory ovarian cancer in first quarter of 2027\" (2026-10-05). Same guidance given 2026-08-14 and 2026-08-31.","closed":0,"created_at":"2026-10-25 11:35:03","updated_at":"2026-10-25 11:35:03","company":"PMV Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":491,"symbol":"PTCT","drug":"votoplam","modality":"small_molecule","area":"cns","event_type":"other","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261029_161020_(PTCT)_sec_0001104659-26-120200-ex991.txt","comments":"\"Due to FDA scheduling, Type C meeting to discuss votoplam Phase 2 data and potential accelerated approval path now scheduled for Q1 2027\" (8-K Ex-99.1, Oct 29 2026); supersedes prior \"second half of 2026\" guidance. Q1 2027 = 2027-01-01..2027-03-31.","closed":0,"created_at":"2026-10-25 11:34:24","updated_at":"2026-10-30T16:02:46Z","company":"PTC Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":484,"symbol":"PYXS","drug":"micvotabart pelidotin (MICVO)","modality":"adc","area":"oncology","event_type":"other","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260909_073445_(PYXS)_sec_0001193125-26-385901-ex991.txt","comments":"\"An End of Phase 2 meeting with the FDA to align on dose selection is anticipated in the first quarter of 2027.\" Regulatory meeting, not a data readout. Reconfirmed 2026-11-05 Q3 release: \"FDA feedback on dose selection from the End-of-Phase 2 meeting expected in the first quarter of 2027\".","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-05T12:29:38Z","company":"Pyxis Oncology","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":464,"symbol":"RAPP","drug":"RAP-219","modality":"small_molecule","area":"cns","event_type":"other","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261020_060517_(RAPP)_sec_0001193125-26-425647-ex991.txt","comments":"End-of-Phase 2 meeting with the FDA expected in Q1 2027 for RAP-219 in bipolar mania: \"Rapport plans to meet with the U.S. Food and Drug Administration (FDA) in the first quarter of 2027 to discuss the Phase 2 data and registrational trial design\" (Q3 2026 8-K EX-99.1, Nov 4, 2026). Phase 3 initiation guided 2H 2027.","closed":0,"created_at":"2026-10-25 11:32:36","updated_at":"2026-11-04T15:45:07Z","company":"Rapport Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":436,"symbol":"REPL","drug":"RP2 (sturlimgene erparepvec)","modality":"gene_therapy","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260814_081029_(REPL)_sec_0001104659-26-096483-ex991.txt","comments":"\"Phase 2/3 transition is expected in Q1 2027\" for the registration-directed REVEAL study of RP2 + nivolumab in metastatic uveal melanoma (company-guided milestone, not a stated topline readout).","closed":0,"created_at":"2026-10-25 07:30:26","updated_at":"2026-10-25 07:30:26","company":"Replimune Group","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":1093,"symbol":"REPL","drug":"RP2 (sturlimgene erparepvec)","modality":"gene_therapy","area":"gi_hepatology","event_type":"data_presentation","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261028_072533_(REPL)_sec_0001628280-26-067722.txt","comments":"FY27 Q2 10-Q: RP2 + atezolizumab/bevacizumab in 2L HCC (Roche collaboration) and new RP2 + durvalumab BTC cohort - \"We are currently evaluating these studies and we expect to share preliminary findings in the first quarter of 2027.\" Distinct dataset from the REVEAL mUM Q1 2027 event (#436); no specific date or venue stated.","closed":0,"created_at":"2026-10-29T09:08:04","updated_at":"2026-10-29T09:08:04","company":"Replimune Group","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":420,"symbol":"RNAC","drug":"Descartes-08","modality":"cell_therapy","area":"cns","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261105_070252_(RNAC)_sec_0001453687-26-000110.txt","comments":"Q2 2026 (2026-08-06): \"data expected in 1Q27\"; reaffirmed Q3 2026 release (2026-11-05): \"Phase 3 AURORA trial of Descartes-08 in myasthenia gravis (MG) advances towards data readout expected in 1Q27\". Primary endpoint MG-ADL >=3-pt improvement at Month 4.","closed":0,"created_at":"2026-10-25 07:28:32","updated_at":"2026-11-05T12:30:13Z","company":"Cartesian Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":373,"symbol":"SEPN","drug":"SEP-479","modality":"small_molecule","area":"metabolic","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260810_160356_(SEPN)_sec_0001193125-26-342328-ex991.txt","comments":"\"Septerna expects to report Phase 1 data from both the SAD and MAD cohorts in the first quarter of 2027\" (Q2 2026 8-K release; 10-Q repeats). MAD dosing extended to 14 days to characterize steady-state PK. Hypoparathyroidism PTH1R agonist.","closed":0,"created_at":"2026-10-25T07:25:17","updated_at":"2026-10-25T07:25:17","company":"Septerna","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":572,"symbol":"SLDB","drug":"SGT-212","modality":"gene_therapy","area":"rare_genetic","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260806_160410_(SLDB)_sec_0001193125-26-337935.txt","comments":"10-Q FALCON Phase 1b: \"with initial data anticipated in the first quarter of 2027, subject to participant enrollment.\"","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Solid Biosciences","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":1139,"symbol":"SLXN","drug":"SIL204","modality":"sirna","area":"oncology","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260810_061608_(SLXN)_sec_0001178913-26-003966-ex991.txt","comments":"Aug 2026 investor deck milestone slide: \"IND application Q1, 2027\" and \"Expansion Phase 2/3 to USA and EU countries submission and initiation Q1, 2027\"; \"pre-IND meeting with FDA expected early 2027\". Q1 2027 window as stated.","closed":0,"created_at":"2026-11-01 20:28:01","updated_at":"2026-11-01 20:28:01","company":"Silexion Therapeutics Corp","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":345,"symbol":"SNDX","drug":"axatilimab + ruxolitinib","modality":"monoclonal_antibody","area":"immunology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261102_160100_(SNDX)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com_7f72b6.txt","comments":"\"The Company expects topline data from the Phase 2 trial of axatilimab in combination with ruxolitinib to be presented at a medical meeting in the first quarter of 2027.\" (3Q26 release, Nov 2, 2026; previously guided to Q4 2026)","closed":0,"created_at":"2026-10-25 11:23:40","updated_at":"2026-11-03T04:22:14Z","company":"Syndax Pharmaceuticals","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.72,"llm_reason":"The readout is an open-label Phase 2 of axatilimab plus ruxolitinib in frontline cGVHD, a label expansion for a drug that is already approved. Syndax has two commercial products, a $1.2B market cap, and an IPF readout landing in the same quarter that likely matters more. Frontline cGVHD combo data alone is unlikely to move the stock 10%.","llm_predicted_at":"2026-10-25T15:49:46Z","llm_source":"live","window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":339,"symbol":"SPRY","drug":"ARS-2","modality":"small_molecule","area":"dermatology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260813_160318_(SPRY)_sec_0001193125-26-349127-ex991.txt","comments":"\"ARS Pharma expects interim Phase 2b data in the first quarter of 2027\" (Q2 2026 release, 2026-08-13). Caveat: enrollment complete in interim population; each patient must log three CSU flare episodes, so timing depends on patient completion.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"ARS Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":338,"symbol":"SRPT","drug":"ELEVIDYS","modality":"gene_therapy","area":"rare_genetic","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260805_160623_(SRPT)_sec_0001193125-26-335056-ex991.txt","comments":"\"For ELEVIDYS, full enrollment of ENDEAVOR Cohort 8 expected by year-end 2026 and 12-week data from the full cohort in Q1 2027.\" Q1 2027 window. Cohort 8 (Study 9001-103) evaluates sirolimus immunosuppression in non-ambulant Duchenne patients.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Sarepta Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":295,"symbol":"TECX","drug":"TX45","modality":"protein","area":"cardiovascular","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260806_161006_(TECX)_sec_0001193125-26-338000-ex991.txt","comments":"\"topline results anticipated in early Q1 2027\" for the APEX Phase 2 trial in PH-HFpEF (enrollment complete June 2026; IDMC recommended continuation in July 2026).","closed":0,"created_at":"2026-10-25T07:20:01","updated_at":"2026-10-25T07:20:01","company":"Tectonic Therapeutic","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":1081,"symbol":"TENX","drug":"TNX-103 (oral levosimendan)","modality":"small_molecule","area":"cardiovascular","event_type":"other","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261008_161554_(TENX)_sec_0001193125-26-417939-ex991.txt","comments":"\"Publication of the LEVEL-2 protocol design paper is expected in Q1 2027. Further updates on levosimendan development are expected in Q1 2027.\" Deck also notes TYPE C meeting requested with FDA (no date) and temporary LEVEL-2 enrollment pause for protocol amendment; also \"further analyses through 1H 2027\".","closed":0,"created_at":"2026-10-28 18:31:58","updated_at":"2026-10-28 18:31:58","company":"Tenax Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":288,"symbol":"TGTX","drug":"ublituximab","modality":"monoclonal_antibody","area":"cns","event_type":"topline_results","expect_date_from":"2026-11-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260803_070558_(TGTX)_sec_0001437749-26-025304-ex991.txt","comments":"\"Announce topline Phase 3 data for subcutaneous BRIUMVI year-end 2026/first quarter 2027\"; 10-Q: \"expected around year-end 2026 or first quarter 2027\". Phase 3 fully enrolled.","closed":0,"created_at":"2026-10-25 11:19:28","updated_at":"2026-10-25 11:19:28","company":"TG Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-01 → 2027-03-31","imminence":146,"state":"open","overdue":false},{"id":283,"symbol":"TLSA","drug":"foralumab","modality":"monoclonal_antibody","area":"cns","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261016_070025_(TLSA)_sec_0001213900-26-110008-ex991.txt","comments":"Phase 2 randomized, placebo-controlled trial in early/mild Alzheimer's disease; last patient began dosing. \"Topline data are anticipated to be announced in Q1 2027.\"","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Tiziana Life Sciences","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":504,"symbol":"TRAX","drug":"ANB033","modality":"monoclonal_antibody","area":"gi_hepatology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261103_161500_(TRAX)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co_72d863.txt","comments":"Q3 2026 release (Nov 3, 2026): \"Enrollment complete with top-line data anticipated in Q1 2027\" - Phase 1b Cohort 2 (mucosal healing) in celiac disease; reaffirms prior Q1 2027 guidance.","closed":0,"created_at":"2026-10-25 11:35:02","updated_at":"2026-11-04T19:56:20Z","company":"First Tracks Biotherapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":8,"symbol":"TRDA","drug":"ENTR-601-44","modality":"aso","area":"rare_genetic","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260805_070000_(TRDA)_yahoo_news_yahoo-77cb9ebfed5f1148e1336f4bceeb2f96-TRDA.txt","comments":"Q2 2026 release: \"ELEVATE-44-201 Cohort 2 enrollment complete with data expected in Q1 2027\".","closed":0,"created_at":"2026-10-25 09:52:36","updated_at":"2026-10-25 09:52:36","company":"Entrada Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":262,"symbol":"TTRX","drug":"GX-03","modality":"other","area":"dermatology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261006_193052_(TTRX)_sec_0001213900-26-107329-ex991.txt","comments":"\"Phase 2 RCT trial underway for moderate to severe AD, topline results expected Q1 2027\"; milestones slide \"Q1 2027: Topline Readout\". Prior guidance (July 2026 deck) was Q4 2026.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Turn Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":255,"symbol":"TYRA","drug":"dabogratinib","modality":"small_molecule","area":"rare_genetic","event_type":"topline_results","expect_date_from":"2027-03-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260804_160446_(TYRA)_sec_0001193125-26-332752-ex991.txt","comments":"\"Initial results from the safety sentinel cohort, including 6-month annualized height velocity and safety data for dose levels 1-5 ... expected to be reported at the end of Q1 2027\" (BEACH301, achondroplasia, ~25 children).","closed":0,"created_at":"2026-10-25 11:16:35","updated_at":"2026-10-25 11:16:35","company":"Tyra Biosciences","tier":"Core","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-03-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":230,"symbol":"VERU","drug":"enobosarm","modality":"small_molecule","area":"metabolic","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260810_070007_(VERU)_sec_0001193125-26-341187-ex991.txt","comments":"\"Results of an interim analysis assessing lean body mass and fat mass as measured by DXA after patients have completed 32 weeks is expected in the first quarter of calendar year 2027.\" Phase 2b PLATEAU fully enrolled (239 patients).","closed":0,"created_at":"2026-10-25 11:15:03","updated_at":"2026-10-25 11:15:03","company":"Veru","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":228,"symbol":"VIR","drug":"elebsiran and tobevibart","modality":"other","area":"gi_hepatology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260805_160955_(VIR)_sec_0001628280-26-053351-ex991.txt","comments":"\"Topline data from the ECLIPSE 2 and ECLIPSE 3 trials are expected in the first quarter of 2027.\" ECLIPSE 2 (switch from bulevirtide, Ph3) and ECLIPSE 3 (Ph2b vs bulevirtide) reported in same guidance window.","closed":0,"created_at":"2026-10-25 11:14:56","updated_at":"2026-10-25 11:14:56","company":"Vir Biotechnology","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":218,"symbol":"VRDN","drug":"elegrobart","modality":"monoclonal_antibody","area":"ophthalmology","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260806_070506_(VRDN)_sec_0001193125-26-336691-ex991.txt","comments":"\"Viridian is on track to submit a Biologics License Application (BLA) to the FDA for elegrobart in Q1 2027.\" Subcutaneous anti-IGF-1R autoinjector in active and chronic TED.","closed":0,"created_at":"2026-10-25 11:14:28","updated_at":"2026-10-25 11:14:28","company":"Viridian Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":211,"symbol":"VYGR","drug":"VY1706","modality":"gene_therapy","area":"cns","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20260806_160323_(VYGR)_sec_0001640266-26-000007-ex991.txt","comments":"\"Early 2027: Potential for initial acute safety data with VY1706, pending enrollment\"; 10-Q: \"initial acute safety data, which we anticipate announcing in early 2027, pending enrollment progress and timing\". Oct-21 8-K still refers to first quarter of 2027.","closed":0,"created_at":"2026-10-25 11:13:35","updated_at":"2026-10-25 11:13:35","company":"Voyager Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":1247,"symbol":"ZVRA","drug":"arimoclomol","modality":"small_molecule","area":"rare_genetic","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-03-31","news_source_file":"documents/20261103_160815_(ZVRA)_sec_0001434647-26-000085-ex991.txt","comments":"Q3 2026 8-K exhibit: after meeting FDA to discuss a potential sNDA for MIPLYFFA in infants <24 months, \"Company anticipates filing sNDA in Q1 2027.\" Window = Q1 2027 (2027-01-01..2027-03-31).","closed":0,"created_at":"2026-11-05 08:24:31","updated_at":"2026-11-05 08:24:31","company":"Zevra Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-03-31","imminence":146,"state":"upcoming","overdue":false},{"id":805,"symbol":"HRMY","drug":"pitolisant GR","modality":"small_molecule","area":"cns","event_type":"pdufa","expect_date_from":"2027-04-01","expect_date_to":"2027-04-01","news_source_file":"documents/20260804_080512_(HRMY)_sec_0001104659-26-090086-ex991.txt","comments":"\"Pitolisant GR NDA Accepted in July; Target PDUFA Date April 1, 2027\"; 10-Q: NDA accepted for full review with target PDUFA date of April 1, 2027.","closed":0,"created_at":"2026-10-25 11:55:45","updated_at":"2026-10-25 11:55:45","company":"Harmony Biosciences Holdings","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-04-01","imminence":147,"state":"upcoming","overdue":false},{"id":763,"symbol":"INBX","drug":"ozekibart (INBRX-109)","modality":"monoclonal_antibody","area":"oncology","event_type":"pdufa","expect_date_from":"2027-04-14","expect_date_to":"2027-04-14","news_source_file":"documents/20260813_161015_(INBX)_sec_0002007919-26-000044-ex991.txt","comments":"\"FDA accepted for filing the Company's BLA for the potential approval of ozekibart in conventional chondrosarcoma and assigned a PDUFA goal date of April 14, 2027.\"","closed":0,"created_at":"2026-10-25T07:53:09","updated_at":"2026-10-25T07:53:09","company":"Inhibrx Biosciences","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-04-14","imminence":160,"state":"upcoming","overdue":false},{"id":518,"symbol":"PHVS","drug":"deucrictibant IR","modality":"small_molecule","area":"immunology","event_type":"pdufa","expect_date_from":"2027-04-23","expect_date_to":"2027-04-23","news_source_file":"documents/20260812_065119_(PHVS)_sec_0001193125-26-345702-ex991.txt","comments":"\"FDA accepted to review the Company's NDA for deucrictibant IR for the on-demand treatment of HAE attacks, with the PDUFA action date set for April 23, 2027.\" On-demand treatment of HAE attacks.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Pharvaris","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-04-23","imminence":169,"state":"upcoming","overdue":false},{"id":562,"symbol":"ORGO","drug":"ReNu","modality":"cell_therapy","area":"dermatology","event_type":"pdufa","expect_date_from":"2027-04-24","expect_date_to":"2027-04-24","news_source_file":"documents/20260806_161536_(ORGO)_sec_0001193125-26-338049.txt","comments":"10-Q: \"completed the submission on April 24, 2026. During June 2026, the FDA accepted the BLA for review and assigned a PDUFA target action date of April 24, 2027.\" PDUFA date per filing, not stated in the Q2 earnings release.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Organogenesis Holdings","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-04-24","imminence":170,"state":"upcoming","overdue":false},{"id":772,"symbol":"IMNM","drug":"varegacestat","modality":"small_molecule","area":"oncology","event_type":"pdufa","expect_date_from":"2027-04-28","expect_date_to":"2027-04-28","news_source_file":"documents/20260811_160517_(IMNM)_sec_0001193125-26-344577-ex991.txt","comments":"\"In July 2026, the U.S. FDA accepted Immunome's NDA for varegacestat for the treatment of adults with desmoid tumors and assigned a PDUFA target action date of April 28, 2027.\" NDA submitted April 2026.","closed":0,"created_at":"2026-10-25 11:53:51","updated_at":"2026-10-25 11:53:51","company":"Immunome","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-04-28","imminence":174,"state":"upcoming","overdue":false},{"id":122,"symbol":"AXSM","drug":"AXS-12","modality":"small_molecule","area":"cns","event_type":"pdufa","expect_date_from":"2027-05-01","expect_date_to":"2027-05-01","news_source_file":"documents/20260715_070515_(AXSM)_sec_0001193125-26-304039-ex991.txt","comments":"\"FDA sets PDUFA target action date of May 1, 2027\" for AXS-12 (reboxetine) NDA for cataplexy in narcolepsy; FDA indicated it does not currently plan to hold an advisory committee meeting.","closed":0,"created_at":"2026-10-25 11:05:34","updated_at":"2026-10-25 11:05:34","company":"Axsome Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-05-01","imminence":177,"state":"upcoming","overdue":false},{"id":1144,"symbol":"QURE","drug":"ifezuntirgene inilparvovec (AMT-130)","modality":"gene_therapy","area":"cns","event_type":"pdufa","expect_date_from":"2027-05-01","expect_date_to":"2027-05-01","news_source_file":"documents/20261102_071522_(QURE)_sec_0001104659-26-120915.txt","comments":"\"FDA sets PDUFA target action date of May 1, 2027\"; BLA accepted with Priority Review under accelerated approval (announced 2026-11-02). FDA \"tentatively planning to discuss this application at an Advisory Committee meeting\" - no adcom date stated yet.","closed":0,"created_at":"2026-11-02","updated_at":"2026-11-02","company":"uniQure","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-05-01","imminence":177,"state":"upcoming","overdue":false},{"id":193,"symbol":"ZBIO","drug":"obexelimab","modality":"monoclonal_antibody","area":"immunology","event_type":"pdufa","expect_date_from":"2027-05-27","expect_date_to":"2027-05-27","news_source_file":"documents/20260813_070549_(ZBIO)_sec_0001104659-26-095437-ex991.txt","comments":"\"The BLA has a Prescription Drug User Fee Act (PDUFA) target action date of May 27, 2027\" (BLA for obexelimab in IgG4-RD accepted by FDA in August 2026).","closed":0,"created_at":"2026-10-25 11:12:19","updated_at":"2026-10-25 11:12:19","company":"Zenas BioPharma","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-05-27","imminence":203,"state":"upcoming","overdue":false},{"id":13,"symbol":"SXTP","drug":"tafenoquine","modality":"small_molecule","area":"infectious","event_type":"regulatory_submission","expect_date_from":"2027-04-01","expect_date_to":"2027-05-31","news_source_file":"documents/20261023_080023_(SXTP)_sec_0001213900-26-111864-ex991.txt","comments":"\"APR / MAY sNDA filing\" / \"APR 2027 Final sNDA submission\" for babesiosis; illustrative timing dependent on FDA alignment and dossier completeness. Oct 6 deck: \"Q2 2027 sNDA filed.\"","closed":0,"created_at":"2026-10-25 09:52:52","updated_at":"2026-10-25 09:52:52","company":"60 DEGREES PHARMACEUTICALS, INC","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-04-01 → 2027-05-31","imminence":207,"state":"upcoming","overdue":false},{"id":1015,"symbol":"URGN","drug":"UGN-103","modality":"small_molecule","area":"oncology","event_type":"pdufa","expect_date_from":"2027-06-14","expect_date_to":"2027-06-14","news_source_file":"documents/20261104_091723_(URGN)_sec_0001437749-26-034780.txt","comments":"Q3 2026 10-Q (2026-11-04): \"in October 2026, we announced the FDA's acceptance of the NDA and the assignment of a Prescription Drug User Fee Act (\\\"PDUFA\\\") target action date of June 14, 2027\" for UGN-103 in recurrent LG-IR-NMIBC. Date refined from prior \"potential FDA approval in 2027\" guidance (Q2 release) to the stated PDUFA date.","closed":0,"created_at":"2026-10-25 16:08:37","updated_at":"2026-11-05T04:14:04Z","company":"UroGen Pharma","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-14","imminence":221,"state":"upcoming","overdue":false},{"id":993,"symbol":"COGT","drug":"bezuclastinib","modality":"small_molecule","area":"hematology","event_type":"pdufa","expect_date_from":"2027-06-29","expect_date_to":"2027-06-29","news_source_file":"documents/20260915_080000_(COGT)_yahoo_news_yahoo-b820481790ae7b118325e4cecd7ac7ad-COGT.txt","comments":"\"PDUFA target action date set for June 29, 2027\" for bezuclastinib NDA in Advanced Systemic Mastocytosis (APEX trial); FDA accepted NDA Sept 15, 2026, no advisory committee planned, no review issues flagged.","closed":0,"created_at":"2026-10-25T08:17:17","updated_at":"2026-10-25T08:17:17","company":"Cogent Biosciences","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-29","imminence":236,"state":"upcoming","overdue":false},{"id":41,"symbol":"ACET","drug":"prula-cel","modality":"cell_therapy","area":"immunology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260928_081531_(ACET)_sec_0001720580-26-000060-ex991.txt","comments":"\"First Half 2027: Anticipated clinical data update in systemic sclerosis (SSc)\"","closed":0,"created_at":"2026-10-25 10:05:15","updated_at":"2026-10-25 10:05:15","company":"Adicet Bio","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":413,"symbol":"ACHV","drug":"cytisinicline","modality":"small_molecule","area":"cns","event_type":"pdufa","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260811_160440_(ACHV)_sec_0001193125-26-344571-ex991.txt","comments":"\"anticipate the potential approval of cytisinicline for smoking cessation in the first half of 2027, followed by U.S. commercial launch\" (Q2 2026 release). No specific action date assigned; contingent on Q4 2026 NDA resubmission. Window = H1 2027.","closed":0,"created_at":"2026-10-25 07:27:48","updated_at":"2026-10-25 07:27:48","company":"Achieve Life Sciences","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":514,"symbol":"ACIU","drug":"ACI-19764","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260820_070004_(ACIU)_sec_0001651625-26-000018-ex991.txt","comments":"\"Full results from the Phase 1/1b trial are expected in H1 2027\"; also \"additional data expected in H1 2027\". H1 2027 = 2027-01-01..2027-06-30.","closed":0,"created_at":"2026-10-25 10:30:00","updated_at":"2026-10-25 10:30:00","company":"AC Immune","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":1014,"symbol":"ACRV","drug":"ACR-7280","modality":"small_molecule","area":"oncology","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261020_083000_(ACRV)_yahoo_news_yahoo-46c38a94c4c6ccbab9a21d6bc56a1a9f-ACRV.txt","comments":"\"IND-enabling studies ongoing with IND submission on track for first half of 2027\" — GlobeNewswire release, Oct 20 2026; window per \"first half of 2027\" = 2027-01-01..2027-06-30. Source is the Yahoo copy of the company/GlobeNewswire release: the GlobeNewswire ingest (documents/20261020_083000_(ACRV)_google_news_gnews-ec8cf698005870802f7ce421cdb5315f-ACRV.txt) is headline-only, so the body quote is taken from the Yahoo copy. Preclinical AML xenograft data only; no clinical readout guided, so no result recorded.","closed":0,"created_at":"2026-10-25T12:08:09","updated_at":"2026-10-26T14:43:36Z","company":"Acrivon Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":179,"symbol":"ADCT","drug":"ZYNLONTA","modality":"adc","area":"hematology","event_type":"data_presentation","expect_date_from":"2027-04-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260813_091434_(ADCT)_sec_0000950103-26-012287-ex991.txt","comments":"Updated FL (follicular lymphoma) data from the University of Miami-led IIT of ZYNLONTA + rituximab: \"We also anticipate presentation of updated FL data in Q2 2027.\" Window covers the whole of Q2 2027.","closed":0,"created_at":"2026-10-25 11:22:00","updated_at":"2026-10-25 11:22:00","company":"ADC Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-04-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":155,"symbol":"ANRO","drug":"ALTO-300","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260812_161432_(ANRO)_sec_0001999480-26-000022-ex991.txt","comments":"\"Topline data remain expected in 1H 2027 for the ALTO-300 Phase 2b MDD trial\". 10-Q also: \"We expect to report topline data from this trial in the first half of 2027.\" Window = 1H 2027.","closed":0,"created_at":"2026-10-25T07:07:46","updated_at":"2026-10-25T07:07:46","company":"Alto Neuroscience","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":353,"symbol":"ASBP","drug":"Instaprin","modality":"small_molecule","area":"cardiovascular","event_type":"regulatory_submission","expect_date_from":"2026-11-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260813_163125_(ASBP)_sec_0001493152-26-037819.txt","comments":"10-Q: \"Aspire plans to submit its FDA 505(b)(2) approval request in late 2026 or early 2027\"; also \"505(b)(2) submission to the FDA planned for the first six months of 2027, once the next clinical trial is concluded\". Widest supported window used; submission contingent on the next clinical trial.","closed":0,"created_at":"2026-10-25T07:24:00","updated_at":"2026-10-25T07:24:00","company":"Aspire-Lakewood Holdings","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-11-01 → 2027-06-30","imminence":237,"state":"open","overdue":false},{"id":352,"symbol":"ATNM","drug":"Actimab-A","modality":"radiopharma","area":"oncology","event_type":"interim_analysis","expect_date_from":"2026-07-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260807_170038_(ATNM)_sec_0001213900-26-086769.txt","comments":"Initial data from the planned Phase 1b basket trial of Actimab-A + pembrolizumab/nivolumab in HNSCC, NSCLC, GBM and MSI-high CRC. 10-Q: \"We expect to report initial data from this trial in 2H:2026 or 1H:2027.\" Trial described as intended to be conducted.","closed":0,"created_at":"2026-10-25 11:23:55","updated_at":"2026-10-25 11:23:55","company":"Actinium Pharmaceuticals Inc. (Delaware)","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-07-01 → 2027-06-30","imminence":237,"state":"open","overdue":false},{"id":130,"symbol":"AVIR","drug":"bemnifosbuvir/ruzasvir (BEM/RZR)","modality":"small_molecule","area":"gi_hepatology","event_type":"regulatory_submission","expect_date_from":"2027-04-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260812_161536_(AVIR)_sec_0001193125-26-346888-ex991.txt","comments":"\"pending results from C-FORWARD, Atea anticipates submitting a new drug application (NDA) to the US FDA in the second quarter of 2027\"; contingent on positive C-FORWARD results.","closed":0,"created_at":"2026-10-25 11:06:00","updated_at":"2026-10-25 11:06:00","company":"Atea Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-04-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":128,"symbol":"AVTX","drug":"AVTX-010","modality":"monoclonal_antibody","area":"immunology","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260806_070135_(AVTX)_sec_0001534120-26-000048-ex991.txt","comments":"\"The Company expects to submit an Investigational New Drug (IND) application in the first half of 2027.\" AVTX-010 is a long-acting next-generation anti-IL-1beta mAb; IND timing is company guidance.","closed":0,"created_at":"2026-10-25 11:06:00","updated_at":"2026-10-25 11:06:00","company":"Avalo Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":105,"symbol":"BEAM","drug":"risto-cel","modality":"cell_therapy","area":"hematology","event_type":"regulatory_submission","expect_date_from":"2026-12-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260804_070908_(BEAM)_sec_0001193125-26-331522-ex991.txt","comments":"\"submit a biologics license application (BLA) for risto-cel as early as year-end 2026\"; window starts at year-end 2026 and allows for slippage. 10-Q repeats: \"expect to submit a BLA for risto-cel as early as year-end 2026.\"","closed":0,"created_at":"2026-10-25 07:04:17","updated_at":"2026-10-25 07:04:17","company":"Beam Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-12-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":59,"symbol":"BLSM","drug":"BH-30643","modality":"small_molecule","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260918_073032_(BLSM)_sec_0001193125-26-395043.txt","comments":"\"We plan to report updated Phase 1 data on durability of response in the C797S population in the first half of 2027\" (10-Q); 8-K: \"1H 2027: Updated Phase 1 data, including C797S durability\".","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"BlossomHill Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":61,"symbol":"BLSM","drug":"BH-30236","modality":"small_molecule","area":"hematology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260918_073032_(BLSM)_sec_0001193125-26-395043.txt","comments":"\"We expect to report updated data on safety and anti-leukemic effects from the BH-30236 Phase 1 trial in the first half of 2027\" (R/R AML and HR-MDS).","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"BlossomHill Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":31,"symbol":"BMEA","drug":"icovamenib","modality":"small_molecule","area":"metabolic","event_type":"topline_results","expect_date_from":"2027-04-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260824_070000_(BMEA)_yahoo_news_yahoo-418a8ca54a6d2f29a23d00381d39bca9-BMEA.txt","comments":"\"COVALENT-212 Phase II enrollment ... is still ongoing, with topline 26-week primary endpoint data anticipated in the second quarter of 2027\". Enrollment expected complete before year end 2026.","closed":0,"created_at":"2026-10-25 05:53:24","updated_at":"2026-10-25 05:53:24","company":"Biomea Fusion","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-04-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":964,"symbol":"CLRB","drug":"iopofosine I 131","modality":"radiopharma","area":"hematology","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261027_071500_(CLRB)_globenewswire_pharma_globenewswire_pharma-sha256-e0eabecf1206e859cb80.txt","comments":"\"FDA filing for accelerated approval remains targeted for 1H27\" (Nov 4 2026 release); \"plans remaining on target to submit an accelerated approval application to the U.S. FDA in the first half of 2027\" (Oct 27 2026). Earlier Aug 2026 8-K said \"mid-2027\". NDA for r/r WM under Accelerated Approval based on CLOVER WaM; confirmatory Phase 3 first patient dosing on track for 1Q 2027.","closed":0,"created_at":"2026-10-25 08:07:28","updated_at":"2026-11-04T15:43:43Z","company":"Cellectar Biosciences","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":71,"symbol":"CLYM","drug":"CLYM116/MIL116","modality":"monoclonal_antibody","area":"renal","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261023_160100_(CLYM)_globenewswire_biotech_globenewswire_biotech-sha256-cf802fa54245d6dca4d.txt","comments":"\"NAVIGATE-2 Phase 2 trial is enrolling, with initial data expected in the first half of 2027\" (IgAN). Global Phase 3 initiation in 2027 pending regulatory feedback (not a catalyst row).","closed":0,"created_at":"2026-10-25 06:34:44","updated_at":"2026-10-25 06:34:44","company":"Climb Bio","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":941,"symbol":"COYA","drug":"COYA 302","modality":"protein","area":"cns","event_type":"topline_results","expect_date_from":"2027-04-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261005_083007_(COYA)_sec_0001193125-26-413218.txt","comments":"\"Topline data from the double-blind treatment phase are anticipated in early Q2 2027\" (Oct 5, 2026 8-K, ALSTARS Ph2/3 ALS, full enrollment of 120 announced); reaffirmed context Oct 14, 2026 8-K. Window widened to all of Q2 2027 per \"early Q2\". Earlier guidance was Q1 2027 (Aug 11, 2026 release). Double-blind phase data; extension continues.","closed":0,"created_at":"2026-10-25T08:06:00","updated_at":"2026-10-25T12:18:43Z","company":"Coya Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-04-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":913,"symbol":"CTMX","drug":"varsetatug masetecan","modality":"adc","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260806_161058_(CTMX)_sec_0001193125-26-338009-ex991.txt","comments":"\"A Phase 1 combination study of Varseta-M and bevacizumab is ongoing... Initial clinical data is anticipated in 1H 2027\" (late-line CRC). 1H 2027 = 2027-01-01..2027-06-30.","closed":0,"created_at":"2026-10-25 12:04:36","updated_at":"2026-10-25 12:04:36","company":"CytomX Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":914,"symbol":"CTMX","drug":"CX-801","modality":"protein","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260806_161058_(CTMX)_sec_0001193125-26-338009-ex991.txt","comments":"\"Initial clinical data for CX-801 in combination with KEYTRUDA(R) in advanced melanoma is expected in the first half of 2027.\" 1H 2027 = 2027-01-01..2027-06-30.","closed":0,"created_at":"2026-10-25 12:04:36","updated_at":"2026-10-25 12:04:36","company":"CytomX Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":894,"symbol":"DFTX","drug":"DT120 ODT","modality":"small_molecule","area":"cns","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260914_080240_(DFTX)_sec_0001104659-26-107275-ex991.txt","comments":"\"NDA filing anticipated in 1H 2027\" for DT120 ODT in GAD.","closed":0,"created_at":"2026-10-25 12:02:58","updated_at":"2026-10-25 12:02:58","company":"Definium Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":884,"symbol":"DNLI","drug":"DNL593 (PTV:PGRN)","modality":"protein","area":"cns","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261103_160310_(DNLI)_sec_0001714899-26-000107-ex991.txt","comments":"\"Data are expected in the first half of 2027.\" (Q3 2026 release, Nov 3 2026) — narrowed from prior year-only \"in 2027\" expectation. Phase 1/2 in FTD-GRN; enrollment complete (n=40). Orphan Drug Designation granted Aug 2026.","closed":0,"created_at":"2026-10-25T08:05:00","updated_at":"2026-11-03T23:10:20Z","company":"Denali Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":886,"symbol":"DNLI","drug":"DNL628 (OTV:MAPT)","modality":"aso","area":"cns","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260806_160319_(DNLI)_sec_0001714899-26-000096-ex991.txt","comments":"\"Initial clinical biomarker data from the ongoing Phase 1b study of DNL628 in participants with Alzheimer's disease are expected in the first half of 2027.\" Biomarker data only, not full topline.","closed":0,"created_at":"2026-10-25T08:05:00","updated_at":"2026-10-25T08:05:00","company":"Denali Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":888,"symbol":"DNLI","drug":"DNL151 (LRRK2 inhibitor)","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260806_160319_(DNLI)_sec_0001714899-26-000096-ex991.txt","comments":"BEACON Phase 2a in LRRK2-variant Parkinson's: \"Data from BEACON are expected in the first half of 2027.\" Idiopathic PD development discontinued after LUMA failure; BEACON continues independently.","closed":0,"created_at":"2026-10-25T08:05:00","updated_at":"2026-10-25T08:05:00","company":"Denali Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":82,"symbol":"EIKN","drug":"EIK1005","modality":"small_molecule","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261023_091500_(EIKN)_globenewswire_biotech_globenewswire_biotech-sha256-dea126dcba62387f2a4.txt","comments":"\"Eikon expects additional results from the combination of EIK1005 with pembrolizumab to be available in the first half of 2027\" (company release, 2026-10-23). First half 2027 = 2027-01-01..2027-06-30.","closed":0,"created_at":"2026-10-25 10:37:29","updated_at":"2026-10-25 10:37:29","company":"Eikon Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":869,"symbol":"ELUT","drug":"NXT-41x","modality":"other","area":"other","event_type":"pdufa","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260813_161524_(ELUT)_sec_0001104659-26-095934-ex991.txt","comments":"Company guided window: \"The Company continues to expect FDA clearance for ... NXT-41x in the first half of 2027.\" Aug 21, 2026 release repeats: \"NXT-41x clearance expected in the first half of 2027.\"","closed":0,"created_at":"2026-10-25 08:00:46","updated_at":"2026-10-25 08:00:46","company":"Elutia","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":857,"symbol":"ENTX","drug":"EB612","modality":"peptide","area":"metabolic","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260807_160622_(ENTX)_sec_0001178913-26-003946-ex991.txt","comments":"\"Entera and OPKO intend to file an Investigational New Drug (IND) application for EB612 in the first half of 2027.\" IND enabling studies ongoing; oral long-acting PTH(1-34) for hypoparathyroidism.","closed":0,"created_at":"2026-10-25 12:00:42","updated_at":"2026-10-25 12:00:42","company":"Entera Bio","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":852,"symbol":"EQ","drug":"EQ504","modality":"small_molecule","area":"gi_hepatology","event_type":"topline_results","expect_date_from":"2027-04-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261026_083000_(EQ)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"\"Topline Phase 1 proof-of-mechanism data anticipated in Q2 2027\" (10/26/2026 PR/SEC 8-K Ex-99.1, first subject dosed in EQ504 Phase 1, NCT07869225). Supersedes 8/13/2026 \"data expected approximately six months after Q4 2026 initiation\". Q2 = Apr-Jun 2027.","closed":0,"created_at":"2026-10-25 12:00:20","updated_at":"2026-10-26T23:07:46Z","company":"Equillium","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-04-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":850,"symbol":"ERAS","drug":"ERAS-0015","modality":"small_molecule","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260811_160519_(ERAS)_sec_0001193125-26-344584-ex991.txt","comments":"Key upcoming milestones: \"Phase 1 monotherapy expansion data expected in the first half of 2027\" and \"Phase 1 combination dose escalation data, including panitumumab combination, expected in the first half of 2027\" (AURORAS-1)","closed":0,"created_at":"2026-10-25 12:00:13","updated_at":"2026-10-25 12:00:13","company":"Erasca","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":848,"symbol":"ETON","drug":"KHINDIVI","modality":"small_molecule","area":"rare_genetic","event_type":"other","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260729_070014_(ETON)_sec_0001437749-26-024746-ex991.txt","comments":"PAS submitted to expand KHINDIVI label to younger pediatric patients; \"Submission allows for a potential first half 2027 approval of the expanded indication.\" No exact date stated.","closed":0,"created_at":"2026-10-25 11:59:59","updated_at":"2026-10-25 11:59:59","company":"Eton Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":837,"symbol":"FATE","drug":"FT836","modality":"cell_therapy","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260813_083159_(FATE)_sec_0001193125-26-347984-ex991.txt","comments":"Q2 2026 8-K: \"The Company expects to provide the next clinical update on FT836 in the first half of 2027.\" Guided next clinical update after ASCO 2026 preliminary Phase 1 data (KRASwt mCRC, multi-dosing + SOC chemo cohort); company did not call it topline.","closed":0,"created_at":"2026-10-25 11:58:57","updated_at":"2026-10-25 11:58:57","company":"Fate Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":838,"symbol":"FDMT","drug":"4D-150","modality":"gene_therapy","area":"ophthalmology","event_type":"topline_results","expect_date_from":"2027-04-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260813_160644_(FDMT)_sec_0001193125-26-349160-ex991.txt","comments":"\"4FRONT-1 ... topline data expected in Q2 2027\" (Q2 2026 earnings release). Enrollment completed Feb 2026; randomization completed Mar 2026 (N=523).","closed":0,"created_at":"2026-10-25 11:59:01","updated_at":"2026-10-25 11:59:01","company":"4D Molecular Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-04-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":797,"symbol":"HURA","drug":"IFx-2.0","modality":"small_molecule","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260814_075016_(HURA)_sec_0001193125-26-350425-ex991.txt","comments":"Q2 2026 release milestones: \"1H2027: Expect preliminary results from IR study IFX-2.0 with Keytruda for deep seated MCC.\"","closed":0,"created_at":"2026-10-25 11:55:19","updated_at":"2026-10-25 11:55:19","company":"TuHURA Biosciences","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":798,"symbol":"HURA","drug":"TBS-2025","modality":"monoclonal_antibody","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260814_075016_(HURA)_sec_0001193125-26-350425-ex991.txt","comments":"Q2 2026 release milestones: \"1H 2027: Expect preliminary safety and response data for VISTA in mutated NMP1 r/r AML.\" VISTA-inhibiting mAb TBS-2025.","closed":0,"created_at":"2026-10-25 11:55:19","updated_at":"2026-10-25 11:55:19","company":"TuHURA Biosciences","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":792,"symbol":"IBIO","drug":"IBIO-800","modality":"bispecific","area":"metabolic","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260914_161645_(IBIO)_sec_0001420720-26-000028-ex991.txt","comments":"\"IBIO-800 IND equivalent filing expected in 1H 2027\" (Sept 2026 corporate presentation, slide \"Anticipated Near Term Catalysts\"); myostatin x Activin A bispecific, initial focus PH-HFpEF. 1H 2027 = 2027-01-01..2027-06-30.","closed":0,"created_at":"2026-10-25 11:54:49","updated_at":"2026-10-25 11:54:49","company":"iBio","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":780,"symbol":"IKT","drug":"IKT-001","modality":"small_molecule","area":"cardiovascular","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260908_164128_(IKT)_sec_0001193125-26-385293-ex991.txt","comments":"Corporate overview: \"1H 2027 Interim safety readout for Part A of Phase 3 IMPROVE-PAH Study (n=50)\"; also \"First Half 2027 - Interim Safety Readout\".","closed":0,"created_at":"2026-10-25 11:54:15","updated_at":"2026-10-25 11:54:15","company":"Inhibikase Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":1105,"symbol":"IMRX","drug":"atebimetinib (IMM-1-104)","modality":"small_molecule","area":"oncology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261029_160500_(IMRX)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"Q3 2026 release (Oct 29, 2026): \"Updated Phase 2 atebimetinib + mGnP pancreatic cancer data (N=55) expected in the first half of 2027\"; CEO: \"provide an update on topline data from the atebimetinib + mGnP arm ... in the first half of 2027.\" Window = 1H 2027 (Jan-Jun). Follow-up extended as patients live longer than projected.","closed":0,"created_at":"2026-10-29 21:27:55","updated_at":"2026-10-29 21:27:55","company":"Immuneering","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":1047,"symbol":"IMTX","drug":"anzu-cel (IMA203)","modality":"cell_therapy","area":"oncology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260818_070414_(IMTX)_sec_0001193125-26-354715-ex991.txt","comments":"\"The Company expects to disclose topline data from the final PFS analysis in the first half of 2027\" - SUPRAME Phase 3 in advanced melanoma; interim/final PFS analyses replaced by a single streamlined final analysis. Half-year window used as stated.","closed":0,"created_at":"2026-10-26 08:40:00","updated_at":"2026-10-26 08:40:00","company":"Immatics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":997,"symbol":"INMB","drug":"pobistrocel","modality":"cell_therapy","area":"rare_genetic","event_type":"regulatory_submission","expect_date_from":"2027-04-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261021_071500_(INMB)_yahoo_news_yahoo-709d54e925f0e03efc8ad404289f7405-INMB.txt","comments":"Oct 21, 2026 release: \"U.S. BLA expected to be submitted in Q2, 2027\" (Ebstrocel/pobistrocel in RDEB). Window = Q2 2027 as stated.","closed":0,"created_at":"2026-10-25 12:18:43","updated_at":"2026-10-25 12:18:43","company":"INmune Bio","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-04-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":1253,"symbol":"IOVA","drug":"lifileucel","modality":"cell_therapy","area":"oncology","event_type":"data_presentation","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261105_070000_(IOVA)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"\"An ongoing IST of lifileucel in cutaneous squamous cell carcinoma (CSCC) and Merkel cell carcinoma (MCC) is accelerating. Confirmed clinical activity in both CSCC and MCC was observed, and initial results are expected in 1H27.\" Window per 1H27 = Jan 1-Jun 30, 2027; no narrower date given.","closed":0,"created_at":"2026-11-05 12:29:30","updated_at":"2026-11-05 12:29:30","company":"Iovance Biotherapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":1064,"symbol":"IPHA","drug":"monalizumab","modality":"monoclonal_antibody","area":"oncology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261027_071307_(IPHA)_sec_0001628280-26-067408.txt","comments":"SEC 6-K exhibit: \"AstraZeneca has updated the expected timing for the PACIFIC-9 Phase 3 trial high-level data readout to the first half of 2027, from the second half of 2026 previously.\" Supersedes 17-Sep-2026 HY-2026 guidance of H2 2026. AZ-sponsored; Innate guiding timing. Same release also indexed by Google News/Business Wire.","closed":0,"created_at":"2026-10-27 03:19:03","updated_at":"2026-10-27T19:51:48Z","company":"Innate Pharma","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":32,"symbol":"IRD","drug":"OPGx-BEST1","modality":"gene_therapy","area":"rare_genetic","event_type":"topline_results","expect_date_from":"2027-04-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260909_073047_(IRD)_sec_0001140361-26-035979-ex991.txt","comments":"\"Cohort 2 over-enrolled, with dosing expected to be completed in Q4 2026 and topline 3-month data expected in Q2 2027.\" Company also guides 6-month low-dose Cohort 1 (BVMD, n=3) data to the same Q2 2027 window. Q2 2027 = 2027-04-01..2027-06-30.","closed":0,"created_at":"2026-10-25 09:53:56","updated_at":"2026-10-25 09:53:56","company":"Opus Genetics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-04-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":20,"symbol":"IVA","drug":"lanifibranor","modality":"small_molecule","area":"gi_hepatology","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260903_060009_(IVA)_sec_0001171843-26-005860-ex991.txt","comments":"\"If the results are favorable, the Company anticipates regulatory submission in the first half of 2027.\" Conditional on positive NATiV3 topline results; potential U.S. launch 2028.","closed":0,"created_at":"2026-10-25 09:53:21","updated_at":"2026-10-25 09:53:21","company":"Inventiva S.A. American Depository Shares","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":732,"symbol":"JANX","drug":"JANX007","modality":"bispecific","area":"oncology","event_type":"data_presentation","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260806_160823_(JANX)_sec_0001193125-26-337977-ex991.txt","comments":"\"Additional clinical data for JANX007 expected to be announced at a future medical congress in the first half of 2027.\" Congress not yet named.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Janux Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":727,"symbol":"JSPR","drug":"vensobafusp alfa","modality":"bispecific","area":"hematology","event_type":"other","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260814_110039_(JSPR)_sec_0001213900-26-089592.txt","comments":"10-Q: \"we are planning for an end-of-Phase 2 meeting with the FDA and plan to announce next steps in the first half of 2027\" (KP-104 in PNH, Phase 3 planning).","closed":0,"created_at":"2026-10-25 07:50:14","updated_at":"2026-10-25 07:50:14","company":"Jasper Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":726,"symbol":"JSPR","drug":"vensobafusp alfa","modality":"bispecific","area":"renal","event_type":"interim_analysis","expect_date_from":"2027-04-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260814_110039_(JSPR)_sec_0001213900-26-089592.txt","comments":"10-Q: \"updated data in the second quarter of 2027, and we plan to report interim data from Stage 2 of the study in the second quarter of 2027\" (KP-104 Phase 2 renal basket). Both Q2 2027 disclosures fall in this window.","closed":0,"created_at":"2026-10-25 07:50:14","updated_at":"2026-10-25 07:50:14","company":"Jasper Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-04-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":717,"symbol":"KARD","drug":"danicamtiv","modality":"small_molecule","area":"cardiovascular","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260811_070015_(KARD)_sec_0001193125-26-343395-ex991.txt","comments":"\"The Company expects to share Phase 2b topline data in the first half of 2027\" for KINSHIP-DCM (Cohort 1 MYH7/TTN); Phase 3 enrollment underway as of 8/11/2026.","closed":0,"created_at":"2026-10-25 11:50:23","updated_at":"2026-10-25 11:50:23","company":"Kardigan","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":718,"symbol":"KARD","drug":"ataciguat","modality":"small_molecule","area":"cardiovascular","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260811_070015_(KARD)_sec_0001193125-26-343395-ex991.txt","comments":"\"expects to share Phase 2b topline data from the interim 24-week analysis in the first half of 2027\" (KATALYST-AV, moderate CAVS).","closed":0,"created_at":"2026-10-25 11:50:23","updated_at":"2026-10-25 11:50:23","company":"Kardigan","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":719,"symbol":"KARD","drug":"tonlamarsen","modality":"aso","area":"cardiovascular","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260811_070015_(KARD)_sec_0001193125-26-343395-ex991.txt","comments":"\"expects to share Phase 2 topline data in the first half of 2027\" (KARDINAL-ASH, acute severe hypertension); first patient randomized in Q2 2026.","closed":0,"created_at":"2026-10-25 11:50:23","updated_at":"2026-10-25 11:50:23","company":"Kardigan","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":712,"symbol":"KLRS","drug":"TH103","modality":"protein","area":"ophthalmology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260811_080528_(KLRS)_sec_0001193125-26-343477-ex991.txt","comments":"\"Preliminary data from the Phase 1b/2 study is expected in the first half of 2027.\" Phase 1b/2 multiple-ascending dose study in nAMD; dosing ongoing as of Aug 11, 2026.","closed":0,"created_at":"2026-10-25 07:49:53","updated_at":"2026-10-25 07:49:53","company":"Kalaris Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":706,"symbol":"KOD","drug":"KSI-101","modality":"bispecific","area":"ophthalmology","event_type":"topline_results","expect_date_from":"2027-04-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260813_160018_(KOD)_sec_0001193125-26-349107-ex991.txt","comments":"\"Completion of enrollment in the second pivotal cohort ... is expected in the fourth quarter of 2026, with topline data anticipated in the second quarter of 2027\" (Pivotal Analysis 2: PEAK 301-600 and PINNACLE 1-300).","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Kodiak Sciences","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-04-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":707,"symbol":"KOD","drug":"KSI-101","modality":"bispecific","area":"ophthalmology","event_type":"regulatory_submission","expect_date_from":"2027-04-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260928_085356_(KOD)_sec_0001193125-26-403481-ex991.txt","comments":"\"We are planning to file a BLA for KSI-101 in the second quarter of 2027.\"","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Kodiak Sciences","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-04-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":697,"symbol":"KROS","drug":"rinvatercept","modality":"protein","area":"rare_genetic","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260928_080107_(KROS)_sec_0001664710-26-000056-ex991.txt","comments":"\"Initial data expected in the first half of 2027\" from Phase 2 DMD trial; first patient dosed Sept 28, 2026. Window covers first half of 2027. Guidance also reiterated in Aug 3, 2026 Q2 release.","closed":0,"created_at":"2026-10-25 11:49:35","updated_at":"2026-10-25 11:49:35","company":"Keros Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":699,"symbol":"KRRO","drug":"KRRO-111","modality":"aso","area":"rare_genetic","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261022_070413_(KRRO)_sec_0001193125-26-428306-ex991.txt","comments":"\"Regulatory submission for KRRO-111 is expected in the first half of 2027\" (following best-in-class preclinical AATD data; GLP tox ongoing). Preclinical data reported 2026-10-22 are not a clinical result.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Korro Bio","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":688,"symbol":"KRYS","drug":"KB407","modality":"gene_therapy","area":"respiratory","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261102_070000_(KRYS)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"\"The Company expects to enroll and dose three additional patients before year end, with interim study results now anticipated in the first half of 2027\" (repeat-dose 24-week CF safety study, NCT05504837). Slipped from prior before-year-end 2026 guidance.","closed":0,"created_at":"2026-10-25 11:49:21","updated_at":"2026-11-02T17:56:10Z","company":"Krystal Biotech","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.6,"llm_reason":"Interim data from a ~5-patient, open-label safety study of KB407 with CFTR expression already disclosed. For a profitable ~$9.5B company with a growing VYJUVEK franchise and a broad pipeline, such a readout is unlikely to move the stock 10%, although CF gene therapy efficacy signals (e.g., FEV1) could surprise in either direction.","llm_predicted_at":"2026-10-25T15:51:05Z","llm_source":"live","window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":694,"symbol":"KRYS","drug":"KB707","modality":"gene_therapy","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260803_070402_(KRYS)_sec_0001711279-26-000058-ex991.txt","comments":"\"plans to report updated interim clinical results from KYANITE-1 and potential registrational study plans in 1H 2027\" (inhaled KB707 + chemotherapy cohort, NSCLC)","closed":0,"created_at":"2026-10-25 11:49:24","updated_at":"2026-10-25 11:49:24","company":"Krystal Biotech","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":685,"symbol":"KRYS","drug":"KB803","modality":"gene_therapy","area":"ophthalmology","event_type":"topline_results","expect_date_from":"2027-02-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261102_070000_(KRYS)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"\"The Company now expects the last patient visit in February 2027 with top-line results reported shortly thereafter\" (IOLITE, registrational). Changed from prior 4Q 2026 guidance; 3 additional patients enrolled, two withdrawals replaced.","closed":0,"created_at":"2026-10-25 11:49:17","updated_at":"2026-11-02T17:56:14Z","company":"Krystal Biotech","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.8,"llm_reason":"KB803 targets a niche DEB ocular indication with small commercial value relative to a ~$9.5B profitable company driven by VYJUVEK. The readout is unlikely to move the stock 10% either way.","llm_predicted_at":"2026-10-25T15:51:04Z","llm_source":"live","window":"2027-02-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":675,"symbol":"LBRX","drug":"LB-102","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260722_081447_(LBRX)_sec_0001193125-26-311357-ex991.txt","comments":"\"it now expects to report topline results from the pivotal Phase 3 NOVA-2 clinical trial of LB-102 in patients with schizophrenia in the first half of 2027\" (accelerated from prior 2H 2027 guidance; enrollment-based projection). Registered schizophrenia; Phase 3 placebo-controlled.","closed":0,"created_at":"2026-10-25 11:48:22","updated_at":"2026-10-25 11:48:22","company":"LB Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":1120,"symbol":"LGND","drug":"AVIM Therapy","modality":"other","area":"cardiovascular","event_type":"topline_results","expect_date_from":"2027-04-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260806_070502_(LGND)_sec_0000886163-26-000041-ex991.txt","comments":"Q2 2026 release: Orchestra BioMed \"is targeting top line data in the second quarter of 2027\" for the BACKBEAT pivotal trial of AVIM Therapy; enrollment completion (330 randomized) reported 2026-10-01 in the Q3 release. Q2 2027 = 2027-04-01..2027-06-30.","closed":0,"created_at":"2026-10-30 13:57:02","updated_at":"2026-10-30 13:57:02","company":"Ligand Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-04-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":814,"symbol":"MANE","drug":"VDPHL01","modality":"small_molecule","area":"dermatology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261019_090614_(MANE)_sec_0001827635-26-000036-ex991.txt","comments":"Topline data from Phase 2/3 Study '306' in female pattern hair loss (n=556, enrollment complete). Oct 19, 2026: \"a readout of topline data anticipated in the first half of 2027\"; Aug 11, 2026 8-K: \"expects to report topline data in the first half of 2027.\"","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Veradermics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":650,"symbol":"MGNX","drug":"lorigerlimab","modality":"bispecific","area":"oncology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260813_160752_(MGNX)_sec_0001125345-26-000054-ex991.txt","comments":"LINNET in advanced gynecologic cancers: \"anticipates reporting updated study results in the first half of 2027.\" First half of 2027 = Jan 1-Jun 30, 2027.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"MacroGenics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":643,"symbol":"MGTX","drug":"AAV2-hAQP1","modality":"gene_therapy","area":"other","event_type":"topline_results","expect_date_from":"2027-04-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260813_080559_(MGTX)_sec_0001104659-26-095491-ex991.txt","comments":"Phase 2 AQUAx2 (randomized, double-blind, placebo-controlled, 30 sites; enrollment completed Q2 2026) \"remains on track for a 12-month pivotal data readout in the second quarter of 2027, which, if positive, would support a BLA filing and potential approval targeted for the end of 2027\". Indication: radiation-induced xerostomia.","closed":0,"created_at":"2026-10-25 11:45:28","updated_at":"2026-10-25T11:45:30Z","company":"MeiraGTx Holdings","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-04-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":633,"symbol":"MIRM","drug":"maralixibat","modality":"small_molecule","area":"gi_hepatology","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261013_080904_(MIRM)_sec_0001759425-26-000051.txt","comments":"8-K: \"plans to submit a supplemental New Drug Application in the United States in the first half of 2027 based on the Phase 3 EXPAND study results.\"","closed":0,"created_at":"2026-10-25 11:45:03","updated_at":"2026-10-25 11:45:03","company":"Mirum Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":637,"symbol":"MIRM","drug":"brelovitug","modality":"monoclonal_antibody","area":"infectious","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260928_080247_(MIRM)_sec_0001759425-26-000049.txt","comments":"8-K: \"expects to submit a Biologics License Application (BLA) to the FDA in the first half of 2027.\"","closed":0,"created_at":"2026-10-25 11:45:03","updated_at":"2026-10-25 11:45:03","company":"Mirum Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":639,"symbol":"MIRM","drug":"volixibat","modality":"small_molecule","area":"gi_hepatology","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260805_160656_(MIRM)_sec_0001759425-26-000045.txt","comments":"10-Q: \"We now expect to submit a potential New Drug Application (NDA) to the FDA in the first half of 2027\" (volixibat in PSC).","closed":0,"created_at":"2026-10-25 11:45:03","updated_at":"2026-10-25 11:45:03","company":"Mirum Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":1060,"symbol":"MIRM","drug":"zilurgisertib","modality":"small_molecule","area":"rare_genetic","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261026_164703_(MIRM)_sec_0001759425-26-000054.txt","comments":"8-K: \"The Company plans a supplemental New Drug Application (sNDA) submission in the first half of 2027 to expand the indication to pediatric patients aged 6 to <12 years\" (based on PROGRESS Cohort 2).","closed":0,"created_at":"2026-10-26T19:10:00Z","updated_at":"2026-10-26T19:10:00Z","company":"Mirum Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":795,"symbol":"MIST","drug":"etripamil","modality":"small_molecule","area":"cardiovascular","event_type":"other","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260812_072840_(MIST)_sec_0001104659-26-094466-ex991.txt","comments":"\"Regulatory review of the marketing authorization application for etripamil for PSVT in Europe remains on track for a decision from the European Medicines Agency (EMA) in the first half of 2027\" (Q2 2026 release, Aug 12, 2026).","closed":0,"created_at":"2026-10-25 07:54:57","updated_at":"2026-10-25 07:54:57","company":"Milestone Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":629,"symbol":"MLTX","drug":"sonelokimab","modality":"bispecific","area":"immunology","event_type":"topline_results","expect_date_from":"2027-04-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261104_070000_(MLTX)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"Nov 4, 2026 release: IZAR-1 (PsA) \"Expected to announce Week 52 topline results in Q2 2027\" (narrowed from H1 2027 guided Aug 10, 2026). Week 16 absolute responses/p values disclosed Aug 2026; placebo comparisons remain blinded until trial completion.","closed":0,"created_at":"2026-10-25 11:44:58","updated_at":"2026-11-04T15:44:51Z","company":"MoonLake Immunotherapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-04-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":588,"symbol":"NVCT","drug":"NXP900","modality":"small_molecule","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261104_070000_(NVCT)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","comments":"NXP900 Phase 1b combinations (osimertinib in EGFR+ NSCLC; lorlatinib in ALK+ NSCLC): \"Update from Phase 1b expected during the first half of 2027.\" Supersedes Aug 4, 2026 guidance of an update by end-2026. First half 2027 = 2027-01-01..2027-06-30.","closed":0,"created_at":"2026-10-25 11:40:47","updated_at":"2026-11-04T17:50:21Z","company":"Nuvectis Pharma","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.72,"llm_reason":"The company has deprioritized NXP900 in favor of the newly in-licensed ciprocopan (NXP100), so the stock's value is now driven mainly by NXP100. The upcoming NXP900 update is an interim look at a small osimertinib combination trial, so a first-session move of 10% or more is unlikely.","llm_predicted_at":"2026-10-25T15:50:38Z","llm_source":"live","window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":580,"symbol":"OBIO","drug":"AVIM Therapy","modality":"other","area":"cardiovascular","event_type":"data_presentation","expect_date_from":"2027-04-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261001_081444_(OBIO)_sec_0001104659-26-112586-ex991.txt","comments":"\"primary endpoint data to be submitted for late-breaking presentation consideration at a major cardiovascular conference in Q2 2027\" — BACKBEAT global pivotal trial, primary efficacy = change in 24-hr ambulatory SBP at 3 months; late-breaker acceptance not yet confirmed.","closed":0,"created_at":"2026-10-25 07:40:00","updated_at":"2026-10-25 07:40:00","company":"Orchestra BioMed Holdings","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-04-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":578,"symbol":"OBX","drug":"OBX-115","modality":"cell_therapy","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260803_170810_(OBX)_sec_0001193125-26-330810-ex991.txt","comments":"\"Phase 1 data from the ongoing non-small cell lung cancer (NSCLC) trial expected in the first half of 2027\" (8-K 8/3/2026, post-merger closing release). Guided as Phase 1 data, not stated as topline.","closed":0,"created_at":"2026-10-25 11:40:03","updated_at":"2026-10-25 11:40:03","company":"Obsidian Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":582,"symbol":"OCGN","drug":"OCU410ST","modality":"gene_therapy","area":"ophthalmology","event_type":"topline_results","expect_date_from":"2027-04-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260806_083036_(OCGN)_sec_0001104659-26-091691-ex991.txt","comments":"\"Topline results anticipated in the second quarter of 2027, with a BLA submission to follow mid-2027.\" Pivotal Phase 2/3 GARDian3 in Stargardt disease; enrollment complete.","closed":0,"created_at":"2026-10-25 07:39:42","updated_at":"2026-10-25 07:39:42","company":"Ocugen","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-04-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":584,"symbol":"OCGN","drug":"OCU400","modality":"gene_therapy","area":"ophthalmology","event_type":"regulatory_submission","expect_date_from":"2027-04-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261015_080105_(OCGN)_sec_0001104659-26-115970-ex991.txt","comments":"\"topline data expected: 1Q 2027\" and \"BLA filing target: 2Q 2027\"; U.S. BLA for retinitis pigmentosa, to follow topline data.","closed":0,"created_at":"2026-10-25 07:39:42","updated_at":"2026-10-25 07:39:42","company":"Ocugen","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-04-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":569,"symbol":"OKUR","drug":"OKI-355","modality":"small_molecule","area":"rare_genetic","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260804_161016_(OKUR)_sec_0001193125-26-332809-ex991.txt","comments":"Q2 2026 release: \"OnKure plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for OKI-355 in the first half of 2027.\" IND-enabling activities ongoing; window = 1H 2027.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"OnKure Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":570,"symbol":"OKUR","drug":"OKI-345","modality":"small_molecule","area":"oncology","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260804_161016_(OKUR)_sec_0001193125-26-332809-ex991.txt","comments":"Q2 2026 release: \"OnKure plans to submit an IND application to the FDA for OKI-345 in the first half of 2027.\" Breast cancer program; window = 1H 2027.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"OnKure Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":564,"symbol":"OPK","drug":null,"modality":"bispecific","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260727_160803_(OPK)_sec_0001193125-26-318069-ex991.txt","comments":"Q3 2026 release reaffirms: \"We expect to report initial safety, tolerability, pharmacokinetic and immune data for both studies in the first half of 2027\" (ModeX MDX2001 and MDX2004 Phase 1). Sentence names no specific drug, so drug left NULL.","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-04T22:00:42Z","company":"OPKO Health","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":546,"symbol":"PBLS","drug":"zolucatetide","modality":"peptide","area":"oncology","event_type":"data_presentation","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260813_071904_(PBLS)_sec_0001193125-26-347869-ex991.txt","comments":"ACP: \"Expect to share clinical data from additional patients in the first half of 2027 for ACP.\"","closed":0,"created_at":"2026-10-25 11:37:24","updated_at":"2026-10-25 11:37:24","company":"Parabilis Medicines","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":541,"symbol":"PBM","drug":"NPX-5","modality":"other","area":"cns","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260806_160143_(PBM)_sec_0001213900-26-086123-ex991.txt","comments":"Investor presentation (Aug 2026): \"Estimated top line study results H1 2027\" for the NPX-5 25mg psilocybin Phase IIb trial in Adjustment Disorder in cancer/palliative care; also \"Projected Upcoming Top line results H1 2027\". Range is the stated half-year.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Psyence Biomedical","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":533,"symbol":"PCVX","drug":"VAX-31","modality":"vaccine","area":"infectious","event_type":"topline_results","expect_date_from":"2026-10-05","expect_date_to":"2027-06-30","news_source_file":"documents/20261005_080108_(PCVX)_sec_0001193125-26-413168-ex991.txt","comments":"\"Announce topline safety, tolerability and immunogenicity data from the VAX-31 infant Phase 2 ... from both the primary three-dose immunization series and booster dose either sequentially or together by the end of the first half of 2027.\"","closed":0,"created_at":"2026-10-25 11:36:55","updated_at":"2026-10-25 11:36:55","company":"Vaxcyte","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-05 → 2027-06-30","imminence":237,"state":"open","overdue":false},{"id":532,"symbol":"PCVX","drug":"VAX-31","modality":"vaccine","area":"infectious","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261005_080108_(PCVX)_sec_0001193125-26-413168-ex991.txt","comments":"\"Company Expects to Report Results from OPUS-2 and OPUS-3 Adult Phase 3 Trials in First Half of 2027.\" Milestones: \"Announce safety, tolerability and immunogenicity data from the OPUS-2 and OPUS-3 Phase 3 trials in the first half of 2027.\" Single row covers both trials (same VAX-31 drug/window).","closed":0,"created_at":"2026-10-25 11:36:55","updated_at":"2026-10-25T11:37:01Z","company":"Vaxcyte","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":537,"symbol":"PDSB","drug":"PDS0301","modality":"protein","area":"oncology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261020_195906_(PDSB)_sec_0001140361-26-040283-ex991.txt","comments":"\"Q1/Q2-2027 NCI-led - Colorectal cancer with liver metastases (Final data readout)\" — final data from NCI-led Phase 2 in MSS/pMMR mCRC with liver metastases.","closed":0,"created_at":"2026-10-25 11:37:04","updated_at":"2026-10-25 11:37:04","company":"PDS Biotechnology","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":529,"symbol":"PEPG","drug":"PGN-EDODM1","modality":"aso","area":"cns","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260806_074021_(PEPG)_sec_0001193125-26-336767-ex991.txt","comments":"\"Results from the 12.5 mg/kg cohort of FREEDOM2 are expected in the first half of 2027.\" Enrollment in this highest dose cohort to start shortly after DSMB recommended escalation.","closed":0,"created_at":"2026-10-25 11:36:34","updated_at":"2026-10-25 11:36:34","company":"PepGen","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":520,"symbol":"PHVS","drug":"deucrictibant XR","modality":"small_molecule","area":"immunology","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260908_065109_(PHVS)_sec_0001193125-26-384339-ex991.txt","comments":"\"Pharvaris plans to submit a New Drug Application to the U.S. Food and Drug Administration for the prophylaxis of bradykinin-mediated angioedema attacks in the first half of 2027.\"","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Pharvaris","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":502,"symbol":"PRME","drug":"PM359","modality":"gene_therapy","area":"immunology","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260806_080217_(PRME)_sec_0001628280-26-053878-ex991.txt","comments":"\"Prime Medicine continues to engage with the FDA on the most efficient path to a BLA submission planned for the first half of 2027\" (CGD; RMAT granted June 2026).","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Prime Medicine","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":497,"symbol":"PROK","drug":"rilparencel","modality":"cell_therapy","area":"renal","event_type":"topline_results","expect_date_from":"2027-04-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260810_161031_(PROK)_sec_0001193125-26-342373.txt","comments":"PROACT 1 (REGEN-006) accelerated-approval efficacy analysis (n~320) eGFR slope topline: \"We anticipate topline data readout of the surrogate endpoint (eGFR slope) in the second quarter of 2027.\" Enrollment for this analysis complete.","closed":0,"created_at":"2026-10-25 11:34:34","updated_at":"2026-10-25 11:34:34","company":"ProKidney","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-04-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":494,"symbol":"PRQR","drug":null,"modality":"aso","area":"gi_hepatology","event_type":"data_presentation","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260813_070008_(PRQR)_sec_0001104659-26-095422-ex991.txt","comments":"NTCP franchise: \"IIT in pediatric biliary atresia in China, with initial data targeted for first half of 2027\" (investigator-initiated trial; drug not named in the sentence).","closed":0,"created_at":"2026-10-25 11:34:31","updated_at":"2026-10-25 11:34:31","company":"ProQR Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":495,"symbol":"PRQR","drug":"AX-0422","modality":"aso","area":"rare_genetic","event_type":"data_presentation","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260813_070008_(PRQR)_sec_0001104659-26-095422-ex991.txt","comments":"\"AX-0422 for MPS I Hurler Syndrome (IDUA) ... initial data expected in the first half of 2027.\"","closed":0,"created_at":"2026-10-25 11:34:31","updated_at":"2026-10-25 11:34:31","company":"ProQR Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":483,"symbol":"PYXS","drug":"micvotabart pelidotin (MICVO)","modality":"adc","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261001_172443_(PYXS)_sec_0001437749-26-031767.txt","comments":"\"publicly discloses the results of the overall survival analysis for its Phase 1 monotherapy study of micvotabart pelidotin (MICVO) in 2L+ R/M HNSCC, which is expected in the first half of 2027\" (2026-10-01 8-K). Reconfirmed 2026-11-05 Q3 release: \"Updated overall survival data ... expected in the first half of 2027.\"","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-05T12:29:38Z","company":"Pyxis Oncology","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":477,"symbol":"QURE","drug":"AMT-260","modality":"gene_therapy","area":"cns","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260729_070613_(QURE)_sec_0001104659-26-087808-ex991.txt","comments":"\"The Company expects to present updated results from the Phase I/IIa study in the first half of 2027\" (AMT-260 in refractory mesial temporal lobe epilepsy). Window per \"first half of 2027\".","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"uniQure","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":1198,"symbol":"QURE","drug":"AMT-191","modality":"gene_therapy","area":"rare_genetic","event_type":"data_presentation","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261104_071024_(QURE)_sec_0001104659-26-122362.txt","comments":"\"The Company expects to present updated results from the Phase I/II study in all dosing cohorts in the first half of 2027\" (AMT-191 in Fabry disease). Window per \"first half of 2027\"; enrollment in mid/high-dose cohorts resumed Aug 2026 after dosing pause.","closed":0,"created_at":"2026-11-04 13:38:54","updated_at":"2026-11-04 13:38:54","company":"uniQure","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":459,"symbol":"RARE","drug":"avalotcagene ontaparvovec (DTX301)","modality":"gene_therapy","area":"metabolic","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260804_160952_(RARE)_sec_0001193125-26-332802-ex991.txt","comments":"\"Data from the second primary endpoint, which evaluates reduction in treatment burden ... are expected in the first half of 2027.\" Phase 3 Enh3ance in OTC deficiency.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Ultragenyx Pharmaceutical","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":440,"symbol":"RCUS","drug":"quemliclustat","modality":"small_molecule","area":"gi_hepatology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260805_160748_(RCUS)_sec_0001724521-26-000042-ex991.txt","comments":"\"Enrollment was completed in September 2025 for PRISM-1, a Phase 3 trial of quemliclustat combined with gemcitabine/nab-paclitaxel ... Results from this study are expected in the first half of 2027.\"","closed":0,"created_at":"2026-10-25 11:31:21","updated_at":"2026-10-25 11:31:21","company":"Arcus Biosciences","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":421,"symbol":"RNAC","drug":"Descartes-08","modality":"cell_therapy","area":"immunology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261105_070252_(RNAC)_sec_0001453687-26-000110.txt","comments":"Q3 2026 release (2026-11-05): \"Phase 2 TRITON trial of Descartes-08 in myositis ... data from subset of patients expected in 1H27 to inform path forward to pivotal trial.\" Partial/subset data.","closed":0,"created_at":"2026-10-25 07:28:32","updated_at":"2026-11-05T12:30:13Z","company":"Cartesian Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":422,"symbol":"RNAC","drug":null,"modality":"cell_therapy","area":"cns","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260806_070344_(RNAC)_sec_0001453687-26-000100-ex991.txt","comments":"Q2 2026 release: WestGene-partnered in vivo CAR-T Ph1 in MG \"expected to initiate in the second half of 2026 with in-human data expected in the first half of 2027\"; Q3 2026 release (2026-11-05) says program remains in preclinical development with no new timing. No drug named in the supporting sentence.","closed":0,"created_at":"2026-10-25 07:28:32","updated_at":"2026-11-05T12:30:13Z","company":"Cartesian Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":425,"symbol":"RNAC","drug":"Descartes-08","modality":"cell_therapy","area":"immunology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261105_070252_(RNAC)_sec_0001453687-26-000110.txt","comments":"Q3 2026 release (2026-11-05): \"Phase 1/2 HELIOS pediatric trial of Descartes-08 in autoimmune diseases, including JDM ... data expected in 1H27\"; enrollment remains ongoing.","closed":0,"created_at":"2026-10-25 07:28:32","updated_at":"2026-11-05T12:30:13Z","company":"Cartesian Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":398,"symbol":"RXRX","drug":"REC-617","modality":"small_molecule","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260805_063136_(RXRX)_sec_0001601830-26-000097-ex991.txt","comments":"\"REC-617 (CDK7): Early Phase 1 safety and PK combination data expected in 1H27\" - window = first half of 2027.","closed":0,"created_at":"2026-10-25 11:27:18","updated_at":"2026-10-25 11:27:18","company":"Recursion Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":399,"symbol":"RXRX","drug":"REC-3565","modality":"small_molecule","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260805_063136_(RXRX)_sec_0001601830-26-000097-ex991.txt","comments":"\"REC-3565 (MALT1): Early Phase 1 safety and PK monotherapy data expected in 1H27\" - window = first half of 2027.","closed":0,"created_at":"2026-10-25 11:27:18","updated_at":"2026-10-25 11:27:18","company":"Recursion Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":1113,"symbol":"RZLT","drug":"ersodetug","modality":"monoclonal_antibody","area":"gi_hepatology","event_type":"other","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261029_161451_(RZLT)_sec_0001104659-26-120205-ex991.txt","comments":"Corporate presentation milestone table: \"1H 2027 Regulatory Discussions\" for ersodetug in GI-Surgery Hypoglycemia (including PBH), listed under Phase 2. Guidance is a half-year window only (1H 2027 = 2027-01-01..2027-06-30); no specific date or meeting type stated.","closed":0,"created_at":"2026-10-30T09:55:07","updated_at":"2026-10-30T09:55:07","company":"Rezolute","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":388,"symbol":"SANA","drug":"SG293","modality":"gene_therapy","area":"oncology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260908_080008_(SANA)_sec_0001193125-26-384405-ex991.txt","comments":"\"SG293 in non-Hodgkin lymphoma - potential to share first-in-human data in 1H 2027\" (Sept 2026 presentation). Earlier 8-K (2026-08-10) guided \"as early as this year\".","closed":0,"created_at":"2026-10-25 11:26:36","updated_at":"2026-10-25 11:26:36","company":"Sana Biotechnology","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":383,"symbol":"SCTX","drug":"STX-1150","modality":"gene_therapy","area":"cardiovascular","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260902_160819_(SCTX)_sec_0001193125-26-380184-ex991.txt","comments":"\"Scribe anticipates reporting initial clinical data, including safety, tolerability, and LDL-C lowering activity, from the single ascending dose (SAD) portion of the STX-1150 Phase 1 trial in the first half of 2027.\" Phase 1 initiated mid-2026 in Australia.","closed":0,"created_at":"2026-10-25 11:26:08","updated_at":"2026-10-25 11:26:08","company":"Scribe Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":370,"symbol":"SER","drug":"SER-252","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260813_160558_(SER)_sec_0001708599-26-000048-ex991.txt","comments":"\"Top-line data from the single-ascending-dose arm targeted for the first half of 2027\" (Phase 1b registrational study in advanced Parkinson's disease). Confirmed in 2026-09-09 8-K.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Serina Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":369,"symbol":"SIGA","drug":"oral TPOXX (tecovirimat)","modality":"small_molecule","area":"infectious","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260806_164621_(SIGA)_sec_0001437749-26-026314.txt","comments":"10-Q: \"The timing of a potential submission of a supplemental New Drug Application to the FDA ... for a smallpox PEP indication for oral TPOXX will be based on the results of ongoing sample analyses from the immunogenicity trial; the Company is currently targeting a Supplemental NDA submission in the first half of 2027.\" Caveat: timing remains contingent on sample analyses.","closed":0,"created_at":"2026-10-25T07:25:00","updated_at":"2026-10-25T07:25:00","company":"SIGA Technologies","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":573,"symbol":"SLDB","drug":"SGT-501","modality":"gene_therapy","area":"cardiovascular","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260806_160410_(SLDB)_sec_0001193125-26-337935.txt","comments":"10-Q ARTEMIS Phase 1b: \"We anticipate dosing our first participant in the second half of 2026 with initial safety data anticipated in the first half of 2027, subject to participant enrollment.\"","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Solid Biosciences","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":333,"symbol":"SPTX","drug":"GlyphAllo","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260803_070303_(SPTX)_sec_0001193125-26-329528-ex991.txt","comments":"\"Topline data from the BUOY-1 trial are expected in the first half of 2027.\" Phase 2b BUOY-1 trial in MDD with or without anxious distress; enrollment on track (reaffirmed in Q3 2026 release, Nov 2, 2026).","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-05T12:30:32Z","company":"Seaport Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":554,"symbol":"STOK","drug":"STK-002","modality":"aso","area":"ophthalmology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261029_160516_(STOK)_sec_0001193125-26-437775-ex991.txt","comments":"Phase 1 OSPREY (ADOA), dose escalation: \"Dosing in the first two cohorts is complete and dosing in the third cohort is underway with the fourth cohort expected to follow in early 2027. ... Safety and efficacy data are anticipated in the first half of 2027.\" First half of 2027 = 2027-01-01..2027-06-30. Confirmed in Q3 2026 release (Oct 29, 2026).","closed":0,"created_at":"2026-10-25 07:40:00","updated_at":"2026-10-30T16:01:52Z","company":"Stoke Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":556,"symbol":"STOK","drug":"zorevunersen","modality":"aso","area":"cns","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261029_160516_(STOK)_sec_0001193125-26-437775-ex991.txt","comments":"\"Stoke plans to continue actively engaging with the FDA and to submit data throughout the first half of 2027 to support rapid completion of the NDA submission in the second half of 2027\" — rolling U.S. NDA for zorevunersen in Dravet syndrome, initiated with data submitted through H1 2027 (2027-01-01..2027-06-30). Newer Q3 2026 release drops the earlier \"initiate in Q1 2027\" wording.","closed":0,"created_at":"2026-10-25 07:40:00","updated_at":"2026-10-30T16:02:03Z","company":"Stoke Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":321,"symbol":"STRO","drug":"STRO-004","modality":"adc","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260812_071523_(STRO)_sec_0001193125-26-345733-ex991.txt","comments":"\"The next STRIVE-01 study update is targeted for the first half of 2027. Initiation of expansion cohorts is planned for the first half of 2027.\"","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Sutro Biopharma","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":300,"symbol":"TARS","drug":"TP-04","modality":"small_molecule","area":"ophthalmology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260806_072301_(TARS)_sec_0001819790-26-000063-ex991.txt","comments":"\"The Phase 2 KORE trial evaluating TP-04 ... for the potential treatment of ocular rosacea, continues to progress, with topline data expected in the first half of 2027.\" First half of 2027 = Jan 1 - Jun 30, 2027. Reaffirmed in Q3 2026 release (2026-11-03): \"topline data expected in the first half of 2027.\"","closed":0,"created_at":"2026-10-25 11:20:58","updated_at":"2026-11-03T23:10:16Z","company":"Tarsus Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":302,"symbol":"TARS","drug":"TP-05","modality":"small_molecule","area":"infectious","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260806_072301_(TARS)_sec_0001819790-26-000063-ex991.txt","comments":"Calliope Phase 2 (Lyme disease prevention) enrollment complete; \"Topline data is expected in the first half of 2027, with the potential to support a Phase 3-ready package.\" H1 2027 = 2027-01-01..2027-06-30. Reaffirmed in Q3 2026 release (2026-11-03): \"topline data expected in the first half of 2027.\"","closed":0,"created_at":"2026-10-25 11:21:01","updated_at":"2026-11-03T23:10:16Z","company":"Tarsus Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":6,"symbol":"TRDA","drug":"ENTR-601-45","modality":"aso","area":"rare_genetic","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261014_075200_(TRDA)_sec_0001689375-26-000057.txt","comments":"8-K: \"on track to report data from Cohort 2 (10 mg/kg) in the first half of 2027, with data from Cohort 3 (up to 15 mg/kg) to follow.\" Cohort 3 has no stated date.","closed":0,"created_at":"2026-10-25 09:52:36","updated_at":"2026-10-25 09:52:36","company":"Entrada Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":260,"symbol":"TSHA","drug":"TSHA-102","modality":"gene_therapy","area":"cns","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260811_160548_(TSHA)_sec_0001193125-26-344594-ex991.txt","comments":"\"Topline data from REVEAL pivotal trial 6-month interim analysis and FDA feedback on the BLA submission pathway for TSHA-102 is expected in the first half of 2027.\" Interim analysis after all 17 patients complete 6 months of follow-up. Dosing complete (n=17).","closed":0,"created_at":"2026-10-25 11:17:15","updated_at":"2026-10-25 11:17:15","company":"Taysha Gene Therapies","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":261,"symbol":"TSHA","drug":"TSHA-102","modality":"gene_therapy","area":"cns","event_type":"other","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260811_160548_(TSHA)_sec_0001193125-26-344594-ex991.txt","comments":"\"Subsequently, Taysha plans to discuss data from the 6-month interim analysis and next steps in the BLA submission pathway with the U.S. FDA and is on track to report topline data and regulatory feedback in 1H 2027.\" FDA feedback on BLA submission pathway; 1H 2027 = 2027-01-01..2027-06-30.","closed":0,"created_at":"2026-10-25 11:17:15","updated_at":"2026-10-25 11:17:15","company":"Taysha Gene Therapies","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":475,"symbol":"VNDA","drug":"milsaperidone (BYSANTI)","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260805_160448_(VNDA)_sec_0001628280-26-053308-ex991.txt","comments":"\"The Phase III study of BYSANTI (milsaperidone) as a once-daily adjunctive treatment for major depressive disorder (MDD), with results expected in the first half of 2027.\"","closed":0,"created_at":"2026-10-25 11:32:56","updated_at":"2026-10-25 11:32:56","company":"Vanda Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":225,"symbol":"VOR","drug":"telitacicept","modality":"protein","area":"immunology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260811_093055_(VOR)_sec_0001193125-26-343607.txt","comments":"10-Q: \"Topline data from the trial is anticipated in the first half of 2027\" (global Phase 3 in gMG). Window = 2027-01-01..2027-06-30 per the stated first half of 2027; no more precise date given.","closed":0,"created_at":"2026-10-25 11:14:34","updated_at":"2026-10-25 11:14:34","company":"Vor Biopharma","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":208,"symbol":"WHWK","drug":"HWK-007","modality":"adc","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260806_160349_(WHWK)_sec_0001193125-26-337933.txt","comments":"10-Q: \"We expect data readouts in the first half of 2027 for each trial\" (HWK-007 and HWK-016 Phase 1). 8-K of 2026-08-06 says \"initial results expected in 1H 2027\". Window widened to full 1H 2027.","closed":0,"created_at":"2026-10-25 11:13:20","updated_at":"2026-10-25 11:13:20","company":"Whitehawk Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":209,"symbol":"WHWK","drug":"HWK-016","modality":"adc","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260806_160349_(WHWK)_sec_0001193125-26-337933.txt","comments":"10-Q: \"We expect data readouts in the first half of 2027 for each trial\" (HWK-007 and HWK-016 Phase 1). Initial Phase 1 results, not stated as topline.","closed":0,"created_at":"2026-10-25 11:13:20","updated_at":"2026-10-25 11:13:20","company":"Whitehawk Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":204,"symbol":"XENE","drug":"azetukalner","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260806_161140_(XENE)_sec_0001193125-26-338019-ex991.txt","comments":"\"topline data from X-NOVA2 expected in H1 2027\"; Phase 3 MDD study. H1 2027 = 2027-01-01..2027-06-30.","closed":0,"created_at":"2026-10-25 11:12:45","updated_at":"2026-10-25 11:12:45","company":"Xenon Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":1042,"symbol":"XNCR","drug":"XmAb819","modality":"bispecific","area":"oncology","event_type":"data_presentation","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261026_075027_(XNCR)_sec_0001213900-26-112279.txt","comments":"\"Present subcutaneous dosing and full 400 ug/kg intravenous dosing cohort data 1H 2027\"; 400 ug/kg is the proposed IV RP3D and enrollment in that cohort is complete (data cut 01-Oct-2026). Guide is from the 2026-10-26 company presentation.","closed":0,"created_at":"2026-10-26 08:40:00","updated_at":"2026-10-26 08:40:00","company":"Xencor","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":1056,"symbol":"XNCR","drug":"XmAb819","modality":"bispecific","area":"oncology","event_type":"other","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261026_075027_(XNCR)_sec_0001213900-26-112279.txt","comments":"2026-10-26 presentation: \"End of Phase 1 meeting to inform potential accelerated approval pathway and design for potential global RCT using tivozanib control arm\" listed under 1H 2027. Regulatory meeting timing; exact date not stated.","closed":0,"created_at":"2026-10-26T15:06:00Z","updated_at":"2026-10-26T15:06:00Z","company":"Xencor","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":401,"symbol":"ZNTL","drug":"azenosertib","modality":"small_molecule","area":"oncology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20260806_161307_(ZNTL)_sec_0001725160-26-000062.txt","comments":"10-Q: \"We expect to provide a topline readout of DENALI Part 2 in the first half of 2027 to allow for data maturation post full enrollment.\" Integrated Part 2a/2b/2c dataset designed to support accelerated approval in Cyclin E1-positive PROC; Part 2c still enrolling.","closed":0,"created_at":"2026-10-25 11:27:32","updated_at":"2026-10-25 11:27:32","company":"Zentalis Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":190,"symbol":"ZURA","drug":"tibulizumab","modality":"bispecific","area":"immunology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-06-30","news_source_file":"documents/20261027_074036_(ZURA)_sec_0001855644-26-000012.txt","comments":"TibuSURE Phase 2 in early diffuse cutaneous systemic sclerosis enrollment complete (91 participants). Q3 2026 8-K (2026-10-27): \"Topline data remains on track for the first half of 2027\"; same guidance in 8-K dated 2026-07-01/2026-08-17.","closed":0,"created_at":"2026-10-25 11:11:39","updated_at":"2026-10-28T00:01:05Z","company":"Zura Bio","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-06-30","imminence":237,"state":"upcoming","overdue":false},{"id":424,"symbol":"ABOS","drug":"ACU301","modality":"monoclonal_antibody","area":"cns","event_type":"regulatory_submission","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20261026_160353_(ABOS)_sec_0001628280-26-067276.txt","comments":"10-Q (Oct 26, 2026): \"an investigational new drug, or IND, application for the lead candidate is targeted for mid-2027\" (EBD candidate ACU301, JCR collaboration); mid 2027 = Jun-Jul 2027.","closed":0,"created_at":"2026-10-25 11:29:13","updated_at":"2026-10-27T11:25:35Z","company":"Acumen Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":42,"symbol":"ACET","drug":"prula-cel","modality":"cell_therapy","area":"immunology","event_type":"interim_analysis","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20260928_081531_(ACET)_sec_0001720580-26-000060-ex991.txt","comments":"\"Mid 2027: Anticipated clinical data update in LN/SLE\"","closed":0,"created_at":"2026-10-25 10:05:15","updated_at":"2026-10-25 10:05:15","company":"Adicet Bio","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":169,"symbol":"ALLO","drug":"cema-cel","modality":"cell_therapy","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20260812_161718_(ALLO)_sec_0001628280-26-056213.txt","comments":"\"We anticipate ... conducting an interim EFS analysis in mid-2027\" for ALPHA3 (1L consolidation LBCL); window = mid 2027.","closed":0,"created_at":"2026-10-25 11:09:51","updated_at":"2026-10-25 11:09:51","company":"Allogene Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":379,"symbol":"ALXO","drug":"evorpacept","modality":"protein","area":"oncology","event_type":"topline_results","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20260806_080522_(ALXO)_sec_0001193125-26-336843-ex991.txt","comments":"\"topline data from 80 patients expected in mid-2027\" (ASPEN-09-Breast Phase 2, evorpacept + trastuzumab and chemo in HER2+ mBC); \"mid-2027\"=2027-06-01..2027-07-31","closed":0,"created_at":"2026-10-25 11:25:51","updated_at":"2026-10-25 11:25:51","company":"ALX Oncology Holdings","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":156,"symbol":"ANRO","drug":"ALTO-100","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20260812_161432_(ANRO)_sec_0001999480-26-000022-ex991.txt","comments":"\"Topline data remain expected ... mid-2027 for the ALTO-100 Phase 2b BPD trial\". Mid-2027 = 2027-06-01..2027-07-31.","closed":0,"created_at":"2026-10-25T07:07:46","updated_at":"2026-10-25T07:07:46","company":"Alto Neuroscience","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":150,"symbol":"ARVN","drug":"ARV-027","modality":"small_molecule","area":"rare_genetic","event_type":"data_presentation","expect_date_from":"2027-01-01","expect_date_to":"2027-07-31","news_source_file":"documents/20261103_080930_(ARVN)_sec_0001628280-26-069101.txt","comments":"\"Initial data from Phase 1 clinical trial evaluating AR degradation in muscle anticipated in 1H 2027\"; milestone slide: \"Share Phase 1 data from healthy volunteer cohort (mid-2027)\" for ARV-027 in SBMA.","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-03T18:57:12Z","company":"Arvinas","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":151,"symbol":"ARVN","drug":"ARV-393","modality":"small_molecule","area":"oncology","event_type":"data_presentation","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20260804_160823_(ARVN)_sec_0001628280-26-052554.txt","comments":"\"We anticipate sharing additional monotherapy data ... in patients with B- and T-cell lymphomas in mid-2027\"; also \"data from this combination cohort of ARV-393 with glofitamab in patients with DLBCL in mid-2027\".","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Arvinas","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":116,"symbol":"BBOT","drug":"BBO-8520","modality":"small_molecule","area":"oncology","event_type":"topline_results","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20260908_161906_(BBOT)_sec_0001193125-26-385225-ex991.txt","comments":"\"Expanded BBO-8520 plus pembrolizumab dataset in 2L+ KRAS G12C inhibitor-experienced NSCLC expected in mid-2027.\" Refines earlier Aug 11, 2026 10-Q guidance of updated data in 2H 2026.","closed":0,"created_at":"2026-10-25 11:05:09","updated_at":"2026-10-25 11:05:09","company":"BridgeBio Oncology Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":119,"symbol":"BBOT","drug":"BBO-11818","modality":"small_molecule","area":"oncology","event_type":"topline_results","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20260908_161906_(BBOT)_sec_0001193125-26-385225-ex991.txt","comments":"\"Data from BBO-11818 and BBO-10203 internal and standard-of-care combination cohorts in colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC) expected in mid-2027.\"","closed":0,"created_at":"2026-10-25 11:05:09","updated_at":"2026-10-25 11:05:09","company":"BridgeBio Oncology Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":120,"symbol":"BBOT","drug":"BBO-10203","modality":"small_molecule","area":"oncology","event_type":"topline_results","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20260908_161906_(BBOT)_sec_0001193125-26-385225-ex991.txt","comments":"\"Data from BBO-11818 and BBO-10203 internal and standard-of-care combination cohorts in colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC) expected in mid-2027.\"","closed":0,"created_at":"2026-10-25 11:05:09","updated_at":"2026-10-25 11:05:09","company":"BridgeBio Oncology Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":114,"symbol":"BCAX","drug":"ficerafusp alfa","modality":"bispecific","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20260811_164602_(BCAX)_sec_0001628280-26-055765.txt","comments":"10-Q: \"We expect to achieve substantial enrollment by the end of 2026 to enable an interim analysis in mid-2027 to support potential accelerated approval and U.S. launch in 2028.\" FORTIFI-HN01 Phase 2/3 (1500mg QW + pembrolizumab, 1L R/M HPV-negative HNSCC).","closed":0,"created_at":"2026-10-25 11:05:02","updated_at":"2026-10-25 11:05:02","company":"Bicara Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":291,"symbol":"CABA","drug":"rese-cabtagene autoleucel","modality":"cell_therapy","area":"immunology","event_type":"topline_results","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20260813_073231_(CABA)_sec_0001759138-26-000038-ex991.txt","comments":"\"Cabaletta continues to anticipate reporting data from the registrational, 17-patient dermatomyositis (DM) and antisynthetase syndrome (ASyS) cohort in mid-2027\" (14 adult DM, 3 adult ASyS). BLA-enabling topline data.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Cabaletta Bio","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":47,"symbol":"CBIO","drug":"CR-001","modality":"bispecific","area":"oncology","event_type":"topline_results","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20261015_162610_(CBIO)_sec_0001628280-26-066006.txt","comments":"\"standard of care chemotherapy combination expansion cohorts of ASCEND ... with initial data anticipated in mid-2027\"; also \"Phase 2 trial of CR-001 (SKB118) and sac-TMT ... in NSCLC ... initial data expected in mid-2027\" (Kelun-Biotech, China).","closed":0,"created_at":"2026-10-25 10:12:42","updated_at":"2026-10-25 10:12:42","company":"Crescent Biopharma","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":44,"symbol":"CCCC","drug":"cemsidomide","modality":"small_molecule","area":"hematology","event_type":"interim_analysis","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20260925_070425_(CCCC)_sec_0001628280-26-063497.txt","comments":"\"Data from all cohorts evaluated in the Phase 1b trial are expected in mid-2027\" (cemsidomide + elranatamab in RRMM). Company did not call it topline; 75 ug dose declared safe by safety data review committee and trial advancing to 100 ug escalation and 75 ug expansion cohorts.","closed":0,"created_at":"2026-10-25 10:12:36","updated_at":"2026-10-25 10:12:36","company":"C4 Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":956,"symbol":"COAG","drug":"HMB-003","modality":"peptide","area":"hematology","event_type":"interim_analysis","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20260811_160045_(COAG)_sec_0001193125-26-344533.txt","comments":"10-Q (Aug 2026): \"We expect to initiate first-in-human studies of HMB-003 in the second half of 2026 with initial clinical data in mid-2027.\" Nov 4, 2026 ASH release reaffirms: Phase 1 (NCT07798505) ongoing, \"with initial clinical data expected in mid-2027.\" Event is the initial clinical data (mid-2027), not the trial start.","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-04T17:49:49Z","company":"Hemab Therapeutics Holdings","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":936,"symbol":"CRDL","drug":"CardiolRx","modality":"small_molecule","area":"cardiovascular","event_type":"topline_results","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20260923_063824_(CRDL)_sec_0001279569-26-000905-ex991.txt","comments":"\"Topline results are now anticipated in mid-2027, compared with our previous Q1 2027 guidance.\" Phase III MAVERIC (recurrent pericarditis); timing delayed due to enrollment expansion from 110 to up to 150 patients after blinded review showed fewer recurrences than expected.","closed":0,"created_at":"2026-10-25 12:05:42","updated_at":"2026-10-25 12:05:42","company":"Cardiol Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":895,"symbol":"DMRA","drug":"DMR-001","modality":"monoclonal_antibody","area":"hematology","event_type":"topline_results","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20260810_160042_(DMRA)_sec_0001193125-26-342307.txt","comments":"\"We expect the readout of two proof-of-concept datasets from this trial beginning mid-2027\" (10-Q, filed 2026-08-10). Window reflects the start of the two Phase 1/1b PoC readouts; second readout timing not stated, so window is open-ended after mid-2027.","closed":0,"created_at":"2026-10-25 12:03:02","updated_at":"2026-10-25 12:03:02","company":"Damora Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":870,"symbol":"ELOX","drug":"exaluren","modality":"small_molecule","area":"rare_genetic","event_type":"topline_results","expect_date_from":"2026-08-11","expect_date_to":"2027-07-31","news_source_file":"documents/20260811_171943_(ELOX)_sec_0001193125-26-345032-ex991.txt","comments":"\"The Company anticipates topline data from the initial 16-week placebo-controlled portion of the study by mid-2027\" (Phase 2b in nonsense mutation Alport syndrome, initiated Q3 2026). Window runs from the Aug 11, 2026 guidance date through 2027-07-31.","closed":0,"created_at":"2026-10-25T08:01:06","updated_at":"2026-10-25T08:01:06","company":"Eloxx Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-08-11 → 2027-07-31","imminence":268,"state":"open","overdue":false},{"id":807,"symbol":"HRMY","drug":"pitolisant (WAKIX)","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20260804_080512_(HRMY)_sec_0001104659-26-090086-ex991.txt","comments":"\"WAKIX (pitolisant): Phase 3 trial in PWS (TEMPO) - Topline data expected in mid-2027\"; 10-Q: \"We anticipate topline data from the TEMPO study in mid-2027.\" Mid-2027 = Jun-Jul 2027.","closed":0,"created_at":"2026-10-25 11:55:47","updated_at":"2026-10-25 11:55:47","company":"Harmony Biosciences Holdings","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":808,"symbol":"HRMY","drug":"EPX-100","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20260804_080512_(HRMY)_sec_0001104659-26-090086-ex991.txt","comments":"Nov 4, 2026 release: \"Topline data expected in mid-2027 and anticipated PDUFA date in 2028\" for two Global Phase 3 registrational trials in rare epilepsies (LGS LIGHTHOUSE; DS ARGUS). One row covering both trials. Mid-2027 = Jun-Jul 2027 (previously broadened to 1H 2027 from Aug 2026 release).","closed":0,"created_at":"2026-10-25 11:55:49","updated_at":"2026-11-04T13:38:25Z","company":"Harmony Biosciences Holdings","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":784,"symbol":"IDYA","drug":"darovasertib","modality":"small_molecule","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20260804_060139_(IDYA)_sec_0001193125-26-331381-ex991.txt","comments":"\"IDEAYA plans to provide an update on the OS data as part of the pre-specified interim analysis expected in mid-2027\" (OptimUM-02, mUM)","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"IDEAYA Biosciences","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":776,"symbol":"IMMX","drug":"NXC-201","modality":"cell_therapy","area":"hematology","event_type":"topline_results","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20260929_070021_(IMMX)_sec_0001493152-26-044761-ex991.txt","comments":"\"NEXICART-2 final readout and BLA submission planned mid-2027\" (body: \"planned in 2027\"); mid-2027 window used.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Immix Biopharma","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":777,"symbol":"IMMX","drug":"NXC-201","modality":"cell_therapy","area":"hematology","event_type":"regulatory_submission","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20260929_070021_(IMMX)_sec_0001493152-26-044761-ex991.txt","comments":"BLA submission for NXC-201 in relapsed/refractory AL amyloidosis planned mid-2027 alongside NEXICART-2 final readout.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Immix Biopharma","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":1123,"symbol":"IMUX","drug":"vidofludimus calcium","modality":"small_molecule","area":"cns","event_type":"regulatory_submission","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20260811_065910_(IMUX)_sec_0001280776-26-000018.txt","comments":"10-Q: \"If the ENSURE trials are positive, we intend to target submission of a New Drug Application (\\\"NDA\\\") to the U.S. Food and Drug Administration in mid-2027, with potential U.S. regulatory approval in 2028.\" Conditional on positive ENSURE topline; mid-2027 = 2027-06-01..2027-07-31.","closed":0,"created_at":"2026-10-30 20:14:15","updated_at":"2026-10-30 20:14:15","company":"Immunic","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":766,"symbol":"INBX","drug":"INBRX-106","modality":"protein","area":"oncology","event_type":"topline_results","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20260908_160151_(INBX)_sec_0002007919-26-000047-ex991.txt","comments":"\"Phase 1/2 study of INBRX-106 in the perioperative setting of non-small cell lung cancer (NSCLC), with initial results targeted by mid-2027.\"","closed":0,"created_at":"2026-10-25T07:53:09","updated_at":"2026-10-25T07:53:09","company":"Inhibrx Biosciences","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":998,"symbol":"INMB","drug":"pobistrocel","modality":"cell_therapy","area":"rare_genetic","event_type":"other","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20261021_071500_(INMB)_yahoo_news_yahoo-709d54e925f0e03efc8ad404289f7405-INMB.txt","comments":"Oct 21, 2026 release headline: \"INmune Bio Advances Ebstrocel Toward Potential UK Approval in Mid-2027\"; revised MAA strategy \"could bring potential UK approval forward by approximately six weeks\". Window = \"mid-2027\"; timing is company guidance, not a decision date.","closed":0,"created_at":"2026-10-25 12:18:43","updated_at":"2026-10-25 12:18:43","company":"INmune Bio","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":743,"symbol":"IRON","drug":"bitopertin","modality":"small_molecule","area":"rare_genetic","event_type":"pdufa","expect_date_from":"2026-10-19","expect_date_to":"2027-07-31","news_source_file":"documents/20261019_070808_(IRON)_sec_0001193125-26-424649-ex991.txt","comments":"\"Disc plans to resubmit an NDA to the U.S. FDA by the end of 2026, with an FDA decision anticipated by mid-2027.\" No PDUFA date assigned yet; window runs from disclosure to mid-2027.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Disc Medicine","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-10-19 → 2027-07-31","imminence":268,"state":"open","overdue":false},{"id":734,"symbol":"IXHL","drug":"IHL-42X","modality":"small_molecule","area":"respiratory","event_type":"other","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20260925_084114_(IXHL)_sec_0001628280-26-063506.txt","comments":"10-K: \"The next major milestone is completion of the DReAMzz Study, estimated for mid-2027, followed by analysis to inform dose selection and the planned Phase 3 design.\" Phase 2 crossover dose-optimization study in OSA; completion/readout not characterized as topline.","closed":0,"created_at":"2026-10-25 11:51:14","updated_at":"2026-10-25 11:51:14","company":"Incannex Healthcare","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":733,"symbol":"JAGX","drug":"crofelemer","modality":"other","area":"gi_hepatology","event_type":"regulatory_submission","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20261005_084507_(JAGX)_sec_0001193125-26-413233-ex991.txt","comments":"\"planned New Drug Application (NDA) filing for crofelemer for MVID in mid-2027\" (Oct 2, 2026 release). Supersedes earlier Q2 2027 guidance (Aug 19, 2026 8-K). Window = mid 2027 per accuracy rules.","closed":0,"created_at":"2026-10-25 11:51:13","updated_at":"2026-10-25 11:51:13","company":"Jaguar Health","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":713,"symbol":"KLRA","drug":"ribupatide injection (KAI-9531)","modality":"peptide","area":"metabolic","event_type":"topline_results","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20261104_160828_(KLRA)_sec_0001193125-26-447232-ex991.txt","comments":"\"Phase 2b high dose clinical trial in obesity fully enrolled with data anticipated mid-2027\" (~260 participants in U.S., BMI >=35 without T2D; 10, 13, 16, 20 mg over 48 weeks). Window = mid-2027.","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-05T12:28:53Z","company":"Kailera Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":715,"symbol":"KLRA","drug":"KAI-7535","modality":"small_molecule","area":"metabolic","event_type":"topline_results","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20261104_160828_(KLRA)_sec_0001193125-26-447232-ex991.txt","comments":"\"Global Phase 2 trial in obesity fully enrolled with data now anticipated in mid-2027\" (safiglipron/KAI-7535, ~300 participants, up to 44 weeks; NCT07497880). Narrowed from full 2027 to mid-2027.","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-05T12:28:53Z","company":"Kailera Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":686,"symbol":"KRSA","drug":"KRSA-028","modality":"monoclonal_antibody","area":"cns","event_type":"topline_results","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20261105_070514_(KRSA)_sec_0001193125-26-448535.txt","comments":"\"Phase 1 healthy volunteer data expected in mid-2027\" for KRSA-028 (shuttled anti-amyloid-beta antibody, Alzheimer's). Window per mid-2027 = 2027-06-01..2027-07-31. Reaffirmed in Nov 5, 2026 Q3 release: \"Phase 1 healthy volunteer data for KRSA-028 expected mid-2027\".","closed":0,"created_at":"2026-10-25 11:49:20","updated_at":"2026-11-05T12:29:59Z","company":"Korsana Biosciences","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":658,"symbol":"LYEL","drug":"ronde-cel","modality":"cell_therapy","area":"hematology","event_type":"topline_results","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20260806_162705_(LYEL)_sec_0001628280-26-054367.txt","comments":"10-Q: \"Pivotal data from the PiNACLE trial are expected in mid-2027\" (mid-2027 = Jun-Jul 2027 window).","closed":0,"created_at":"2026-10-25 07:46:06","updated_at":"2026-10-25 07:46:06","company":"Lyell Immunopharma","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":644,"symbol":"MGTX","drug":"AAV2-hAQP1","modality":"gene_therapy","area":"other","event_type":"regulatory_submission","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20260813_080559_(MGTX)_sec_0001104659-26-095491-ex991.txt","comments":"\"potential BLA filing for AAV2-hAQP1 in mid-2027\"; PR body: \"preparing for AAV2-hAQP1 filings mid next year\". Mid-2027 = 2027-06-01..2027-07-31. Conditional on positive AQUAx2 12-month data.","closed":0,"created_at":"2026-10-25 11:45:28","updated_at":"2026-10-25 11:45:28","company":"MeiraGTx Holdings","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":585,"symbol":"OCGN","drug":"OCU410ST","modality":"gene_therapy","area":"ophthalmology","event_type":"regulatory_submission","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20260806_083036_(OCGN)_sec_0001104659-26-091691-ex991.txt","comments":"\"Topline results anticipated in the second quarter of 2027, with a BLA submission to follow mid-2027.\" U.S. BLA for Stargardt disease.","closed":0,"created_at":"2026-10-25 07:39:42","updated_at":"2026-10-25 07:39:42","company":"Ocugen","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":673,"symbol":"ORIC","drug":"enozertinib","modality":"small_molecule","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20261023_080023_(ORIC)_sec_0001193125-26-429465-ex991.txt","comments":"Timeline slide: \"Phase 1b Monotherapy, combos w/ amivantamab and w/ chemo Data: Mid-2027\" in 1L EGFR exon 20 NSCLC (combo collaboration with J&J). Previous guidance was data in 2H 2026; now mid-2027. Redwood-2 Phase 3 initiation in exon 20 expected after these data.","closed":0,"created_at":"2026-10-25 07:50:00","updated_at":"2026-10-25 07:50:00","company":"Oric Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":441,"symbol":"RCUS","drug":"AB102","modality":"small_molecule","area":"immunology","event_type":"topline_results","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20260805_160748_(RCUS)_sec_0001724521-26-000042-ex991.txt","comments":"\"A proof-of-concept study evaluating AB102 as a potential oral therapy for patients with chronic spontaneous urticaria is expected in mid-2027.\" Mid 2027 window; study was expected to start FIH in Aug 2026.","closed":0,"created_at":"2026-10-25 11:31:21","updated_at":"2026-10-25 11:31:21","company":"Arcus Biosciences","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":423,"symbol":"RNAC","drug":"Descartes-08","modality":"cell_therapy","area":"cns","event_type":"regulatory_submission","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20261105_070252_(RNAC)_sec_0001453687-26-000110.txt","comments":"Q2 2026 (2026-08-06): \"BLA filing planned for mid-2027\"; reaffirmed Q3 2026 release (2026-11-05): \"biologics license application (BLA) filing planned for mid-2027\" -> 2027-06-01..2027-07-31.","closed":0,"created_at":"2026-10-25 07:28:32","updated_at":"2026-11-05T12:30:13Z","company":"Cartesian Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":393,"symbol":"RZLT","drug":"ersodetug","modality":"monoclonal_antibody","area":"rare_genetic","event_type":"regulatory_submission","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20260924_162457_(RZLT)_sec_0001104659-26-110420.txt","comments":"Company presentation (10/29/26 8-K) lists milestone \"2027 BLA filing\" for congenital HI; original guidance: \"assuming supportive data, submit a Biologics License Application to the FDA for ersodetug in mid-2027\" (FY2026 10-K). Contingent on supportive upLIFT data and FDA alignment in congenital HI.","closed":0,"created_at":"2026-10-25 11:27:11","updated_at":"2026-10-30T13:55:35Z","company":"Rezolute","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":320,"symbol":"SUPN","drug":"ONAPGO (apomorphine HCl)","modality":"other","area":"cns","event_type":"pdufa","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20261021_210747_(SUPN)_sec_0001104659-26-117937-ex991.txt","comments":"\"continues to expect potential FDA approval of the second supplier by mid-year 2027\" (8-K/EX-99.1, 2026-10-21); mid-year 2027 = 2027-06-01..2027-07-31. sNDA for second ONAPGO supplier submitted in Q3 2026; no formal PDUFA date given. Q3 2026 10-Q (2026-10-29) confirms: \"In October 2026 the Company submitted a supplemental New Drug Application (sNDA) to the FDA for a second supplier for ONAPGO, with potential FDA approval by mid-year 2027.\"","closed":0,"created_at":"2026-10-25 11:21:42","updated_at":"2026-10-30T16:00:55Z","company":"Supernus Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":274,"symbol":"TNXP","drug":"TNX-102 SL","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20260810_071525_(TNXP)_sec_0001493152-26-036740-ex991.txt","comments":"\"Topline data is expected to be reported mid-2027\" for the DoD-funded OASIS study of TNX-102 SL in acute stress disorder/reaction; investigator-initiated study conducted by the University of North Carolina.","closed":0,"created_at":"2026-10-25 11:18:05","updated_at":"2026-10-25 11:18:05","company":"Tonix Pharmaceuticals Holding","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":217,"symbol":"VRCA","drug":"VP-102 (YCANTH)","modality":"small_molecule","area":"dermatology","event_type":"topline_results","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20260806_163451_(VRCA)_sec_0001193125-26-338273-ex991.txt","comments":"Q2 2026 release: \"Topline data from our global Phase 3 program is currently expected in mid-2027, as our studies are recruiting well.\" 10-Q: \"Top-line data from our Program is expected in mid-2027.\" Program = COVE-2/COVE-3/COVE-4 common warts (US/Japan).","closed":0,"created_at":"2026-10-25 11:14:27","updated_at":"2026-10-25 11:14:27","company":"Verrica Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":15,"symbol":"VSTM","drug":"avutometinib + defactinib","modality":"small_molecule","area":"oncology","event_type":"topline_results","expect_date_from":"2027-06-01","expect_date_to":"2027-07-31","news_source_file":"documents/20260806_162952_(VSTM)_sec_0001104659-26-092058-ex991.txt","comments":"Guided milestone: \"Report a topline readout of the primary endpoint in the RAMP 301 trial in mid-2027.\"","closed":0,"created_at":"2026-10-25 09:52:56","updated_at":"2026-10-25 09:52:56","company":"Verastem","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-06-01 → 2027-07-31","imminence":268,"state":"upcoming","overdue":false},{"id":386,"symbol":"ALGS","drug":"pevifoscorvir sodium","modality":"small_molecule","area":"infectious","event_type":"topline_results","expect_date_from":"2027-09-01","expect_date_to":"2027-09-30","news_source_file":"documents/20260806_080037_(ALGS)_sec_0001171843-26-005294-ex991.txt","comments":"\"Topline data for both the HBeAg+ and HBeAg- cohorts are expected in late Q3 2027\" (Phase 2 B-SUPREME, NCT06963710; enrollment complete: 131 HBeAg+ Part 1a, 114 HBeAg- Part 2a). Reiterated in 10-Q filed 2026-08-06.","closed":0,"created_at":"2026-10-25 11:26:27","updated_at":"2026-10-25 11:26:27","company":"Aligos Therapeutics","tier":"Core","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-09-01 → 2027-09-30","imminence":329,"state":"upcoming","overdue":false},{"id":160,"symbol":"ANNX","drug":"vonaprument","modality":"monoclonal_antibody","area":"ophthalmology","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-09-30","news_source_file":"documents/20260812_063026_(ANNX)_sec_0001193125-26-345672-ex991.txt","comments":"\"final trial completion, including the Month 24 primary endpoint expected in the third quarter of 2027\" (ARCHER II dual primary endpoint added).","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Annexon","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-09-30","imminence":329,"state":"upcoming","overdue":false},{"id":107,"symbol":"BCRX","drug":"navenibart","modality":"monoclonal_antibody","area":"immunology","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-09-30","news_source_file":"documents/20260805_070239_(BCRX)_sec_0001171843-26-005223-ex991.txt","comments":"\"The program remains on track to report top-line results from both doses in Q3 2027\"; ALPHA-ORBIT Phase 3 in HAE, enrollment completed June 2026.","closed":0,"created_at":"2026-10-25 11:04:49","updated_at":"2026-10-25 11:04:49","company":"BioCryst Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-09-30","imminence":329,"state":"upcoming","overdue":false},{"id":822,"symbol":"GOSS","drug":"seralutinib","modality":"small_molecule","area":"cardiovascular","event_type":"other","expect_date_from":"2027-07-01","expect_date_to":"2027-09-30","news_source_file":"documents/20260727_160109_(GOSS)_sec_0001728117-26-000064.txt","comments":"\"If the NDA is accepted for filing, seralutinib could be eligible for an FDA approval decision in the third quarter of 2027.\" Contingent on FDA acceptance of the NDA; confirms in 8/13/26 10-Q.","closed":0,"created_at":"2026-10-25 11:57:20","updated_at":"2026-10-25 11:57:20","company":"Gossamer Bio","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-09-30","imminence":329,"state":"upcoming","overdue":false},{"id":730,"symbol":"JSPR","drug":"KP-701","modality":"monoclonal_antibody","area":"immunology","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-09-30","news_source_file":"documents/20260814_110039_(JSPR)_sec_0001213900-26-089592.txt","comments":"10-Q: \"we plan to report first-in-human data in the third quarter of 2027\" (KP-701 Phase 1).","closed":0,"created_at":"2026-10-25 07:50:14","updated_at":"2026-10-25 07:50:14","company":"Jasper Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-09-30","imminence":329,"state":"upcoming","overdue":false},{"id":538,"symbol":"PDSB","drug":"PDS0301","modality":"protein","area":"oncology","event_type":"topline_results","expect_date_from":"2027-04-01","expect_date_to":"2027-09-30","news_source_file":"documents/20261020_195906_(PDSB)_sec_0001140361-26-040283-ex991.txt","comments":"\"Q2/Q3-2027 Metastatic castration resistant prostate cancer (Final data readout)\" — PDS0301 + docetaxel mCRPC study.","closed":0,"created_at":"2026-10-25 11:37:04","updated_at":"2026-10-25 11:37:04","company":"PDS Biotechnology","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-04-01 → 2027-09-30","imminence":329,"state":"upcoming","overdue":false},{"id":465,"symbol":"RAPP","drug":"RAP-219","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-09-30","news_source_file":"documents/20261104_071215_(RAPP)_sec_0001193125-26-446202.txt","comments":"\"Phase 1 pharmacokinetic data expected in the third quarter of 2027\" for an LAI formulation of RAP-219 (Q3 2026 8-K EX-99.1, Nov 4, 2026).","closed":0,"created_at":"2026-10-25 11:32:36","updated_at":"2026-11-04T15:45:07Z","company":"Rapport Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-09-30","imminence":329,"state":"upcoming","overdue":false},{"id":553,"symbol":"STOK","drug":"zorevunersen","modality":"aso","area":"cns","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-09-30","news_source_file":"documents/20260803_160517_(STOK)_sec_0001193125-26-330537-ex991.txt","comments":"Phase 3 EMPEROR (Dravet syndrome) in U.S./UK/Japan, enrollment complete n=162: \"A Phase 3 readout is anticipated in the third quarter of 2027.\" Primary endpoint Week 28 but study remains blinded and all data analyzed at Week 52. Q3 2027 = 2027-07-01..2027-09-30.","closed":0,"created_at":"2026-10-25 07:40:00","updated_at":"2026-10-25 07:40:00","company":"Stoke Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-09-30","imminence":329,"state":"upcoming","overdue":false},{"id":505,"symbol":"TRAX","drug":"ANB033","modality":"monoclonal_antibody","area":"gi_hepatology","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-09-30","news_source_file":"documents/20261103_161500_(TRAX)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co_72d863.txt","comments":"Q3 2026 release (Nov 3, 2026): \"Top-line data anticipated in Q3 2027\" - Phase 1b 50-patient randomized trial of ANB033 vs placebo in eosinophilic esophagitis; reaffirms prior Q3 2027 guidance.","closed":0,"created_at":"2026-10-25 11:35:02","updated_at":"2026-11-04T19:56:20Z","company":"First Tracks Biotherapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-09-30","imminence":329,"state":"upcoming","overdue":false},{"id":264,"symbol":"TTRX","drug":"GX-03","modality":"other","area":"dermatology","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-09-30","news_source_file":"documents/20261006_193052_(TTRX)_sec_0001213900-26-107329-ex991.txt","comments":"HS Phase 2a: \"Q3 2027 Topline Readout Expected\" (planned 30 GX-03 : 30 vehicle, 12 weeks). July 2026 deck had guided Q1 2028. First patient dosing planned Q1 2027.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Turn Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-09-30","imminence":329,"state":"upcoming","overdue":false},{"id":183,"symbol":"ABSI","drug":"ABS-201","modality":"monoclonal_antibody","area":"womens_health","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260811_160614_(ABSI)_sec_0001672688-26-000134-ex991.txt","comments":"Data window per Aug-11 8-K/10-Q: \"potential proof-of-concept data in the second half of 2027\" after a planned Phase 2 in endometriosis. Sept 24, 2026 release revised initiation: \"Anticipated initiation of Phase 2 trial in mid-2027\" (previously Q4 2026); no revised data timing stated.","closed":0,"created_at":"2026-10-25 11:11:13","updated_at":"2026-10-25T16:09:33Z","company":"Absci","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":1134,"symbol":"AEON","drug":"ABP-450","modality":"protein","area":"cns","event_type":"other","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260930_080024_(AEON)_sec_0001837607-26-000064-ex991.txt","comments":"Planned FDA interaction (BPD) on integrated analytical/PD/comparative evidence package: \"AEON plans to return to the FDA in 2027 with its integrated evidence package.\" Year-only timing, no specific quarter given.","closed":0,"created_at":"2026-11-01 13:08:16","updated_at":"2026-11-01 13:08:16","company":"AEON Biopharma","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":376,"symbol":"AGEN","drug":"botensilimab + balstilimab","modality":"monoclonal_antibody","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260713_063023_(AGEN)_sec_0001193125-26-301414-ex991.txt","comments":"\"Interim pathologic response data: anticipated in second half of 2027\" for the ROBBIN Phase 3 neoadjuvant trial in high-risk Stage II/III MSS colon cancer.","closed":0,"created_at":"2026-10-25 11:25:32","updated_at":"2026-10-25 11:25:32","company":"Agenus","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":172,"symbol":"AKTS","drug":"AKY-2519","modality":"radiopharma","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260813_160416_(AKTS)_sec_0001193125-26-349133-ex991.txt","comments":"\"Expect preliminary data from Phase 1b mCRPC clinical trial in 2027.\" BActinium-1 Phase 1b in PLUVICTO-naive and -experienced mCRPC; only year given.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Aktis Oncology","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":36,"symbol":"ALKS","drug":"ALKS 7290","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260921_071039_(ALKS)_sec_0001193125-26-396065-ex991.txt","comments":"Phase 2 study in adults with ADHD (NCT07755410, ~312 participants) enrolling; \"Data Expected in 2027\" per Sept 21, 2026 release headline.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Alkermes","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":167,"symbol":"ALMR","drug":"ARGO HT/DX","modality":"other","area":"other","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260810_203041_(ALMR)_sec_0001193125-26-343003.txt","comments":"\"we intend to provide a submission to the FDA for marketing authorization in 2027\" for the ARGO HT/DX IVD instrument (10-Q MD&A; only year-level guidance given, so window spans all of 2027).","closed":0,"created_at":"2026-10-25 07:09:21","updated_at":"2026-10-25 07:09:21","company":"Alamar Biosciences","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":381,"symbol":"ALT","drug":"pemvidutide","modality":"peptide","area":"gi_hepatology","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260812_160409_(ALT)_sec_0001326190-26-000052.txt","comments":"RESTORE Ph2 ALD (48-week study, ~120 patients): \"The Company expects to report topline data in the second half of 2027.\" Enrollment completed July 2026; protocol amended to assess LSM hierarchically at Week 48 then Week 24.","closed":0,"created_at":"2026-10-25 11:26:08","updated_at":"2026-10-25 11:26:08","company":"Altimmune","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":154,"symbol":"ANRO","drug":"ALTO-207","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260812_161432_(ANRO)_sec_0001999480-26-000022-ex991.txt","comments":"\"topline data expected in 2H 2027\" for PACE-1, the potentially registrational Phase 2b trial of ALTO-207 as adjunctive treatment in TRD (~178 patients, MADRS primary endpoint). Window per 2H 2027 = 2027-07-01..2027-12-31.","closed":0,"created_at":"2026-10-25T07:07:46","updated_at":"2026-10-25T07:07:46","company":"Alto Neuroscience","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":329,"symbol":"ANTX","drug":"epetraborole","modality":"small_molecule","area":"hematology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260811_160142_(ANTX)_sec_0001193125-26-344549-ex991.txt","comments":"Q2 2026 8-K: \"The Company anticipates releasing Part 1 data periodically throughout 2027\" from the open-label Part 1 of the Phase 2 EBO-PV-201 study in phlebotomy-dependent polycythemia vera; exact timing not stated.","closed":0,"created_at":"2026-10-25 11:22:24","updated_at":"2026-10-25 11:22:24","company":"AN2 Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":330,"symbol":"ANTX","drug":"epetraborole","modality":"small_molecule","area":"infectious","event_type":"topline_results","expect_date_from":"2027-11-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260811_160142_(ANTX)_sec_0001193125-26-344549-ex991.txt","comments":"Q2 2026 8-K: \"We anticipate reporting topline results in late 2027, subject to enrollment progress.\" 84-patient investigator-initiated Phase 2 in M. abscessus lung disease; timing is enrollment-dependent.","closed":0,"created_at":"2026-10-25 11:22:24","updated_at":"2026-10-25 11:22:24","company":"AN2 Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-11-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":148,"symbol":"ARDX","drug":"tenapanor","modality":"small_molecule","area":"gi_hepatology","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261103_160350_(ARDX)_sec_0001437402-26-000058-ex991.txt","comments":"Q3 2026 release (2026-11-03): \"The Company has completed enrollment ahead of schedule in its Phase 3 clinical trial, ACCEL ... The Company is on track to announce topline data in the second half of 2027.\" 10-Q confirms enrollment complete. Window = 2H 2027.","closed":0,"created_at":"2026-10-25T07:07:03","updated_at":"2026-11-04T22:01:28Z","company":"Ardelyx","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":1169,"symbol":"ARVN","drug":"ARV-6723","modality":"small_molecule","area":"oncology","event_type":"data_presentation","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261103_080930_(ARVN)_sec_0001628280-26-069101.txt","comments":"\"Share initial Phase 1 clinical data in patients with advanced solid tumors (2H 2027)\" for ARV-6723, an oral HPK1 degrader; Q3 2026 release notes dosing initiated in the Phase 1/2 monotherapy cohort.","closed":0,"created_at":"2026-11-03 18:57:12","updated_at":"2026-11-03 18:57:12","company":"Arvinas","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":1103,"symbol":"ASMB","drug":"ABI-6250","modality":"small_molecule","area":"infectious","event_type":"interim_analysis","expect_date_from":"2027-10-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261029_160000_(ASMB)_globenewswire_pharma_globenewswire_pharma-sha256-cd7ef541cf1c23642f8b.txt","comments":"\"Initial data from the study is expected in the fourth quarter of 2027.\" Phase 2 (ABI-6250-201) in chronic HDV; first two participants dosed Oct 29, 2026; initial data readout after Week 16 primary endpoint analysis of main cohort.","closed":0,"created_at":"2026-10-29 21:27:47","updated_at":"2026-10-29 21:27:47","company":"Assembly Biosciences","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-10-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":131,"symbol":"AURA","drug":"bel-sar","modality":"other","area":"oncology","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260811_070526_(AURA)_sec_0001193125-26-343408-ex991.txt","comments":"\"Topline data from the 15-month primary endpoint remain on track for the second half of 2027, consistent with previously communicated guidance.\" Phase 3 CoMpass in early choroidal melanoma, fully enrolled (n=108); under SPA with FDA.","closed":0,"created_at":"2026-10-25 11:06:14","updated_at":"2026-10-25 11:06:14","company":"Aura Biosciences","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":137,"symbol":"AUTL","drug":"obe-cel","modality":"cell_therapy","area":"oncology","event_type":"data_presentation","expect_date_from":"2026-08-11","expect_date_to":"2027-12-31","news_source_file":"documents/20260811_073342_(AUTL)_sec_0001730463-26-000119-ex991.txt","comments":"\"Phase 2 portion of the ongoing CATULUS trial ... is on track and data are expected to be reported at the end of 2027\" (summary: By year-end 2027); pediatric r/r B-ALL.","closed":0,"created_at":"2026-10-25 11:06:26","updated_at":"2026-10-25 11:06:26","company":"Autolus Therapeutics plc American Depositary Share","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-08-11 → 2027-12-31","imminence":421,"state":"open","overdue":false},{"id":136,"symbol":"AUTL","drug":"obe-cel","modality":"cell_therapy","area":"cns","event_type":"data_presentation","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260811_073342_(AUTL)_sec_0001730463-26-000119-ex991.txt","comments":"\"A larger data set with longer follow up will be reported in the second half of 2027\" (BOBCAT Phase 1, progressive MS).","closed":0,"created_at":"2026-10-25 11:06:26","updated_at":"2026-10-25 11:06:26","company":"Autolus Therapeutics plc American Depositary Share","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":1041,"symbol":"AVBP","drug":"ARR-217","modality":"adc","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261026_060049_(AVBP)_sec_0001104659-26-118550.txt","comments":"\"ARR-217 has advanced into Phase 1b dose optimization at doses of 5 and 6 mg/kg Q3W with further dose optimization data expected in 2027\"; CEO quote: \"we look forward to dose optimization data expected in 2027.\" Window per \"in 2027\".","closed":0,"created_at":"2026-10-26 12:37:32","updated_at":"2026-10-26 12:37:32","company":"ArriVent BioPharma","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":341,"symbol":"AVLN","drug":"AP01","modality":"small_molecule","area":"respiratory","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260812_080635_(AVLN)_sec_0001193125-26-345807-ex991.txt","comments":"\"Completed enrollment of MIST global Phase 2b trial of AP01 with 398 patients; topline data expected in the second half of 2027\" (Q2 2026 release, 2026-08-12). 52-week PPF trial; second half of 2027 mapped to 2027-07-01..2027-12-31.","closed":0,"created_at":"2026-10-25 11:23:08","updated_at":"2026-10-25 11:23:08","company":"Avalyn Pharma","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":342,"symbol":"AVLN","drug":"AP02","modality":"small_molecule","area":"respiratory","event_type":"topline_results","expect_date_from":"2027-11-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260812_080635_(AVLN)_sec_0001193125-26-345807-ex991.txt","comments":"AURA Phase 2 (IPF, 12-week, 160 patients): \"Topline data are anticipated in late 2027.\" (Q2 2026 release, 2026-08-12). \"late 2027\" mapped to 2027-11-01..2027-12-31.","closed":0,"created_at":"2026-10-25 11:23:08","updated_at":"2026-10-25 11:23:08","company":"Avalyn Pharma","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-11-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":124,"symbol":"AXSM","drug":"solriamfetol","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261102_070522_(AXSM)_sec_0001193125-26-442628.txt","comments":"\"The Company anticipates topline results from SUSTAIN in the second half of 2027\" (solriamfetol in shift work disorder in adults); same 3Q 2026 update also guides FOCUS-2 (children) and FOCUS-3 (adolescents) ADHD topline results to 2H 2027 for solriamfetol, so those share this window. Narrowed from prior \"in 2027\" guidance.","closed":0,"created_at":"2026-10-25 11:05:34","updated_at":"2026-11-02T17:56:37Z","company":"Axsome Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":1150,"symbol":"AXSM","drug":"AXS-05","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261102_070522_(AXSM)_sec_0001193125-26-442628.txt","comments":"\"The Company anticipates topline results from the SUMMIT Phase 3 trial in the second half of 2027\" - AXS-05 (dextromethorphan-bupropion) in smoking cessation; Phase 3 trial initiated August 2026.","closed":0,"created_at":"2026-11-02T12:56:12","updated_at":"2026-11-02T12:56:12","company":"Axsome Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":1098,"symbol":"BHVN","drug":"taldefgrobep alfa","modality":"protein","area":"metabolic","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261029_160503_(BHVN)_sec_0001935979-26-000093-ex991.txt","comments":"\"As a result of the amended study design, we now anticipate topline data from the monotherapy and combination therapy portions of the trial in 2H 2027\" (2H 2027 = 2027-07-01..2027-12-31). Amended to add a GLP-1 combination cohort; supersedes earlier 2H 2026 guidance.","closed":0,"created_at":"2026-10-29 15:12:16","updated_at":"2026-10-30T20:14:57Z","company":"Biohaven","tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.55,"llm_reason":"The taldefgrobep Phase 2 obesity readout is a secondary program. Expectations are low after the drug's prior SMA failure. The stock's value rests mostly on the degraders and opakalim, so a modest move is more likely. Low cash raises some risk of a downside move on a clear miss.","llm_predicted_at":"2026-10-29T15:14:26Z","llm_source":"live","window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":55,"symbol":"BIOA","drug":"BGE-102","modality":"small_molecule","area":"ophthalmology","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261002_161514_(BIOA)_sec_0001193125-26-412300.txt","comments":"8-K (Oct 2, 2026): QUELL-DME Phase 2 (oral BGE-102 90 mg, NLRP3 inhibitor) in diabetic macular edema, ~180 participants; \"Topline results expected in the second half of 2027\". First participant dosed; dosing is not itself a catalyst. Confirms earlier Q2 guidance.","closed":0,"created_at":"2026-10-25 10:13:12","updated_at":"2026-10-26T00:19:35Z","company":"BioAge Labs","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":60,"symbol":"BLSM","drug":"BH-30643","modality":"small_molecule","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260918_073032_(BLSM)_sec_0001193125-26-395043.txt","comments":"\"initial Phase 1 data on a chemotherapy combination cohort in the second half of 2027, and updated Phase 1 data on durability of response in TKI-naive patients in the second half of 2027\".","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"BlossomHill Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":1131,"symbol":"BOLT","drug":"PRA-216","modality":"bispecific","area":"immunology","event_type":"topline_results","expect_date_from":"2027-04-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261023_103129_(BOLT)_sec_0001193125-26-429647-ex991.txt","comments":"\"Phase 2 development in asthma, COPD, and atopic dermatitis has been initiated, with a Phase 2 study in EoE planned, and with patient data from all four trials expected beginning in the second quarter of 2027 and continuing through the fourth quarter of 2027.\" Single guided window covers all four Phase 2 trials (asthma, COPD, AD, EoE).","closed":0,"created_at":"2026-11-01 13:08:03","updated_at":"2026-11-01 13:08:03","company":"Bolt Biotherapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-04-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":1132,"symbol":"BOLT","drug":"IL-31 bispecific (Program 2)","modality":"bispecific","area":"immunology","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261023_103129_(BOLT)_sec_0001193125-26-429647-ex991.txt","comments":"\"Prana's second program is an IL-31 containing bispecific antibody being developed initially for atopic dermatitis. First-in-human studies in healthy volunteers and patients are expected to begin in the second half of 2027, with clinical data also expected in the second half of 2027.\" Unnamed program; caveat: same period as study start.","closed":0,"created_at":"2026-11-01 13:08:06","updated_at":"2026-11-01 13:08:06","company":"Bolt Biotherapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":95,"symbol":"BRVE","drug":"BHB-1893","modality":"small_molecule","area":"cardiovascular","event_type":"interim_analysis","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260908_160655_(BRVE)_sec_0001628280-26-060904-ex991.txt","comments":"\"We continue to expect results from an interim analysis from LIONHEART-HCM in the second half of 2027.\" Phase 3 oHCM trial of BHB-1893 vs metoprolol; first patient dosing guided for 2026 (trial start, not a catalyst).","closed":0,"created_at":"2026-10-25 07:03:35","updated_at":"2026-10-25 07:03:35","company":"Braveheart Bio","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":292,"symbol":"CABA","drug":"rese-cabtagene autoleucel","modality":"cell_therapy","area":"immunology","event_type":"regulatory_submission","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260813_073231_(CABA)_sec_0001759138-26-000038-ex991.txt","comments":"\"Cabaletta plans to submit its first Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in 2H27\", inclusive of registrational and juvenile DM data; may support Priority Review Voucher.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Cabaletta Bio","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":49,"symbol":"CBIO","drug":"CR-002","modality":"adc","area":"oncology","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261015_162610_(CBIO)_sec_0001628280-26-066006.txt","comments":"\"Initial data are expected in the second half of 2027\" from global Phase 1/2 APOLLO trial of CR-002 (PD-L1 topoisomerase inhibitor ADC), on track to start Q4 2026 after IND allowance.","closed":0,"created_at":"2026-10-25 10:12:43","updated_at":"2026-10-25 10:12:43","company":"Crescent Biopharma","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":125,"symbol":"CCCC","drug":"cemsidomide","modality":"small_molecule","area":"hematology","event_type":"interim_analysis","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260811_072911_(CCCC)_sec_0001628280-26-055494.txt","comments":"\"Enrollment for the Phase 2 MOMENTUM trial is expected to be complete in the first quarter of 2027 with initial investigator-assessed overall response rate data expected in the second half of 2027\" (cemsidomide + dexamethasone in RRMM). Company did not call it topline; initial investigator-assessed ORR data.","closed":0,"created_at":"2026-10-25 07:10:00","updated_at":"2026-10-25 07:10:00","company":"C4 Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":1256,"symbol":"CGTX","drug":"zervimesine","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261105_060000_(CGTX)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","comments":"Q3 2026 business update: \"Top-line results from START are anticipated in the second half of 2027\" (Phase 2 START in MCI/early Alzheimer's, with ACTC). Window covers H2 2027; no more precise date given.","closed":0,"created_at":"2026-11-05T07:29:36","updated_at":"2026-11-05T07:29:36","company":"Cognition Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":24,"symbol":"CLDX","drug":"barzolvolimab","modality":"monoclonal_antibody","area":"dermatology","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260922_070901_(CLDX)_sec_0001104659-26-109465-ex991.txt","comments":"\"BLA submission anticipated in 2027\" / \"plans to submit a Biologics License Application (BLA) to the FDA in 2027\".","closed":0,"created_at":"2026-10-25 09:53:51","updated_at":"2026-10-25 09:53:51","company":"Celldex Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":72,"symbol":"CLYM","drug":"budoprutug","modality":"monoclonal_antibody","area":"renal","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261024_193000_(CLYM)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"\"additional data from the PrisMN Phase 2 study anticipated in 2027\" (pMN; 600 mg/1000 mg cohorts). Enrollment ongoing in 1000 mg cohort.","closed":0,"created_at":"2026-10-25 06:34:44","updated_at":"2026-10-25 06:34:44","company":"Climb Bio","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":952,"symbol":"CORT","drug":"relacorilant","modality":"small_molecule","area":"oncology","event_type":"topline_results","expect_date_from":"2026-07-29","expect_date_to":"2027-12-31","news_source_file":"documents/20260729_160719_(CORT)_sec_0001628280-26-050607-ex991.txt","comments":"\"BELLA Part B ... Results expected by the end of next year\" (platinum-sensitive ovarian cancer post-PARP inhibitor). BELLA Part C, TRIDENT and the Phase 2 relacorilant+enzalutamide prostate cancer trial are also guided to results by the end of next year (8-K 2026-11-03: \"will generate important data in 2027\"). STELLA (cervical) newly initiated, no results guidance.","closed":0,"created_at":"2026-10-25T08:06:32","updated_at":"2026-11-04T09:32:36Z","company":"Corcept Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-07-29 → 2027-12-31","imminence":421,"state":"open","overdue":false},{"id":953,"symbol":"CORT","drug":"nenocorilant","modality":"small_molecule","area":"oncology","event_type":"topline_results","expect_date_from":"2026-07-29","expect_date_to":"2027-12-31","news_source_file":"documents/20260729_160719_(CORT)_sec_0001628280-26-050607-ex991.txt","comments":"\"Our study of nenocorilant with the PD-1 checkpoint inhibitor nivolumab ... will also produce results by the end of next year\" (SYNERGY Phase 1b, solid tumors).","closed":0,"created_at":"2026-10-25T08:06:32","updated_at":"2026-10-25T08:06:32","company":"Corcept Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-07-29 → 2027-12-31","imminence":421,"state":"open","overdue":false},{"id":902,"symbol":"DARE","drug":"DARE-HPV","modality":"small_molecule","area":"infectious","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260813_160219_(DARE)_sec_0001493152-26-037737-ex991.txt","comments":"Q2 2026 release: \"initiated a Phase 2 study expected to enroll approximately 100 women with persistent high-risk human papillomavirus (HPV) infection. Topline results are expected in 2027.\" Only year stated, so full-2027 window.","closed":0,"created_at":"2026-10-25 12:03:35","updated_at":"2026-10-25 12:03:35","company":"Dare Bioscience","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":892,"symbol":"DFTX","drug":"DT120 ODT","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260806_161059_(DFTX)_sec_0001193125-26-338006-ex991.txt","comments":"\"Topline data expected in 2027\" for Phase 3 Ascend study in MDD.","closed":0,"created_at":"2026-10-25 12:02:58","updated_at":"2026-10-25 12:02:58","company":"Definium Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":897,"symbol":"DMRA","drug":"DMR-003","modality":"bispecific","area":"hematology","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260810_160042_(DMRA)_sec_0001193125-26-342307.txt","comments":"\"we plan to make our first regulatory submissions for DMR-002 in the second half of 2026 and for DMR-003 in 2027\" (10-Q, filed 2026-08-10); in 2027 = 2027-01-01..2027-12-31.","closed":0,"created_at":"2026-10-25 12:03:02","updated_at":"2026-10-25 12:03:02","company":"Damora Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":885,"symbol":"DNLI","drug":"DNL952 (ETV:GAA)","modality":"protein","area":"rare_genetic","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260806_160319_(DNLI)_sec_0001714899-26-000096-ex991.txt","comments":"\"Dosing of participants with late-onset Pompe disease began in the Phase 1 study of DNL952 in the second quarter of 2026, and initial clinical data are expected in 2027.\" Year-only window.","closed":0,"created_at":"2026-10-25T08:05:00","updated_at":"2026-10-25T08:05:00","company":"Denali Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":887,"symbol":"DNLI","drug":"DNL921 (ATV:Abeta)","modality":"monoclonal_antibody","area":"cns","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260806_160319_(DNLI)_sec_0001714899-26-000096-ex991.txt","comments":"\"Safety and clinical proof-of-concept data from the ongoing Phase 1/1b study of DNL921 in healthy volunteers and participants with Alzheimer's disease are expected in 2027.\" Year-only window.","closed":0,"created_at":"2026-10-25T08:05:00","updated_at":"2026-10-25T08:05:00","company":"Denali Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":889,"symbol":"DNLI","drug":"zafinofusp alfa (DNL126)","modality":"protein","area":"rare_genetic","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261103_160310_(DNLI)_sec_0001714899-26-000107-ex991.txt","comments":"\"A Biologics License Application (BLA) submission in 2027 seeking accelerated approval is on track.\" (Q3 2026 release, Nov 3 2026; unchanged from prior guidance). Sanfilippo syndrome type A (MPS IIIA); global Phase 3 confirmatory study start-up underway.","closed":0,"created_at":"2026-10-25T08:05:00","updated_at":"2026-11-03T23:10:23Z","company":"Denali Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":990,"symbol":"DSGN","drug":"DT-818","modality":"small_molecule","area":"rare_genetic","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260803_080340_(DSGN)_sec_0001193125-26-329570-ex991.txt","comments":"\"Design anticipates reporting data from this trial in 2027\" (Phase 1 MAD trial of DT-818 in myotonic dystrophy type 1); reconfirmed 2026-11-04: \"Clinical readouts expected in 2027\". No narrower window given.","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-04T22:02:26Z","company":"Design Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":991,"symbol":"DSGN","drug":"DT-168","modality":"small_molecule","area":"ophthalmology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260803_080340_(DSGN)_sec_0001193125-26-329570-ex991.txt","comments":"\"Data is now expected in 2027 due to a delay in the anticipated supply of DT-168 blow-fill-seal eye droppers\" (Phase 2 biomarker trial in FECD); reconfirmed 2026-11-04: \"data expected in 2027\".","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-04T22:02:26Z","company":"Design Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":1188,"symbol":"DTIL","drug":"PBGENE-DMD","modality":"gene_therapy","area":"rare_genetic","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261103_080930_(DTIL)_sec_0001628280-26-069092.txt","comments":"\"Initial safety data are targeted for year-end 2026, with efficacy data at distinct timepoints expected to follow in the first and second half of 2027.\" FUNCTION-DMD Phase 1/2; no specific dates given, so window covers all of 2027.","closed":0,"created_at":"2026-11-04T04:31:16","updated_at":"2026-11-04T04:31:16","company":"Precision BioSciences","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":876,"symbol":"EDIT","drug":"EDIT-401","modality":"gene_therapy","area":"metabolic","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261008_070433_(EDIT)_sec_0001650664-26-000093.txt","comments":"Part 1 dose-finding topline: \"plans to complete enrollment in Part 1 ... with topline safety and efficacy data results available later in 2027.\" 10-Q: data on at least three patients \"by the end of the third quarter of 2027\". Exact timing not stated, so H2 2027.","closed":0,"created_at":"2026-10-25 08:01:28","updated_at":"2026-10-25 08:01:28","company":"Editas Medicine","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":874,"symbol":"EDSA","drug":"EB06","modality":"monoclonal_antibody","area":"dermatology","event_type":"topline_results","expect_date_from":"2027-10-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261015_091514_(EDSA)_sec_0001171843-26-006647.txt","comments":"Phase 2 double-blind placebo-controlled study of EB06 in up to 80 adults with moderate-to-severe nonsegmental vitiligo (primary endpoint F-VASI change at Week 28): \"The Company anticipates that topline data will be available fourth quarter 2027.\" Fourth quarter 2027 = 2027-10-01..2027-12-31.","closed":0,"created_at":"2026-10-25 12:01:50","updated_at":"2026-10-25 12:01:50","company":"Edesa Biotech","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-10-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":83,"symbol":"EIKN","drug":"EIK1005","modality":"small_molecule","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261023_091500_(EIKN)_globenewswire_biotech_globenewswire_biotech-sha256-dea126dcba62387f2a4.txt","comments":"\"complete results for EIK1005 monotherapy available in the second half of 2027\" (company release, 2026-10-23). Second half 2027 = 2027-07-01..2027-12-31.","closed":0,"created_at":"2026-10-25 10:37:29","updated_at":"2026-10-25 10:37:29","company":"Eikon Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":84,"symbol":"EIKN","drug":"EIK1004","modality":"small_molecule","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261023_091500_(EIKN)_globenewswire_biotech_globenewswire_biotech-sha256-dea126dcba62387f2a4.txt","comments":"\"Eikon plans to initiate a combination arm of EIK1004-001 evaluating EIK1004 in combination with docetaxel, with plans to report initial results from that combination arm in the second half of 2027.\" Second half 2027 = 2027-07-01..2027-12-31.","closed":0,"created_at":"2026-10-25 10:37:29","updated_at":"2026-10-25 10:37:29","company":"Eikon Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":85,"symbol":"EIKN","drug":"EIK1003","modality":"small_molecule","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261023_091500_(EIKN)_globenewswire_biotech_globenewswire_biotech-sha256-dea126dcba62387f2a4.txt","comments":"\"Eikon is currently enrolling an additional Cohort 1D evaluating EIK1003 in combination with paclitaxel and platinum-based chemotherapy, for which initial results are expected in the second half of 2027.\" Second half 2027 = 2027-07-01..2027-12-31.","closed":0,"created_at":"2026-10-25 10:37:29","updated_at":"2026-10-25 10:37:29","company":"Eikon Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":1045,"symbol":"EIKN","drug":"EIK1001","modality":"small_molecule","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261026_060036_(EIKN)_sec_0001193125-26-430860.txt","comments":"TeLuRide-008 (Phase 2/3 NSCLC): \"Eikon expects to conduct a first interim analysis to select the single dose of EIK1001 to take forward for the remainder of this trial in the second half of 2027.\" 2H 2027 = 2027-07-01..2027-12-31.","closed":0,"created_at":"2026-10-26 12:38:09","updated_at":"2026-10-26 12:38:09","company":"Eikon Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":871,"symbol":"ELOX","drug":"exaluren","modality":"small_molecule","area":"rare_genetic","event_type":"topline_results","expect_date_from":"2026-08-11","expect_date_to":"2027-12-31","news_source_file":"documents/20260811_171943_(ELOX)_sec_0001193125-26-345032-ex991.txt","comments":"\"with the final readout by the end of 2027\" — final readout of the Phase 2b Alport syndrome study, separate from the initial 16-week topline. \"By the end of 2027\" window starts at the Aug 11, 2026 document date.","closed":0,"created_at":"2026-10-25T08:01:06","updated_at":"2026-10-25T08:01:06","company":"Eloxx Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-08-11 → 2027-12-31","imminence":421,"state":"open","overdue":false},{"id":866,"symbol":"ENGN","drug":"detalimogene","modality":"gene_therapy","area":"oncology","event_type":"other","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260908_073318_(ENGN)_sec_0001193125-26-384380-ex991.txt","comments":"\"Potential FDA approval decision for detalimogene and platform designation in 2027.\" Company-guided expectation; contingent on 4Q 2026 BLA submission, no specific date stated.","closed":0,"created_at":"2026-10-25 12:01:03","updated_at":"2026-10-25 12:01:03","company":"enGene Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":860,"symbol":"ENTA","drug":"zelicapavir","modality":"small_molecule","area":"infectious","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260810_160518_(ENTA)_sec_0001193125-26-342336-ex991.txt","comments":"LOTUS Phase 2b in pediatric RSV: \"Dosing began in LOTUS ... with topline data expected in 2027.\" Document states only the year, so full-year window.","closed":0,"created_at":"2026-10-25 12:01:02","updated_at":"2026-10-25 12:01:02","company":"Enanta Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":861,"symbol":"ENTA","drug":"zelicapavir (RESOLVE)","modality":"small_molecule","area":"infectious","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261026_070000_(ENTA)_yahoo_news_yahoo-38b67e7bfce92b97893183791eac4eea-ENTA.txt","comments":"RESOLVE Phase 2b/3 (adults at high risk of severe RSV): \"Topline data from the Phase 2b portion of the study are expected in 2027\" (release 2026-10-26 announcing first patient dosed). Year-only guidance, full-year window. Drug label includes trial name to distinguish from LOTUS event.","closed":0,"created_at":"2026-10-25 12:01:02","updated_at":"2026-10-26T16:51:54Z","company":"Enanta Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":854,"symbol":"EOLS","drug":"Evolysse Lips","modality":"other","area":"dermatology","event_type":"pdufa","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260805_165642_(EOLS)_sec_0001628280-26-053468.txt","comments":"10-Q: two additional Evolysse products \"to be approved in the United States in the fourth quarter of 2026 and 2027, respectively\" (Lips = 2027). No specific date stated; approval dependent on Symatese FDA submissions.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Evolus","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":849,"symbol":"ETON","drug":"ASN-001","modality":"small_molecule","area":"dermatology","event_type":"regulatory_submission","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260805_070010_(ETON)_sec_0001437749-26-025781-ex991.txt","comments":"\"Anticipate NDA submission in 2H 2027\"; \"intends to submit the New Drug Application (NDA) upon completion of the study in the second half of 2027.\"","closed":0,"created_at":"2026-10-25 11:59:59","updated_at":"2026-10-25 11:59:59","company":"Eton Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":845,"symbol":"EVMN","drug":"EVO756","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260730_080101_(EVMN)_sec_0001193125-26-324972-ex991.txt","comments":"Phase 2b migraine prophylaxis trial: \"Top-line data expected in 2027\" (reiterated in Sept 2026 presentation: \"Expect top-line data from Phase 2b migraine trial in 2027\").","closed":0,"created_at":"2026-10-25T07:59:11","updated_at":"2026-10-25T07:59:11","company":"Evommune","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":981,"symbol":"EYPT","drug":"DURAVYU","modality":"small_molecule","area":"ophthalmology","event_type":"topline_results","expect_date_from":"2027-10-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261019_070519_(EYPT)_sec_0001193125-26-424644-ex991.txt","comments":"\"DME program remains on track with pivotal Phase 3 topline data from two identical clinical trials anticipated in Q4 2027\" (Oct 19, 2026 LUCIA results release); refers to COMO and CAPRI.","closed":0,"created_at":"2026-10-25T08:08:58","updated_at":"2026-10-25T08:08:58","company":"EyePoint","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-10-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":839,"symbol":"FDMT","drug":"4D-150","modality":"gene_therapy","area":"ophthalmology","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260813_160644_(FDMT)_sec_0001193125-26-349160-ex991.txt","comments":"\"4FRONT-2 ... topline data expected in H2 2027\" (Q2 2026 earnings release). Enrollment completed June 2026.","closed":0,"created_at":"2026-10-25 11:59:01","updated_at":"2026-10-25 11:59:01","company":"4D Molecular Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":834,"symbol":"FHTX","drug":"EP300 degrader","modality":"small_molecule","area":"hematology","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260806_070144_(FHTX)_sec_0001628280-26-053817-ex991.txt","comments":"\"IND targeted in 2027, with a focus in MM and DLBCL.\" Selective EP300 degrader; 2027 window per \"in 2027\" rule.","closed":0,"created_at":"2026-10-25 11:58:33","updated_at":"2026-10-25 11:58:33","company":"Foghorn Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":835,"symbol":"FHTX","drug":null,"modality":"small_molecule","area":"immunology","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260806_070144_(FHTX)_sec_0001628280-26-053817-ex991.txt","comments":"\"We are targeting an IND in 2027 for this asset\" — novel oral small molecule in immunology and inflammation; program undisclosed, so drug left NULL.","closed":0,"created_at":"2026-10-25 11:58:36","updated_at":"2026-10-25 11:58:36","company":"Foghorn Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":978,"symbol":"FTH","drug":"PIKTOR","modality":"small_molecule","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260804_074027_(FTH)_sec_0001193125-26-331563-ex991.txt","comments":"\"We look forward to reporting initial safety and efficacy data from PIK-101 in 2027\"; first patient dosed April 2026 in Phase 1b/2 HR+/HER2- breast cancer.","closed":0,"created_at":"2026-10-25 12:09:09","updated_at":"2026-10-25 12:09:09","company":"Faeth Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":1086,"symbol":"GLUE","drug":"CCNE1-directed MGD","modality":"small_molecule","area":"oncology","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260806_070402_(GLUE)_sec_0001193125-26-336681-ex991.txt","comments":"Q2 2026 release: \"Monte Rosa expects to submit an IND application for its cyclin E1 (CCNE1)-directed molecular glue degrader program in 2027.\" Year-only guidance -> full-year 2027 window.","closed":0,"created_at":"2026-10-28 20:39:54","updated_at":"2026-10-28 20:39:54","company":"Monte Rosa Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":825,"symbol":"GLUE","drug":"MRT-8102","modality":"small_molecule","area":"immunology","event_type":"interim_analysis","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261001_073804_(GLUE)_sec_0001193125-26-409833-ex991.txt","comments":"GEMINI-1 Phase 2 in gout: \"expected to initiate in Q4 2026 or Q1 2027 ... Initial data are expected in H2 2027.\" Window H2 2027.","closed":0,"created_at":"2026-10-25T07:57:04","updated_at":"2026-10-25T07:57:04","company":"Monte Rosa Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":806,"symbol":"HRMY","drug":"pitolisant HD","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260804_080512_(HRMY)_sec_0001104659-26-090086-ex991.txt","comments":"\"Phase 3 registrational clinical trials ongoing in narcolepsy (ONSTRIDE 1) and idiopathic hypersomnia (IH) (ONSTRIDE 2) ... Topline data expected in 2027\". Year-only window.","closed":0,"created_at":"2026-10-25 11:55:47","updated_at":"2026-10-25 11:55:47","company":"Harmony Biosciences Holdings","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":796,"symbol":"HURA","drug":"IFx-2.0","modality":"small_molecule","area":"oncology","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260814_080041_(HURA)_sec_0001193125-26-350451.txt","comments":"10-Q: \"We anticipate topline results from the Phase 3 accelerated approval trial of IFx-2.0 in the second half of 2027.\" Phase 3 in first-line Merkel cell carcinoma with Keytruda.","closed":0,"created_at":"2026-10-25 11:55:19","updated_at":"2026-10-25 11:55:19","company":"TuHURA Biosciences","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":789,"symbol":"IDYA","drug":"IDE034","modality":"adc","area":"oncology","event_type":"data_presentation","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261103_080427_(IDYA)_sec_0001193125-26-444225-ex991.txt","comments":"\"IDEAYA plans to provide initial clinical data from its ongoing Phase 1 dose escalation trial in 2027, which is expected to include preliminary safety and efficacy data\"; 10-Q: \"targeting to provide a clinical data update in 2027\" (prior guidance: by end of 2026 or early 2027).","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-04T09:31:18Z","company":"IDEAYA Biosciences","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":1186,"symbol":"IFRX","drug":"izicopan","modality":"small_molecule","area":"renal","event_type":"interim_analysis","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261103_163400_(IFRX)_sec_0001140361-26-041828.txt","comments":"\"Initial data from an investigator-initiated open-label pilot study in atypical hemolytic uremic syndrome (aHUS) anticipated in the second half of 2027\"; \"expected to provide initial select patient data in 2H 2027\".","closed":0,"created_at":"2026-11-04 05:25:49","updated_at":"2026-11-04 05:25:49","company":"InflaRx","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":778,"symbol":"IMA","drug":"olevaprubart","modality":"monoclonal_antibody","area":"dermatology","event_type":"topline_results","expect_date_from":"2027-10-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260805_080510_(IMA)_sec_0001193125-26-333912-ex991.txt","comments":"\"Topline data from the study is anticipated in the fourth quarter of 2027\" (Phase 2b ADAPTIVE trial in moderate-to-severe atopic dermatitis, under amended protocol). 10-Q (same day) repeats \"expected in the fourth quarter of 2027\".","closed":0,"created_at":"2026-10-25 07:53:54","updated_at":"2026-10-25 07:53:54","company":"ImageneBio","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-10-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":771,"symbol":"IMRX","drug":"atebimetinib (IMM-1-104)","modality":"small_molecule","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-11-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261029_160500_(IMRX)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"Q3 2026 release (Oct 29, 2026): \"4Q 2026: Dose the first patient in Phase 2 trial of atebimetinib + anti-PD-1 (cemiplimab) in lung cancer, with a preliminary data readout expected in late-2027\" and \"Late-2027: Preliminary data readout expected from Phase 2 trial of atebimetinib + anti-PD-1 (cemiplimab) in lung cancer.\" Window = late 2027 (Nov-Dec); preliminary readout, not topline.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-29T21:27:55Z","company":"Immuneering","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-11-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":69,"symbol":"IMTX","drug":"IMA402 + IMA401","modality":"bispecific","area":"oncology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261024_023000_(IMTX)_globenewswire_biotech_globenewswire_biotech-sha256-883a738886957778db7.txt","comments":"\"IMA402 in combination with the Company's MAGEA4/8-directed bispecific, IMA401, in lung cancer with first data expected in 2027\" - only the year is stated, so full-year window.","closed":0,"created_at":"2026-10-25 10:34:46","updated_at":"2026-10-25 10:34:46","company":"Immatics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":1049,"symbol":"IMTX","drug":"anzu-cel (IMA203)","modality":"cell_therapy","area":"oncology","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260818_070414_(IMTX)_sec_0001193125-26-354715-ex991.txt","comments":"\"topline data from the final PFS analysis in the first half of 2027, followed by a BLA submission in 2027\" - only the year 2027 is stated for the BLA submission, so full-year window.","closed":0,"created_at":"2026-10-26 08:41:00","updated_at":"2026-10-26 08:41:00","company":"Immatics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":769,"symbol":"IMVT","drug":"IMVT-1402","modality":"monoclonal_antibody","area":"immunology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260806_071524_(IMVT)_sec_0001764013-26-000100-ex991.txt","comments":"Graves disease (NCT06727604, NCT07018323) and myasthenia gravis (NCT07039916) potentially registrational trials: \"In calendar year 2027, topline data are anticipated for the potentially registrational trials evaluating IMVT-1402 in GD and MG.\" Rows combined because both share the identical guided window.","closed":0,"created_at":"2026-10-25 11:53:39","updated_at":"2026-10-25 11:53:39","company":"Immunovant","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":907,"symbol":"IONS","drug":"obudanersen","modality":"aso","area":"cns","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260729_073102_(IONS)_sec_0001140361-26-029960-ex991.txt","comments":"\"Obudanersen ... completed enrollment in the Phase 3 REVEAL study, with data anticipated in the second half of 2027\". Enrollment completion itself is not a catalyst; readout window only.","closed":0,"created_at":"2026-10-25T08:07:00","updated_at":"2026-10-25T08:07:00","company":"Ionis Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":1106,"symbol":"IOVA","drug":"lifileucel","modality":"cell_therapy","area":"oncology","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261029_170028_(IOVA)_sec_0001104659-26-120261.txt","comments":"\"an sBLA for lifileucel in non-squamous mNSCLC is planned for 2027\"; Cohorts 1 and 2 completing enrollment (~80 patients expected in final dataset), FDA discussions ongoing. Caveat: date stated only as 2027, no narrower window.","closed":0,"created_at":"2026-10-29 21:28:32","updated_at":"2026-10-29 21:28:32","company":"Iovance Biotherapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":753,"symbol":"IPSC","drug":"CNTY-813","modality":"cell_therapy","area":"metabolic","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261002_081825_(IPSC)_sec_0001104659-26-113055-ex991.txt","comments":"\"Initial safety and early efficacy data from the first-in-human CNTY-813 study are anticipated in the second half of 2027\" (reaffirmed 2026-10-02). Contingent on IND submission in 4Q 2026.","closed":0,"created_at":"2026-10-25 11:52:23","updated_at":"2026-10-26T14:42:03Z","company":"Century Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":29,"symbol":"IRD","drug":"OPGx-LCA5","modality":"gene_therapy","area":"rare_genetic","event_type":"topline_results","expect_date_from":"2026-08-03","expect_date_to":"2027-12-31","news_source_file":"documents/20260803_070000_(IRD)_yahoo_news_yahoo-ab8e01c70903f6669b847a6ca61359f9-IRD.txt","comments":"\"the Company expects to initiate dosing of OPGx-LCA5 in the fourth quarter of 2026, with topline data expected by the end of 2027.\" Registrational Phase 3 fully enrolled (8 pts, 6-month run-in); \"by the end of 2027\" = 2026-08-03..2027-12-31.","closed":0,"created_at":"2026-10-25 09:53:54","updated_at":"2026-10-25 09:53:54","company":"Opus Genetics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-08-03 → 2027-12-31","imminence":421,"state":"open","overdue":false},{"id":748,"symbol":"IRON","drug":"selcodebart (DISC-0974)","modality":"monoclonal_antibody","area":"gi_hepatology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260730_083249_(IRON)_sec_0001193125-26-325031-ex991.txt","comments":"RALLY-IBD Phase 2 in inflammatory bowel disease: \"initial data expected in 2027\".","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Disc Medicine","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":721,"symbol":"JBIO","drug":"JADE101","modality":"monoclonal_antibody","area":"renal","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260810_071338_(JBIO)_sec_0001193125-26-341229-ex991.txt","comments":"\"Announced dosing began in JUNIPER, a Phase 2 trial of JADE101 in IgAN... Interim data are expected in 2027.\" Window per \"expected in 2027\".","closed":0,"created_at":"2026-10-25 11:50:42","updated_at":"2026-10-25 11:50:42","company":"Jade Biosciences","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":722,"symbol":"JBIO","drug":"JADE201","modality":"monoclonal_antibody","area":"immunology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260810_071338_(JBIO)_sec_0001193125-26-341229-ex991.txt","comments":"\"interim, biomarker-rich data expected in 2027\" from the Phase 1 trial of JADE201 in rheumatoid arthritis. Window per \"expected in 2027\"; no narrower date given.","closed":0,"created_at":"2026-10-25 11:50:42","updated_at":"2026-10-25 11:50:42","company":"Jade Biosciences","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":723,"symbol":"JBIO","drug":"JADE301","modality":"monoclonal_antibody","area":"dermatology","event_type":"interim_analysis","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260930_071331_(JBIO)_sec_0001193125-26-408287.txt","comments":"\"interim data anticipated in the second half of 2027\" from the Phase 1 SAD trial of subcutaneous JADE301 in 24 healthy volunteers (trial start Q4 2026). Second half of 2027 per company guidance.","closed":0,"created_at":"2026-10-25 11:50:42","updated_at":"2026-10-25 11:50:42","company":"Jade Biosciences","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":716,"symbol":"KLRA","drug":"KAI-4729","modality":"peptide","area":"metabolic","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261104_160828_(KLRA)_sec_0001193125-26-447232-ex991.txt","comments":"\"IND now active with U.S. FDA; on track to initiate Phase 1 single-dose injection site/ethnic bridging trial by the end of 2026, with data anticipated in 2027.\" Window = full 2027.","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-05T12:28:53Z","company":"Kailera Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":1067,"symbol":"KNSA","drug":"KPL-387","modality":"monoclonal_antibody","area":"cardiovascular","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261027_073000_(KNSA)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","comments":"Q3 2026 release: \"Kiniksa is enrolling and dosing patients in the Phase 3 pivotal trial of KPL-387 in recurrent pericarditis, PASTORALE, and expects data in the second half of 2027.\" Window = 2H 2027 (Q3/Q4). Trial is event-driven.","closed":0,"created_at":"2026-10-27T09:31:03","updated_at":"2026-10-27T09:31:03","company":"Kiniksa Pharmaceuticals International","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":698,"symbol":"KRRO","drug":"KRRO-121","modality":"aso","area":"metabolic","event_type":"interim_analysis","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261005_161013_(KRRO)_sec_0001193125-26-414118-ex991.txt","comments":"\"Dosing of UCD patients is expected to start in the first half of 2027, with an interim clinical readout expected in the second half of 2027\" (ANCHOR Part 2, UCD patients).","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Korro Bio","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":695,"symbol":"KRYS","drug":"KB408","modality":"gene_therapy","area":"respiratory","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260803_070402_(KRYS)_sec_0001711279-26-000058-ex991.txt","comments":"\"expects to report interim study results in 2027\" (SERPENTINE-1 repeat dose Cohort 2B, AATD lung disease, NCT06049082); 10-Q says interim safety and delivery data from Cohort 2B in 2027","closed":0,"created_at":"2026-10-25 11:49:26","updated_at":"2026-10-25 11:49:26","company":"Krystal Biotech","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":1149,"symbol":"KRYS","drug":"KB801","modality":"gene_therapy","area":"ophthalmology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261102_070000_(KRYS)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"\"The Company now expects to complete enrollment of approximately 60 patients in EMERALD-1 and report top-line results in 2027\" (registrational, placebo-controlled, neurotrophic keratitis, NCT06999733); enrollment slower than anticipated.","closed":0,"created_at":"2026-11-02T12:55:52","updated_at":"2026-11-02T12:55:52","company":"Krystal Biotech","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":691,"symbol":"KURA","drug":"darlifarnib","modality":"small_molecule","area":"oncology","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260812_161019_(KURA)_sec_0001193125-26-346856-ex991.txt","comments":"\"Complete enrollment in the randomized FIT-001 Phase 1b study evaluating darlifarnib plus cabozantinib in cabozantinib-naive ccRCC in 1H 2027 and report initial clinical data in 2H 2027\". Event covers the initial data; enrollment completion not tracked.","closed":0,"created_at":"2026-10-25 11:49:22","updated_at":"2026-10-25 11:49:22","company":"Kura Oncology","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":1118,"symbol":"LGND","drug":"lasofoxifene","modality":"small_molecule","area":"oncology","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261029_071444_(LGND)_sec_0000886163-26-000058.txt","comments":"Q3 2026 release: LeonaBio \"is on track to complete enrollment of approximately 600 patients in the Phase 3 Elaine-3 clinical trial evaluating lasofoxifene in ER+/HER2-negative, ESR1-mutated metastatic breast cancer in the fourth quarter of 2026 with topline data expected in the second half of 2027.\" Second half of 2027 = 2027-07-01..2027-12-31.","closed":0,"created_at":"2026-10-30 13:57:02","updated_at":"2026-10-30 13:57:02","company":"Ligand Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":1119,"symbol":"LGND","drug":"Qtorin rapamycin","modality":"small_molecule","area":"rare_genetic","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260806_070502_(LGND)_sec_0000886163-26-000041-ex991.txt","comments":"Q2 2026 release (2026-08-06): Palvella dosed first patients in LOTU Phase 2 in clinically significant angiokeratomas and \"Topline results from the Phase 2 trial are expected in the second half of 2027\" = 2027-07-01..2027-12-31.","closed":0,"created_at":"2026-10-30 13:57:02","updated_at":"2026-10-30 13:57:02","company":"Ligand Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":670,"symbol":"LONA","drug":"lasofoxifene","modality":"small_molecule","area":"oncology","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260814_160725_(LONA)_sec_0001193125-26-352208-ex991.txt","comments":"\"remain on track to complete enrollment of ELAINE-3 in the fourth quarter of 2026 with topline data expected in the second half of 2027\" (Q2 2026 release, Aug 14 2026). Phase 3 ELAINE-3 (NCT05696626): lasofoxifene + abemaciclib in ER+/HER2- ESR1-mutated mBC; primary endpoint PFS by BICR. Window = second half of 2027 per guidance.","closed":0,"created_at":"2026-10-25T07:46:52","updated_at":"2026-10-25T07:46:52","company":"LeonaBio","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":665,"symbol":"LSTA","drug":"MAR001","modality":"monoclonal_antibody","area":"metabolic","event_type":"topline_results","expect_date_from":"2027-10-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260917_092726_(LSTA)_sec_0001140361-26-036866-ex991.txt","comments":"\"Both studies are expected to report topline data in the fourth quarter of 2027\" (ongoing Phase 2b in sHTG; MAR001/005). CEO quote refers to \"next year\"; Q4 2027 is the precise stated timing.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Lisata Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-10-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":666,"symbol":"LSTA","drug":"MAR002","modality":"monoclonal_antibody","area":"rare_genetic","event_type":"topline_results","expect_date_from":"2027-10-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260917_092726_(LSTA)_sec_0001140361-26-036866-ex991.txt","comments":"\"Both studies are expected to report topline data in the fourth quarter of 2027\"; MAR002 described as \"Phase 2 proof of concept data in patients with acromegaly next year\". Timing stated as Q4 2027; caveat: described elsewhere as \"next year\".","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Lisata Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-10-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":667,"symbol":"LTGO","drug":"onzotrigine","modality":"small_molecule","area":"pain_anesthesia","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260903_161539_(LTGO)_sec_0001193125-26-381912-ex991.txt","comments":"\"Expect to report topline results from the Phase 3 bunionectomy and open-label safety clinical trials in the second half of 2027.\" 10-Q: placebo-controlled Phase 3 bunionectomy trial and open-label Phase 3 safety trial to initiate 2H 2026, topline expected 2H 2027. Reconfirmed 11/5/2026 Q3 release: \"topline results expected in the second half of 2027\"; bunionectomy Phase 3 now to add oxycodone/acetaminophen comparator arm and enroll ~480 patients.","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-05T12:30:50Z","company":"Latigo Biotherapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":668,"symbol":"LTGO","drug":"LTG-321","modality":"small_molecule","area":"pain_anesthesia","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260903_161539_(LTGO)_sec_0001193125-26-381912-ex991.txt","comments":"Phase 2 randomized, double-blind, placebo-controlled crossover trial in ~120 knee OA patients: \"Expect to report topline results from the Phase 2 clinical trial in the second half of 2027.\" Enrollment underway at sites in Denmark. Reconfirmed 11/5/2026 Q3 release: \"topline results expected in the second half of 2027\"; bunionectomy Phase 3 now to add oxycodone/acetaminophen comparator arm and enroll ~480 patients.","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-05T12:30:50Z","company":"Latigo Biotherapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":662,"symbol":"LXEO","drug":"LX2006","modality":"gene_therapy","area":"rare_genetic","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260812_070257_(LXEO)_sec_0001193125-26-345722-ex991.txt","comments":"\"Topline data readout expected in second half of 2027\" for SUNRISE-FA 2 pivotal trial in FA cardiomyopathy; reaffirmed 2026-09-22 as on track for 2H 2027.","closed":0,"created_at":"2026-10-25 11:46:39","updated_at":"2026-10-25 11:46:39","company":"Lexeo Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":660,"symbol":"LYEL","drug":"LYL273","modality":"cell_therapy","area":"oncology","event_type":"data_presentation","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260910_161352_(LYEL)_sec_0001193125-26-387890-ex991.txt","comments":"8-K Ex-99.1 (Sept 10, 2026): \"Additional clinical data from the Phase 1/2 trial of LYL273 ... now expected in 2027.\" Supersedes the prior \"second half of 2026\" guidance in the Aug 6, 2026 10-Q.","closed":0,"created_at":"2026-10-25 07:46:06","updated_at":"2026-10-25 07:46:06","company":"Lyell Immunopharma","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":661,"symbol":"LYEL","drug":"LYL273","modality":"cell_therapy","area":"oncology","event_type":"other","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260910_161352_(LYEL)_sec_0001193125-26-387890-ex991.txt","comments":"8-K Ex-99.1: \"End-of-Phase 1 meeting with FDA expected in 2027\"; regulatory meeting to align on pivotal Phase 2 path. Previously guided to 2H 2026.","closed":0,"created_at":"2026-10-25 07:46:06","updated_at":"2026-10-25 07:46:06","company":"Lyell Immunopharma","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":659,"symbol":"LYEL","drug":"ronde-cel","modality":"cell_therapy","area":"hematology","event_type":"regulatory_submission","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260806_162705_(LYEL)_sec_0001628280-26-054367.txt","comments":"10-Q: \"with a BLA submission expected to follow in the second half of 2027\" for ronde-cel in R/R LBCL.","closed":0,"created_at":"2026-10-25 07:46:06","updated_at":"2026-10-25 07:46:06","company":"Lyell Immunopharma","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":655,"symbol":"MAZE","drug":"MZE782","modality":"small_molecule","area":"metabolic","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260811_164516_(MAZE)_sec_0001193125-26-344878-ex991.txt","comments":"\"Phase 2 CIPheR trial of MZE782 in PKU initiated and enrollment ongoing; topline data expected in 2027\". Date not further specified.","closed":0,"created_at":"2026-10-25 11:46:12","updated_at":"2026-10-25 11:46:12","company":"Maze Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":653,"symbol":"MDGL","drug":"resmetirom","modality":"small_molecule","area":"gi_hepatology","event_type":"topline_results","expect_date_from":"2027-11-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261103_070000_(MDGL)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","comments":"Q3 2026 release (11/3/26): \"MAESTRO NASH OUTCOMES on track, data expected late 2027\"; forward-looking statements cite \"expected receipt of data from the MAESTRO-NASH OUTCOMES trial in late 2027.\" Narrows prior \"in 2027\" guidance. F4c compensated cirrhosis, event-driven outcomes trial.","closed":0,"created_at":"2026-10-25 11:45:53","updated_at":"2026-11-03T12:33:59Z","company":"Madrigal Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-11-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":640,"symbol":"MIRM","drug":"MRM-3379","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260805_160656_(MIRM)_sec_0001759425-26-000045.txt","comments":"10-Q: BLOOM Phase 2 study in Fragile-X Syndrome, \"expect topline data in 2027.\"","closed":0,"created_at":"2026-10-25 11:45:03","updated_at":"2026-10-25 11:45:03","company":"Mirum Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":636,"symbol":"MIRM","drug":"brelovitug","modality":"monoclonal_antibody","area":"infectious","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260928_080247_(MIRM)_sec_0001759425-26-000049.txt","comments":"8-K: \"Topline results from the Phase 3 AZURE-2 and AZURE-3 studies are expected in the second half of 2027.\" Two separate studies; one row for the guided window.","closed":0,"created_at":"2026-10-25 11:45:03","updated_at":"2026-10-25 11:45:03","company":"Mirum Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":1211,"symbol":"MLTX","drug":"sonelokimab","modality":"bispecific","area":"dermatology","event_type":"data_presentation","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261104_070000_(MLTX)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"Nov 4, 2026 release milestones: \"Expected to present year 1 VELA OLE data in H2 2027\" (open-label extension of the Phase 3 VELA-1/VELA-2 HS trials).","closed":0,"created_at":"2026-11-04T10:46:00","updated_at":"2026-11-04T10:46:00","company":"MoonLake Immunotherapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":1210,"symbol":"MLTX","drug":"sonelokimab","modality":"bispecific","area":"immunology","event_type":"topline_results","expect_date_from":"2027-10-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261104_070000_(MLTX)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"Nov 4, 2026 release milestones: IZAR-2 \"Week 52 topline results in Q4 2027\" (Phase 3 PsA, TNF-IR population).","closed":0,"created_at":"2026-11-04T10:46:00","updated_at":"2026-11-04T10:46:00","company":"MoonLake Immunotherapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-10-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":618,"symbol":"MPLT","drug":"ML-007C-MA","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260813_165137_(MPLT)_sec_0001193125-26-349490-ex991.txt","comments":"\"Topline results from VISTA are expected in the second half of 2027\" (Phase 2 VISTA in Alzheimer's disease psychosis; enrollment ongoing). Also stated in 10-Q filed 2026-08-13.","closed":0,"created_at":"2026-10-25 11:44:04","updated_at":"2026-10-25 11:44:04","company":"MapLight Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":612,"symbol":"NERV","drug":"roluperidone","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260807_071334_(NERV)_sec_0001193125-26-339147-ex991.txt","comments":"Q2 2026 release: \"Topline data from Phase A of the trial is expected in the second half of 2027.\" Phase A = 12-week roluperidone 64 mg vs placebo (N=380 C19 study); primary endpoint Marder NSFS at week 12.","closed":0,"created_at":"2026-10-25 11:42:39","updated_at":"2026-10-25 11:42:39","company":"Minerva Neurosciences","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":611,"symbol":"NGNE","drug":"NGN-401","modality":"gene_therapy","area":"cns","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260811_165743_(NGNE)_sec_0001404644-26-000059.txt","comments":"\"We expect to report top-line data in the second half of 2027\" from the Embolden registrational trial (1E15 vg dose, females with Rett syndrome); primary analysis after first 24 participants complete 12 months follow-up; no interim data updates planned.","closed":0,"created_at":"2026-10-25 11:42:31","updated_at":"2026-10-25 11:42:31","company":"Neurogene","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":579,"symbol":"OBX","drug":"OBX-115","modality":"cell_therapy","area":"oncology","event_type":"topline_results","expect_date_from":"2026-08-03","expect_date_to":"2027-12-31","news_source_file":"documents/20260803_170810_(OBX)_sec_0001193125-26-330810-ex991.txt","comments":"\"topline data from the melanoma registration-enabling trial, which are expected by year-end 2027\"; window starts at release date 2026-08-03 per \"by year-end 2027\".","closed":0,"created_at":"2026-10-25 11:40:03","updated_at":"2026-10-25 11:40:03","company":"Obsidian Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-08-03 → 2027-12-31","imminence":421,"state":"open","overdue":false},{"id":738,"symbol":"ODTX","drug":"OD-001","modality":"small_molecule","area":"gi_hepatology","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261020_070021_(ODTX)_sec_0001193125-26-425684-ex991.txt","comments":"OD-001 topline induction results from two guided trials: randomized placebo-controlled Phase 2b monotherapy and randomized active-controlled Phase 2a combination (OD-001+vedolizumab vs vedolizumab+placebo). \"Both studies will be double-blind, with topline induction results expected in the second half of 2027.\" = 2027-07-01..2027-12-31.","closed":0,"created_at":"2026-10-25 08:00:01","updated_at":"2026-10-25T11:51:41Z","company":"Odyssey Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":1197,"symbol":"ODTX","drug":"OD-002","modality":"small_molecule","area":"immunology","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261104_070014_(ODTX)_sec_0001193125-26-446174.txt","comments":"Q3 2026 update: OD-002 Phase 1/2a starts H1 2027 in healthy participants; \"The Company expects to report healthy participant data in the second half of 2027, including results from an ex vivo stimulation assay.\" H2 2027 = 2027-07-01..2027-12-31. Patient-cohort efficacy readouts remain guided for H2 2028.","closed":0,"created_at":"2026-11-04T08:38:33","updated_at":"2026-11-04T08:38:33","company":"Odyssey Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":574,"symbol":"OGN","drug":"Nexplanon","modality":"other","area":"womens_health","event_type":"other","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261030_080342_(OGN)_sec_0001821825-26-000004.txt","comments":"Nexplanon EU application for five-year duration of use: \"The EU application is currently under review, with potential approval in 2027, subject to health authority review and approval\" (Q3 2026 10-Q, MD&A Contraception). UK application approved April 2026; US five-year label already approved. Broad 2027 window per \"in 2027\". Window unchanged from prior 10-Q.","closed":0,"created_at":"2026-10-25 11:39:30","updated_at":"2026-10-31T16:46:08Z","company":"Organon &","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":566,"symbol":"OLMA","drug":"palazestrant","modality":"small_molecule","area":"oncology","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260810_161039_(OLMA)_sec_0001193125-26-342383.txt","comments":"10-Q: \"anticipate top-line results for this trial in the first quarter of 2027, expect to submit the new drug application (NDA) in 2027\". NDA for palazestrant in ER+/HER2- MBC.","closed":0,"created_at":"2026-10-25 11:39:03","updated_at":"2026-10-25 11:39:03","company":"Olema Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":1053,"symbol":"ORKA","drug":"ORKA-001","modality":"monoclonal_antibody","area":"dermatology","event_type":"interim_analysis","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261026_070000_(ORKA)_globenewswire_biotech_globenewswire_biotech-sha256-6173724fa9cbdaf4e85.txt","comments":"\"Oruka expects to share 52-week results from EVERLAST-A in December 2026, as well as 52-week results from EVERLAST-B in the second half of 2027.\" Second half of 2027 = 2027-07-01..2027-12-31.","closed":0,"created_at":"2026-10-26 14:44:07","updated_at":"2026-10-26 14:44:07","company":"Oruka Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":547,"symbol":"PALI","drug":"PALI-2108","modality":"small_molecule","area":"gi_hepatology","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260923_084500_(PALI)_yahoo_news_yahoo-2202c037c8d6e608c62fa27eb0ada757-PALI.txt","comments":"2026-09-23 Health Canada CTA clearance release: \"Primary efficacy results from approximately 204 patients with moderately to severely active ulcerative colitis expected in the second half of 2027\" (2H 2027 = 2027-07-01..2027-12-31) for Phase 2b ASCENTRA-UC; unchanged from Q2-2026/10-Q guidance.","closed":0,"created_at":"2026-10-25 11:37:36","updated_at":"2026-10-25T15:58:54Z","company":"Palisade Bio","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":542,"symbol":"PBM","drug":"NPX-5","modality":"other","area":"cns","event_type":"other","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260806_160143_(PBM)_sec_0001213900-26-086123-ex991.txt","comments":"Investor presentation (Aug 2026) development timeline lists \"End of Phase II/Type C Meeting with FDA\" in H2 2027 for the NPX-5 Adjustment Disorder program. Company-guided regulatory meeting; no exact date given.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Psyence Biomedical","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":534,"symbol":"PCVX","drug":"VAX-A1","modality":"vaccine","area":"infectious","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260805_161304_(PCVX)_sec_0001649094-26-000043.txt","comments":"10-Q: \"We expect to report topline data from this study in the second half of 2027.\" (VAX-A1 Phase 1 adult study, Group A Strep.)","closed":0,"created_at":"2026-10-25 11:36:55","updated_at":"2026-10-25 11:36:55","company":"Vaxcyte","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":539,"symbol":"PDSB","drug":"PDS0301","modality":"protein","area":"oncology","event_type":"topline_results","expect_date_from":"2027-10-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261020_195906_(PDSB)_sec_0001140361-26-040283-ex991.txt","comments":"\"Q4-2027 Biochemically recurrent prostate cancer (Final data readout)\" — final data from PDS0301 + enzalutamide study.","closed":0,"created_at":"2026-10-25 11:37:04","updated_at":"2026-10-25 11:37:04","company":"PDS Biotechnology","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-10-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":521,"symbol":"PLRX","drug":"PLN-101095","modality":"small_molecule","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260811_160834_(PLRX)_sec_0001746473-26-000113.txt","comments":"10-Q Q2 2026: \"Enrollment remains strong, progressing ahead of schedule. Interim data is expected in 2027.\" Refers to FORTIFY Phase 1b indication expansion trial (NSCLC, ccRCC, high TMB) of PLN-101095 +/- pembrolizumab. Only \"in 2027\" stated; no narrower window given.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Pliant Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":516,"symbol":"PLX","drug":"PRX-115","modality":"protein","area":"metabolic","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260812_065947_(PLX)_sec_0001104659-26-094433-ex991.txt","comments":"Q2 2026 release: \"The Company continues to anticipate top-line results in the second half of 2027\" for the RELEASE Phase 2 trial of PRX-115 (recombinant PEGylated uricase) in uncontrolled gout. No change to prior guidance.","closed":0,"created_at":"2026-10-25 07:35:20","updated_at":"2026-10-25 07:35:20","company":"Protalix BioTherapeutics Inc. (DE)","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":511,"symbol":"PRAX","drug":"elsunersen","modality":"aso","area":"cns","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260806_083228_(PRAX)_sec_0001689548-26-000083.txt","comments":"10-Q: \"We are currently enrolling EMBRAVE3, a Phase 3 registrational study for early-seizure-onset SCN2A DEE, and expect to announce topline results in 2027.\"","closed":0,"created_at":"2026-10-25 11:35:05","updated_at":"2026-10-25 11:35:05","company":"Praxis Precision Medicines","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":500,"symbol":"PRME","drug":"PM577a","modality":"gene_therapy","area":"rare_genetic","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260806_080217_(PRME)_sec_0001628280-26-053878-ex991.txt","comments":"\"Prime Medicine has initiated study startup activities, with initial clinical data anticipated in 2027\" for the global Phase 1/2 study in Wilson disease (IND cleared July 2026, NZ CTA June 2026).","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Prime Medicine","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":501,"symbol":"PRME","drug":"PM647","modality":"gene_therapy","area":"rare_genetic","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260806_080217_(PRME)_sec_0001628280-26-053878-ex991.txt","comments":"\"Prime Medicine expects to submit an IND and/or CTA for PM647 in the third quarter of 2026, with initial clinical data expected in 2027\" (AATD). No narrower timing stated.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Prime Medicine","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":487,"symbol":"PVLA","drug":"QTORIN rapamycin","modality":"small_molecule","area":"dermatology","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260804_073019_(PVLA)_sec_0001193125-26-331556-ex991.txt","comments":"\"Topline results from LOTU are expected in the second half of 2027.\" Phase 2 trial in clinically significant angiokeratomas; first patients dosed April 2026.","closed":0,"created_at":"2026-10-25 07:33:32","updated_at":"2026-10-25 07:33:32","company":"Palvella Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":485,"symbol":"PYXS","drug":"micvotabart pelidotin (MICVO) + pembrolizumab","modality":"adc","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260909_073445_(PYXS)_sec_0001193125-26-385901-ex991.txt","comments":"\"Additional data evaluating initial durability and selection of the recommended Phase 3 dose (RP3D) for the 1L combination are expected in the second half of 2027.\"","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Pyxis Oncology","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":479,"symbol":"QTTB","drug":"bempikibart","modality":"monoclonal_antibody","area":"dermatology","event_type":"other","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260805_070935_(QTTB)_sec_0001193125-26-333831.txt","comments":"\"Q32 Bio anticipates data from the Part B OLE in the second half of 2027\" (Q3 2026 8-K, 2026-11-04, repeats Q2 10-Q guidance); OLE dosing ongoing.","closed":0,"created_at":"2026-10-25 11:33:18","updated_at":"2026-11-04T13:37:18Z","company":"Q32 Bio","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":468,"symbol":"RANI","drug":"RT-114","modality":"peptide","area":"metabolic","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260813_161656_(RANI)_sec_0001193125-26-349245.txt","comments":"\"The Phase 1b study ... is expected to begin in 2026, with data anticipated in 2027.\" Window = calendar 2027. Guidance reiterated 2026-10-21 (\"Eyes 2027 Obesity Data\", MarketBeat/Yahoo) and in Q2 2026 8-K (2026-08-13); no date change.","closed":0,"created_at":"2026-10-25 11:32:50","updated_at":"2026-11-02T20:04:51Z","company":"Rani Therapeutics Holdings","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":466,"symbol":"RAPP","drug":"RAP-641","modality":"small_molecule","area":null,"event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261104_071215_(RAPP)_sec_0001193125-26-446202.txt","comments":"RAP-641 (a6b4 nAChR agonist): IND cleared by FDA; \"preliminary results expected in the second half of 2027\" (Q3 2026 8-K EX-99.1, Nov 4, 2026).","closed":0,"created_at":"2026-10-25 11:32:36","updated_at":"2026-11-04T15:45:07Z","company":"Rapport Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":418,"symbol":"RNA","drug":"ATR 1086","modality":"sirna","area":"rare_genetic","event_type":"regulatory_submission","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260813_165028_(RNA)_sec_0001193125-26-349482-ex991.txt","comments":"\"File IND application for ATR 1086 in 2027, with IND-enabling studies initiating in 2026.\" Confirmed in Q2 10-Q: \"We expect to file an IND for ATR 1086 in 2027.\" PLN cardiomyopathy.","closed":0,"created_at":"2026-10-25 07:28:35","updated_at":"2026-10-25 07:28:35","company":"Atrium Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":417,"symbol":"RNA","drug":"ATR 1072","modality":"sirna","area":"rare_genetic","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260813_165028_(RNA)_sec_0001193125-26-349482-ex991.txt","comments":"\"Initial proof of concept data expected in second half of 2027.\" Reaffirmed in 11/2/26 8-K (\"We now look to the ongoing Phase 1/2 Corventis trial and expect initial proof of concept data in the second half of 2027\"), also 10/27/26 8-K (first patient dosed, ~37 pts, PRKAG2 syndrome), 7/14/26 8-K and Q2 10-Q.","closed":0,"created_at":"2026-10-25 07:28:35","updated_at":"2026-11-02T13:46:35Z","company":"Atrium Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":410,"symbol":"RNXT","drug":"IAG (intra-arterial gemcitabine via RenovoCath)","modality":"small_molecule","area":"oncology","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260812_161629_(RNXT)_sec_0001193125-26-346894-ex991.txt","comments":"\"initial topline trial data is expected to be available during the second half of 2027\"; trial completion expected 1H 2027 after 86 death events (78 as of Aug 11, 2026). Primary endpoint overall survival; Phase III TIGeR-PaC in LAPC. Earlier Aug 4 release said \"mid to late 2027\".","closed":0,"created_at":"2026-10-25 07:27:50","updated_at":"2026-10-25 07:27:50","company":"RenovoRx","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":400,"symbol":"RXRX","drug":"REC-4539","modality":"small_molecule","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260805_063136_(RXRX)_sec_0001601830-26-000097-ex991.txt","comments":"\"REC-4539 (LSD1): Early Phase 1 safety and PK monotherapy data expected in 2H27\" - window = second half of 2027.","closed":0,"created_at":"2026-10-25 11:27:18","updated_at":"2026-10-25 11:27:18","company":"Recursion Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":1160,"symbol":"RXRX","drug":"REC-1245","modality":"small_molecule","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261102_163256_(RXRX)_sec_0001601830-26-000144.txt","comments":"\"Preliminary dose expansion data in endometrial cancer are expected in the second half of 2027\" (Nov 2, 2026 8-K). Window per \"second half of 2027\" = 2027-07-01..2027-12-31.","closed":0,"created_at":"2026-11-02T23:21:24","updated_at":"2026-11-02T23:21:24","company":"Recursion Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":391,"symbol":"SABS","drug":"SAB-142","modality":"protein","area":"immunology","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261013_083610_(SABS)_sec_0001193125-26-419769-ex991.txt","comments":"\"SAB-142 is currently being evaluated in the registrational Phase 2b SAFEGUARD study ... with enrollment expected to be completed in Q4 2026 and topline data anticipated in 2H 2027.\" Window per 2H 2027 rule.","closed":0,"created_at":"2026-10-25 11:26:56","updated_at":"2026-10-25 11:26:56","company":"SAB Biotherapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":385,"symbol":"SCYX","drug":"SCY-770","modality":"small_molecule","area":"renal","event_type":"interim_analysis","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260810_160141_(SCYX)_sec_0001178253-26-000027.txt","comments":"10-Q guidance: \"obtaining an early efficacy readout during the second half of 2027\" (Phase 2 proof-of-concept study in ADPKD, initiation guided Q4 2026).","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"SCYNEXIS","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":371,"symbol":"SGMT","drug":"denifanstat","modality":"small_molecule","area":"dermatology","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261022_071509_(SGMT)_sec_0001193125-26-428314-ex991.txt","comments":"AURORA US Phase 3 in moderate to severe acne (adults and adolescents >=12): \"topline results expected in 2H 2027\" = 2027-07-01..2027-12-31. First patient dosed Oct 22, 2026 per company release (\"Sagimet Biosciences Announces First Patient Dosed in AURORA Phase 3 U.S. Clinical Trial\").","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-26T16:51:32Z","company":"Sagimet Biosciences Inc. Series A","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":348,"symbol":"SNDX","drug":"revumenib","modality":"small_molecule","area":"hematology","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260804_160218_(SNDX)_sec_0001193125-26-332736-ex991.txt","comments":"\"Phase 1/2 proof-of-principle trial of revumenib in MF ... expected to initiate in the fourth quarter of 2026 with initial clinical data expected in the second half of 2027.\"","closed":0,"created_at":"2026-10-25 11:23:40","updated_at":"2026-10-25 11:23:40","company":"Syndax Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":326,"symbol":"SRZN","drug":"SZN-8141","modality":"bispecific","area":"ophthalmology","event_type":"interim_analysis","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260806_161555_(SRZN)_sec_0001193125-26-338068-ex991.txt","comments":"\"Expect to initiate SZN-8141 Phase 1b/2a study, DUET, by year-end 2026 with initial data anticipated in the second half of 2027\" (reaffirmed Oct 20, 2026: \"initial data expected in the second half of 2027\"). Initial data, not stated as topline.","closed":0,"created_at":"2026-10-25 11:22:06","updated_at":"2026-10-25 11:22:06","company":"Surrozen","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":557,"symbol":"STOK","drug":"zorevunersen","modality":"aso","area":"cns","event_type":"regulatory_submission","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260803_160517_(STOK)_sec_0001193125-26-330537-ex991.txt","comments":"Rolling U.S. NDA submission \"with completion expected in the second half of 2027\", dependent on Q3 2027 Phase 3 EMPEROR data. Second half of 2027 = 2027-07-01..2027-12-31.","closed":0,"created_at":"2026-10-25 07:40:00","updated_at":"2026-10-25 07:40:00","company":"Stoke Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":1190,"symbol":"STRO","drug":"STRO-006","modality":"adc","area":"oncology","event_type":"interim_analysis","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261104_080000_(STRO)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"Initial Phase 1 clinical data for ITGB6-targeting ADC STRO-006: \"Initial clinical data expected in the second half of 2027\" (guidance quoted in the Nov 4, 2026 release's referenced Oct 21, 2026 first-patient-dosed announcement). Note: full Oct 21 release not in workspace; guidance taken from its snippet in this release.","closed":0,"created_at":"2026-11-04","updated_at":"2026-11-04","company":"Sutro Biopharma","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":324,"symbol":"STTK","drug":"SL-846","modality":"bispecific","area":"immunology","event_type":"interim_analysis","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260811_065717_(STTK)_sec_0001628280-26-055483.txt","comments":"\"we expect ... to share initial Phase 1 clinical data for SL-846 in 2027.\" Initial Phase 1 data for the dual DR3/IL-23 receptor bispecific; NHP tox data guided for 2H 2026 (preclinical, not recorded).","closed":0,"created_at":"2026-10-25 11:22:02","updated_at":"2026-10-25 11:22:02","company":"Shattuck Labs","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":307,"symbol":"TARA","drug":"TARA-002","modality":"cell_therapy","area":"rare_genetic","event_type":"regulatory_submission","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260811_080536_(TARA)_sec_0001213900-26-087506-ex991.txt","comments":"\"expect to submit a Biologics License Application for TARA-002 in LMs in 2H 2027\" based on pivotal STARBORN-1 results (BLA, not an FDA decision date).","closed":0,"created_at":"2026-10-25 07:20:46","updated_at":"2026-10-25 07:20:46","company":"Protara Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":268,"symbol":"TRVI","drug":"Haduvio (nalbuphine ER) / OCEAN-2","modality":"small_molecule","area":"respiratory","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260806_160820_(TRVI)_sec_0001193125-26-337974-ex991.txt","comments":"Phase 3 OCEAN-2 (IPF-related chronic cough): \"plans to initiate the 12-week fixed dosing OCEAN-2 trial, in the third quarter of 2026, with topline results expected in the second half of 2027.\" Trial initiation is not itself recorded.","closed":0,"created_at":"2026-10-25 11:17:39","updated_at":"2026-10-25 11:17:39","company":"Trevi Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":270,"symbol":"TRVI","drug":"Haduvio (nalbuphine ER) / LAKE","modality":"small_molecule","area":"respiratory","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260806_160820_(TRVI)_sec_0001193125-26-337974-ex991.txt","comments":"Phase 2b LAKE (refractory chronic cough, initiated Q2 2026): \"expects to report topline results from the trial in the second half of 2027.\" SSRE outcome expected earlier (Q4 2026) is recorded separately.","closed":0,"created_at":"2026-10-25 11:17:39","updated_at":"2026-10-25 11:17:39","company":"Trevi Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":271,"symbol":"TRVI","drug":"Haduvio (nalbuphine ER) / non-IPF ILD Phase 2b","modality":"small_molecule","area":"respiratory","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260806_161229_(TRVI)_sec_0001193125-26-338023.txt","comments":"10-Q: \"We plan to initiate an adaptive design Phase 2b clinical trial ... for non-IPF ILD-related chronic cough in the second half of 2026, subject to a meeting with the FDA ... we would expect topline results from the Phase 2b trial in the second half of 2027.\" Trial start not yet confirmed.","closed":0,"created_at":"2026-10-25 11:17:39","updated_at":"2026-10-25 11:17:39","company":"Trevi Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":259,"symbol":"TVTX","drug":"sparsentan","modality":"small_molecule","area":"renal","event_type":"data_presentation","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260804_160524_(TVTX)_sec_0001438533-26-000062-ex991.txt","comments":"\"The SPARX Study evaluating FILSPARI in post-transplant patients with recurrent IgAN or FSGS has completed enrollment, with data anticipated in 2027\" (\"in 2027\" = 2027-01-01..2027-12-31); no specific congress or date stated. Reiterated in Q3 2026 release (2026-11-02).","closed":0,"created_at":"2026-10-25 11:16:58","updated_at":"2026-11-03T16:48:26Z","company":"Travere Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":258,"symbol":"TVTX","drug":"pegtibatinase","modality":"protein","area":"metabolic","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260804_160524_(TVTX)_sec_0001438533-26-000062-ex991.txt","comments":"\"Enrollment of pegtibatinase Phase 3 HARMONY Study in HCU continues; Topline data expected in 2H 2027\"; body: \"with topline data anticipated in 2H 2027\" (2H 2027 = 2027-07-01..2027-12-31). Enrollment restarted Q1 2026 after manufacturing-driven pause.","closed":0,"created_at":"2026-10-25 11:16:58","updated_at":"2026-10-25 11:16:58","company":"Travere Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":254,"symbol":"TYRA","drug":"dabogratinib","modality":"small_molecule","area":"oncology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260804_160446_(TYRA)_sec_0001193125-26-332752-ex991.txt","comments":"\"SURF303: initial results - 2027\"; 10-Q: \"initial results expected in 2027\" for Phase 2a/b LG-UTUC study (60/80 mg QD). Remains open; only a single-participant observation disclosed 2026-09-09.","closed":0,"created_at":"2026-10-25 11:16:35","updated_at":"2026-10-25 11:16:35","company":"Tyra Biosciences","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":244,"symbol":"UPB","drug":"verekitug","modality":"monoclonal_antibody","area":"respiratory","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260811_070523_(UPB)_sec_0001193125-26-343407-ex991.txt","comments":"\"completed enrollment in the VENTURE trial in COPD with 481 participants. Data are expected in the second half of 2027\" — Phase 2 VENTURE (NCT06981078); window 2027-07-01..2027-12-31 per \"second half of 2027\".","closed":0,"created_at":"2026-10-25 11:16:03","updated_at":"2026-10-25 11:16:03","company":"Upstream Bio","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":245,"symbol":"UPB","drug":"verekitug","modality":"monoclonal_antibody","area":"respiratory","event_type":"interim_analysis","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260811_070523_(UPB)_sec_0001193125-26-343407-ex991.txt","comments":"Phase 2 VALOUR long-term extension (NCT06966479) in severe asthma: \"Data from the study are expected in the second half of 2027\"; enrollment completed March 2026. Window 2027-07-01..2027-12-31.","closed":0,"created_at":"2026-10-25 11:16:12","updated_at":"2026-10-25 11:16:12","company":"Upstream Bio","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":1129,"symbol":"VERA","drug":"atacicept","modality":"protein","area":"renal","event_type":"pdufa","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260810_161043_(VERA)_sec_0001193125-26-342380.txt","comments":"10-Q (2026-08-10): sBLA \"expected in the fourth quarter of 2026 which could lead to potential full FDA approval of TRUTAKNA in 2027\"; reaffirmed 2026-10-22 release: \"Plan to submit supplemental BLA ... in Q4 2026 for full approval expected in 2027.\" No specific PDUFA date given; window covers all of 2027.","closed":0,"created_at":"2026-11-01 00:57:35","updated_at":"2026-11-01 00:57:35","company":"Vera Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":231,"symbol":"VERU","drug":"enobosarm","modality":"small_molecule","area":"metabolic","event_type":"topline_results","expect_date_from":"2027-10-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260810_070007_(VERU)_sec_0001193125-26-341187-ex991.txt","comments":"\"Final topline clinical data is expected in the fourth quarter of calendar year 2027.\" Phase 2b PLATEAU (68-week primary endpoint, % change in total body weight).","closed":0,"created_at":"2026-10-25 11:15:05","updated_at":"2026-10-25 11:15:05","company":"Veru","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-10-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":1095,"symbol":"VKTX","drug":"VK2735","modality":"peptide","area":"metabolic","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261028_161009_(VKTX)_sec_0001193125-26-436145-ex991.txt","comments":"Q3-26 release guidance for VK2735 Phase 3 VANQUISH-1/-2 (SC): \"The company expects these studies to be completed in 2027.\" Also, Part 2 of the maintenance dosing study \"results ... to be available in 2027.\" Both fall in the 2027 window; tracked in one row per natural-key constraint.","closed":0,"created_at":"2026-10-29","updated_at":"2026-10-29T15:12:03Z","company":"Viking Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":212,"symbol":"VYGR","drug":"VY1706","modality":"gene_therapy","area":"cns","event_type":"interim_analysis","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260806_160323_(VYGR)_sec_0001640266-26-000007-ex991.txt","comments":"\"H2 2027: Potential for initial biomarker-based data for VY1706, pending enrollment\"; 10-Q: initial CSF tau biomarker-based data anticipated in second half of 2027, pending enrollment.","closed":0,"created_at":"2026-10-25 11:13:35","updated_at":"2026-10-25 11:13:35","company":"Voyager Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":198,"symbol":"XLO","drug":"masked CLDN18.2 TCE","modality":"bispecific","area":"oncology","event_type":"regulatory_submission","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260812_073526_(XLO)_sec_0001193125-26-345753-ex991.txt","comments":"\"Xilio plans to submit INDs for its CLDN18.2 and PSMA+STEAP1 programs in the second half of 2027.\" Preclinical IND-enabling stage; window 2027-07-01..2027-12-31.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Xilio Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":199,"symbol":"XLO","drug":"masked PSMA+STEAP1 TCE","modality":"bispecific","area":"oncology","event_type":"regulatory_submission","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260812_073526_(XLO)_sec_0001193125-26-345753-ex991.txt","comments":"\"Xilio plans to submit INDs for its CLDN18.2 and PSMA+STEAP1 programs in the second half of 2027.\" Preclinical IND-enabling stage; window 2027-07-01..2027-12-31.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Xilio Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":197,"symbol":"XLO","drug":"XTX501","modality":"bispecific","area":"oncology","event_type":"topline_results","expect_date_from":"2027-10-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261026_073000_(XLO)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","comments":"\"Xilio plans to report initial Phase 1 data in patients with metastatic NSCLC in the fourth quarter of 2027.\" Window narrowed from second half to Q4 2027: 2027-10-01..2027-12-31.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-26T12:37:20Z","company":"Xilio Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-10-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":1043,"symbol":"XNCR","drug":"XmAb819","modality":"bispecific","area":"oncology","event_type":"data_presentation","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261026_075027_(XNCR)_sec_0001213900-26-112279.txt","comments":"2027 plan slide: \"Present first data from post 1L IO - IO for IMDC intermediate/poor risk patients\" (listed under 2027, no narrower date given). Proof of concept data in the post-nivolumab/ipilimumab (TKI-naive) population.","closed":0,"created_at":"2026-10-26 08:41:00","updated_at":"2026-10-26 08:41:00","company":"Xencor","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":1062,"symbol":"XNCR","drug":"XmAb942","modality":"monoclonal_antibody","area":"immunology","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20261026_075027_(XNCR)_sec_0001213900-26-112279.txt","comments":"2026-10-26 pipeline timeline: \"Phase 2b XENITH-UC\" ... \"Primary endpoint analysis in ~2H27\". Approximate 2H2027 window; exact date not stated.","closed":0,"created_at":"2026-10-26T23:22:00Z","updated_at":"2026-10-26T23:22:00Z","company":"Xencor","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":200,"symbol":"YARW","drug":"YB-101","modality":"monoclonal_antibody","area":"immunology","event_type":"topline_results","expect_date_from":"2027-07-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260728_171131_(YARW)_sec_0001104659-26-087601-ex991.txt","comments":"Company's Phase 2a/2b GD trial: \"Data from the Phase 2a portion of the trial are expected in the second half of 2027.\" Phase 2a is placebo-controlled proof-of-concept (NCT07682896); 2H 2027 = 2027-07-01..2027-12-31.","closed":0,"created_at":"2026-10-25 11:12:30","updated_at":"2026-10-25 11:12:30","company":"Yarrow Bioscience","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-07-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":1082,"symbol":"ZBIO","drug":"ZB021","modality":"small_molecule","area":"dermatology","event_type":"topline_results","expect_date_from":"2027-01-01","expect_date_to":"2027-12-31","news_source_file":"documents/20260813_070549_(ZBIO)_sec_0001104659-26-095437-ex991.txt","comments":"\"Upon completion and evaluation of the SAD and MAD study, Zenas plans to initiate a proof-of-concept (POC) trial in North America to evaluate clinical activity and safety in psoriasis patients with results anticipated in 2027.\" Window covers stated \"in 2027\"; date not narrowed.","closed":0,"created_at":"2026-10-28","updated_at":"2026-10-28","company":"Zenas BioPharma","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2027-01-01 → 2027-12-31","imminence":421,"state":"upcoming","overdue":false},{"id":366,"symbol":"ANVS","drug":"buntanetap","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2028-01-01","expect_date_to":"2028-03-31","news_source_file":"documents/20260814_160542_(ANVS)_sec_0001104659-26-097091-ex991.txt","comments":"Q2 2026 release (Aug 14, 2026): timeline gives database lock for the 6-month analysis in Q1 2027 and \"The disease-modifying data readout is expected a year later\" -> Q1 2028. 2026-07-09 release states \"Q1 2028: 18-month disease-modifying top-line data readout.\" Phase 3 AD 18-month portion, separate NDA planned.","closed":0,"created_at":"2026-10-25 11:24:51","updated_at":"2026-10-25 11:24:51","company":"Annovis Bio","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-03-31","imminence":512,"state":"upcoming","overdue":false},{"id":750,"symbol":"IRLA","drug":"LAM-001","modality":"small_molecule","area":"respiratory","event_type":"topline_results","expect_date_from":"2028-01-01","expect_date_to":"2028-03-31","news_source_file":"documents/20261009_075932_(IRLA)_sec_0001193125-26-418538-ex991.txt","comments":"\"The Company recently initiated a Phase 2b trial in PH-ILD, and data are anticipated in the first quarter of 2028.\" Reiterated in Oct 19 2026 corporate presentation (1Q28 PH-ILD Phase 2b data).","closed":0,"created_at":"2026-10-25 11:52:10","updated_at":"2026-10-25 11:52:10","company":"IRulya Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-03-31","imminence":512,"state":"upcoming","overdue":false},{"id":687,"symbol":"KRSA","drug":"KRSA-028","modality":"monoclonal_antibody","area":"cns","event_type":"interim_analysis","expect_date_from":"2026-09-11","expect_date_to":"2028-03-31","news_source_file":"documents/20261105_070514_(KRSA)_sec_0001193125-26-448535.txt","comments":"\"interim proof-of-concept data evaluating amyloid plaque clearance in Alzheimer's disease patients anticipated by the end of 2027 or the first quarter of 2028.\" Window spans issue date through Q1 2028. Reaffirmed Nov 5, 2026 Q3 release: \"interim proof-of-concept data in Alzheimer's disease patients anticipated by year-end 2027 or first quarter of 2028\".","closed":0,"created_at":"2026-10-25 11:49:20","updated_at":"2026-11-05T12:29:59Z","company":"Korsana Biosciences","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-09-11 → 2028-03-31","imminence":512,"state":"open","overdue":false},{"id":676,"symbol":"LBRX","drug":"LB-102","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2028-01-01","expect_date_to":"2028-03-31","news_source_file":"documents/20260811_080545_(LBRX)_sec_0001193125-26-343479-ex991.txt","comments":"\"The Phase 2 ILLUMINATE-1 trial evaluating the efficacy and safety of LB-102 in patients with bipolar 1 depression is enrolling patients, with topline data expected in the first quarter of 2028.\"","closed":0,"created_at":"2026-10-25 11:48:22","updated_at":"2026-10-25 11:48:22","company":"LB Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-03-31","imminence":512,"state":"upcoming","overdue":false},{"id":576,"symbol":"OCUL","drug":"AXPAXLI","modality":"small_molecule","area":"ophthalmology","event_type":"topline_results","expect_date_from":"2028-01-01","expect_date_to":"2028-03-31","news_source_file":"documents/20260803_070736_(OCUL)_sec_0001104659-26-089443-ex991.txt","comments":"\"Following these changes, topline SOL-R results are now expected in the first quarter of 2028\" - delayed from prior guidance after protocol amendment adding Week 96 superiority vs aflibercept 8 mg; primary non-inferiority endpoint at Week 56 unchanged.","closed":0,"created_at":"2026-10-25 11:39:44","updated_at":"2026-10-25 11:39:44","company":"Ocular Therapeutix","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-03-31","imminence":512,"state":"upcoming","overdue":false},{"id":549,"symbol":"PALI","drug":"PALI-2108","modality":"small_molecule","area":"gi_hepatology","event_type":"topline_results","expect_date_from":"2028-01-01","expect_date_to":"2028-03-31","news_source_file":"documents/20260922_083500_(PALI)_yahoo_news_yahoo-962e5adaefe96dc86168d4b470afc513-PALI.txt","comments":"2026-09-22 IND-clearance release: \"First patient dosing targeted for Q1 2027; primary efficacy readout (Week 12 endoscopic response) targeted for Q1 2028\" for Phase 2 ASCENTRA-CD (~60 patients). Q1 2028 = 2028-01-01..2028-03-31 (earlier 10-Q said \"early 2028\").","closed":0,"created_at":"2026-10-25 11:37:36","updated_at":"2026-10-25T15:58:54Z","company":"Palisade Bio","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-03-31","imminence":512,"state":"upcoming","overdue":false},{"id":646,"symbol":"PHAT","drug":"vonoprazan","modality":"small_molecule","area":"gi_hepatology","event_type":"topline_results","expect_date_from":"2028-01-01","expect_date_to":"2028-03-31","news_source_file":"documents/20261029_070000_(PHAT)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","comments":"\"Topline results are expected in the first quarter 2028\" for registrational Phase 3 pHalcon-NERD-302 (as-needed VOQUEZNA 10 mg in NERD); first subject dosed, sites enrolling across the U.S.","closed":0,"created_at":"2026-10-25 11:45:28","updated_at":"2026-10-29T13:07:39Z","company":"Phathom Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-03-31","imminence":512,"state":"upcoming","overdue":false},{"id":346,"symbol":"SNDX","drug":"axatilimab + corticosteroids","modality":"monoclonal_antibody","area":"immunology","event_type":"topline_results","expect_date_from":"2028-01-01","expect_date_to":"2028-03-31","news_source_file":"documents/20260804_160218_(SNDX)_sec_0001193125-26-332736-ex991.txt","comments":"\"A pivotal Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of axatilimab in combination with corticosteroids ... newly diagnosed cGVHD. Topline data are anticipated in early 2028.\"","closed":0,"created_at":"2026-10-25 11:23:40","updated_at":"2026-10-25 11:23:40","company":"Syndax Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-03-31","imminence":512,"state":"upcoming","overdue":false},{"id":202,"symbol":"XFOR","drug":"mavorixafor","modality":"small_molecule","area":"hematology","event_type":"topline_results","expect_date_from":"2028-01-01","expect_date_to":"2028-03-31","news_source_file":"documents/20261029_095945_(XFOR)_sec_0001501697-26-000084.txt","comments":"Oct 29, 2026 investor day presentation: \"Topline data expected in Q1 2028\" for the pivotal Phase 3 4WARD trial (previously guided as H1 2028 in the Oct 8, 2026 release). Narrowed to Q1 2028 per the newer document.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-29T15:11:50Z","company":"X4 Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-03-31","imminence":512,"state":"upcoming","overdue":false},{"id":191,"symbol":"ZYME","drug":"zanidatamab","modality":"bispecific","area":"oncology","event_type":"topline_results","expect_date_from":"2026-08-06","expect_date_to":"2028-03-31","news_source_file":"documents/20260806_160905_(ZYME)_sec_0001937653-26-000046-ex991.txt","comments":"\"The EmpowHER-303 trial is expected to complete patient enrollment in mid-2027 with top-line data expected by the end of 2027 or early 2028.\" Wide window per text (end of 2027 through early 2028); enrollment completion itself not recorded as a catalyst.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Zymeworks","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-08-06 → 2028-03-31","imminence":512,"state":"open","overdue":false},{"id":334,"symbol":"SPTX","drug":"GlyphAgo","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2028-01-01","expect_date_to":"2028-04-30","news_source_file":"documents/20260803_070303_(SPTX)_sec_0001193125-26-329528-ex991.txt","comments":"\"We expect topline data from this Phase 2a trial in early 2028.\" Phase 2a proof-of-pharmacology trial in GAD patients with sleep disturbance; first patient dosed (Oct 7, 2026); timing reaffirmed in Q3 2026 release, Nov 2, 2026.","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-05T12:30:32Z","company":"Seaport Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-04-30","imminence":542,"state":"upcoming","overdue":false},{"id":111,"symbol":"BDTX","drug":"silevertinib","modality":"small_molecule","area":"oncology","event_type":"interim_analysis","expect_date_from":"2028-01-01","expect_date_to":"2028-06-30","news_source_file":"documents/20260805_160438_(BDTX)_sec_0001701541-26-000025.txt","comments":"10-Q: Phase 2 silevertinib+temozolomide in newly diagnosed EGFRvIII+ MGMT-unmethylated GBM has \"an interim PFS analysis anticipated in the first half of 2028.\" Randomized portion initiation Q4 2026 not recorded (trial start).","closed":0,"created_at":"2026-10-25 11:04:52","updated_at":"2026-10-25 11:04:52","company":"Black Diamond Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-06-30","imminence":603,"state":"upcoming","overdue":false},{"id":940,"symbol":"CRBP","drug":"CRB-701","modality":"adc","area":"oncology","event_type":"interim_analysis","expect_date_from":"2028-01-01","expect_date_to":"2028-06-30","news_source_file":"documents/20261015_102748_(CRBP)_sec_0001193125-26-422437-ex991.txt","comments":"\"Interim ORR readout in 2L OPSCC - 1H 2028\" per Oct 15, 2026 corporate presentation milestones for TEMPO-1.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Corbus Pharmaceuticals Holdings","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-06-30","imminence":603,"state":"upcoming","overdue":false},{"id":1178,"symbol":"CTNM","drug":"PIPE-791","modality":"small_molecule","area":"respiratory","event_type":"topline_results","expect_date_from":"2028-06-01","expect_date_to":"2028-06-30","news_source_file":"documents/20261103_161335_(CTNM)_sec_0001628280-26-069515.txt","comments":"10-Q: \"Based on enrollment to date at our clinical sites, we believe we remain on track to complete the PROPEL-IPF clinical trial in June 2028.\" Phase 2 PROPEL-IPF (NCT07284459), ~324 IPF patients, 26 weeks; window reflects stated month only — topline timing after completion is not separately disclosed.","closed":0,"created_at":"2026-11-03 23:10:32","updated_at":"2026-11-03 23:10:32","company":"Contineum Therapeutics","tier":"Core","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-06-01 → 2028-06-30","imminence":603,"state":"upcoming","overdue":false},{"id":1177,"symbol":"DNLI","drug":"tividenofusp alfa-eknm (AVLAYAH)","modality":"protein","area":"rare_genetic","event_type":"topline_results","expect_date_from":"2028-01-01","expect_date_to":"2028-06-30","news_source_file":"documents/20261103_160310_(DNLI)_sec_0001714899-26-000107-ex991.txt","comments":"\"Denali also completed enrollment of Cohort B, for a total enrollment of 65 participants across Cohorts A and B, in the global Phase 2/3 COMPASS study... Data from the COMPASS study are expected in the first half of 2028.\" Confirmatory study in MPS II (Hunter syndrome).","closed":0,"created_at":"2026-11-03T18:10:09","updated_at":"2026-11-03T18:10:09","company":"Denali Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-06-30","imminence":603,"state":"upcoming","overdue":false},{"id":664,"symbol":"LXEO","drug":"LX2006","modality":"gene_therapy","area":"rare_genetic","event_type":"regulatory_submission","expect_date_from":"2028-01-01","expect_date_to":"2028-06-30","news_source_file":"documents/20260812_070257_(LXEO)_sec_0001193125-26-345722-ex991.txt","comments":"\"Potential BLA submission under accelerated approval pathway in first half of 2028\" for LX2006 in FA cardiomyopathy.","closed":0,"created_at":"2026-10-25 11:46:39","updated_at":"2026-10-25 11:46:39","company":"Lexeo Therapeutics","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-06-30","imminence":603,"state":"upcoming","overdue":false},{"id":1235,"symbol":"PCVX","drug":"VAX-31","modality":"vaccine","area":"infectious","event_type":"regulatory_submission","expect_date_from":"2028-01-01","expect_date_to":"2028-06-30","news_source_file":"documents/20261104_160500_(PCVX)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"Q3 2026 release: \"we expect to submit a BLA in the first half of 2028\" for VAX-31 adult indication (OPUS-1 plus OPUS-2/OPUS-3 and a manufacturing consistency study), following the positive OPUS-1 topline. No exact date stated.","closed":0,"created_at":"2026-11-04 22:00:46","updated_at":"2026-11-04 22:00:46","company":"Vaxcyte","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-06-30","imminence":603,"state":"upcoming","overdue":false},{"id":540,"symbol":"PDSB","drug":"PDS0301","modality":"protein","area":"oncology","event_type":"interim_analysis","expect_date_from":"2028-04-01","expect_date_to":"2028-06-30","news_source_file":"documents/20261020_195906_(PDSB)_sec_0001140361-26-040283-ex991.txt","comments":"\"Q2-2028 Phase 3 – Colorectal cancer with liver metastases (Interim data readout)\" — registrational Phase 3 protocol still in design as of Oct 2026.","closed":0,"created_at":"2026-10-25 11:37:04","updated_at":"2026-10-25 11:37:04","company":"PDS Biotechnology","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-04-01 → 2028-06-30","imminence":603,"state":"upcoming","overdue":false},{"id":322,"symbol":"STTK","drug":"SL-325","modality":"monoclonal_antibody","area":"immunology","event_type":"topline_results","expect_date_from":"2028-01-01","expect_date_to":"2028-06-30","news_source_file":"documents/20260811_065717_(STTK)_sec_0001628280-26-055483.txt","comments":"\"Data from the induction portion of the trial are expected in the first half of 2028.\" RECEPTIVE-CD1 Phase 2b in Crohn's disease, expected to initiate Q3 2026; primary endpoint endoscopic response at 12 weeks.","closed":0,"created_at":"2026-10-25 11:22:00","updated_at":"2026-10-25 11:22:00","company":"Shattuck Labs","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-06-30","imminence":603,"state":"upcoming","overdue":false},{"id":267,"symbol":"TRVI","drug":"Haduvio (nalbuphine ER) / OCEAN-1","modality":"small_molecule","area":"respiratory","event_type":"topline_results","expect_date_from":"2028-01-01","expect_date_to":"2028-06-30","news_source_file":"documents/20260806_160820_(TRVI)_sec_0001193125-26-337974-ex991.txt","comments":"Phase 3 OCEAN-1 (IPF-related chronic cough, 52-wk fixed dosing, initiated Q2 2026): \"Topline data from the 52-week fixed dosing OCEAN-1 trial is expected in the first half of 2028.\" Same in 10-Q.","closed":0,"created_at":"2026-10-25 11:17:39","updated_at":"2026-10-25 11:17:39","company":"Trevi Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-06-30","imminence":603,"state":"upcoming","overdue":false},{"id":265,"symbol":"TTRX","drug":"GX-03","modality":"other","area":"infectious","event_type":"interim_analysis","expect_date_from":"2028-01-01","expect_date_to":"2028-06-30","news_source_file":"documents/20261006_193052_(TTRX)_sec_0001213900-26-107329-ex991.txt","comments":"Planned Phase 3 onychomycosis trial: \"1H 2028 Interim Analysis Expected\" (Week 26 interim, N~250, primary complete cure at Week 52). Phase 3 first patient dosing planned Q1 2027.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Turn Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-06-30","imminence":603,"state":"upcoming","overdue":false},{"id":1094,"symbol":"XFOR","drug":"mavorixafor","modality":"small_molecule","area":"hematology","event_type":"topline_results","expect_date_from":"2028-01-01","expect_date_to":"2028-06-30","news_source_file":"documents/20261029_095945_(XFOR)_sec_0001501697-26-000084.txt","comments":"Oct 29, 2026 investor day presentation / pipeline slide: 4STEPS Phase 2b (G-CSF dose reduction) \"Topline data H1 2028\"; trial initiation guided for Q1 2027.","closed":0,"created_at":"2026-10-29T11:11:38Z","updated_at":"2026-10-29T11:11:38Z","company":"X4 Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-06-30","imminence":603,"state":"upcoming","overdue":false},{"id":170,"symbol":"ALLO","drug":"cema-cel","modality":"cell_therapy","area":"oncology","event_type":"topline_results","expect_date_from":"2028-06-01","expect_date_to":"2028-07-31","news_source_file":"documents/20260812_161718_(ALLO)_sec_0001628280-26-056213.txt","comments":"\"We anticipate ... conducting the primary EFS analysis in mid-2028\" for ALPHA3; window = mid 2028.","closed":0,"created_at":"2026-10-25 11:09:51","updated_at":"2026-10-25 11:09:51","company":"Allogene Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-06-01 → 2028-07-31","imminence":634,"state":"upcoming","overdue":false},{"id":781,"symbol":"IKT","drug":"IKT-001","modality":"small_molecule","area":"cardiovascular","event_type":"topline_results","expect_date_from":"2028-06-01","expect_date_to":"2028-07-31","news_source_file":"documents/20260908_164128_(IKT)_sec_0001193125-26-385293-ex991.txt","comments":"Corporate overview: \"Mid 2028 Unblinded Data (PVR reduction) readout for Part A of Phase 3 IMPROVE-PAH Study (n=120)\"; \"Mid 2028 - Part A - PVR Efficacy Data\".","closed":0,"created_at":"2026-10-25 11:54:15","updated_at":"2026-10-25 11:54:15","company":"Inhibikase Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-06-01 → 2028-07-31","imminence":634,"state":"upcoming","overdue":false},{"id":775,"symbol":"IMRX","drug":"atebimetinib (IMM-1-104)","modality":"small_molecule","area":"oncology","event_type":"topline_results","expect_date_from":"2028-06-01","expect_date_to":"2028-07-31","news_source_file":"documents/20261029_160500_(IMRX)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","comments":"Q3 2026 release (Oct 29, 2026): \"Mid-2028: Topline data readout from the MAPKeeper 301 trial\"; enrollment ahead of schedule (target expanding 510 to 570 patients) with \"potential to accelerate current mid-2028 topline data guidance.\" Window unchanged = mid 2028 (Jun-Jul).","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-29T21:27:57Z","company":"Immuneering","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-06-01 → 2028-07-31","imminence":634,"state":"upcoming","overdue":false},{"id":714,"symbol":"KLRA","drug":"ribupatide injection (KAI-9531)","modality":"peptide","area":"metabolic","event_type":"topline_results","expect_date_from":"2028-06-01","expect_date_to":"2028-07-31","news_source_file":"documents/20261104_160828_(KLRA)_sec_0001193125-26-447232-ex991.txt","comments":"\"KaiNETIC Global Phase 3 program in obesity fully enrolled with data anticipated mid-2028\" (3 trials, ~5,000 participants, up to 10 mg weekly over 76 weeks). Narrowed from 2028 to mid-2028.","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-05T12:28:53Z","company":"Kailera Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-06-01 → 2028-07-31","imminence":634,"state":"upcoming","overdue":false},{"id":610,"symbol":"NKTR","drug":"rezpegaldesleukin","modality":"protein","area":"dermatology","event_type":"topline_results","expect_date_from":"2028-06-01","expect_date_to":"2028-07-31","news_source_file":"documents/20260813_162523_(NKTR)_sec_0001213900-26-089137-ex991.txt","comments":"\"cash runway that extends into the third quarter of 2028, past the initial Phase 3 data readouts expected in mid-2028\" (Q2 2026 earnings release, Aug 13, 2026). Company-guided initial Phase 3 (ZENITH AD) data readouts; no specific trial/date given.","closed":0,"created_at":"2026-10-25 11:42:25","updated_at":"2026-10-25 11:42:25","company":"Nektar Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-06-01 → 2028-07-31","imminence":634,"state":"upcoming","overdue":false},{"id":496,"symbol":"PRQR","drug":null,"modality":"aso","area":"gi_hepatology","event_type":"interim_analysis","expect_date_from":"2028-06-01","expect_date_to":"2028-07-31","news_source_file":"documents/20260813_070008_(PRQR)_sec_0001104659-26-095422-ex991.txt","comments":"NTCP franchise: potentially registration-enabling Phase 2 program \"expected to start in mid-2027 with first interim analysis data expected by mid-2028\", subject to regulatory interactions.","closed":0,"created_at":"2026-10-25 11:34:31","updated_at":"2026-10-25 11:34:31","company":"ProQR Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-06-01 → 2028-07-31","imminence":634,"state":"upcoming","overdue":false},{"id":138,"symbol":"AUTL","drug":"obe-cel","modality":"cell_therapy","area":"immunology","event_type":"data_presentation","expect_date_from":"2028-01-01","expect_date_to":"2028-12-31","news_source_file":"documents/20260811_073342_(AUTL)_sec_0001730463-26-000119-ex991.txt","comments":"\"LUMINA, the pivotal Phase 2 study of obe-cel in patients with refractory LN continues enrolling in five countries and the Company expects to report data in 2028\" (summary: In 2028).","closed":0,"created_at":"2026-10-25 11:06:26","updated_at":"2026-10-25 11:06:26","company":"Autolus Therapeutics plc American Depositary Share","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-12-31","imminence":787,"state":"upcoming","overdue":false},{"id":882,"symbol":"DNTH","drug":"claseprubart","modality":"monoclonal_antibody","area":"immunology","event_type":"topline_results","expect_date_from":"2028-07-01","expect_date_to":"2028-12-31","news_source_file":"documents/20260804_160803_(DNTH)_sec_0001690585-26-000034.txt","comments":"\"We expect to report top-line results from this trial in the second half of 2028\" (Phase 3 EMERGE registrational trial in gMG, initiated June 2026).","closed":0,"created_at":"2026-10-25 12:02:41","updated_at":"2026-10-25 12:02:41","company":"Dianthus Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-07-01 → 2028-12-31","imminence":787,"state":"upcoming","overdue":false},{"id":856,"symbol":"ENTX","drug":"EB613","modality":"peptide","area":"metabolic","event_type":"topline_results","expect_date_from":"2028-07-01","expect_date_to":"2028-12-31","news_source_file":"documents/20260807_160622_(ENTX)_sec_0001178913-26-003946-ex991.txt","comments":"\"Entera plans to initiate the registrational Phase 3 study in late 2026, with topline results anticipated in the second half of 2028.\" (12-month Phase 3, ~750 postmenopausal women, total hip BMD primary endpoint).","closed":0,"created_at":"2026-10-25 12:00:42","updated_at":"2026-10-25 12:00:42","company":"Entera Bio","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-07-01 → 2028-12-31","imminence":787,"state":"upcoming","overdue":false},{"id":847,"symbol":"EVMN","drug":"EVO301","modality":"protein","area":"dermatology","event_type":"topline_results","expect_date_from":"2028-01-01","expect_date_to":"2028-12-31","news_source_file":"documents/20260915_083023_(EVMN)_sec_0001193125-26-391390-ex991.txt","comments":"Pipeline slide: EVO301 (IL-18BP) atopic dermatitis \"Phase 2b Data Anticipated 2028\"; Phase 2b trial planned to start mid-2027, so readout year only.","closed":0,"created_at":"2026-10-25T07:59:11","updated_at":"2026-10-25T07:59:11","company":"Evommune","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-12-31","imminence":787,"state":"upcoming","overdue":false},{"id":812,"symbol":"HELP","drug":"HLP003","modality":"small_molecule","area":"cns","event_type":"regulatory_submission","expect_date_from":"2028-01-01","expect_date_to":"2028-12-31","news_source_file":"documents/20261021_163350_(HELP)_sec_0001062993-26-005468-ex991.txt","comments":"\"Helus Pharma expects to file a New Drug Application with the FDA in 2028.\" HLP003 has Breakthrough Therapy Designation; year-only guidance.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Helus Pharma","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-12-31","imminence":787,"state":"upcoming","overdue":false},{"id":1185,"symbol":"IFRX","drug":"izicopan","modality":"small_molecule","area":"immunology","event_type":"topline_results","expect_date_from":"2028-01-01","expect_date_to":"2028-12-31","news_source_file":"documents/20261103_163400_(IFRX)_sec_0001140361-26-041828.txt","comments":"\"intends to begin two Phase 2 trials in 2027, with first data readout anticipated in 2028\" - randomized, double-blind, placebo-controlled Phase 2 in AAV with renal involvement (site initiation early 2027; key readouts at 24 weeks). Open-label GC-replacement Phase 2 first data also guided to 2028. Year-level window only.","closed":0,"created_at":"2026-11-04 05:25:49","updated_at":"2026-11-04 05:25:49","company":"InflaRx","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-12-31","imminence":787,"state":"upcoming","overdue":false},{"id":1187,"symbol":"IFRX","drug":"izicopan","modality":"small_molecule","area":"renal","event_type":"interim_analysis","expect_date_from":"2028-01-01","expect_date_to":"2028-12-31","news_source_file":"documents/20261103_163400_(IFRX)_sec_0001140361-26-041828.txt","comments":"\"InflaRx planning pilot study in IgA nephropathy (IgAN) to be initiated in 2027, with expected early data readout in 2028\" (includes rapidly progressive IgAN/RPGN); year-level window only.","closed":0,"created_at":"2026-11-04 05:25:49","updated_at":"2026-11-04 05:25:49","company":"InflaRx","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-12-31","imminence":787,"state":"upcoming","overdue":false},{"id":779,"symbol":"IMA","drug":"olevaprubart","modality":"monoclonal_antibody","area":"dermatology","event_type":"topline_results","expect_date_from":"2028-01-01","expect_date_to":"2028-12-31","news_source_file":"documents/20260805_080510_(IMA)_sec_0001193125-26-333912-ex991.txt","comments":"\"Initial data expected in 2028\" from the Phase 2 alopecia areata study, which the company plans to initiate in 2026. Only a year is given; window spans 2028.","closed":0,"created_at":"2026-10-25 07:53:54","updated_at":"2026-10-25 07:53:54","company":"ImageneBio","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-12-31","imminence":787,"state":"upcoming","overdue":false},{"id":770,"symbol":"IMVT","drug":"IMVT-1402","modality":"monoclonal_antibody","area":"cns","event_type":"topline_results","expect_date_from":"2028-01-01","expect_date_to":"2028-12-31","news_source_file":"documents/20260806_071524_(IMVT)_sec_0001764013-26-000100-ex991.txt","comments":"CIDP (NCT07032662) and Sjogren's disease (NCT06979531) potentially registrational trials: \"Topline data are expected to follow in calendar year 2028 for the potentially registrational trials of IMVT-1402 in CIDP and SjD\". Rows combined (identical guided window; CIDP neurological, SjD immunology).","closed":0,"created_at":"2026-10-25 11:53:39","updated_at":"2026-10-25 11:53:39","company":"Immunovant","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-12-31","imminence":787,"state":"upcoming","overdue":false},{"id":751,"symbol":"IRLA","drug":"LAM-001","modality":"small_molecule","area":"respiratory","event_type":"topline_results","expect_date_from":"2028-10-01","expect_date_to":"2028-12-31","news_source_file":"documents/20261009_075932_(IRLA)_sec_0001193125-26-418538-ex991.txt","comments":"\"The Company plans to initiate a Phase 2 study in SAPH in 4Q26, with data anticipated in the fourth quarter of 2028.\" Trial start itself not recorded; reiterated in Oct 19 2026 presentation (4Q28 SAPH Phase 2 data).","closed":0,"created_at":"2026-10-25 11:52:10","updated_at":"2026-10-25 11:52:10","company":"IRulya Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-10-01 → 2028-12-31","imminence":787,"state":"upcoming","overdue":false},{"id":692,"symbol":"KURA","drug":"ziftomenib","modality":"small_molecule","area":"oncology","event_type":"topline_results","expect_date_from":"2028-01-01","expect_date_to":"2028-12-31","news_source_file":"documents/20260812_161538_(KURA)_sec_0001193125-26-346884.txt","comments":"10-Q: \"we anticipate topline results from the MRD-negative CR accelerated endpoint in the intensive chemotherapy setting in 2028\" (KOMET-017-IC). Year-level guidance only.","closed":0,"created_at":"2026-10-25 11:49:22","updated_at":"2026-10-25 11:49:22","company":"Kura Oncology","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-12-31","imminence":787,"state":"upcoming","overdue":false},{"id":652,"symbol":"MDGL","drug":"resmetirom","modality":"small_molecule","area":"gi_hepatology","event_type":"topline_results","expect_date_from":"2028-01-01","expect_date_to":"2028-12-31","news_source_file":"documents/20261103_091018_(MDGL)_sec_0001628280-26-069145.txt","comments":"Q3 2026 10-Q (11/3/26): MAESTRO-NASH remains ongoing generating confirmatory outcomes data to 54-months that, if positive, is expected to verify a clinical benefit and support full FDA approval; \"We expect outcomes data from MAESTRO-NASH in 2028.\" Full-approval risk window.","closed":0,"created_at":"2026-10-25 11:45:53","updated_at":"2026-11-04T01:17:55Z","company":"Madrigal Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-12-31","imminence":787,"state":"upcoming","overdue":false},{"id":619,"symbol":"MPLT","drug":"ML-007C-MA","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2028-01-01","expect_date_to":"2028-12-31","news_source_file":"documents/20260813_165137_(MPLT)_sec_0001193125-26-349490-ex991.txt","comments":"Planned registrational Phase 3 ZEPHYR-2 in schizophrenia: Company \"plans to engage with the FDA at an End-of-Phase 2 meeting ... including the planned Phase 3 ZEPHYR-2 trial, with topline results expected in 2028\". Subject to FDA feedback at EOP2.","closed":0,"created_at":"2026-10-25 11:44:04","updated_at":"2026-10-25 11:44:04","company":"MapLight Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-12-31","imminence":787,"state":"upcoming","overdue":false},{"id":613,"symbol":"NERV","drug":"roluperidone","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2028-07-01","expect_date_to":"2028-12-31","news_source_file":"documents/20260807_071334_(NERV)_sec_0001193125-26-339147-ex991.txt","comments":"Q2 2026 release: \"Topline data from Phase B of the trial is expected in the second half of 2028.\" Phase B = 52-week double-dummy relapse assessment vs risperidone/aripiprazole/olanzapine.","closed":0,"created_at":"2026-10-25 11:42:39","updated_at":"2026-10-25 11:42:39","company":"Minerva Neurosciences","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-07-01 → 2028-12-31","imminence":787,"state":"upcoming","overdue":false},{"id":583,"symbol":"OCGN","drug":"OCU410","modality":"gene_therapy","area":"ophthalmology","event_type":"topline_results","expect_date_from":"2028-01-01","expect_date_to":"2028-12-31","news_source_file":"documents/20261015_080105_(OCGN)_sec_0001104659-26-115970-ex991.txt","comments":"\"2028 Phase 3 topline data; BLA submission\" for OCU410 in geographic atrophy; Phase 3 (ArMaDa, n~237) initiated 3Q 2026, first patient dosed.","closed":0,"created_at":"2026-10-25 07:39:42","updated_at":"2026-10-25 07:39:42","company":"Ocugen","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-12-31","imminence":787,"state":"upcoming","overdue":false},{"id":586,"symbol":"OCGN","drug":"OCU410","modality":"gene_therapy","area":"ophthalmology","event_type":"regulatory_submission","expect_date_from":"2028-01-01","expect_date_to":"2028-12-31","news_source_file":"documents/20261015_080105_(OCGN)_sec_0001104659-26-115970-ex991.txt","comments":"Pipeline table: \"Target BLA/MAA Submission\" for OCU410 in geographic atrophy in 2028; deck also lists \"2028 Phase 3 topline data; BLA submission.\"","closed":0,"created_at":"2026-10-25 07:39:42","updated_at":"2026-10-25 07:39:42","company":"Ocugen","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-12-31","imminence":787,"state":"upcoming","overdue":false},{"id":1142,"symbol":"ODTX","drug":"OD-002","modality":"small_molecule","area":"immunology","event_type":"topline_results","expect_date_from":"2028-07-01","expect_date_to":"2028-12-31","news_source_file":"documents/20260908_191019_(ODTX)_sec_0001193125-26-385477-ex991.txt","comments":"Company-guided: \"Phase 1/2a Trial Initiation Expected in H1 2027 With Efficacy Readouts Expected in H2 2028\" (OD-002, oral SLC15A4 inhibitor; Phase 1 healthy volunteers then Phase 2a basket cohorts incl. cutaneous lupus erythematosus). \"Second half of 2028\" = 2028-07-01..2028-12-31. Timeline from Sept 2026 corporate deck; readout window only, no specific data date.","closed":0,"created_at":"2026-11-02 05:36:03","updated_at":"2026-11-02 05:36:03","company":"Odyssey Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-07-01 → 2028-12-31","imminence":787,"state":"upcoming","overdue":false},{"id":335,"symbol":"SPTX","drug":"GlyphAgo","modality":"small_molecule","area":"cns","event_type":"topline_results","expect_date_from":"2026-08-03","expect_date_to":"2028-12-31","news_source_file":"documents/20260803_070303_(SPTX)_sec_0001193125-26-329528-ex991.txt","comments":"\"We expect to initiate a Phase 2/3 trial ... in the first half of 2027, with topline data expected by the end of 2028.\" Randomized, double-blind, placebo-controlled GAD trial; not yet initiated (reaffirmed in Q3 2026 release, Nov 2, 2026).","closed":0,"created_at":"2026-10-25","updated_at":"2026-11-05T12:30:32Z","company":"Seaport Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2026-08-03 → 2028-12-31","imminence":787,"state":"open","overdue":false},{"id":303,"symbol":"TARS","drug":"IRX-101","modality":"small_molecule","area":"ophthalmology","event_type":"topline_results","expect_date_from":"2028-01-01","expect_date_to":"2028-12-31","news_source_file":"documents/20260806_072530_(TARS)_sec_0001819790-26-000064.txt","comments":"Q3 2026 release (2026-11-03): \"Plan to initiate the Phase 3 Comfort study ... in the first half of 2027, with topline results expected in 2028.\" Year only = 2028-01-01..2028-12-31. Trial not yet started; company guidance.","closed":0,"created_at":"2026-10-25 11:21:01","updated_at":"2026-11-03T23:10:16Z","company":"Tarsus Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-01-01 → 2028-12-31","imminence":787,"state":"upcoming","overdue":false},{"id":266,"symbol":"TTRX","drug":"GX-03","modality":"other","area":"infectious","event_type":"topline_results","expect_date_from":"2028-10-01","expect_date_to":"2028-12-31","news_source_file":"documents/20261006_193052_(TTRX)_sec_0001213900-26-107329-ex991.txt","comments":"Planned Phase 3 onychomycosis trial: \"Q4 2028 Topline Results Expected\"; primary endpoint complete cure at Week 52, BID topical, N~250.","closed":0,"created_at":"2026-10-25","updated_at":"2026-10-25","company":"Turn Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-10-01 → 2028-12-31","imminence":787,"state":"upcoming","overdue":false},{"id":438,"symbol":"XERS","drug":"XP-8121","modality":"small_molecule","area":"metabolic","event_type":"topline_results","expect_date_from":"2028-11-01","expect_date_to":"2028-12-31","news_source_file":"documents/20260909_083341_(XERS)_sec_0001867096-26-000077-ex991.txt","comments":"\"Cornerstone trial expected to initiate by year-end, ... data expected late 2028\"; \"expected timing of topline results in late 2028\" for the Phase 3 Cornerstone study in hypothyroidism (500 patients, TSH primary endpoint). Guided window = Nov-Dec 2028.","closed":0,"created_at":"2026-10-25T07:30:40","updated_at":"2026-10-25T07:30:40","company":"Xeris Biopharma Holdings","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2028-11-01 → 2028-12-31","imminence":787,"state":"upcoming","overdue":false},{"id":872,"symbol":"ELOX","drug":"exaluren","modality":"small_molecule","area":"rare_genetic","event_type":"topline_results","expect_date_from":"2029-01-01","expect_date_to":"2029-06-30","news_source_file":"documents/20261021_193145_(ELOX)_sec_0001193125-26-428116.txt","comments":"EXPRESS Phase 2 in nonsense-mutation ADPKD (design finalized per Oct 20, 2026 PR; disclosed in 8-K item 8.01): \"First patient dosing is expected in the third quarter of 2027, with topline data expected in the first half of 2029.\" Supersedes Aug 2026 guidance of ADPKD topline \"by mid-2028\".","closed":0,"created_at":"2026-10-25T08:01:06","updated_at":"2026-10-26T14:42:21Z","company":"Eloxx Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2029-01-01 → 2029-06-30","imminence":968,"state":"upcoming","overdue":false},{"id":782,"symbol":"IKT","drug":"IKT-001","modality":"small_molecule","area":"cardiovascular","event_type":"topline_results","expect_date_from":"2029-06-01","expect_date_to":"2029-07-31","news_source_file":"documents/20260908_164128_(IKT)_sec_0001193125-26-385293-ex991.txt","comments":"Corporate overview: \"Mid 2029 Topline 6MWD readout from Part B of Phase 3 IMPROVE-PAH Study (n=300)\"; \"Mid 2029 - Part B - 6MWD Efficacy\".","closed":0,"created_at":"2026-10-25 11:54:15","updated_at":"2026-10-25 11:54:15","company":"Inhibikase Therapeutics","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2029-06-01 → 2029-07-31","imminence":999,"state":"upcoming","overdue":false},{"id":377,"symbol":"AGEN","drug":"botensilimab + balstilimab","modality":"monoclonal_antibody","area":"oncology","event_type":"interim_analysis","expect_date_from":"2029-07-01","expect_date_to":"2029-12-31","news_source_file":"documents/20260713_063023_(AGEN)_sec_0001193125-26-301414-ex991.txt","comments":"\"Interim analysis of EFS: anticipated in second half of 2029\" (ROBBIN Phase 3).","closed":0,"created_at":"2026-10-25 11:25:32","updated_at":"2026-10-25 11:25:32","company":"Agenus","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2029-07-01 → 2029-12-31","imminence":1152,"state":"upcoming","overdue":false},{"id":382,"symbol":"ALT","drug":"pemvidutide","modality":"peptide","area":"gi_hepatology","event_type":"topline_results","expect_date_from":"2029-01-01","expect_date_to":"2029-12-31","news_source_file":"documents/20260812_160409_(ALT)_sec_0001326190-26-000052.txt","comments":"PERFORMA Ph3 MASH: \"The 52-week data readout from the PERFORMA trial to support the accelerated approval of pemvidutide is anticipated in 2029.\" Trial enrolling since Aug 2026; final liver-event outcome data ~60 months.","closed":0,"created_at":"2026-10-25 11:26:08","updated_at":"2026-10-25 11:26:08","company":"Altimmune","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2029-01-01 → 2029-12-31","imminence":1152,"state":"upcoming","overdue":false},{"id":1249,"symbol":"IRWD","drug":"apraglutide","modality":"peptide","area":"gi_hepatology","event_type":"regulatory_submission","expect_date_from":"2029-01-01","expect_date_to":"2029-12-31","news_source_file":"documents/20261105_070538_(IRWD)_sec_0001104659-26-123029.txt","comments":"Q3 2026 release: \"Subject to the results of the STARS-2 clinical trial, Ironwood plans to file for regulatory approval in 2029\" for apraglutide in SBS-IF. Caveat: contingent on STARS-2 (initiated June 2026); company \"aims to identify opportunities to accelerate\" the program, so timing may move earlier.","closed":0,"created_at":"2026-11-05 12:28:56","updated_at":"2026-11-05 12:28:56","company":"Ironwood Pharmaceuticals","tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2029-01-01 → 2029-12-31","imminence":1152,"state":"upcoming","overdue":false},{"id":1213,"symbol":"PBLS","drug":"zolucatetide","modality":"peptide","area":"oncology","event_type":"topline_results","expect_date_from":"2029-01-01","expect_date_to":"2029-12-31","news_source_file":"documents/20261024_084500_(PBLS)_yahoo_news_yahoo-1b48b7e354dac93f612dc87cb3388d2f-PBLS.txt","comments":"PEDESTAL Phase 3 registrational trial in desmoid tumors: \"initiation planned in the first half of 2027 and topline results anticipated in 2029.\" Year-only guidance => 2029-01-01..2029-12-31.","closed":0,"created_at":"2026-11-04T12:50:00","updated_at":"2026-11-04T12:50:00","company":"Parabilis Medicines","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2029-01-01 → 2029-12-31","imminence":1152,"state":"upcoming","overdue":false},{"id":498,"symbol":"PROK","drug":"rilparencel","modality":"cell_therapy","area":"renal","event_type":"topline_results","expect_date_from":"2029-07-01","expect_date_to":"2029-12-31","news_source_file":"documents/20260810_161031_(PROK)_sec_0001193125-26-342373.txt","comments":"PROACT 1 confirmatory composite time-to-event analysis topline: \"anticipate topline data readout of the confirmatory endpoint (composite time-to-event) in the second half of 2029\"; full enrollment ~470 patients expected 2H 2026.","closed":0,"created_at":"2026-10-25 11:34:34","updated_at":"2026-10-25 11:34:34","company":"ProKidney","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2029-07-01 → 2029-12-31","imminence":1152,"state":"upcoming","overdue":false},{"id":304,"symbol":"TARS","drug":"gildeuretinol","modality":"small_molecule","area":"rare_genetic","event_type":"topline_results","expect_date_from":"2029-01-01","expect_date_to":"2029-12-31","news_source_file":"documents/20260910_160537_(TARS)_sec_0001819790-26-000066-ex991.txt","comments":"NORTHSTAR Phase 3 (Stargardt disease, ALK-001, acquired with Alkeus): \"currently being evaluated in the global NORTHSTAR Phase 3 trial, with topline data anticipated in 2029.\" Year only = 2029-01-01..2029-12-31. Reaffirmed in Q3 2026 release (2026-11-03).","closed":0,"created_at":"2026-10-25 11:21:03","updated_at":"2026-11-03T23:10:16Z","company":"Tarsus Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2029-01-01 → 2029-12-31","imminence":1152,"state":"upcoming","overdue":false},{"id":378,"symbol":"AGEN","drug":"botensilimab + balstilimab","modality":"monoclonal_antibody","area":"oncology","event_type":"topline_results","expect_date_from":"2030-07-01","expect_date_to":"2030-12-31","news_source_file":"documents/20260713_063023_(AGEN)_sec_0001193125-26-301414-ex991.txt","comments":"\"Final analysis of EFS: anticipated in second half of 2030\" (ROBBIN Phase 3).","closed":0,"created_at":"2026-10-25 11:25:32","updated_at":"2026-10-25 11:25:32","company":"Agenus","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2030-07-01 → 2030-12-31","imminence":1517,"state":"upcoming","overdue":false},{"id":437,"symbol":"REPL","drug":"RP1 (vusolimogene oderparepvec)","modality":"gene_therapy","area":"oncology","event_type":"topline_results","expect_date_from":"2030-01-01","expect_date_to":"2030-12-31","news_source_file":"documents/20260814_081029_(REPL)_sec_0001104659-26-096483-ex991.txt","comments":"IGNYTE-3 confirmatory Phase 3 (OS primary endpoint): \"The primary endpoint, expected to readout in 2030, is overall survival.\" Year only; widened to full year 2030.","closed":0,"created_at":"2026-10-25 07:30:26","updated_at":"2026-10-25 07:30:26","company":"Replimune Group","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2030-01-01 → 2030-12-31","imminence":1517,"state":"upcoming","overdue":false},{"id":1182,"symbol":"MDGL","drug":"resmetirom","modality":"small_molecule","area":"gi_hepatology","event_type":"topline_results","expect_date_from":"2030-01-01","expect_date_to":"2032-12-31","news_source_file":"documents/20261103_091018_(MDGL)_sec_0001628280-26-069145.txt","comments":"Q3 2026 10-Q (11/3/26): new Phase 3 MAESTRO-CSPH outcomes trial in F4c with CSPH enrichment (n>2,000); \"we expect to initiate MAESTRO-CSPH in the first half of 2027 and anticipate results in the early 2030s.\" Wide window; dependent on regulatory discussions.","closed":0,"created_at":"2026-11-03T20:17:43","updated_at":"2026-11-03T20:17:43","company":"Madrigal Pharmaceuticals","tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null,"window":"2030-01-01 → 2032-12-31","imminence":2248,"state":"upcoming","overdue":false}]