[{"id":624,"join_event_id":1261,"symbol":"LTGO","drug":"onzotrigine","modality":"small_molecule","area":"pain_anesthesia","result_type":"data_presentation","news_source_file":"documents/20261105_064700_(LTGO)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","market_impact_date":"2026-11-05","day1_return":null,"day2_return":null,"prior_1w_return":null,"comments":"ASRA abdominoplasty responder analysis disclosed in 11/5/2026 Q3 release ahead of the 11/6 poster: \"36% of participants treated with onzotrigine achieved greater than 70% pain reduction at 24 hours compared to 24% ... opioid comparator and 13% ... placebo.\" Exploratory/subgroup analysis of previously reported abdominoplasty trial.","created_at":"2026-11-05","updated_at":"2026-11-05T12:31:20Z","company":"Latigo Biotherapeutics","event_type":"data_presentation","expect_date_from":"2026-11-06","expect_date_to":"2026-11-06","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":623,"join_event_id":null,"symbol":"IOVA","drug":"lifileucel","modality":"cell_therapy","area":"oncology","result_type":"interim_analysis","news_source_file":"documents/20261105_070000_(IOVA)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","market_impact_date":"2026-11-05","day1_return":null,"day2_return":null,"prior_1w_return":null,"comments":"Updated post-ESMO data analysis of pilot lifileucel in chemotherapy-refractory UPS/DDLPS: \"the confirmed ORR by RECIST v1.1 increased to 55.6% (5/9) with multiple durable responses observed, including two responses ongoing more than a year from infusion\" (prior ESMO data: 50%, 4/8). Same Q3 release reconfirms 24.6% ORR in 69 non-squamous mNSCLC patients; no new readout.","created_at":"2026-11-05 12:29:30","updated_at":"2026-11-05T12:31:20Z","company":"Iovance Biotherapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":622,"join_event_id":null,"symbol":"LXRX","drug":"sotagliflozin","modality":"small_molecule","area":"metabolic","result_type":"safety_update","news_source_file":"documents/20261105_070000_(LXRX)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","market_impact_date":"2026-11-05","day1_return":null,"day2_return":null,"prior_1w_return":null,"comments":"\"STENO1 ... has achieved the patient exposure and safety data requirements agreed upon with the U.S. Food and Drug Administration (FDA) to support resubmission of the Company's New Drug Application (NDA). Positive safety data showed low rates of DKA comparable to standard of care in STENO1.\" Third-party investigator-initiated study in T1D; no numerical data disclosed.","created_at":"2026-11-05 12:29:20","updated_at":"2026-11-05T12:31:20Z","company":"Lexicon Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":621,"join_event_id":null,"symbol":"KRRO","drug":"KRRO-121","modality":"aso","area":"rare_genetic","result_type":"other","news_source_file":"documents/20261105_070000_(KRRO)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","market_impact_date":"2026-11-05","day1_return":null,"day2_return":null,"prior_1w_return":null,"comments":"\"Received rare pediatric disease designation from the U.S. Food and Drug Administration (FDA) for KRRO-121 for the treatment of UCDs\" (Q3 2026 corporate update). No specific grant date stated; disclosed 2026-11-05. Same release also issued via SEC 8-K exhibit 99.1.","created_at":"2026-11-05T07:28:59","updated_at":"2026-11-05T12:31:20Z","company":"Korro Bio","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":620,"join_event_id":null,"symbol":"FATE","drug":"FT819","modality":"cell_therapy","area":"immunology","result_type":"data_presentation","news_source_file":"documents/20261105_070401_(FATE)_sec_0001193125-26-448530.txt","market_impact_date":"2026-11-05","day1_return":null,"day2_return":null,"prior_1w_return":null,"comments":"Q3 2026 8-K: \"In October, updated Phase 1 data from the ongoing FT819-102 study were featured in an oral presentation at the ASN Kidney Week 2026.\" In the active-LN bendamustine cohort (the RECLAIM-LN regimen), Month 6 patients (n=2) achieved CRR or PERR; CRR sustained to Month 24 in one patient. Exact presentation day not stated.","created_at":"2026-11-05T07:30:00","updated_at":"2026-11-05T12:31:20Z","company":"Fate Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":619,"join_event_id":null,"symbol":"DMRA","drug":"DMR-001","modality":"monoclonal_antibody","area":"hematology","result_type":"other","news_source_file":"documents/20261104_160600_(DMRA)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","market_impact_date":"2026-11-05","day1_return":null,"day2_return":null,"prior_1w_return":null,"comments":"\"Achieved FDA clearance of an IND application for DMR-001, enabling initiation of the CLARITY-101 Phase 1/1b trial\" (Q3 2026 results release, 2026-11-04). FDA IND clearance enabling U.S. trial start; exact clearance date not stated in the release, so the first disclosure in our files is the 2026-11-04 release.","created_at":"2026-11-04T19:08:13","updated_at":"2026-11-05T00:09:48Z","company":"Damora Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":617,"join_event_id":1181,"symbol":"PGEN","drug":null,"modality":null,"area":null,"result_type":"other","news_source_file":"documents/20261104_160500_(PGEN)_yahoo_news_yahoo-cd001481013d6e0b570c00d4cd54d13e-PGEN.txt","market_impact_date":"2026-11-05","day1_return":null,"day2_return":null,"prior_1w_return":null,"comments":"Q3 2026 financial results and business updates delivered as guided: \"today announced third quarter 2026 financial results and business updates,\" highlighted by \"Strong Sequential PAPZIMEOS Revenue Growth and Positive Cash Flow Ahead of Guidance.\" Financial/commercial update only; no new clinical data disclosed. Yahoo copy of company release; full text not available in workspace.","created_at":"2026-11-05 00:08:09","updated_at":"2026-11-05T00:09:48Z","company":"Precigen","event_type":"other","expect_date_from":"2026-11-04","expect_date_to":"2026-11-04","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":616,"join_event_id":null,"symbol":"MLYS","drug":"lorundrostat","modality":"small_molecule","area":"cardiovascular","result_type":"data_presentation","news_source_file":"documents/20261104_160500_(MLYS)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","market_impact_date":"2026-11-05","day1_return":null,"day2_return":null,"prior_1w_return":null,"comments":"Q3 2026 release: new Launch-HTN analysis - \"46% of lorundrostat-treated participants (50 mg) achieved the AHA/ACC guideline-recommended office systolic blood pressure (SBP) target of <130 mmHg\" at Week 12, >2/3 with SBP reduction >=10 mmHg. New subgroup analysis (presented at ASN Kidney Week) showed consistent reductions with/without CKD (Stages 1-3) and 52% albuminuria reduction vs placebo.","created_at":"2026-11-04T19:07:32","updated_at":"2026-11-05T00:09:48Z","company":"Mineralys Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":615,"join_event_id":null,"symbol":"MLYS","drug":"lorundrostat","modality":"small_molecule","area":"respiratory","result_type":"topline_results","news_source_file":"documents/20261104_160500_(MLYS)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","market_impact_date":"2026-11-05","day1_return":null,"day2_return":null,"prior_1w_return":null,"comments":"Final results from Phase 2 Explore-OSA (Q3 2026 release): \"lorundrostat 50 mg taken once daily in the evening reduced morning SBP by 11.1 mmHg at Week 4 (p<0.0001), compared with a 1.0 mmHg reduction with placebo (p=NS). No measurable change in apnea-hypopnea index.\" Follows the 2026-03-09 topline that missed the AHI endpoint; favorable safety, no hyperkalemia.","created_at":"2026-11-04T19:07:32","updated_at":"2026-11-05T00:09:48Z","company":"Mineralys Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":614,"join_event_id":1237,"symbol":"AAPG","drug":"APG-5918","modality":"small_molecule","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261104_183000_(AAPG)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","market_impact_date":"2026-11-05","day1_return":null,"day2_return":null,"prior_1w_return":null,"comments":"First-in-human Phase 1 APG-5918 (EED inhibitor) in R/R T-cell lymphoma, data as of July 30, 2026: among 47 efficacy-evaluable patients ORR 44.7% (2 CR, 19 PR), DCR 74.5%; 600 mg QD (n=20) ORR 65.0%, DCR 95.0%. Disclosed in the ASH 2026 abstract release; oral presentation scheduled 12/13/2026.","created_at":"2026-11-05 00:07:24","updated_at":"2026-11-05T00:09:48Z","company":"Ascentage Pharma Group International American Depository Shares","event_type":"data_presentation","expect_date_from":"2026-12-13","expect_date_to":"2026-12-13","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":612,"join_event_id":174,"symbol":"ADMA","drug":"SG-001","modality":"protein","area":"infectious","result_type":"other","news_source_file":"documents/20261104_160500_(ADMA)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","market_impact_date":"2026-11-05","day1_return":null,"day2_return":null,"prior_1w_return":null,"comments":"SG-001 pre-IND meeting outcome (disclosed Nov 4, 2026): \"The Company recently received constructive FDA feedback on its SG-001 pre-IND meeting package regarding the proposed clinical development strategy... The FDA also indicated that ADMA's proposed assay would be acceptable for product testing, subject to appropriate validation.\" No IND submission date given.","created_at":"2026-11-04 17:02:15","updated_at":"2026-11-04T22:02:58Z","company":"ADMA Biologics","event_type":"regulatory_submission","expect_date_from":"2026-08-05","expect_date_to":"2026-12-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":611,"join_event_id":null,"symbol":"MYGN","drug":null,"modality":"other","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261104_160500_(MYGN)_globenewswire_biotech_globenewswire_biotech-sha256-a93b95d4374b058a0d5.txt","market_impact_date":"2026-11-05","day1_return":null,"day2_return":null,"prior_1w_return":null,"comments":"\"In late October 2026, new MONSTAR-SCREEN-3 data was presented as part of the European Society for Medical Oncology Congress 2026\" (Q3 2026 release, 2026-11-04). Company separately announced the data on 2026-10-22 (not in workspace), so this disclosure is a later copy, not the first.","created_at":"2026-11-04 22:02:11","updated_at":"2026-11-04T22:02:58Z","company":"Myriad Genetics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":610,"join_event_id":null,"symbol":"CTXR","drug":"LYMPHIR (denileukin diftitox-cxdl)","modality":"protein","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261104_163013_(CTXR)_sec_0001213900-26-115962.txt","market_impact_date":"2026-11-05","day1_return":null,"day2_return":null,"prior_1w_return":null,"comments":"HRQoL data from pivotal Study 302 in r/r CTCL: oral presentation at EORTC-CLTG 2026 Annual Meeting, \"held October 8–10, 2026, in Berlin, Germany\"; press release dated Nov 4, 2026. Responders (n=25) mean Skindex-29 change -5.38 to -13.69; 32% (13/41) with baseline itch >=20mm had clinically meaningful improvement. Exploratory/descriptive, not in Prescribing Information.","created_at":"2026-11-04 22:01:08","updated_at":"2026-11-04T22:02:58Z","company":"Citius Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":609,"join_event_id":null,"symbol":"CTOR","drug":"LYMPHIR (denileukin diftitox-cxdl)","modality":"protein","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261104_163014_(CTOR)_sec_0001213900-26-115964.txt","market_impact_date":"2026-11-05","day1_return":null,"day2_return":null,"prior_1w_return":null,"comments":"HRQoL results from pivotal Study 302 (NCT01871727) in r/r CTCL delivered as oral presentation at EORTC-CLTG 2026 Annual Meeting \"held October 8-10, 2026, in Berlin\"; data disclosed at that presentation, press release Nov 4. Exploratory/descriptive analyses, not in labeling.","created_at":"2026-11-04T17:00:50","updated_at":"2026-11-04T22:02:58Z","company":"Citius Oncology","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":618,"join_event_id":null,"symbol":"SLS","drug":"SLS009","modality":"small_molecule","area":"hematology","result_type":"data_presentation","news_source_file":"documents/20261104_090000_(SLS)_yahoo_news_yahoo-5684b9ed6d1f8edba2ef66e09bd40b7c-SLS.txt","market_impact_date":"2026-11-04","day1_return":0.03044,"day2_return":null,"prior_1w_return":-0.271159,"comments":"Nov 4, 2026 GlobeNewswire (via Yahoo Finance): Phase 2 SLS009 (tambiciclib) + azacitidine + venetoclax in 62 post-venetoclax AML patients: relapsed/refractory monocytic AML 54% ORR, mOS 5.8 mo; TP53-mutated 57% ORR, mOS 8.8 mo vs ~2.5 mo historical. Data disclosed with ASH 2026 abstract release; ASH presentation to follow.","created_at":"2026-11-05 00:08:37","updated_at":"2026-11-05T12:31:21Z","company":"SELLAS Life Sciences Group","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":613,"join_event_id":null,"symbol":"ONCY","drug":"pelareorep","modality":"other","area":"oncology","result_type":"other","news_source_file":"documents/20261104_093618_(ONCY)_sec_0001129928-26-000078.txt","market_impact_date":"2026-11-04","day1_return":0.076923,"day2_return":null,"prior_1w_return":-0.152174,"comments":"8-K (11/4/2026): \"issued a press release announcing translational data from its study in squamous cell anal cancer patients, specifically pelareorep's ability to impact the immune system in HPV-driven tumors.\" Translational/immunology data, not a clinical efficacy readout. Exhibit 99.1 not in workspace.","created_at":"2026-11-05 00:06:53","updated_at":"2026-11-05T12:31:20Z","company":"Oncolytics Biotech","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":607,"join_event_id":null,"symbol":"BCRX","drug":"STAR-0310","modality":"monoclonal_antibody","area":"dermatology","result_type":"trial_discontinuation","news_source_file":"documents/20261104_070312_(BCRX)_sec_0001171843-26-007097.txt","market_impact_date":"2026-11-04","day1_return":-0.038506,"day2_return":null,"prior_1w_return":0.058025,"comments":"2026-11-04 8-K/Q3 release: \"The company has discontinued development of STAR-0310, the early-stage atopic dermatitis program acquired through the acquisition of Astria Therapeutics, to focus resources on rare diseases.\" Previously paused pending partnering. First disclosure of discontinuation.","created_at":"2026-11-04 19:55:05","updated_at":"2026-11-05T12:31:20Z","company":"BioCryst Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":606,"join_event_id":954,"symbol":"COAG","drug":"sutacimig","modality":"bispecific","area":"hematology","result_type":"data_presentation","news_source_file":"documents/20261104_090500_(COAG)_globenewswire_biotech_globenewswire_biotech-sha256-44fbb5cd77e70d200df.txt","market_impact_date":"2026-11-04","day1_return":0.046172,"day2_return":null,"prior_1w_return":0.122396,"comments":"First clinical data for sutacimig in congenital FVII deficiency (abstract abs26-10755, now public via ASH): as of July 24, 2026, two severe FVIID participants received one SC dose; baseline PT >=180 s shortened >50%; ~5x accumulation of endogenous total FVII(a) maintained through Day 22; AEs low grade, not treatment related. Updated data to be presented at ASH (Dec 14, 2026).","created_at":"2026-11-04 17:49:49","updated_at":"2026-11-05T12:31:20Z","company":"Hemab Therapeutics Holdings","event_type":"interim_analysis","expect_date_from":"2026-11-01","expect_date_to":"2027-03-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":602,"join_event_id":657,"symbol":"LYEL","drug":"ronde-cel","modality":"cell_therapy","area":"hematology","result_type":"data_presentation","news_source_file":"documents/20261104_090100_(LYEL)_yahoo_news_yahoo-939ae8c25191757dd6224c8ef5f056f0-LYEL.txt","market_impact_date":"2026-11-04","day1_return":0.432683,"day2_return":null,"prior_1w_return":0.064229,"comments":"Updated ronde-cel data disclosed Nov 4, 2026 (company release, 9:01 ET): \"91% overall response rate and 77% complete response rate... in 44 patients with 3L+ R/R LBCL in the PiNACLE pivotal trial\"; Phase 1/2 2L cohort \"95% ORR and 76% CR\" in 37 patients; no Gr>=3 CRS. Same figures repeated in the Q3 2026 business-highlights release later that day. Full presentation at ASH 2026 (Dec). Yahoo syndication used - no company wire/SEC file in workspace.","created_at":"2026-11-04 10:44:13","updated_at":"2026-11-05T12:31:20Z","company":"Lyell Immunopharma","event_type":"data_presentation","expect_date_from":"2026-12-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":600,"join_event_id":803,"symbol":"HRMY","drug":"BP-205","modality":"small_molecule","area":"cns","result_type":"topline_results","news_source_file":"documents/20261104_073000_(HRMY)_globenewswire_biotech_globenewswire_biotech-sha256-786e675a8731ca50e45.txt","market_impact_date":"2026-11-04","day1_return":-0.070367,"day2_return":null,"prior_1w_return":-0.024506,"comments":"Preliminary MAD results (14-day repeated once-daily dosing, 94 healthy volunteers): Tmax ~60 min, mean t1/2 ~29h supportive of once-daily dosing; headache ~25%; insomnia <20%; no serious/severe TEAEs, no liver/visual or cardiovascular events. \"The complete MAD study results will be presented at an upcoming medical meeting.\"","created_at":"2026-11-04 13:38:22","updated_at":"2026-11-05T12:31:20Z","company":"Harmony Biosciences Holdings","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.78,"llm_reason":"The Q4 readout is Phase 1 MAD safety and PK data in healthy volunteers, which rarely moves a profitable $2B company with roughly $1B in WAKIX revenue. Efficacy data (the sleep-deprived Phase 1b) is not due until 2027, and the October patent closing arguments are a separate driver.","llm_predicted_at":"2026-10-25T15:51:33Z","llm_source":"live"},{"id":599,"join_event_id":null,"symbol":"DFTX","drug":"DT120 ODT","modality":"small_molecule","area":"cns","result_type":"data_presentation","news_source_file":"documents/20261104_070000_(DFTX)_gnews_businesswire_gnews_businesswire-sha256-ae0d3037217242d5273fbc.txt","market_impact_date":"2026-11-04","day1_return":-0.021251,"day2_return":null,"prior_1w_return":-0.098975,"comments":"2026 NEI Fall Congress presentation of DT120 ODT topline Phase 3 data in GAD and MDD, announced 2026-11-04 07:00 ET: \"Presents Topline Phase 3 Data for DT120 ODT in GAD and MDD at 2026 NEI Fall Congress\". No new data values; underlying results first reported 2026-08-12 (Voyage), 2026-09-14 (Panorama), June 2026 (Emerge). Source is a Google News/Business Wire headline stub, no primary release in workspace. First-disclosure dates remain the impact dates.","created_at":"2026-11-04 13:37:59","updated_at":"2026-11-05T12:31:20Z","company":"Definium Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":598,"join_event_id":950,"symbol":"CORT","drug":"miricorilant","modality":"small_molecule","area":"gi_hepatology","result_type":"topline_results","news_source_file":"documents/20261103_160908_(CORT)_sec_0001628280-26-069494-ex991.txt","market_impact_date":"2026-11-04","day1_return":-0.033077,"day2_return":null,"prior_1w_return":-0.064619,"comments":"Phase 2b MONARCH (miricorilant, MASH, 175 pts): \"Patients who received 200 mg of miricorilant twice weekly experienced a significantly larger reduction in liver fat than patients who received 100 mg\"; \"comparison between those who received miricorilant and placebo was not statistically significant\"; Cohort A fibrosis improvement 19.2% at 48 weeks. Announced 2026-11-03.","created_at":"2026-11-04 09:32:30","updated_at":"2026-11-05T12:31:20Z","company":"Corcept Therapeutics","event_type":"topline_results","expect_date_from":"2026-07-29","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.8,"llm_reason":"Miricorilant MASH Phase 2b is a minor pipeline asset for a $9B commercial company driven by Korlym, Lifyorli and the relacorilant Cushing's PDUFA. A MONARCH readout is unlikely to move the stock 10% or more.","llm_predicted_at":"2026-11-01T13:10:54Z","llm_source":"live"},{"id":595,"join_event_id":null,"symbol":"LENZ","drug":"VIZZ","modality":"small_molecule","area":"ophthalmology","result_type":"other","news_source_file":"documents/20261103_160852_(LENZ)_sec_0001815776-26-000059.txt","market_impact_date":"2026-11-04","day1_return":-0.011429,"day2_return":null,"prior_1w_return":0.111111,"comments":"UAE marketing authorization: \"In October 2026, the Emirates Drug Establishment granted Product Marketing Authorization Approval in the UAE for VIZZ... first ex-U.S. regulatory approval of VIZZ and first approval under the Lunatus License.\" Exact October day not stated; disclosed in Q3 10-Q filed 2026-11-03.","created_at":"2026-11-04 09:30:04","updated_at":"2026-11-05T12:31:20Z","company":"LENZ Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":594,"join_event_id":458,"symbol":"RARE","drug":null,"modality":"gene_therapy","area":"gi_hepatology","result_type":"trial_discontinuation","news_source_file":"documents/20261103_211407_(RARE)_yahoo_news_yahoo-dffa049ea2de7878d70af3eb13128b9b-RARE.txt","market_impact_date":"2026-11-04","day1_return":0.03187,"day2_return":null,"prior_1w_return":-0.007164,"comments":"Q3 2026 earnings-call summary (2026-11-03): quarter included \"the termination of its Wilson disease program\"; the guided Q4 2026 Stage 1 UX701 (Cyprus2+) data will therefore not be reported. Aggregator summary of the call transcript; no drug name given in the sentence, so drug left NULL.","created_at":"2026-11-04 05:25:34","updated_at":"2026-11-05T12:31:20Z","company":"Ultragenyx Pharmaceutical","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"","llm_prediction":"small_impact","llm_confidence":0.68,"llm_reason":"UX701 cohort-4 dose-finding data in Wilson disease is a secondary catalyst. RARE's valuation is driven by GTX-102, the two PDUFA dates and Crysvita revenue. Interim dose-finding results are unlikely to move the stock by 10% or more, though the depressed ~$1.6B market cap adds some volatility risk.","llm_predicted_at":"2026-10-25T15:50:10Z","llm_source":"live"},{"id":589,"join_event_id":null,"symbol":"CBLL","drug":"Ceribell System (Quantitative EEG Trending and Amplitude-Integrated EEG Analysis algorithms)","modality":"other","area":"cns","result_type":"fda_approval","news_source_file":"documents/20261103_163625_(CBLL)_sec_0001193125-26-445487.txt","market_impact_date":"2026-11-04","day1_return":-0.031128,"day2_return":null,"prior_1w_return":0.038575,"comments":"Q3 2026 earnings release (8-K Ex-99.1, Nov 3, 2026): \"Received U.S. Food and Drug Administration 510(k) clearance for Quantitative EEG Trending and Amplitude-Integrated EEG Analysis\". Clearance day not stated; first public disclosure is this release. Device/software, not a drug. No event existed for this clearance.","created_at":"2026-11-03 18:09:38","updated_at":"2026-11-05T12:31:20Z","company":"CeriBell","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":588,"join_event_id":null,"symbol":"NRIX","drug":"SAR448272","modality":"small_molecule","area":"immunology","result_type":"trial_discontinuation","news_source_file":"documents/20261103_160100_(NRIX)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","market_impact_date":"2026-11-04","day1_return":-0.382262,"day2_return":null,"prior_1w_return":-0.032959,"comments":"Nurix release 2026-11-03: \"Sanofi notified Nurix of its decision to discontinue the Phase 1 first-in-human clinical trial of SAR448272, an oral STAT6 degrader, and to terminate the SAR448272 program.\" Partner-initiated; Nurix announced it for its own collaboration. Nurix no longer eligible for SAR448272 milestones/royalties.","created_at":"2026-11-03 23:09:35","updated_at":"2026-11-05T12:31:20Z","company":"Nurix Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":597,"join_event_id":null,"symbol":"IDYA","drug":"darovasertib","modality":"small_molecule","area":"oncology","result_type":"trial_discontinuation","news_source_file":"documents/20261103_080427_(IDYA)_sec_0001193125-26-444225-ex991.txt","market_impact_date":"2026-11-03","day1_return":-0.009798,"day2_return":0.032876,"prior_1w_return":-0.037713,"comments":"\"Due to ongoing site activation and enrollment challenges, IDEAYA has decided to stop enrollment and close the Phase 3 OptimUM-010 trial\" (neoadjuvant primary uveal melanoma); est. cost savings $100-125M to be reallocated. No prior event existed for OptimUM-010.","created_at":"2026-11-04T04:31:00","updated_at":"2026-11-04T22:02:59Z","company":"IDEAYA Biosciences","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":596,"join_event_id":783,"symbol":"IDYA","drug":"darovasertib + crizotinib","modality":"small_molecule","area":"oncology","result_type":"other","news_source_file":"documents/20261103_080427_(IDYA)_sec_0001193125-26-444225-ex991.txt","market_impact_date":"2026-11-03","day1_return":-0.009798,"day2_return":0.032876,"prior_1w_return":-0.037713,"comments":"Q3 2026 business update: \"Completed NDA submission in Q3'26 to support the potential U.S. approval of darovasertib plus crizotinib in metastatic uveal melanoma\"; filed under FDA RTOR program. Resolves the H2 2026 submission guidance.","created_at":"2026-11-04T04:31:00","updated_at":"2026-11-04T22:02:59Z","company":"IDEAYA Biosciences","event_type":"regulatory_submission","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":592,"join_event_id":null,"symbol":"CMPS","drug":"COMP360","modality":"small_molecule","area":"cns","result_type":"topline_results","news_source_file":"documents/20261103_080722_(CMPS)_sec_0001816590-26-000076.txt","market_impact_date":"2026-11-03","day1_return":0.021403,"day2_return":0.001164,"prior_1w_return":-0.238914,"comments":"Phase 3 COMP005 Part C open-label long-term data, first announced Sept 2026 (\"In September 2026, we announced Part C results from our Phase 3 COMP005 trial\"); this 10-Q is the earliest source in the workspace. Key results: \"average 13-point reduction from baseline at week 52\"; 40%-45% responders, ~30% remitters post Part C dose; safety consistent with Parts A and B.","created_at":"2026-11-04 01:18:32","updated_at":"2026-11-05T04:16:58Z","company":"COMPASS Pathways Plc American Depository Shares","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":587,"join_event_id":null,"symbol":"FTH","drug":"PIKTOR","modality":"small_molecule","area":"oncology","result_type":"other","news_source_file":"documents/20261103_081410_(FTH)_sec_0001193125-26-444410.txt","market_impact_date":"2026-11-03","day1_return":0.021841,"day2_return":0.017303,"prior_1w_return":0.142602,"comments":"First disclosure of FDA Fast Track designation: \"FDA granted Fast Track designation to PIKTOR in combination with paclitaxel for the treatment of patients with advanced or recurrent endometrial cancer whose tumors harbor a PAM pathway alteration and who have previously been treated with platinum-based chemotherapy and an immune checkpoint inhibitor.\" Announced in 3Q26 results (Business Wire 2026-11-03 07:30); exact designation date not given.","created_at":"2026-11-03T16:03:16","updated_at":"2026-11-04T22:02:59Z","company":"Faeth Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":585,"join_event_id":null,"symbol":"TVTX","drug":"sparsentan","modality":"small_molecule","area":"renal","result_type":"data_presentation","news_source_file":"documents/20261102_160531_(TVTX)_sec_0001438533-26-000074-ex991.txt","market_impact_date":"2026-11-03","day1_return":0.003045,"day2_return":0.074985,"prior_1w_return":-0.014209,"comments":"Q3 2026 release: FILSPARI data \"presented at ASN Kidney Week 2026\" - PROTECT urinary biomarkers (macrophage/B-cell, inflammation, complement) fell more than irbesartan at wk110; DUPLEX post hoc (n=254 FSGS) 48% vs 27% UPCR reduction at wk108; SPARTAN Ph2 final analysis 75% complete proteinuria remission, eGFR slope -1.11 through wk110.","created_at":"2026-11-03 16:48:35","updated_at":"2026-11-04T17:51:33Z","company":"Travere Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":584,"join_event_id":null,"symbol":"MCRB","drug":"SER-155","modality":"other","area":"hematology","result_type":"data_presentation","news_source_file":"documents/20261103_070000_(MCRB)_globenewswire_biotech_globenewswire_biotech-sha256-dbf07ea37d5ea0aba25.txt","market_impact_date":"2026-11-03","day1_return":0.071038,"day2_return":0.066326,"prior_1w_return":-0.075758,"comments":"GlobeNewswire (Nov 3, 2026): \"Seres Therapeutics Announces Publication of SER-155 Phase 1b Results in Nature Medicine\"; \"a 77% relative risk reduction in bloodstream infections and significantly lower systemic antibiotic exposure with SER-155 compared with placebo\" in allo-HCT recipients. Peer-reviewed publication of the Phase 1b dataset (distinct from the July 8, 2026 irEC IST topline). Release text available was a summary/abstract only.","created_at":"2026-11-03 07:34:07","updated_at":"2026-11-05T04:16:57Z","company":"Seres Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":582,"join_event_id":null,"symbol":"CRSP","drug":"CTX310","modality":"gene_therapy","area":"cardiovascular","result_type":"other","news_source_file":"documents/20261102_160100_(CRSP)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","market_impact_date":"2026-11-03","day1_return":0.0,"day2_return":0.035707,"prior_1w_return":0.019996,"comments":"Q3 2026 release (2026-11-02): \"the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designations to CTX310 for the treatment of severe hypertriglyceridemia (sHTG) and for the treatment of patients with elevated LDL-C.\"","created_at":"2026-11-03 04:24:02","updated_at":"2026-11-04T22:02:59Z","company":"CRISPR Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":581,"join_event_id":344,"symbol":"SNDX","drug":"axatilimab","modality":"monoclonal_antibody","area":"respiratory","result_type":"trial_discontinuation","news_source_file":"documents/20261102_160100_(SNDX)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com_7f72b6.txt","market_impact_date":"2026-11-03","day1_return":0.09084,"day2_return":-0.284815,"prior_1w_return":-0.009077,"comments":"3Q26 business update (Nov 2, 2026, 16:01 ET): \"Based on the results observed, Syndax does not plan to move forward with further development of axatilimab in IPF.\" Follows the Oct 12, 2026 MAXPIRe Phase 2 miss (result #480); company states the decision does not affect ongoing axatilimab trials in other indications.","created_at":"2026-11-02 23:21:51","updated_at":"2026-11-04T17:51:33Z","company":"Syndax Pharmaceuticals","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"","llm_prediction":"small_impact","llm_confidence":0.6,"llm_reason":"The IPF Phase 2 (MAXPIRe) is a speculative add-on for a $1.2B company with two commercial drugs driving value. IPF expectations for CSF-1R are likely modest and the readout is shared 50/50 with Incyte, so the move is likely under 10% either way. A clear success could still exceed 10%.","llm_predicted_at":"2026-10-25T15:49:45Z","llm_source":"live"},{"id":586,"join_event_id":395,"symbol":"RXRX","drug":"REC-4881","modality":"small_molecule","area":"gi_hepatology","result_type":"data_presentation","news_source_file":"documents/20261102_163256_(RXRX)_sec_0001601830-26-000144.txt","market_impact_date":"2026-11-02","day1_return":-0.049628,"day2_return":0.005196,"prior_1w_return":0.089189,"comments":"CGA-IGC Presidential Plenary (Nov 2, 2026) presented new TUPELO analyses: \"9 of 11 patients (82%) with measurable lower GI polyp burden at baseline had reductions after 12 weeks of treatment, with a 50% median reduction\"; \"6 of 8 patients with polyps >5 mm at baseline had fewer of these polyps\"; 85% below baseline 12 weeks off treatment. Prior upper-GI/total-burden results first disclosed Oct 15 (result 478).","created_at":"2026-11-03 16:51:42","updated_at":"2026-11-03T16:51:46Z","company":"Recursion Pharmaceuticals","event_type":"data_presentation","expect_date_from":"2026-11-02","expect_date_to":"2026-11-02","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":579,"join_event_id":282,"symbol":"TLSA","drug":"foralumab","modality":"monoclonal_antibody","area":"cns","result_type":"topline_results","news_source_file":"documents/20261102_070008_(TLSA)_sec_0001213900-26-114650.txt","market_impact_date":"2026-11-02","day1_return":-0.1625,"day2_return":0.03,"prior_1w_return":-0.157895,"comments":"INFORM-MS Phase 2a (na-SPMS) topline met dual primary endpoints: TSPO PET microglial activation reduction for 50 ug vs placebo (-0.0231 WM SUVR, p=0.0168) and safety/tolerability; MFIS -6.17 (50 ug, p=0.035), -7.18 (100 ug, p=0.040) vs -3.12 placebo. Caveat: \"no statistically significant difference in PET... in patients treated with 100 ug\"; EDSS unchanged.","created_at":"2026-11-02 20:04:25","updated_at":"2026-11-05T00:08:25Z","company":"Tiziana Life Sciences","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.55,"llm_reason":"Small-cap ($127M) with going-concern doubt and a lead-asset readout from the randomized, placebo-controlled Phase 2a INFORM-MS trial in na-SPMS. The stock should move sharply either way. Progressive MS is a hard indication and the trial is likely small, which raises failure risk, but company spin and retail interest could drive a rally.","llm_predicted_at":"2026-10-25T15:49:33Z","llm_source":"live"},{"id":577,"join_event_id":332,"symbol":"SPTX","drug":"GlyphAllo","modality":"small_molecule","area":"cns","result_type":"topline_results","news_source_file":"documents/20261102_070354_(SPTX)_sec_0001193125-26-442625.txt","market_impact_date":"2026-11-02","day1_return":0.020918,"day2_return":0.009495,"prior_1w_return":-0.049005,"comments":"Phase 1 driving simulation trial in healthy volunteers met primary and key secondary endpoints: \"evening dosing of GlyphAllo at 375 mg did not impair next-morning driving performance compared to placebo on Day 5\"; well-tolerated, no SAEs. 10-Q: \"In September 2026, we reported positive topline data\" — result first disclosed Sept 2026; Nov 2, 2026 8-K is the earliest primary source in the workspace.","created_at":"2026-11-02 17:57:01","updated_at":"2026-11-03T21:04:58Z","company":"Seaport Therapeutics","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.72,"llm_reason":"The 2H 2026 readout is a Phase 1 driving-simulation safety study in healthy volunteers, not efficacy, and the Phase 2b BUOY-1 data that drive value are due in 1H 2027. A clean result is likely expected and largely priced in; only a clear impairment signal would cause a big drop.","llm_predicted_at":"2026-10-25T15:49:39Z","llm_source":"live"},{"id":576,"join_event_id":374,"symbol":"AGEN","drug":"botensilimab + balstilimab","modality":"monoclonal_antibody","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261102_064200_(AGEN)_yahoo_news_yahoo-758d0067fbe006f9cb08df4c7b70db33-AGEN.txt","market_impact_date":"2026-11-02","day1_return":-0.045322,"day2_return":0.021439,"prior_1w_return":0.080569,"comments":"2026-11-02: \"today announced the peer-reviewed publication of results from the investigator-sponsored, multicenter Phase 2 UNICORN trial evaluating ... neoadjuvant botensilimab (BOT) ... alone or in combination with balstilimab (BAL) ... in patients with resectable, locally advanced colon cancer.\" Full text is the Business Wire release syndicated via Yahoo (same 06:42 timestamp).","created_at":"2026-11-02 17:56:51","updated_at":"2026-11-04T13:39:34Z","company":"Agenus","event_type":"data_presentation","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":575,"join_event_id":470,"symbol":"QURE","drug":"ifezuntirgene inilparvovec (AMT-130)","modality":"gene_therapy","area":"cns","result_type":"other","news_source_file":"documents/20261102_070500_(QURE)_globenewswire_biotech_globenewswire_biotech-sha256-3434fc99347344529ad.txt","market_impact_date":"2026-11-02","day1_return":-0.074909,"day2_return":0.017632,"prior_1w_return":0.107,"comments":"FDA accepted the BLA for review and granted Priority Review with PDUFA target action date of May 1, 2027 (announced 2026-11-02), completing the filing review of the submission event.","created_at":"2026-11-02","updated_at":"2026-11-03T16:51:46Z","company":"uniQure","event_type":"regulatory_submission","expect_date_from":"2026-07-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":574,"join_event_id":331,"symbol":"ANTX","drug":"epetraborole","modality":"small_molecule","area":"hematology","result_type":"other","news_source_file":"documents/20261102_070000_(ANTX)_gnews_businesswire_gnews_businesswire-sha256-736058ab082c18483816ef.txt","market_impact_date":"2026-11-02","day1_return":-0.039735,"day2_return":-0.027586,"prior_1w_return":0.276056,"comments":"U.S. FDA IND clearance to proceed with planned global Phase 2 study of oral epetraborole in polycythemia vera; headline published 2026-11-02 07:00 ET (\"AN2 Therapeutics Receives U.S. FDA IND Clearance to Proceed with Planned Phase 2 Global Study...\"). Caveat: Google News aggregator copy of the Business Wire release; only the headline text is available (no primary filing/full text in workspace), so details beyond clearance are unconfirmed.","created_at":"2026-11-02 13:46:05","updated_at":"2026-11-03T16:51:46Z","company":"AN2 Therapeutics","event_type":"regulatory_submission","expect_date_from":"2026-07-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":573,"join_event_id":1143,"symbol":"DRUG","drug":"BMB-101","modality":"small_molecule","area":"cns","result_type":"clinical_hold","news_source_file":"documents/20261102_073000_(DRUG)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","market_impact_date":"2026-11-02","day1_return":-0.523463,"day2_return":-0.094084,"prior_1w_return":0.047637,"comments":"\"its investigational new drug application ('IND') for Developmental and Epileptic Encephalopathies ('DEEs') and related Protocol BMB-101-105 has been placed on a partial clinical hold following the FDA's review\" (Nov 2, 2026). Company says hold covers only planned US Phase 2 DEE trial; cause: mouse toxicity and inadequate PK/juvenile tox data for pediatric enrollment. No prior event existed.","created_at":"2026-11-02 13:45:30","updated_at":"2026-11-03T21:01:53Z","company":"Bright Minds Biosciences","event_type":"other","expect_date_from":"2026-11-02","expect_date_to":"2026-12-02","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":560,"join_event_id":755,"symbol":"INO","drug":"INO-3107","modality":"dna_vaccine","area":"rare_genetic","result_type":"fda_approval","news_source_file":"documents/20261030_180100_(INO)_prnewswire_biotech_prnewswire_biotech-sha256-21ff4c0ca1ae8928d91759.txt","market_impact_date":"2026-11-02","day1_return":2.15,"day2_return":-0.005291,"prior_1w_return":-0.333333,"comments":"FDA granted accelerated approval of VOCERYQ (formerly INO-3107) on Oct 30, 2026 to reduce frequency of surgery in adults with RRP; based on 7/26 (27%) complete responders in RRP-001. Confirms PDUFA date. Earliest disclosure: FDA press release 16:32 ET; company PR 18:01 ET and 8-K EX-99.1 (2026-11-02 07:15) are duplicates of the same event.","created_at":"2026-10-30","updated_at":"2026-11-03T16:51:46Z","company":"Inovio Pharmaceuticals","event_type":"pdufa","expect_date_from":"2026-10-30","expect_date_to":"2026-10-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":605,"join_event_id":1214,"symbol":"STOK","drug":"zorevunersen","modality":"aso","area":"cns","result_type":"data_presentation","news_source_file":"documents/20261029_160516_(STOK)_sec_0001193125-26-437775-ex991.txt","market_impact_date":"2026-10-30","day1_return":-0.002277,"day2_return":0.007227,"prior_1w_return":0.025292,"comments":"New exploratory Vineland-3 sub-analysis (multicomponent assessment of four subdomains) from Phase 1/2a and OLE studies presented Oct 29, 2026; 10-Q: \"we presented a new exploratory analysis of Vineland-3 data ... using the multicomponent assessment\". Exploratory only; EMPEROR Q3 2027 readout remains the catalyst.","created_at":"2026-11-04T12:48:54","updated_at":"2026-11-04T17:51:33Z","company":"Stoke Therapeutics","event_type":"data_presentation","expect_date_from":"2026-10-29","expect_date_to":"2026-10-29","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":593,"join_event_id":1125,"symbol":"AGIO","drug":"mitapivat","modality":"small_molecule","area":"hematology","result_type":"other","news_source_file":"documents/20261030_070000_(AGIO)_yahoo_news_yahoo-e1448eed5a2a574ecaf0022db147c9dc-AGIO.txt","market_impact_date":"2026-10-30","day1_return":-0.179425,"day2_return":-0.01964,"prior_1w_return":0.001076,"comments":"Outcome of the original Nov 1, 2026 PDUFA goal date: FDA \"classified Agios' response to the information request as a major amendment to the mitapivat sNDA, resulting in a three-month review extension\"; new goal date February 1, 2027. FDA requested additional information on whether a REMS is needed in SCD. Review-extension decision, not an approval/CRL. Confirmed by later coverage (GEN, AllSci, HCPLive, 2026-11-02).","created_at":"2026-11-04T00:22:57","updated_at":"2026-11-04T05:25:53Z","company":"Agios Pharmaceuticals","event_type":"pdufa","expect_date_from":"2026-11-01","expect_date_to":"2026-11-01","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":567,"join_event_id":null,"symbol":"CRSP","drug":"CASGEVY (exagamglogene autotemcel)","modality":"cell_therapy","area":"hematology","result_type":"other","news_source_file":"documents/20261030_100300_(CRSP)_google_news_google_news-f0e836eed86c0f0007f715a49dc92cb6-CRS.txt","market_impact_date":"2026-10-30","day1_return":-0.052341,"day2_return":-0.020031,"prior_1w_return":0.085417,"comments":"UK MHRA expanded CASGEVY approval to children five and over with SCD or TDT: \"UK's MHRA Expands Approval of CRISPR Therapy Casgevy to Children Five and Over\" (GenomeWeb, 2026-10-30 10:03 EDT). This follows the Q2 2026 release noting \"Regulatory submissions have also been completed for CASGEVY in ... the United Kingdom (U.K.) for the treatment of children 5 to 11 years of age.\" Headline-only aggregator copy; no SEC/wire primary source available in workspace. Non-US regulatory decision, recorded as result_type other.","created_at":"2026-11-01 17:16:10","updated_at":"2026-11-02T17:59:34Z","company":"CRISPR Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":563,"join_event_id":1072,"symbol":"MGTX","drug":null,"modality":null,"area":null,"result_type":"data_presentation","news_source_file":"documents/20261029_201009_(MGTX)_google_news_google_news-19ac140e77af0b00550671241840580a-MGT.txt","market_impact_date":"2026-10-30","day1_return":-0.022154,"day2_return":-0.015806,"prior_1w_return":-0.006653,"comments":"Aggregator (ad-hoc-news.de) headline, no primary release found in workspace: \"New gene-therapy data span eye, ALS and xerostomia\" — confirms the ESGCT 2026 posters (Oct 27-30, Hamburg) were presented. No numeric data or drug attribution in available text; source is a Google News summary, so details are unverified.","created_at":"2026-10-31 16:44:42","updated_at":"2026-11-02T17:59:34Z","company":"MeiraGTx Holdings","event_type":"data_presentation","expect_date_from":"2026-10-27","expect_date_to":"2026-10-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":557,"join_event_id":419,"symbol":"ABOS","drug":"sabirnetug","modality":"monoclonal_antibody","area":"cns","result_type":"topline_results","news_source_file":"documents/20261030_070612_(ABOS)_sec_0001628280-26-068425.txt","market_impact_date":"2026-10-30","day1_return":-0.908297,"day2_return":0.141429,"prior_1w_return":0.11165,"comments":"8-K (Oct 30, 2026): Phase 2 ALTITUDE-AD \"did not meet its primary endpoint of change from baseline in cognitive and functional decline ... iADRS at 18 months compared to placebo at either the 35 mg/kg or the 50 mg/kg dose\"; CDR-SB missed; ARIA-E ~10%; significant amyloid PET reduction; company plans to cease sabirnetug development.","created_at":"2026-10-30 18:06:44","updated_at":"2026-11-02T22:10:33Z","company":"Acumen Pharmaceuticals","event_type":"topline_results","expect_date_from":"2026-11-01","expect_date_to":"2026-11-30","event_closed":1,"tier":"Core","llm_prediction":"large_impact","llm_confidence":0.8,"llm_reason":"The binary Phase 2 ALTITUDE-AD readout of sabirnetug's 18-month iADRS endpoint is the defining catalyst for a ~$149M company. Cash covers only into early 2027 and there is a going-concern warning, so the stock should move well over 10% either way. Direction is uncertain: the AβO-selective approach is unproven in efficacy trials, but a clean ARIA profile with clinical benefit could produce a large rally.","llm_predicted_at":"2026-10-25T15:50:06Z","llm_source":"live"},{"id":556,"join_event_id":489,"symbol":"PRTA","drug":"PRX019","modality":"monoclonal_antibody","area":"cns","result_type":"trial_discontinuation","news_source_file":"documents/20261029_160327_(PRTA)_sec_0001559053-26-000026.txt","market_impact_date":"2026-10-30","day1_return":-0.046171,"day2_return":-0.022432,"prior_1w_return":0.076364,"comments":"8-K Item 1.02 (filed 2026-10-29 16:03, earliest disclosure): \"Bristol Myers Squibb informed Prothena ... on October 28, 2026 that it has decided not to advance PRX019 further in the clinic.\" License agreement terminates 2027-01-28; no further milestones payable. Earlier aggregator headline (TipRanks) superseded.","created_at":"2026-10-30 16:03:30","updated_at":"2026-11-02T17:59:34Z","company":"Prothena","event_type":"other","expect_date_from":"2026-08-06","expect_date_to":"2026-12-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":555,"join_event_id":605,"symbol":"NRXP","drug":"preservative-free ketamine","modality":"small_molecule","area":"cns","result_type":"fda_approval","news_source_file":"documents/20261030_070000_(NRXP)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","market_impact_date":"2026-10-30","day1_return":-0.146617,"day2_return":-0.044053,"prior_1w_return":0.108333,"comments":"FDA approved the ANDA for Preservative-Free Ketamine, ahead of the Nov 10, 2026 GDUFA goal date: \"FDA has approved the Company's Abbreviated New Drug Application (ANDA) for Preservative-Free Ketamine. The approval comes ahead of the FDA-announced November 10, approval goal date.\"","created_at":"2026-10-30T07:50:57Z","updated_at":"2026-11-03T04:24:50Z","company":"NRX Pharmaceuticals","event_type":"pdufa","expect_date_from":"2026-11-10","expect_date_to":"2026-11-10","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":554,"join_event_id":773,"symbol":"IMNM","drug":"varegacestat","modality":"small_molecule","area":"oncology","result_type":"other","news_source_file":"documents/20261030_073000_(IMNM)_gnews_businesswire_gnews_businesswire-sha256-c6a727908d91d812cf2634.txt","market_impact_date":"2026-10-30","day1_return":-0.004374,"day2_return":0.075783,"prior_1w_return":0.001643,"comments":"Business Wire release 2026-10-30 07:30 ET (earliest copy; same text on Yahoo Finance/Google News): \"Immunome Announces EMA Validation of Marketing Authorization Application for Varegacestat ... the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for varegacestat ... for the treatment of adults with desmoid tumors.\" Validation confirms the MAA is complete; review ongoing (no decision date stated).","created_at":"2026-10-30 07:50:36","updated_at":"2026-11-03T04:24:50Z","company":"Immunome","event_type":"regulatory_submission","expect_date_from":"2026-08-11","expect_date_to":"2026-12-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":550,"join_event_id":1108,"symbol":"ENTA","drug":null,"modality":"small_molecule","area":"infectious","result_type":"other","news_source_file":"documents/20261029_160515_(ENTA)_sec_0001193125-26-437774.txt","market_impact_date":"2026-10-30","day1_return":-0.039462,"day2_return":-0.026144,"prior_1w_return":-0.040448,"comments":"8-K 8.01 (2026-10-29): \"On October 29, 2026, the UPC released its decision concluding that the '265 Patent is invalid. The UPC also determined that the infringement action was unfounded.\" Legal/patent outcome, no drug data; drug left NULL as the sentence names no company molecule.","created_at":"2026-10-29 19:33:06","updated_at":"2026-11-03T04:24:50Z","company":"Enanta Pharmaceuticals","event_type":"other","expect_date_from":"2026-09-29","expect_date_to":"2026-12-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":549,"join_event_id":1087,"symbol":"IOVA","drug":"lifileucel","modality":"cell_therapy","area":"oncology","result_type":"topline_results","news_source_file":"documents/20261029_170028_(IOVA)_sec_0001104659-26-120261.txt","market_impact_date":"2026-10-30","day1_return":-0.112971,"day2_return":-0.054245,"prior_1w_return":-0.323904,"comments":"Updated IOV-LUN-202 Cohorts 1 and 2 (non-squamous mNSCLC, Oct 14, 2026 data cutoff): 24.6% ORR (17/69; 15 confirmed + 2 uPR) vs 25.6% previously in 39 patients; KRAS-wt 43.3% (13/30) vs KRAS-mutant 11.4% (4/35); biomarker-enriched subgroup (KRAS-wt/HER2-wt/ever smoker) 59.1% (13/22). sBLA planned 2027.","created_at":"2026-10-29 21:28:30","updated_at":"2026-11-03T04:24:50Z","company":"Iovance Biotherapeutics","event_type":"topline_results","expect_date_from":"2026-10-29","expect_date_to":"2026-10-29","event_closed":1,"tier":"Core","llm_prediction":"large_upside","llm_confidence":0.5,"llm_reason":"The company pre-announced 'positive' registrational Phase 2 data for lifileucel in nonsquamous mNSCLC, a large market expansion beyond melanoma. A $6.4B cap suggests the stock has already rallied on prior data, but a positive registrational lung readout could still move it more than 10%.","llm_predicted_at":"2026-10-29T00:52:00Z","llm_source":"live"},{"id":551,"join_event_id":1101,"symbol":"ACRV","drug":"ACR-2316","modality":"small_molecule","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261029_080000_(ACRV)_yahoo_news_yahoo-17cba81e46b240addd7c4ac404ed883d-ACRV.txt","market_impact_date":"2026-10-29","day1_return":-0.01676,"day2_return":-0.039773,"prior_1w_return":-0.019178,"comments":"\"Durable clinical activity, including confirmed complete and partial responses (RECIST 1.1) with ACR-2316 monotherapy in heavily pretreated, AP3-predicted tumor types, including endometrial and lung cancers\" (Acrivon release, Oct 29 2026) — actual data disclosed ahead of the Nov 20 2026 EORTC-NCI-AACR late-breaking oral plenary (event #1101), which remains open. Yahoo copy used; GlobeNewswire ingest is headline-only.","created_at":"2026-10-30 03:39:40","updated_at":"2026-10-30T20:13:42Z","company":"Acrivon Therapeutics","event_type":"data_presentation","expect_date_from":"2026-11-20","expect_date_to":"2026-11-20","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":548,"join_event_id":1141,"symbol":"ELOX","drug":"exaluren","modality":"small_molecule","area":"rare_genetic","result_type":"other","news_source_file":"documents/20261029_080000_(ELOX)_yahoo_news_yahoo-43a484e31dd9c293e1a8fe219c00b783-ELOX.txt","market_impact_date":"2026-10-29","day1_return":0.006098,"day2_return":0.018939,"prior_1w_return":-0.013534,"comments":"FDA cleared the IND for exaluren in nonsense-mutation ADPKD, enabling EXPRESS Phase 2: \"the FDA has cleared the Company's Investigational New Drug (IND) application for exaluren for the treatment of nonsense-mutation autosomal dominant polycystic kidney disease (ADPKD).\" No SEC filing for this release; earliest copy is the 2026-10-29 08:00 ET wire syndication (Yahoo), so that text is used.","created_at":"2026-10-29T15:23:44","updated_at":"2026-11-02T22:09:40Z","company":"Eloxx Pharmaceuticals","event_type":"regulatory_submission","expect_date_from":"2026-10-29","expect_date_to":"2026-10-29","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":547,"join_event_id":null,"symbol":"ADCT","drug":"ZYNLONTA","modality":"adc","area":"hematology","result_type":"other","news_source_file":"documents/20261029_073000_(ADCT)_yahoo_news_yahoo-a92f378e3344020efb11145117f91e6a-ADCT.txt","market_impact_date":"2026-10-29","day1_return":-0.080247,"day2_return":0.013423,"prior_1w_return":0.08,"comments":"Japan regulatory milestone by licensee Tanabe Pharma: \"filed a marketing authorization application with Japan's Ministry of Health, Labor and Welfare on October 29, 2026, for ZYNLONTA (loncastuximab tesirine-lpyl)\" in r/r DLBCL. Filing by partner; no approval-decision date stated, so no event created. Earliest copy is the company release carried by Yahoo (07:30 ET); Google News/Finansavisen and Investing.com copies are duplicates.","created_at":"2026-10-29 19:23:53","updated_at":"2026-11-01T13:10:37Z","company":"ADC Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":546,"join_event_id":null,"symbol":"BCTX","drug":"Bria-IMT","modality":"vaccine","area":"oncology","result_type":"safety_update","news_source_file":"documents/20261028_164306_(BCTX)_sec_0001493152-26-049041.txt","market_impact_date":"2026-10-29","day1_return":-0.054286,"day2_return":-0.08006,"prior_1w_return":-0.027778,"comments":"10-K (FY ended 2026-07-31): independent DSMB issued its seventh consecutive positive recommendation after reviewing Phase 3 Bria-ABC (Bria-IMT + CPI, NCT06072612) data in metastatic breast cancer: \"As of September 14, 2026, the DSMB had issued seven consecutive positive recommendations, in each case identifying no safety concerns and recommending continuation of the study.\" Outcome announced 2026-09-14; earliest available primary source is this SEC 10-K narrative.","created_at":"2026-10-29 15:22:03","updated_at":"2026-10-30T20:15:34Z","company":"BriaCell Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":543,"join_event_id":433,"symbol":"RFL","drug":"Trappsol Cyclo","modality":"other","area":"rare_genetic","result_type":"other","news_source_file":"documents/20261029_081618_(RFL)_sec_0001213900-26-113564.txt","market_impact_date":"2026-10-29","day1_return":-0.07438,"day2_return":0.026875,"prior_1w_return":-0.069231,"comments":"NDA submitted to FDA on 2026-10-28 by Cyclo Therapeutics for remibetadex (Trappsol Cyclo) in Niemann-Pick Disease Type C: \"On October 28, 2026, Cyclo Therapeutics submitted a New Drug Application (NDA) to the FDA seeking approval of remibetadex\". Includes request for rare pediatric disease priority review voucher; acceptance/filing not yet confirmed.","created_at":"2026-10-29 13:07:32","updated_at":"2026-10-30T16:04:05Z","company":"Rafael Holdings","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":540,"join_event_id":967,"symbol":"CHRS","drug":"tagmokitug","modality":"monoclonal_antibody","area":"oncology","result_type":"interim_analysis","news_source_file":"documents/20261028_160500_(CHRS)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","market_impact_date":"2026-10-29","day1_return":-0.225862,"day2_return":-0.000891,"prior_1w_return":0.137255,"comments":"Interim TREGCHECK data (cutoff Oct 14, 2026) announced Oct 28, 2026: 1L ESCC cORR 75% (6/8), 89% (8/9) post-cutoff, 100% cORR PD-L1+; 2L ESCC 700mg cORR 16.7%, mPFS 5.5 mo; HNSCC/GI/CRC activity. Company plans to expand ESCC cohorts. Earliest source: GlobeNewswire Oct 28 16:05 ET; same release filed as 8-K ex-99.1 on Oct 29 08:10.","created_at":"2026-10-29 00:50:06","updated_at":"2026-11-02T15:52:44Z","company":"Coherus Oncology","event_type":"interim_analysis","expect_date_from":"2026-10-28","expect_date_to":"2026-10-28","event_closed":1,"tier":"Core","llm_prediction":"large_impact","llm_confidence":0.5,"llm_reason":"Small-cap ($162M) company with a dedicated KOL webcast on interim CCR8 antibody data. Tagmokitug is the key pipeline value driver, so a 10%+ move either way is likely. The CCR8 class history is mixed and the new ATM adds dilution risk, so direction is uncertain.","llm_predicted_at":"2026-10-25T15:47:42Z","llm_source":"live"},{"id":544,"join_event_id":1075,"symbol":"ECOR","drug":"Quell","modality":"other","area":"oncology","result_type":"topline_results","news_source_file":"documents/20261028_080000_(ECOR)_globenewswire_biotech_globenewswire_biotech-sha256-f4944ce1d05f9b5a9d2.txt","market_impact_date":"2026-10-28","day1_return":0.085052,"day2_return":-0.036817,"prior_1w_return":0.036048,"comments":"Completed CIPN study data disclosed with 510(k) submission: \"neuropathic pain scores decreased by approximately 40%, compared with approximately 24-33% in the sham group\" (142-subject RCT) and 11.6% vs 8.7% EORTC-CIPN20 improvement (between-group difference met 0.2 threshold); 26-subject open-label study +13%. Post-hoc moderate/severe subgroup ~50% vs ~30%.","created_at":"2026-10-29T09:10:00","updated_at":"2026-10-30T03:41:04Z","company":"electroCore","event_type":"regulatory_submission","expect_date_from":"2026-10-28","expect_date_to":"2026-10-28","event_closed":1,"tier":"Core","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":541,"join_event_id":1078,"symbol":"COYA","drug":"COYA 302","modality":"protein","area":"cns","result_type":"data_presentation","news_source_file":"documents/20261028_080000_(COYA)_gnews_businesswire_gnews_businesswire-sha256-02c5befa3805eaa18843f0.txt","market_impact_date":"2026-10-28","day1_return":-0.014563,"day2_return":-0.019704,"prior_1w_return":-0.021378,"comments":"Poster presented at the 2026 Annual NEALS Meeting on Oct 28, 2026: NfL biomarker stratification methodology in the ALSTARS Trial (COYA 302 in ALS). Source quote: \"announces a poster presentation at the 2026 Annual NEALS Meeting on October 28th in Clearwater, Florida\". No numerical data in the release or in the Oct 29 BioSpace reprint (duplicate), which repeats \"to Present\"; poster listed as methodology, not a topline readout.","created_at":"2026-10-29 09:03:23","updated_at":"2026-10-29T21:30:27Z","company":"Coya Therapeutics","event_type":"data_presentation","expect_date_from":"2026-10-28","expect_date_to":"2026-10-28","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":536,"join_event_id":828,"symbol":"GERN","drug":"imetelstat","modality":"aso","area":"hematology","result_type":"trial_discontinuation","news_source_file":"documents/20261028_080000_(GERN)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","market_impact_date":"2026-10-28","day1_return":-0.156522,"day2_return":-0.020619,"prior_1w_return":-0.072581,"comments":"IMpactMF Phase 3 (R/R myelofibrosis) discontinued after independent DMC advised trial unlikely to meet primary OS endpoint; no new safety signals. Quote: \"the decision to discontinue the Phase 3 IMpactMF trial ... This decision was based on a recommendation from the independent Data Monitoring Committee (DMC).\" Also confirmed in 8-K/Ex-99.1 filed later same day (documents/20261028_164735_(GERN)_sec_0001193125-26-436272.txt); Y! and Google News copies are duplicates of the 08:00 ET wire.","created_at":"2026-10-28 12:17:41","updated_at":"2026-10-30T03:41:03Z","company":"Geron","event_type":"interim_analysis","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"","llm_prediction":"large_impact","llm_confidence":0.55,"llm_reason":"The IMpactMF interim OS analysis is a binary Phase 3 readout and the main value driver beyond flat-ish RYTELO sales, at a ~$726M market cap. Stopping early for efficacy would likely send shares sharply up. A failure, or merely continuing to the 2028 final analysis, could cut either way. Either outcome could move the stock ≥10%, but the direction is uncertain.","llm_predicted_at":"2026-10-25T15:51:45Z","llm_source":"live"},{"id":535,"join_event_id":null,"symbol":"PVLA","drug":"QTORIN rapamycin","modality":"small_molecule","area":"dermatology","result_type":"other","news_source_file":"documents/20261028_073013_(PVLA)_sec_0001193125-26-435113.txt","market_impact_date":"2026-10-28","day1_return":0.109548,"day2_return":0.02787,"prior_1w_return":0.072547,"comments":"\"FDA has accepted for filing and granted Priority Review to the Company's New Drug Application (NDA) for QTORIN 3.9% rapamycin anhydrous gel ... for microcystic lymphatic malformations\"; PDUFA target action date February 28, 2027.","created_at":"2026-10-28 12:17:10","updated_at":"2026-10-30T03:41:03Z","company":"Palvella Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":534,"join_event_id":52,"symbol":"BNTC","drug":"BB-301","modality":"gene_therapy","area":"rare_genetic","result_type":"data_presentation","news_source_file":"documents/20261028_080330_(BNTC)_sec_0001193125-26-435159.txt","market_impact_date":"2026-10-28","day1_return":0.013825,"day2_return":0.003409,"prior_1w_return":-0.039823,"comments":"\"today announced positive interim clinical results from the ongoing BB-301 Phase 1b/2a first-in-human study ... for Patients treated with high dose BB-301 and continued durable improvements ... low dose\"; 100% of treated patients (6 low dose, 3 high dose) responders; no SAEs. Released Oct 28 2026 alongside ESGCT late-breaking poster.","created_at":"2026-10-28 08:16:34","updated_at":"2026-10-30T03:41:03Z","company":"Benitec Biopharma","event_type":"data_presentation","expect_date_from":"2026-10-27","expect_date_to":"2026-10-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":533,"join_event_id":null,"symbol":"MLYS","drug":"lorundrostat","modality":"small_molecule","area":"renal","result_type":"topline_results","news_source_file":"documents/20261028_070500_(MLYS)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","market_impact_date":"2026-10-28","day1_return":0.011832,"day2_return":-0.006548,"prior_1w_return":-0.020853,"comments":"Press release (2026-10-28): \"Explore-CKD met its primary endpoint; lorundrostat 25 mg once daily added to an SGLT2 inhibitor achieved a statistically significant reduction in systolic blood pressure at four weeks.\" Results published in Kidney International; only the headline bullet is in the workspace file, no numeric detail.","created_at":"2026-10-28T08:16:00","updated_at":"2026-10-30T03:41:03Z","company":"Mineralys Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":538,"join_event_id":1084,"symbol":"ARWR","drug":"plozasiran","modality":"sirna","area":"metabolic","result_type":"fda_approval","news_source_file":"documents/20261027_113600_(ARWR)_yahoo_news_yahoo-f019fc2ff628cd65598de96f6fc00fe2-ARWR.txt","market_impact_date":"2026-10-27","day1_return":0.000848,"day2_return":-0.004066,"prior_1w_return":0.030578,"comments":"Oct 27, 2026 company release: REDEMPLO (plozasiran) is a \"newly licensed new treatment option available on the NHS\" for adults in England and Wales with FCS; Oct 28 trade headline: \"Arrowhead gains UK marketing authorisation for Redemplo\" (MHRA licence covering patients diagnosed by genetic testing or clinical criteria). Same event; earliest disclosure used.","created_at":"2026-10-28 16:27:19","updated_at":"2026-10-28T18:34:23Z","company":"Arrowhead Pharmaceuticals","event_type":"other","expect_date_from":"2026-10-27","expect_date_to":"2026-10-27","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":530,"join_event_id":568,"symbol":"ONCY","drug":"pelareorep","modality":"other","area":"oncology","result_type":"topline_results","news_source_file":"documents/20261027_094602_(ONCY)_sec_0001129928-26-000076.txt","market_impact_date":"2026-10-27","day1_return":-0.021277,"day2_return":-0.037609,"prior_1w_return":-0.06,"comments":"8-K (10/27/2026): \"On October 27, 2026, Oncolytics Biotech Inc. issued a press release announcing updated data from Cohort 4 of the GOBLET study, which is evaluating pelareorep and atezolizumab in second-line and later squamous cell anal cancer.\" Same-day GlobeNewswire release (09:30 ET) headlined \"Strong Durability and Survival\"; Stock Titan summary: \"every patient who responded to treatment survived beyond a year. Some lived past two years.\" 8-K cover only; Exhibit 99.1 not in workspace. Cohort 5 data still pending.","created_at":"2026-10-28T00:04:59","updated_at":"2026-10-28T18:32:35Z","company":"Oncolytics Biotech","event_type":"topline_results","expect_date_from":"2026-10-14","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.68,"llm_reason":"The expected readout is additional data from GOBLET Cohorts 4 and 5, a Phase 1/2 study being wound down. Incremental single-arm data from a known program, released over months, rarely moves the stock 10% or more, even at a ~$66M market cap.","llm_predicted_at":"2026-10-25T15:50:38Z","llm_source":"live"},{"id":525,"join_event_id":472,"symbol":"VNDA","drug":"tradipitant (NEREUS)","modality":"small_molecule","area":"gi_hepatology","result_type":"topline_results","news_source_file":"documents/20261027_065000_(VNDA)_yahoo_news_yahoo-a6260cfb1a1056b0558fc871241aead6-VNDA.txt","market_impact_date":"2026-10-27","day1_return":0.01269,"day2_return":-0.028822,"prior_1w_return":-0.036675,"comments":"\"positive results from Study 3601 (VP-VLY-686-3601), a Phase III randomized, placebo-controlled study evaluating NEREUS (tradipitant) ... for the prevention of vomiting associated with GLP-1 receptor agonist therapy. The study showed significant reduction in overall vomiting episodes (27% p=0.006 as well as reduction of frequent (60% p=0.008) and extreme vomiting (81% p=0.0003) episodes.\" Company release text carried by Yahoo; no SEC exhibit or wire original in this run.","created_at":"2026-10-27 15:39:27","updated_at":"2026-10-28T16:28:44Z","company":"Vanda Pharmaceuticals","event_type":"topline_results","expect_date_from":"2026-08-05","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.6,"llm_reason":"Phase III of already-approved tradipitant in GLP-1 vomiting is a label expansion. Investor attention is split across many catalysts, including Bysanti, the Quimilza PDUFA and other Phase IIIs, and Vanda readouts have historically drawn muted, skeptical reactions. Though the ~$245M market cap gives some sensitivity, a move under 10% is most likely.","llm_predicted_at":"2026-10-25T15:50:17Z","llm_source":"live"},{"id":524,"join_event_id":null,"symbol":"ARTV","drug":"AlloNK","modality":"cell_therapy","area":"immunology","result_type":"safety_update","news_source_file":"documents/20261027_073000_(ARTV)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","market_impact_date":"2026-10-27","day1_return":-0.306818,"day2_return":0.004684,"prior_1w_return":0.04584,"comments":"Disclosed two Grade 5 events: leukoencephalopathy in a Phase 2a participant \"assessed as likely related to fludarabine-associated neurotoxicity\" and a second sudden death assessed as unrelated. \"Following notification, the FDA asked Artiva to pause enrollment and dosing in the Phase 2a study.\" Disclosed publicly Oct 27, 2026; event dates not stated.","created_at":"2026-10-27T09:31:17","updated_at":"2026-10-28T16:28:44Z","company":"Artiva Biotherapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":523,"join_event_id":359,"symbol":"ARTV","drug":"AlloNK","modality":"cell_therapy","area":"immunology","result_type":"trial_discontinuation","news_source_file":"documents/20261027_073000_(ARTV)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","market_impact_date":"2026-10-27","day1_return":-0.306818,"day2_return":0.004684,"prior_1w_return":0.04584,"comments":"Oct 27, 2026: \"it will discontinue further development of AlloNK (AB-101)... updated longer-term data showed that durability of clinical response did not meet the threshold the Company required.\" Planned Phase 3 pivotal trial will not be initiated; no additional patients dosed.","created_at":"2026-10-27T09:31:17","updated_at":"2026-10-28T16:28:44Z","company":"Artiva Biotherapeutics","event_type":"topline_results","expect_date_from":"2028-07-01","expect_date_to":"2028-12-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":522,"join_event_id":11,"symbol":"SXTP","drug":"tafenoquine","modality":"small_molecule","area":"infectious","result_type":"interim_analysis","news_source_file":"documents/20261027_080517_(SXTP)_sec_0001213900-26-112698.txt","market_impact_date":"2026-10-27","day1_return":-0.147465,"day2_return":0.128243,"prior_1w_return":0.049577,"comments":"Expanded access study (NCT06478641) results for first five completed patients: all five \"much improved or very much improved\" and negative on conventional PCR; \"Four of the five patients (80%) were also nonreactive on a highly sensitive blood-donor nucleic acid amplification test (NAT)\". Two patients remain on treatment; study open pending FDA discussions. Disclosed early vs guided NOV 2026 window.","created_at":"2026-10-27 13:31:29","updated_at":"2026-10-28T16:28:43Z","company":"60 DEGREES PHARMACEUTICALS, INC","event_type":"other","expect_date_from":"2026-11-01","expect_date_to":"2026-11-30","event_closed":1,"tier":"Core","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":521,"join_event_id":184,"symbol":"ACRS","drug":"ATI-052","modality":"bispecific","area":"immunology","result_type":"topline_results","news_source_file":"documents/20261027_060000_(ACRS)_globenewswire_pharma_globenewswire_pharma-sha256-349980251e9ef51ba07b.txt","market_impact_date":"2026-10-27","day1_return":0.0,"day2_return":0.044855,"prior_1w_return":0.08908,"comments":"Positive Phase 1b POC primary analysis results for both AD and asthma trials: AD (n=14) 45% placebo-adjusted EASI change at day 57, 78% placebo-adjusted EASI-50; asthma single 480 mg dose, 59% FeNO reduction at day 15, 200 mL FEV1 improvement; no conjunctivitis. Same release filed as 8-K EX-99.1 at 06:06 ET.","created_at":"2026-10-27T07:30:00","updated_at":"2026-10-29T13:08:38Z","company":"Aclaris Therapeutics","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.5,"llm_reason":"ATI-052 is the lead asset driving most of the ~$560M valuation. Placebo-controlled Phase 1b proof-of-concept readouts in asthma and atopic dermatitis are binary for a small-cap, so a move of at least 10% is likely. Direction is uncertain given high expectations from the potency claims.","llm_predicted_at":"2026-10-25T15:49:02Z","llm_source":"live"},{"id":520,"join_event_id":1066,"symbol":"TNXP","drug":"TONMYA (cyclobenzaprine HCl sublingual tablets)","modality":"small_molecule","area":"cns","result_type":"data_presentation","news_source_file":"documents/20261027_070000_(TNXP)_globenewswire_pharma_globenewswire_pharma-sha256-75253c33232c1b414428.txt","market_impact_date":"2026-10-27","day1_return":0.016981,"day2_return":-0.003711,"prior_1w_return":-0.075044,"comments":"IASP poster analysis of Phase 3 RELIEF/RESILIENT: greater reduction in FIQR Symptoms and Function scores vs placebo at Weeks 2, 6, 10, 14; Week 14 significant (p<=0.001 RESILIENT; nominally p<0.01 RELIEF). Post-hoc analysis of previously reported studies.","created_at":"2026-10-27","updated_at":"2026-10-29T13:08:38Z","company":"Tonix Pharmaceuticals Holding","event_type":"data_presentation","expect_date_from":"2026-10-26","expect_date_to":"2026-10-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":519,"join_event_id":1065,"symbol":"BEAM","drug":"BEAM-301","modality":"gene_therapy","area":"metabolic","result_type":"data_presentation","news_source_file":"documents/20261027_070000_(BEAM)_yahoo_news_yahoo-80a3619af8c4ace0efeb5c5c58040743-BEAM.txt","market_impact_date":"2026-10-27","day1_return":0.046658,"day2_return":0.155823,"prior_1w_return":-0.016536,"comments":"BEAM-301 GSDIa Phase 1/2 initial data presented at ESGCT 33rd Annual Congress (Oct 27-30, 2026); 2026-10-27 GlobeNewswire release: \"In the 40 mg Cohort, Two Patients Achieved 15 Hours of Controlled Fasting... and No Longer Required Starch Supplementation.\" Underlying data first disclosed 2026-10-13 (see result 474). The 2026-10-27 11:05 MarketBeat/Yahoo and Google News items are later copies of the same release, not new data. Source is the Yahoo copy of the GlobeNewswire release.","created_at":"2026-10-27T07:26:05","updated_at":"2026-10-29T13:08:38Z","company":"Beam Therapeutics","event_type":"data_presentation","expect_date_from":"2026-10-27","expect_date_to":"2026-10-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":518,"join_event_id":null,"symbol":"CLRB","drug":"iopofosine I 131","modality":"radiopharma","area":"hematology","result_type":"other","news_source_file":"documents/20261027_071500_(CLRB)_globenewswire_pharma_globenewswire_pharma-sha256-e0eabecf1206e859cb80.txt","market_impact_date":"2026-10-27","day1_return":0.0,"day2_return":0.024793,"prior_1w_return":0.080357,"comments":"Case study: 53-yo patient with double-hit DLBCL, 4 prior lines, single 57.5 mCi dose (Mar 2018) produced CR by Day 85 with complete resolution of target lesion; \"durable complete response lasting more than eight years\"; no progression and no further therapy as of May 2026. Single-patient data; company plans journal publication/meeting presentation (no date).","created_at":"2026-10-27 07:30:00","updated_at":"2026-10-29T13:08:37Z","company":"Cellectar Biosciences","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":517,"join_event_id":null,"symbol":"CGEM","drug":"velinotamig","modality":"bispecific","area":"hematology","result_type":"other","news_source_file":"documents/20261027_070000_(CGEM)_globenewswire_biotech_globenewswire_biotech-sha256-03e8e9e31a12163ee53.txt","market_impact_date":"2026-10-27","day1_return":0.020633,"day2_return":0.048518,"prior_1w_return":0.040057,"comments":"FDA and Australian TGA \"have granted clearance to initiate its global Phase 1b/2a clinical trial in adults with relapsing and refractory immune thrombocytopenia (ITP) and warm autoimmune hemolytic anemia (wAIHA)\" (BCMAxCD3 T cell engager, SC dosing; NCT07738822). Regulatory clearance, not approval; no outcome data yet.","created_at":"2026-10-27 11:25:16","updated_at":"2026-10-29T13:08:37Z","company":"Cullinan Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":604,"join_event_id":544,"symbol":"PBLS","drug":"zolucatetide","modality":"peptide","area":"oncology","result_type":"other","news_source_file":"documents/20261024_084500_(PBLS)_yahoo_news_yahoo-1b48b7e354dac93f612dc87cb3388d2f-PBLS.txt","market_impact_date":"2026-10-26","day1_return":0.024141,"day2_return":0.059129,"prior_1w_return":0.074286,"comments":"FDA alignment on dose/regimen for the PEDESTAL Phase 3 desmoid trial: \"Data informed FDA-aligned dose and regimen selection for upcoming PEDESTAL Phase 3 registrational trial.\" Evidence that the guided Q4 2026 FDA interaction occurred; source text is an excerpt of the Oct 24, 2026 GlobeNewswire release.","created_at":"2026-11-04T12:52:00","updated_at":"2026-11-04T17:51:33Z","company":"Parabilis Medicines","event_type":"other","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":566,"join_event_id":949,"symbol":"CORT","drug":"relacorilant","modality":"small_molecule","area":"oncology","result_type":"topline_results","news_source_file":"documents/20261026_080000_(CORT)_yahoo_news_yahoo-06380281957c385b783691bda8b379ad-CORT.txt","market_impact_date":"2026-10-26","day1_return":0.014791,"day2_return":0.005279,"prior_1w_return":-0.220588,"comments":"Part A of Phase 2 BELLA (relacorilant/Lifyorli + nab-paclitaxel + bevacizumab in 95 patients with platinum-resistant ovarian cancer): \"announced positive results from Part A of the company's Phase 2 BELLA trial\" — Business Wire release 2026-10-26 08:00 ET, here via Yahoo syndication (SEC exhibit not in run). Reported 59% response rate, longer median PFS and higher ORR vs comparators, no new safety signals; stronger in bevacizumab-naive patients.","created_at":"2026-11-01 13:08:34","updated_at":"2026-11-03T12:36:16Z","company":"Corcept Therapeutics","event_type":"topline_results","expect_date_from":"2026-07-29","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":526,"join_event_id":648,"symbol":"MGNX","drug":"lorigerlimab","modality":"bispecific","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261026_070600_(MGNX)_resolution_news_resolution_news-713d88e75ce22ff02c2ec65ae0a309cd.txt","market_impact_date":"2026-10-26","day1_return":-0.026667,"day2_return":0.105023,"prior_1w_return":-0.307692,"comments":"LINNET Phase 2 interim results, ESMO 2026 poster 1278P (2026-10-26): \"Four patients with clear cell gynecologic cancer responded; all four responses were ongoing at cutoff\" (Stock Titan 07:06 EDT); \"MacroGenics Announces Positive Interim Phase 2 LINNET Results for Lorigerlimab in Advanced Clear Cell Gynecologic Cancer\" (TradingView 07:27 EDT); Investing.com 07:33 EDT. Aggregator sources only - no primary company release/8-K in workspace. Event 648 closed: update now guided for 1H 2027 (event 650).","created_at":"2026-10-27","updated_at":"2026-10-27T17:43:48Z","company":"MacroGenics","event_type":"data_presentation","expect_date_from":"2026-10-26","expect_date_to":"2026-10-26","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":515,"join_event_id":null,"symbol":"ZVRA","drug":"arimoclomol","modality":"small_molecule","area":"rare_genetic","result_type":"data_presentation","news_source_file":"documents/20261025_082138_(ZVRA)_google_news_google_news-0d70e45b15f250190893e47da379f31e-ZVR.txt","market_impact_date":"2026-10-26","day1_return":-0.028542,"day2_return":0.055089,"prior_1w_return":-0.013078,"comments":"Aggregator item: \"Zevra publishes positive MIPLYFFA data in infants with NPC\". Same data (open-label pediatric substudy in NPC, ages 12 to <24 months) was first published by Zevra in June 2026 in Molecular Genetics and Metabolism Reports per the Q2 10-Q, so the 2026-10-25 item is a later re-report; only a Google News headline exists in the workspace, so date may lag first disclosure.","created_at":"2026-10-26","updated_at":"2026-10-28T16:26:54Z","company":"Zevra Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":512,"join_event_id":null,"symbol":"CPIX","drug":"ifetroban","modality":"small_molecule","area":"rare_genetic","result_type":"other","news_source_file":"documents/20261026_164000_(CPIX)_prnewswire_biotech_prnewswire_biotech-https-www.prnewswire.com-news.txt","market_impact_date":"2026-10-26","day1_return":-0.487633,"day2_return":0.043678,"prior_1w_return":0.182451,"comments":"PR: pre-NDA meeting held this fall; \"Following the meeting FDA granted the Company's request for a rolling review of the NDA\" for ifetroban in DMD cardiomyopathy, and Cumberland \"announced plans to submit\" an NDA (FIGHT DMD as pivotal). No NDA submission date stated; rolling review granted, no filing window given.","created_at":"2026-10-26 21:02:33","updated_at":"2026-10-27T15:40:29Z","company":"Cumberland Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":508,"join_event_id":1059,"symbol":"IMNM","drug":"varegacestat","modality":"small_molecule","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261026_070000_(IMNM)_gnews_businesswire_gnews_businesswire-sha256-15ac9c9c92e3791cb1b796.txt","market_impact_date":"2026-10-26","day1_return":-0.005559,"day2_return":0.050308,"prior_1w_return":0.092289,"comments":"Business Wire release, 2026-10-26 07:00 ET (earliest copy; same text carried by Yahoo Finance, BioSpace and Finviz later that day): \"today announced the presentation of additional clinical data for varegacestat ... at the 2026 European Society for Medical Oncology (ESMO) Congress. The data were featured in four presentations, including a rapid oral presentation on patient-rep...\" Released text truncated in capture; all four presentations cover varegacestat desmoid tumor data, recorded as one result.","created_at":"2026-10-26 18:55:55","updated_at":"2026-10-27T19:52:12Z","company":"Immunome","event_type":"data_presentation","expect_date_from":"2026-10-26","expect_date_to":"2026-10-26","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":504,"join_event_id":162,"symbol":"ANAB","drug":"dostarlimab","modality":"monoclonal_antibody","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261024_181141_(ANAB)_resolution_news_resolution_news-f344f552eb9bdf0e6dc4d408c114c253.txt","market_impact_date":"2026-10-26","day1_return":0.000821,"day2_return":0.025118,"prior_1w_return":0.045484,"comments":"GSK reported positive interim results from pivotal Phase 2 AZUR-1 (dostarlimab monotherapy, dMMR/MSI-H locally advanced rectal cancer) on Oct 24, 2026 (\"GSK Says Positive Interim Results From Phase Ii Azur-1 Trial\"), followed by ESMO 2026 late-breaking presentation coverage on Oct 25 (\"AZUR-1 at ESMO 2026\", Oncodaily). Caveat: only aggregator/secondary coverage in workspace; no GSK primary release or SEC exhibit. Data first disclosed by GSK July 2026 (result 97).","created_at":"2026-10-26T10:45:57","updated_at":"2026-10-27T15:40:31Z","company":"AnaptysBio","event_type":"data_presentation","expect_date_from":"2026-10-25","expect_date_to":"2026-10-25","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":503,"join_event_id":560,"symbol":"ORKA","drug":"ORKA-001","modality":"monoclonal_antibody","area":"dermatology","result_type":"topline_results","news_source_file":"documents/20261026_070000_(ORKA)_globenewswire_biotech_globenewswire_biotech-sha256-6173724fa9cbdaf4e85.txt","market_impact_date":"2026-10-26","day1_return":0.127012,"day2_return":0.064209,"prior_1w_return":0.114278,"comments":"EVERLAST-B Phase 2b Week 16 topline: \"61% of patients in the high-dose group achieved the primary endpoint of PASI 100 at Week 16, compared to 0% of patients receiving placebo (p<0.0001)\"; PASI 90 86% and IGA 0/1 86% high dose. Safety consistent with IL-23p19 class. Company PR 2026-10-26 07:00 ET; same release filed as 8-K EX-99.1 at 08:00 ET.","created_at":"2026-10-26 14:44:04","updated_at":"2026-10-27T15:40:30Z","company":"Oruka Therapeutics","event_type":"topline_results","expect_date_from":"2026-10-26","expect_date_to":"2026-10-26","event_closed":1,"tier":"Core","llm_prediction":"small_impact","llm_confidence":0.6,"llm_reason":"The Q4 2026 readout is likely EVERLAST-B Week 16 dose-ranging data or EVERLAST-A 52-week durability data. The mechanism is already de-risked by strong Phase 2a results (63.5% PASI 100), and the $5.4B market cap prices in much of that success. A confirmatory IL-23 readout is therefore likely to move the stock less than 10%.","llm_predicted_at":"2026-10-25T15:50:35Z","llm_source":"live"},{"id":502,"join_event_id":587,"symbol":"NVCT","drug":"NXP200","modality":"small_molecule","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261026_083000_(NVCT)_globenewswire_pharma_globenewswire_pharma-sha256-9e2f6ddb069522d801f1.txt","market_impact_date":"2026-10-26","day1_return":-0.077805,"day2_return":-0.000541,"prior_1w_return":0.077957,"comments":"ESMO 2026 oral presentation (Madrid, Oct 23-27, 2026) of Phase 1b NXP200 monotherapy in recurrent/progressive BRAF V600-mutant glioma (data cutoff May 4, 2026): ORR 40.0% (8/20) high-grade incl. 3 CRs (1 preliminary); 42.9% (3/7) low-grade incl. 1 confirmed CR; 12-mo survival 95% high-grade / 100% low-grade; mOS 17.15 mo high-grade; DCR 85.2%; 14.3% G3+ TRAEs. Study run by Haisco. Oct 26 copies: yahoo, Stock Titan, Manila Times, TradingView.","created_at":"2026-10-26T08:38:12","updated_at":"2026-10-28T22:44:26Z","company":"Nuvectis Pharma","event_type":"data_presentation","expect_date_from":"2026-10-23","expect_date_to":"2026-10-27","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":501,"join_event_id":1046,"symbol":"IMTX","drug":"anzu-cel (IMA203)","modality":"cell_therapy","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261024_023000_(IMTX)_globenewswire_biotech_globenewswire_biotech-sha256-883a738886957778db7.txt","market_impact_date":"2026-10-26","day1_return":-0.021888,"day2_return":0.028671,"prior_1w_return":0.086181,"comments":"Poster 2128P (ESMO 2026, Madrid; Sapna Patel): exploratory analyses of anzu-cel Phase 1b melanoma cohort, data cutoff Sept 24, 2025, \"demonstrated durable clinical benefit following a one-time treatment\"; no single baseline characteristic predicted prolonged PFS; lower tumor burden, lower LDH and higher effector-to-target ratio associated with longer PFS. Exploratory only. First disclosed in Oct 24, 2026 press release.","created_at":"2026-10-26 08:41:00","updated_at":"2026-10-27T15:40:28Z","company":"Immatics","event_type":"data_presentation","expect_date_from":"2026-10-23","expect_date_to":"2026-10-27","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":500,"join_event_id":91,"symbol":"EIKN","drug":"EIK1001","modality":"small_molecule","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261026_060036_(EIKN)_sec_0001193125-26-430860.txt","market_impact_date":"2026-10-26","day1_return":-0.236915,"day2_return":0.043321,"prior_1w_return":-0.021563,"comments":"ESMO 2026 updated TeLuRide-005 data (topline ORR/DCR): efficacy-evaluable n=65, pooled ORR 63.1%, DCR 89.2%; squamous ORR 72.4%, DCR 100%, median DOR 12.9 mo; non-squamous ORR 55.6%. Safety n=72, G3+ TRAEs 48.6%, no G3+ CRS. \"presentation of updated data for EIK1001 at the 2026 ESMO Congress\", 2026-10-26.","created_at":"2026-10-26 12:37:58","updated_at":"2026-10-27T15:40:30Z","company":"Eikon Therapeutics","event_type":"data_presentation","expect_date_from":"2026-10-26","expect_date_to":"2026-10-26","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":499,"join_event_id":76,"symbol":"IOVA","drug":"lifileucel","modality":"cell_therapy","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261026_070000_(IOVA)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","market_impact_date":"2026-10-26","day1_return":-0.022001,"day2_return":0.060595,"prior_1w_return":0.034508,"comments":"Pilot trial of one-time lifileucel monotherapy in refractory metastatic UPS and DDLPS: 50% confirmed ORR (4/8 PRs, 2 UPS + 2 DDLPS), all responses ongoing at 6+/26+/40+/46+ weeks; data cut-off Sept 9, 2026. Presented orally at ESMO Congress 2026 (Oct 26).","created_at":"2026-10-26T08:40:00","updated_at":"2026-10-27T15:40:30Z","company":"Iovance Biotherapeutics","event_type":"data_presentation","expect_date_from":"2026-10-26","expect_date_to":"2026-10-26","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":498,"join_event_id":null,"symbol":"AVBP","drug":"ARR-217","modality":"adc","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261026_060049_(AVBP)_sec_0001104659-26-118550.txt","market_impact_date":"2026-10-26","day1_return":-0.268571,"day2_return":-0.014323,"prior_1w_return":0.260504,"comments":"Initial Phase 1 data (NCT07066657, cutoff 2026-08-05) \"presented as part of an oral presentation at the 2026 European Society for Medical Oncology (ESMO) Congress 2026\": 44.8% (13/29) ORR at 6 mg/kg Q3W in pre-treated CRC; 30.1% (37/123) Gr>=3 TRAE; no Gr5 TRAE or ILD. First disclosure via 8-K exhibit (release dated Oct 25, 2026).","created_at":"2026-10-26 12:37:31","updated_at":"2026-10-27T15:40:30Z","company":"ArriVent BioPharma","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":497,"join_event_id":null,"symbol":"MIRM","drug":"zilurgisertib","modality":"small_molecule","area":"rare_genetic","result_type":"topline_results","news_source_file":"documents/20261026_164703_(MIRM)_sec_0001759425-26-000054.txt","market_impact_date":"2026-10-26","day1_return":0.035825,"day2_return":0.007326,"prior_1w_return":0.00312,"comments":"8-K (event 2026-10-26): Positive results from Cohort 2 of pivotal PROGRESS study of ATEBRIOZ (zilurgisertib) in pediatric FOP ages 6 to <12. Week 24 total HO lesion volume -8.09 cm3 vs +9.14 cm3 placebo (nominal p=0.003); no new HO lesions in treated patients; CAJIS improved -0.80 vs -0.09. sNDA planned 1H2027 for ages 6-<12.","created_at":"2026-10-26 12:37:04","updated_at":"2026-10-27T15:40:30Z","company":"Mirum Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":496,"join_event_id":null,"symbol":"CVM","drug":"Multikine","modality":"protein","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261026_080000_(CVM)_gnews_businesswire_gnews_businesswire-sha256-f414312bdec1e98e201433.txt","market_impact_date":"2026-10-26","day1_return":-0.030488,"day2_return":-0.049497,"prior_1w_return":-0.083799,"comments":"Aggregator (Google News/Business Wire) headline only; no primary release available in workspace. Title: \"CEL-SCI Presents New Phase 3 Multikine Data at World Congress: Pre-Surgical Biomarkers Identify Head & Neck Cancer Patients Achieving 73% 5-Year Survival\". Congress name and presentation date not stated in available text; 2026-10-26 is the disclosure date.","created_at":"2026-10-26T08:36:13","updated_at":"2026-10-27T15:40:30Z","company":"Cel-Sci","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":495,"join_event_id":1038,"symbol":"ELDN","drug":"tegoprubart","modality":"monoclonal_antibody","area":"renal","result_type":"data_presentation","news_source_file":"documents/20261026_070000_(ELDN)_globenewswire_pharma_globenewswire_pharma-sha256-8fbce8dd8fe7e649bb9b.txt","market_impact_date":"2026-10-26","day1_return":-0.03913,"day2_return":0.060452,"prior_1w_return":0.079812,"comments":"Phase 2 BESTOW patient-reported outcomes at 12 months: \"statistically significant improvement in the symptoms and problems subscale compared with tacrolimus at Month 12, with mean changes from baseline of 9.0 and 3.3 points, respectively (p<0.05)\"; SF-12 MCS +1.5 vs -1.6. Data first disclosed in the oral session on Oct 23, 2026; this release is the company's first written disclosure.","created_at":"2026-10-26","updated_at":"2026-10-27T15:40:30Z","company":"Eledon Pharmaceuticals","event_type":"data_presentation","expect_date_from":"2026-10-21","expect_date_to":"2026-10-25","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":492,"join_event_id":1085,"symbol":"AMRN","drug":"icosapent ethyl (VAZKEPA/VASCEPA)","modality":"other","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261025_081100_(AMRN)_globenewswire_biotech_globenewswire_biotech-sha256-51e33c91a6a4f2944f1.txt","market_impact_date":"2026-10-26","day1_return":0.025445,"day2_return":-0.007444,"prior_1w_return":0.041519,"comments":"Late-breaker at ESMO 2026 (Madrid): \"the trial did not meet its pre-specified primary endpoint of progression-free survival\" (median PFS 13.5 vs 12.9 mo, HR 0.89, p=0.329); key secondary OS 5-yr 62.0% vs 45.1%, HR 0.68, p=0.030. Investigator-initiated Phase 3 sponsored by University of Leeds; Amarin supplied IPE. Press release dated Oct 25, 2026.","created_at":"2026-10-26 04:25:03","updated_at":"2026-10-28T20:39:27Z","company":"Amarin","event_type":"data_presentation","expect_date_from":"2026-10-25","expect_date_to":"2026-10-25","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":438,"join_event_id":543,"symbol":"PBLS","drug":"zolucatetide","modality":"peptide","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261024_084500_(PBLS)_yahoo_news_yahoo-1b48b7e354dac93f612dc87cb3388d2f-PBLS.txt","market_impact_date":"2026-10-26","day1_return":0.024141,"day2_return":0.059928,"prior_1w_return":0.074286,"comments":"Updated Phase 1/2 desmoid data presented in ESMO oral session Oct 24, 2026 (2:45pm CEST); first public disclosure was the GlobeNewswire release at 08:45 EDT Oct 24. \"Objective response rate of 72.2% among response-evaluable patients receiving a starting dose of >=450 mg at 32-week landmark\"; DCR 100% with no progression. Source text in workspace is an excerpt of the wire release.","created_at":"2026-10-25 12:47:57","updated_at":"2026-11-04T17:48:48Z","company":"Parabilis Medicines","event_type":"data_presentation","expect_date_from":"2026-10-24","expect_date_to":"2026-10-24","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":287,"join_event_id":647,"symbol":"MGNX","drug":"MGC026","modality":"adc","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261023_160551_(MGNX)_sec_0001125345-26-000066.txt","market_impact_date":"2026-10-26","day1_return":-0.026667,"day2_return":0.105023,"prior_1w_return":-0.307692,"comments":"8-K: \"issued a press release announcing interim data related to its Phase 1 study evaluating MGC026, a B7-H3-directed antibody-drug conjugate, in patients with advanced solid tumors\"; interim data presented in ESMO poster, Oct 23-27, 2026, Madrid.","created_at":"2026-10-25","updated_at":"2026-10-27T15:40:29Z","company":"MacroGenics","event_type":"data_presentation","expect_date_from":"2026-10-23","expect_date_to":"2026-10-23","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":53,"join_event_id":461,"symbol":"XNCR","drug":"XmAb819","modality":"bispecific","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261025_043500_(XNCR)_gnews_businesswire_gnews_businesswire-sha256-f88fdab4a9406b84235a6e.txt","market_impact_date":"2026-10-26","day1_return":0.158856,"day2_return":0.02159,"prior_1w_return":0.101969,"comments":"XmAb819 (ENPP3 x CD3) Ph1 updated dose-expansion results in advanced ccRCC (data cut 01-Sep-2026; 400 ug/kg cohort cut 01-Oct-2026): confirmed ORR 30% at 100 ug/kg (n=30), 44% at 200 ug/kg (n=25), 45% at 400 ug/kg (n=11), 55% unconfirmed ORR and ~82% 6-mo PFS estimate at 400 ug/kg; DCR 87%/64%/82%; cORR 45.2% prior >=2 VEGFR-TKI, 34.8% prior HIF2a. Safety: CRS mostly low grade, transient asymptomatic transaminase increases, no treatment-related deaths. Presented at ESMO 2026 (abstract 2684, 25-Oct-2026); primary exhibit 99.1 presentation dated 2026-10-26.","created_at":"2026-10-25 10:35:28","updated_at":"2026-11-04T09:31:09Z","company":"Xencor","event_type":"data_presentation","expect_date_from":"2026-10-25","expect_date_to":"2026-10-25","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":48,"join_event_id":94,"symbol":"CLYM","drug":"budoprutug","modality":"monoclonal_antibody","area":"renal","result_type":"data_presentation","news_source_file":"documents/20261024_193000_(CLYM)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","market_impact_date":"2026-10-26","day1_return":-0.135427,"day2_return":0.125426,"prior_1w_return":0.037678,"comments":"Initial PrisMN Phase 2 (pMN) oral presentation at ASN Kidney Week on 2026-10-24: 200 mg cohort \"Mean PLA2R antibody reduction of 70% at Week 12; five of 13 patients (38%) achieved immunologic remission.\" Separate MCD case study (100 mg) presented 2026-10-23: three-year steroid-free remission. Enrollment ongoing in 1000 mg cohort.","created_at":"2026-10-25 06:34:44","updated_at":"2026-10-27T15:40:28Z","company":"Climb Bio","event_type":"data_presentation","expect_date_from":"2026-10-24","expect_date_to":"2026-10-24","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":47,"join_event_id":93,"symbol":"CLYM","drug":"CLYM116/MIL116","modality":"monoclonal_antibody","area":"renal","result_type":"data_presentation","news_source_file":"documents/20261023_160100_(CLYM)_globenewswire_biotech_globenewswire_biotech-sha256-cf802fa54245d6dca4d.txt","market_impact_date":"2026-10-26","day1_return":-0.135427,"day2_return":0.125426,"prior_1w_return":0.037678,"comments":"ASN Kidney Week 2026 Phase 1 data: \"≥90% free APRIL suppression through the full 12-week dosing interval following a single SC injection at dose levels ≥480 mg\"; ~70% Gd-IgA1 and ~60% IgA reduction at 12 weeks (800 mg); ~33-day half-life. First disclosure: GlobeNewswire 2026-10-23 16:01 ET (8-K exhibit 17:26 same release).","created_at":"2026-10-25 06:34:44","updated_at":"2026-10-27T15:40:28Z","company":"Climb Bio","event_type":"data_presentation","expect_date_from":"2026-10-21","expect_date_to":"2026-10-25","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":45,"join_event_id":97,"symbol":"IMTX","drug":"IMA203CD8","modality":"cell_therapy","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261024_023000_(IMTX)_globenewswire_biotech_globenewswire_biotech-sha256-883a738886957778db7.txt","market_impact_date":"2026-10-26","day1_return":-0.021888,"day2_return":0.028671,"prior_1w_return":0.086181,"comments":"Phase 1 data in oral presentation 1946O at 2026 ESMO; data cutoff Aug 7, 2026; n=90 efficacy-evaluable. ORR 51% (46/90), cORR 41% (36/87), DCR 82%. Gynecologic cancers at >=DL4c (n=20): ORR 60%, cORR 55%, mDOR 8.4 mo. \"the IMA203CD8 data were presented in an oral presentation (1946O)\"","created_at":"2026-10-25 10:34:46","updated_at":"2026-10-27T15:40:28Z","company":"Immatics","event_type":"data_presentation","expect_date_from":"2026-10-23","expect_date_to":"2026-10-27","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":44,"join_event_id":96,"symbol":"IMTX","drug":"IMA402","modality":"bispecific","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261024_023000_(IMTX)_globenewswire_biotech_globenewswire_biotech-sha256-883a738886957778db7.txt","market_impact_date":"2026-10-26","day1_return":-0.021888,"day2_return":0.028671,"prior_1w_return":0.086181,"comments":"Updated Phase 1b data in rapid oral presentation 1955RO at 2026 ESMO (Madrid); data cutoff Jun 1, 2026. RP2D-range efficacy pop n=40: cORR 25%, DCR 63%; PRAME-high cORR 32% (10/31), PRAME-high melanoma 32% (7/22), mDOR 12.5 mo, 1-yr OS 91%. ESMO slides also filed in 6-K 2026-10-23.","created_at":"2026-10-25 10:34:46","updated_at":"2026-10-27T15:40:28Z","company":"Immatics","event_type":"data_presentation","expect_date_from":"2026-10-23","expect_date_to":"2026-10-27","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":511,"join_event_id":null,"symbol":"IBRX","drug":"ANKTIVA","modality":"protein","area":"oncology","result_type":"other","news_source_file":"documents/20261025_131347_(IBRX)_google_news_google_news-7d863ea6b9fd79b0d150a6d68de2debc-IBR.txt","market_impact_date":"2026-10-25","day1_return":null,"day2_return":null,"prior_1w_return":null,"comments":"Stocktwits headline via Google News (2026-10-25 13:13 ET): \"ImmunityBio Resubmits Anktiva Application To FDA With Additional Data\". Article body not captured; no primary filing in workspace, so details/which application are unclear. Aggregator timestamp used as impact date.","created_at":"2026-10-26 18:57:43","updated_at":"2026-10-26 18:57:43","company":"ImmunityBio","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":484,"join_event_id":1054,"symbol":"AGEN","drug":"botensilimab + balstilimab","modality":"monoclonal_antibody","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261025_070000_(AGEN)_yahoo_news_yahoo-838a83d3b7413b689e91ff6353754010-AGEN.txt","market_impact_date":"2026-10-25","day1_return":null,"day2_return":null,"prior_1w_return":null,"comments":"\"today announced early Phase 2 results from the mismatch repair-deficient (dMMR) colon cancer cohort of NEOASIS ... at ESMO 2026\"; 72% of patients had no cancer remaining at surgery (83% little or no residual cancer) after six weeks of BOT+BAL. Same-timestamp Business Wire release text as syndicated by Yahoo; the gnews_businesswire copy for this item is headline-only.","created_at":"2026-10-26 00:19:46","updated_at":"2026-11-01T17:16:55Z","company":"Agenus","event_type":"data_presentation","expect_date_from":"2026-10-23","expect_date_to":"2026-10-27","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":570,"join_event_id":959,"symbol":"CMPX","drug":"tovecimig","modality":"bispecific","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261024_030000_(CMPX)_resolution_news_resolution_news-dbdebcd83d2849c663ab697b8cc7a81b.txt","market_impact_date":"2026-10-24","day1_return":-0.018397,"day2_return":0.0,"prior_1w_return":-0.115116,"comments":"COMPANION-002 Phase 2/3 tovecimig results published in the Journal of Clinical Oncology; data also presented in an oral session at ESMO 2026 (October). Headlines: \"Compass Therapeutics publishes tovecimig trial results in JCO\"; \"Announces Publication of Phase 2/3 COMPANION-002 Results ... and Oral Presentation at ESMO 2026\". Full dataset previously reported April 2026; no new efficacy data. Caveat: only Google News/aggregator copies exist in workspace (no primary release/SEC filing); earliest copy 2026-10-24 03:00 EDT used as disclosure date (three duplicate copies same day).","created_at":"2026-11-01 21:24:53","updated_at":"2026-11-02T20:03:35Z","company":"Compass Therapeutics","event_type":"data_presentation","expect_date_from":"2026-10-01","expect_date_to":"2026-10-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":461,"join_event_id":1037,"symbol":"ZYME","drug":"ZW191","modality":"adc","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261024_023000_(ZYME)_yahoo_news_yahoo-df819b2b465d775b1a9fb86079e4eb1c-ZYME.txt","market_impact_date":"2026-10-24","day1_return":null,"day2_return":null,"prior_1w_return":null,"comments":"Phase 1 data at ESMO Congress 2026: \"Confirmed objective response rates (cORR) of 64.5% at the 6.4 mg/kg dose in patients with high-grade serous platinum-resistant ovarian cancer\"; mDOR not reached, 6-mo PFS 61%. Only source found is a truncated Yahoo/aggregator copy of the Zymeworks release; no primary wire or SEC copy available, and no exact presentation day stated.","created_at":"2026-10-25","updated_at":"2026-10-26T08:32:58Z","company":"Zymeworks","event_type":"data_presentation","expect_date_from":"2026-10-23","expect_date_to":"2026-10-27","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":539,"join_event_id":279,"symbol":"TNGX","drug":"vopimetostat","modality":"small_molecule","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261023_063000_(TNGX)_yahoo_news_yahoo-1db2a9842457c9cea063675991d6ddd9-TNGX.txt","market_impact_date":"2026-10-23","day1_return":-0.164339,"day2_return":-0.049057,"prior_1w_return":0.230396,"comments":"Separate ESMO 2026 dataset (vopimetostat + zoldonrasib arm), cutoff Aug 20, 2026: 54% ORR (19/35; 18 cPR, 1 CR), 61% 9-month PFS, 97% DCR, no DLTs, no TRAE discontinuations. Quote: \"Vopimetostat plus zoldonrasib was generally well-tolerated across dose levels.\" Same company release as 8-K Ex-99.1 (Oct 23, 2026); distinct from the daraxonrasib PDAC dataset.","created_at":"2026-10-28","updated_at":"2026-10-28T20:40:31Z","company":"Tango Therapeutics","event_type":"data_presentation","expect_date_from":"2026-10-23","expect_date_to":"2026-10-27","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":467,"join_event_id":287,"symbol":"TGTX","drug":"azer-cel","modality":"cell_therapy","area":"cns","result_type":"data_presentation","news_source_file":"documents/20261023_105500_(TGTX)_gnews_businesswire_gnews_businesswire-sha256-e4059ecb4b2d6a740ce393.txt","market_impact_date":"2026-10-23","day1_return":0.018999,"day2_return":0.011446,"prior_1w_return":-0.050714,"comments":"TG announced initial results from Phase 1 study of azer-cel (allogeneic CD19-directed CAR T) in progressive MS, presented in a late-breaking oral session at MSToronto2026 on 2026-10-23. Quote: \"today announced initial results from the Company's Phase 1 study evaluating ... azer-cel ... in patients with progressive multiple sclerosis\", \"presented in a late-breaking oral session\".","created_at":"2026-10-25 20:13:23","updated_at":"2026-10-26T21:04:40Z","company":"TG Therapeutics","event_type":"data_presentation","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":449,"join_event_id":787,"symbol":"IDYA","drug":"IDE849","modality":"adc","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261023_060000_(IDYA)_yahoo_news_yahoo-d1059272170a4a472b25d6e5b7313a2a-IDYA.txt","market_impact_date":"2026-10-23","day1_return":-0.039037,"day2_return":-0.052723,"prior_1w_return":0.067061,"comments":"2026-10-23 release: IDE849 (SHR-4849) DLL3 TOP1 ADC \"updated clinical results that show promising anti-tumor activity and preliminary overall survival results\"; Hengrui presenting Phase 1 China data in relapsed SCLC and NEC at ESMO 2026. Secondary coverage (Stock Titan, 2026-10-23): \"17.4 months was median survival after one prior treatment in an early small-cell lung cancer study.\" Conference presentation, not a topline readout; feed copies truncated.","created_at":"2026-10-25 13:23:10","updated_at":"2026-10-27T03:16:33Z","company":"IDEAYA Biosciences","event_type":"data_presentation","expect_date_from":"2026-10-01","expect_date_to":"2026-10-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":391,"join_event_id":null,"symbol":"CPIX","drug":"ifetroban","modality":"small_molecule","area":"immunology","result_type":"topline_results","news_source_file":"documents/20261023_170157_(CPIX)_sec_0001087294-26-000070.txt","market_impact_date":"2026-10-23","day1_return":0.001179,"day2_return":-0.487633,"prior_1w_return":0.124668,"comments":"8-K: \"announced top-line results from its Phase 2a ASSIST-SSc trial evaluating oral ifetroban for patients with systemic sclerosis. These results support the safety and tolerability of ifetroban in this rare disease population.\" Safety/tolerability only; no efficacy detail disclosed.","created_at":"2026-10-25 12:06:32","updated_at":"2026-10-27T15:40:29Z","company":"Cumberland Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":207,"join_event_id":null,"symbol":"XBIT","drug":null,"modality":null,"area":"oncology","result_type":"topline_results","news_source_file":"documents/20261023_091700_(XBIT)_globenewswire_biotech_globenewswire_biotech-https-www.globenewswire.co.txt","market_impact_date":"2026-10-23","day1_return":-0.020305,"day2_return":-0.041451,"prior_1w_return":-0.087963,"comments":"Investigator-sponsored Phase II TASKIN trial in refractory metastatic colorectal cancer met its prespecified primary efficacy endpoint; 12-month OS 61.3%. Only available as a \"Recommended Reading\" summary of the 2026-10-19 18:59 ET XBiotech release (primary release not in workspace); drug not named in snippet, so left NULL.","created_at":"2026-10-25 11:28:04","updated_at":"2026-10-27T03:16:32Z","company":"XBiotech","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":158,"join_event_id":null,"symbol":"ANIP","drug":null,"modality":null,"area":"ophthalmology","result_type":"data_presentation","news_source_file":"documents/20261023_065500_(ANIP)_globenewswire_pharma_globenewswire_pharma-https-www.globenewswire.com.txt","market_impact_date":"2026-10-23","day1_return":-0.015458,"day2_return":-0.000138,"prior_1w_return":0.020338,"comments":"ANI Phase 4 open-label SYNCHRONICITY results \"presented as Late Breaking Oral Presentation at the American Academy of Ophthalmology 2026 Annual Meeting\" on 2026-10-12; \"Trial met both co-primary endpoints of mean change from baseline in BCVA letter score and ... CST ... at 6 months, and these changes were maintained\". Details taken from the GlobeNewswire \"Recommended Reading\" listing of ANI's Oct 12, 2026 release (full release not in workspace); drug not named in that summary.","created_at":"2026-10-25 11:20:39","updated_at":"2026-10-27T03:16:32Z","company":"ANI Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":150,"join_event_id":279,"symbol":"TNGX","drug":"vopimetostat","modality":"small_molecule","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261023_063606_(TNGX)_sec_0001193125-26-429423-ex991.txt","market_impact_date":"2026-10-23","day1_return":-0.164339,"day2_return":-0.049057,"prior_1w_return":0.230396,"comments":"ESMO 2026 (Oct 23-27) dataset, vopimetostat + daraxonrasib, cutoff Aug 20, 2026: 82% ORR (18/22) in 2L/3L MTAP-del/RAS-mut PDAC, median PFS not reached, 88% 9-month PFS, 100% DCR; NSCLC 80% ORR (4/5). Quote: \"The results are being presented at the European Society for Medical Oncology (ESMO) 2026 Congress being held in Madrid, Spain on October 23-27, 2026.\" First disclosure: 8-K Ex-99.1, Oct 23, 2026.\n\nESMO 2026 (Oct 23-27) separate dataset: vopimetostat + zoldonrasib in MTAP-del/KRAS G12D PDAC, cutoff Aug 20, 2026: 54% ORR (19/35; 18 cPR, 1 CR), 61% 9-month PFS, 97% DCR. Quote: \"the results are being presented at ... ESMO 2026 Congress ... October 23-27, 2026.\" Distinct combination arm from the daraxonrasib dataset.","created_at":"2026-10-25 11:18:27","updated_at":"2026-10-28T00:02:37Z","company":"Tango Therapeutics","event_type":"data_presentation","expect_date_from":"2026-10-23","expect_date_to":"2026-10-27","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":143,"join_event_id":23,"symbol":"EVAX","drug":"EVX-01","modality":"peptide","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261023_060012_(EVAX)_sec_0001171843-26-006788-ex991.txt","market_impact_date":"2026-10-23","day1_return":0.013477,"day2_return":-0.180851,"prior_1w_return":0.325,"comments":"Three-year immune data first disclosed Oct 23, 2026 (prior release only said \"new immune data ... will be presented\"): \"89% of its personalised vaccine antigen targets inducing a tumor-specific immune response\"; sustained T-cell magnitude/breadth in year 3 of EVX-01 monotherapy. Same dataset presented in ESMO 2026 poster 2006P on Oct 24 and webinar Oct 29, 2026.","created_at":"2026-10-25 11:17:37","updated_at":"2026-10-27T03:16:32Z","company":"Evaxion A/S American Depositary Share","event_type":"data_presentation","expect_date_from":"2026-10-24","expect_date_to":"2026-10-24","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":81,"join_event_id":77,"symbol":"LXRX","drug":"sotagliflozin","modality":"small_molecule","area":"cardiovascular","result_type":"data_presentation","news_source_file":"documents/20261023_083000_(LXRX)_globenewswire_pharma_globenewswire_pharma-sha256-0c32ba11685bfc9772e6.txt","market_impact_date":"2026-10-23","day1_return":-0.04698,"day2_return":0.021127,"prior_1w_return":-0.09697,"comments":"Lexicon disclosed SONATA-HCM baseline characteristics: \"SONATA-HCM enrolled 542 patients across more than 130 sites in 20 countries\" (440 nHCM, 102 oHCM), \"mean baseline Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) of 59\". Baseline data only, no efficacy results; detailed presentation by Dr. Sharlene Day on Oct 24, 2026 at International HCM Summit.","created_at":"2026-10-25 11:05:38","updated_at":"2026-10-27T03:16:32Z","company":"Lexicon Pharmaceuticals","event_type":"data_presentation","expect_date_from":"2026-10-24","expect_date_to":"2026-10-24","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":71,"join_event_id":null,"symbol":"EIKN","drug":"EIK1005","modality":"small_molecule","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261023_091500_(EIKN)_globenewswire_biotech_globenewswire_biotech-sha256-dea126dcba62387f2a4.txt","market_impact_date":"2026-10-23","day1_return":-0.118932,"day2_return":-0.236915,"prior_1w_return":0.092838,"comments":"Preliminary EIK1005-002 data at ESMO 2026: no DLTs at 50/100/200 mg QW monotherapy; 6/8 (75%) best response SD, all MSI-H/dMMR; PR in the single pembrolizumab-combination participant; t1/2 ~9.4 days. \"Preliminary data were presented from EIK1005-002\"; disclosed 2026-10-23.","created_at":"2026-10-25 10:37:23","updated_at":"2026-10-27T03:16:32Z","company":"Eikon Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":70,"join_event_id":null,"symbol":"EIKN","drug":"EIK1004","modality":"small_molecule","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261023_091500_(EIKN)_globenewswire_biotech_globenewswire_biotech-sha256-dea126dcba62387f2a4.txt","market_impact_date":"2026-10-23","day1_return":-0.118932,"day2_return":-0.236915,"prior_1w_return":0.092838,"comments":"Initial EIK1004-001 data at ESMO 2026: no DLTs across dose levels; ORR 12.1% (7/58), DCR 62.1%; Grade 3+ anemia and neutropenia 1.5% (1/68) each. \"initial data for EIK1004 ... at the 2026 European Society for Medical Oncology (ESMO) Congress\"; disclosed 2026-10-23.","created_at":"2026-10-25 10:37:23","updated_at":"2026-10-27T03:16:32Z","company":"Eikon Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":69,"join_event_id":null,"symbol":"EIKN","drug":"EIK1003","modality":"small_molecule","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261023_091500_(EIKN)_globenewswire_biotech_globenewswire_biotech-sha256-dea126dcba62387f2a4.txt","market_impact_date":"2026-10-23","day1_return":-0.118932,"day2_return":-0.236915,"prior_1w_return":0.092838,"comments":"ESMO 2026 presentation of EIK1003-001: Cohort 1A ORR 14.3% (7/49); Cohort 1B with abiraterone ORR 20.8% (5/24); Cohort 1C with paclitaxel ORR 26.4% (14/53). \"presentation of initial and updated data for EIK1003 ... at the 2026 European Society for Medical Oncology (ESMO) Congress\"; disclosed 2026-10-23.","created_at":"2026-10-25 10:37:23","updated_at":"2026-10-27T03:16:32Z","company":"Eikon Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":68,"join_event_id":127,"symbol":"HUMA","drug":"ATEV (Symvess)","modality":"other","area":"renal","result_type":"interim_analysis","news_source_file":"documents/20261023_080000_(HUMA)_globenewswire_biotech_globenewswire_biotech-sha256-88967b8bba8a88094c5.txt","market_impact_date":"2026-10-23","day1_return":0.053269,"day2_return":-0.078161,"prior_1w_return":-0.061364,"comments":"Prespecified interim analysis of first 80 patients in V012 Phase 3 (NCT05908084) presented as late-breaking podium at ASN Kidney Week, Thursday, October 22, 2026: 220.4 vs 129.3 catheter-free days at 12 months (p<0.001); primary endpoint met and enrollment stopped. First company release of the data: Oct 23, 2026 GlobeNewswire.","created_at":"1","updated_at":"2026-10-27T03:16:31Z","company":"Humacyte","event_type":"data_presentation","expect_date_from":"2026-10-22","expect_date_to":"2026-10-22","event_closed":1,"tier":"Core","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":67,"join_event_id":80,"symbol":"ORIC","drug":"enozertinib","modality":"small_molecule","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261023_031500_(ORIC)_globenewswire_biotech_globenewswire_biotech-sha256-7f6aeb028e392245382.txt","market_impact_date":"2026-10-23","day1_return":-0.033749,"day2_return":-0.320046,"prior_1w_return":0.067345,"comments":"ESMO 2026 Phase 1b (n=26, 80 mg QD; cutoff Sep 4, 2026): 84% (21/25) confirmed systemic ORR by investigator, 80% by BICR; 70% confirmed intracranial ORR by investigator; 67% (10/15) intracranial ORR and 40% (6/15) intracranial CR by BICR RANO-BM; 6-month landmark PFS 88%; no treatment-related discontinuations.","created_at":"2026-10-25 06:36:57","updated_at":"2026-10-27T03:16:31Z","company":"Oric Pharmaceuticals","event_type":"data_presentation","expect_date_from":"2026-10-23","expect_date_to":"2026-10-26","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":66,"join_event_id":79,"symbol":"ZNTL","drug":"azenosertib","modality":"small_molecule","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261023_101500_(ZNTL)_globenewswire_pharma_globenewswire_pharma-sha256-579fc40b70ab9c5d1939.txt","market_impact_date":"2026-10-23","day1_return":-0.082988,"day2_return":-0.063348,"prior_1w_return":0.075893,"comments":"DENALI Part 1b interim analysis (data cutoff May 22, 2026): median OS 15.9 mo in Cyclin E1 IHC-positive (n=48) vs 7.5 mo in Cyclin E1-negative (n=46); ORR 37.2% (n=43 evaluable); median DOR 5.5 mo; safety consistent with prior. First OS data disclosed in ESMO abstract (Oct 18, 2026; aggregator copy only).","created_at":"2026-10-25 10:37:06","updated_at":"2026-10-27T03:16:31Z","company":"Zentalis Pharmaceuticals","event_type":"data_presentation","expect_date_from":"2026-10-18","expect_date_to":"2026-10-23","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":65,"join_event_id":985,"symbol":"ELTX","drug":"camupepimut (ELI-002 7P)","modality":"peptide","area":"oncology","result_type":"topline_results","news_source_file":"documents/20261023_090000_(ELTX)_globenewswire_pharma_globenewswire_pharma-sha256-4ef6fc8bd74179d844a4.txt","market_impact_date":"2026-10-23","day1_return":-0.020619,"day2_return":-0.105263,"prior_1w_return":0.089888,"comments":"Randomized Phase 2 AMPLIFY-7P results presented in late-breaking Proffered Paper oral session at ESMO Congress 2026 (Oct 23, 2026) and published simultaneously in Nature Medicine; primary DFS endpoint not met in ITT (HR 0.85), favorable trends in ctDNA subgroups (HR 0.51 ctDNA-neg, 0.57 ctDNA-pos, adj HR 0.47). Quote: \"presented in a late-breaking Proffered Paper oral session at ESMO Congress 2026 ... and simultaneously published in Nature Medicine\". Original topline report: June 15, 2026 (per 10-Q).","created_at":"2026-10-25 10:36:49","updated_at":"2026-10-27T03:16:31Z","company":"Elicio Therapeutics","event_type":"data_presentation","expect_date_from":"2026-10-23","expect_date_to":"2026-10-23","event_closed":1,"tier":"Core","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":58,"join_event_id":75,"symbol":"IOVA","drug":"lifileucel","modality":"cell_therapy","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261023_101500_(IOVA)_globenewswire_biotech_globenewswire_biotech-sha256-8ddc73f1f2ad930aff5.txt","market_impact_date":"2026-10-23","day1_return":-0.003536,"day2_return":-0.022001,"prior_1w_return":-0.039402,"comments":"Final Phase 2 (IOV-COM-202 Cohort 1A) in frontline advanced melanoma: 62.5% confirmed ORR (15/24), 29.2% CR, median DOR and OS not reached (50.9 mo median follow-up). Presented at ESMO oral session Oct 23, 2026.","created_at":"2026-10-25","updated_at":"2026-10-27T03:16:31Z","company":"Iovance Biotherapeutics","event_type":"data_presentation","expect_date_from":"2026-10-23","expect_date_to":"2026-10-23","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":24,"join_event_id":153,"symbol":"CATX","drug":"VMT-alpha-NET","modality":"radiopharma","area":"oncology","result_type":"interim_analysis","news_source_file":"documents/20261023_105232_(CATX)_sec_0001193125-26-429770-ex991.txt","market_impact_date":"2026-10-23","day1_return":-0.287611,"day2_return":-0.248447,"prior_1w_return":-0.034188,"comments":"Interim Phase 1/2a data (cutoff 2026-09-02) presented in rapid oral session at ESMO 2026 (Oct 23-27): ORR 33% Cohort 2 (5.0 mCi, n=46), 50% Cohort 3 (6.0 mCi, n=20); DCR 89%/95%; PFS 72% at 18 mo; no DLTs. \"These data are being presented as a rapid oral presentation at ... ESMO Congress 2026\"","created_at":"2026-10-25 10:12:37","updated_at":"2026-10-27T03:16:30Z","company":"Perspective Therapeutics","event_type":"data_presentation","expect_date_from":"2026-10-23","expect_date_to":"2026-10-27","event_closed":1,"tier":"Core","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":16,"join_event_id":33,"symbol":"AARD","drug":"ARD-101","modality":"small_molecule","area":"rare_genetic","result_type":"interim_analysis","news_source_file":"documents/20261023_083838_(AARD)_sec_0001193125-26-429509-ex991.txt","market_impact_date":"2026-10-23","day1_return":-0.648101,"day2_return":-0.223022,"prior_1w_return":0.023316,"comments":"Exploratory efficacy data from terminated HERO/OLE: \"HQ-CT scores fell by Week 2 of dose escalation on ARD-101 and returned to near baseline within two weeks of stopping\"; OLE placebo-switchers had ~6-point HQ-CT reduction by Day 28. HERO stopped early (67/90 randomized); data exploratory.","created_at":"2026-10-25 05:53:55","updated_at":"2026-10-27T03:16:30Z","company":"Aardvark Therapeutics","event_type":"interim_analysis","expect_date_from":"2026-07-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.45,"llm_reason":"The $86M market cap sits just above $73.9M cash, so the stock already prices in little value for ARD-101. Both trials were terminated under a full FDA clinical hold. Positive unblinded HERO/OLE data could spark a large rally, while a weak result or a wind-down could still cut the stock 10% or more. The direction is uncertain, but the move is likely large.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":15,"join_event_id":null,"symbol":"AARD","drug":"ARD-101","modality":"small_molecule","area":"rare_genetic","result_type":"clinical_hold","news_source_file":"documents/20261022_161709_(AARD)_sec_0001193125-26-428943-ex991.txt","market_impact_date":"2026-10-23","day1_return":-0.648101,"day2_return":-0.223022,"prior_1w_return":0.023316,"comments":"FDA lifted the clinical hold: \"the FDA has lifted the clinical hold on the Company's Investigational New Drug application for ARD-101 for the treatment of hyperphagia in PWS.\" Hold had been placed May 2026; ECG study at 200/400 mg BID showed no cardiac events.","created_at":"2026-10-25 05:53:55","updated_at":"2026-10-27T03:16:30Z","company":"Aardvark Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":608,"join_event_id":null,"symbol":"OCS","drug":"Privosegtor","modality":"small_molecule","area":"cns","result_type":"data_presentation","news_source_file":"documents/20261022_020000_(OCS)_yahoo_news_yahoo-2dfe21231760b1395389aec525f9f1cc-OCS.txt","market_impact_date":"2026-10-22","day1_return":0.027954,"day2_return":-0.023486,"prior_1w_return":0.097629,"comments":"New Phase 2 ACUITY biomarker data disclosed 2026-10-22: \"Privosegtor reduced post-onset increases in plasma neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP) compared with placebo\", supporting \"previously reported functional (LCVA) +18-letter gains and structural retinal preservation at Month 3\". Late-breaking presentation at the 10th Joint ACTRIMS-ECTRIMS meeting; earliest available copy is the company release syndicated via Yahoo (no SEC exhibit in file set). No event was previously guided for this dataset.","created_at":"2026-11-04 19:55:05","updated_at":"2026-11-04T19:57:42Z","company":"Oculis Holding","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":569,"join_event_id":1000,"symbol":"ENTA","drug":"zelicapavir","modality":"small_molecule","area":"infectious","result_type":"data_presentation","news_source_file":"documents/20261022_030000_(ENTA)_google_news_google_news-ba87ff2c5b8d286959515b66973abae8-ENT.txt","market_impact_date":"2026-10-22","day1_return":0.027409,"day2_return":0.001721,"prior_1w_return":0.011628,"comments":"IDWeek 2026 presentation of zelicapavir RSV data; trade-press headline (Contagion Live, via Google News, 2026-10-22): \"Zelicapavir Shortens RSV Symptoms Despite Missing Primary End Point\". No company wire/SEC version of the presented data found in the document set, so an aggregator headline is the only source; details not confirmed.","created_at":"2026-11-01T16:21:12","updated_at":"2026-11-01T21:24:00Z","company":"Enanta Pharmaceuticals","event_type":"data_presentation","expect_date_from":"2026-10-21","expect_date_to":"2026-10-24","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":564,"join_event_id":1011,"symbol":"VERA","drug":"atacicept","modality":"protein","area":"renal","result_type":"data_presentation","news_source_file":"documents/20261022_030000_(VERA)_google_news_google_news-a1e93d7c530240855c7ea9a066e08e58-VER.txt","market_impact_date":"2026-10-22","day1_return":-0.06891,"day2_return":-0.036489,"prior_1w_return":0.166791,"comments":"\"Positive ORIGIN 3 Final Efficacy Analysis of TRUTAKNA (atacicept-vymj) in IgA Nephropathy Presented at ASN Kidney Week 2026 and Published in the New England Journal of Medicine\" - company release (Nasdaq copy, 2026-10-22 03:00, earliest announcement of the presentation/NEJM publication); the same final analysis was first disclosed 2026-09-15 (result #134); body text via Yahoo copy 10:05: \"achieved statistical significance in all prespecified endpoints\".","created_at":"2026-11-01 00:57:35","updated_at":"2026-11-01T21:22:45Z","company":"Vera Therapeutics","event_type":"data_presentation","expect_date_from":"2026-10-22","expect_date_to":"2026-10-25","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":451,"join_event_id":null,"symbol":"IONS","drug":null,"modality":null,"area":"cns","result_type":"other","news_source_file":"documents/20261022_140044_(IONS)_yahoo_news_yahoo-0b0c4dd96d73b25543ea8218ab21f492-IONS.txt","market_impact_date":"2026-10-22","day1_return":-0.008132,"day2_return":-0.022318,"prior_1w_return":0.036768,"comments":"Ionis \"Secures FDA Orphan Drug Designation For Rare Epilepsy Treatment\"; the treatment targets the SCN1A gene. Headline-level Yahoo/Stocktwits item only (no company release or SEC filing in workspace; secondary source used). Source names no drug and gives no separate designation date, so publication date used.","created_at":"2026-10-25 15:58:54","updated_at":"2026-10-25T16:04:04Z","company":"Ionis Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":433,"join_event_id":384,"symbol":"SCYX","drug":"SCY-247","modality":"small_molecule","area":"infectious","result_type":"topline_results","news_source_file":"documents/20261022_080000_(SCYX)_resolution_news_resolution_news-ca8b37100f6d86dcbf7437119683bd9a.txt","market_impact_date":"2026-10-22","day1_return":0.006605,"day2_return":-0.006562,"prior_1w_return":-0.044192,"comments":"Phase 1 IV formulation data reported 2026-10-22: \"56 healthy participants had no drug-related serious events with an experimental antifungal\" (Stock Titan headline, 08:00 ET); same-day items: \"SCYNEXIS reports phase 1 results for IV antifungal SCY-247\" (Investing.com 08:36), \"Reports Positive Phase 1 Data for SCY-247\" (GuruFocus 09:02). Caveat: only aggregator items available, no company wire or SEC exhibit in workspace.","created_at":"2026-10-25 12:45:43","updated_at":"2026-10-25T12:48:03Z","company":"SCYNEXIS","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"Watch","llm_prediction":"large_downside","llm_confidence":0.45,"llm_reason":"SCY-247 is a key asset for a $38M microcap, so a topline readout is likely to move the stock at least 10%. Cash of about $71M exceeds the market cap, which limits downside, but dilution overhang from warrants is heavy. The company's pivot toward ADPKD (SCY-770) makes the direction unclear.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":403,"join_event_id":null,"symbol":"CGTX","drug":"zervimesine","modality":"small_molecule","area":"cns","result_type":"other","news_source_file":"documents/20261022_060625_(CGTX)_sec_0001104659-26-117948-ex991.txt","market_impact_date":"2026-10-22","day1_return":-0.06158,"day2_return":0.025678,"prior_1w_return":-0.03861,"comments":"Announced alignment with FDA on key elements (patient selection, dose, duration, endpoints) of a pivotal Phase 3 DLB study: \"has aligned with the U.S. Food and Drug Administration (FDA) on key elements of a Phase 3 study in dementia with Lewy bodies (DLB)\". No trial-start date or data disclosed.","created_at":"2026-10-25 12:08:19","updated_at":"2026-10-25T12:10:47Z","company":"Cognition Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":373,"join_event_id":904,"symbol":"IONS","drug":"bepirovirsen","modality":"aso","area":"infectious","result_type":"fda_approval","news_source_file":"documents/20261021_161517_(IONS)_sec_0001140361-26-040388-ex991.txt","market_impact_date":"2026-10-22","day1_return":-0.008132,"day2_return":-0.022318,"prior_1w_return":0.036768,"comments":"\"partner GSK today announced that the U.S. Food and Drug Administration (FDA) has approved Hibsago (bepirovirsen) for the treatment of chronic hepatitis B (CHB)\" - approval under priority review and Breakthrough Therapy designation. Release dated Oct. 20, 2026; 8-K exhibit filed 2026-10-21 16:15 ET (approval ahead of Oct. 26 PDUFA).","created_at":"2026-10-25T08:08:00","updated_at":"2026-10-25T12:10:11Z","company":"Ionis Pharmaceuticals","event_type":"pdufa","expect_date_from":"2026-10-26","expect_date_to":"2026-10-26","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":164,"join_event_id":null,"symbol":"SUPN","drug":"ONAPGO (apomorphine HCl)","modality":"other","area":"cns","result_type":"other","news_source_file":"documents/20261021_210747_(SUPN)_sec_0001104659-26-117937-ex991.txt","market_impact_date":"2026-10-22","day1_return":0.020869,"day2_return":-0.032565,"prior_1w_return":0.025635,"comments":"FDA decision 2026-10-21: \"the U.S. Food and Drug Administration (FDA) has recognized seven years of orphan-drug exclusive approval for ONAPGO (apomorphine HCl) for the treatment of motor fluctuations in adults with advanced Parkinson's disease\"; exclusivity began February 3, 2025 (approval date).","created_at":"2026-10-25 11:21:45","updated_at":"2026-10-25T12:10:21Z","company":"Supernus Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":144,"join_event_id":null,"symbol":"BHVN","drug":"troriluzole","modality":"small_molecule","area":"cns","result_type":"other","news_source_file":"documents/20261022_070007_(BHVN)_sec_0001935979-26-000083.txt","market_impact_date":"2026-10-22","day1_return":0.250213,"day2_return":-0.05514,"prior_1w_return":0.075023,"comments":"FDA informed Biohaven that its NDA resubmission for Vyglxia (troriluzole) in spinocerebellar ataxia \"has been accepted for review\" and considers it a complete response to the November 4, 2025 action letter; user fee goal date set in Q1 2027. Not an approval; FDA plans a PCNS advisory committee meeting (date TBA).","created_at":"2026-10-25 11:18:08","updated_at":"2026-10-25T12:10:19Z","company":"Biohaven","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":42,"join_event_id":null,"symbol":"AAPG","drug":"lisaftoclax","modality":"small_molecule","area":"hematology","result_type":"other","news_source_file":"documents/20261021_165509_(AAPG)_sec_0001213900-26-111393-ex991.txt","market_impact_date":"2026-10-22","day1_return":-0.086903,"day2_return":0.034853,"prior_1w_return":0.100337,"comments":"CDE/NMPA granted Breakthrough Therapy Designation to lisaftoclax (APG-2575) + acalabrutinib for treatment-naive adult CLL/SLL: \"has been granted a Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE)\". Press release dated Oct 20, 2026; filed via SEC 6-K Oct 21, 2026. BTD is a regulatory designation, not an approval.","created_at":"2026-10-25 10:34:42","updated_at":"2026-10-25T12:10:09Z","company":"Ascentage Pharma Group International American Depository Shares","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":22,"join_event_id":null,"symbol":"ABUS","drug":"AB-101","modality":"small_molecule","area":"infectious","result_type":"clinical_hold","news_source_file":"documents/20261022_073119_(ABUS)_sec_0001171843-26-006753-ex991.txt","market_impact_date":"2026-10-22","day1_return":0.007177,"day2_return":-0.002375,"prior_1w_return":-0.002387,"comments":"FDA notified Arbutus that \"the clinical hold on the Investigational New Drug (IND) application for AB-101 has been removed\" (Oct 22, 2026); company evaluating next steps, no new date guided.","created_at":"2026-10-25 10:05:20","updated_at":"2026-10-25T10:05:35Z","company":"Arbutus Biopharma","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":486,"join_event_id":null,"symbol":"BCRX","drug":"ORLADEYO (berotralstat)","modality":"small_molecule","area":"immunology","result_type":"fda_approval","news_source_file":"documents/20261021_070000_(BCRX)_yahoo_news_yahoo-3a03ee7e00760ea15015964526ebce30-BCRX.txt","market_impact_date":"2026-10-21","day1_return":-0.023929,"day2_return":0.003871,"prior_1w_return":-0.016109,"comments":"\"FDA has approved\" ORLADEYO (berotralstat) 150 mg oral pellets for adults and adolescents with HAE (aged 12+); first disclosure in company GlobeNewswire release on 2026-10-21.","created_at":"2026-10-26 00:19:56","updated_at":"2026-10-26T00:21:52Z","company":"BioCryst Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":481,"join_event_id":1021,"symbol":"ACHV","drug":"cytisinicline","modality":"small_molecule","area":"cns","result_type":"data_presentation","news_source_file":"documents/20261021_083000_(ACHV)_yahoo_news_yahoo-9054b88b7aedb3f531f428ed2b107bc0-ACHV.txt","market_impact_date":"2026-10-21","day1_return":0.0,"day2_return":-0.001536,"prior_1w_return":-0.07,"comments":"CHEST 2026 presentation of 52-week ORCA-OL efficacy data: \"Nearly one in three adults who were still smoking or vaping after a prior ORCA trial had quit at the end of a year of cytisinicline treatment, with quit rates rising through the year\"; 39% quit among participants new to cytisinicline. Only a Yahoo News copy of the release was available (no SEC exhibit).","created_at":"2026-10-26 00:19:14","updated_at":"2026-10-26T00:21:51Z","company":"Achieve Life Sciences","event_type":"data_presentation","expect_date_from":"2026-10-18","expect_date_to":"2026-10-21","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":446,"join_event_id":536,"symbol":"PDSB","drug":"PDS0301","modality":"protein","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261020_195906_(PDSB)_sec_0001140361-26-040283-ex991.txt","market_impact_date":"2026-10-21","day1_return":0.290323,"day2_return":-0.064516,"prior_1w_return":-0.399375,"comments":"PDS0301 Phase 2 (NCI-led) in MSS/pMMR mCRC with liver metastases, presented at the Oct 15, 2026 KOL event and detailed in the Oct 20, 2026 8-K investor deck: \"71.4% objective response rate at six months\" (chemo alone 35%), \"approximately 80% of patients were alive at 24 months, with median overall survival (mOS) currently exceeding 34 months\" (preliminary, non-randomized sequential studies).","created_at":"2026-10-25 13:22:35","updated_at":"2026-10-25T13:23:40Z","company":"PDS Biotechnology","event_type":"data_presentation","expect_date_from":"2026-10-15","expect_date_to":"2026-10-15","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":417,"join_event_id":996,"symbol":"IMUX","drug":"vidofludimus calcium","modality":"small_molecule","area":"cns","result_type":"data_presentation","news_source_file":"documents/20261021_070000_(IMUX)_yahoo_news_yahoo-d533fa44cdb0abaeae0319330f89773b-IMUX.txt","market_impact_date":"2026-10-21","day1_return":0.009447,"day2_return":-0.034759,"prior_1w_return":0.075472,"comments":"Four posters presented at MSToronto2026 (Oct 21-23, 2026); clinical poster reported Phase 2 CALLIPER open-label extension long-term disability data (\"favourable trends in disability outcomes were maintained during the open-label extension phase, with low treatment discontinuation\"), plus biomarker and preclinical Nurr1 posters. Company release via Yahoo; no SEC exhibit for this item.","created_at":"2026-10-25T08:18:27","updated_at":"2026-10-25T12:20:07Z","company":"Immunic","event_type":"data_presentation","expect_date_from":"2026-10-21","expect_date_to":"2026-10-23","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":14,"join_event_id":null,"symbol":"IRD","drug":"OPGx-RDH12","modality":"gene_therapy","area":"rare_genetic","result_type":"other","news_source_file":"documents/20261021_070000_(IRD)_yahoo_news_yahoo-786684ba798b43eab47d088189651f11-IRD.txt","market_impact_date":"2026-10-21","day1_return":0.027431,"day2_return":-0.072816,"prior_1w_return":-0.054245,"comments":"\"the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for OPGx-RDH12, an investigational gene therapy for the treatment of RDH12-associated LCA.\" Announced Oct 21, 2026 (GlobeNewswire release; full text via Yahoo copy). Company plans to initiate a Phase 1/2 trial this quarter (Q4 2026) - trial start, no event created.","created_at":"2026-10-25 09:54:00","updated_at":"2026-10-31T16:45:28Z","company":"Opus Genetics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":601,"join_event_id":1199,"symbol":"BIVI","drug":"Bezisterim","modality":"small_molecule","area":"cns","result_type":"data_presentation","news_source_file":"documents/20261020_095300_(BIVI)_resolution_news_resolution_news-33b2574753a6a97b6a381251483bba9b.txt","market_impact_date":"2026-10-20","day1_return":-0.094891,"day2_return":0.016129,"prior_1w_return":0.037879,"comments":"Headline-only copy (Yahoo Finance Canada reprint, 2026-10-20 09:53 EDT): \"BioVie reports positive Phase 2 Parkinson's data for bezisterim\". Drug-level detail, from BioVie's 2026-10-26 wire: \"Parkinson's patients [with] elevated baseline inflammation demonstrated statistically significant improvements in both motor and non-motor symptoms with Bezisterim compared to placebo.\" No quantitative data in workspace; primary release text unavailable.","created_at":"2026-11-04 08:38:58","updated_at":"2026-11-04T13:39:35Z","company":"BioVie","event_type":"data_presentation","expect_date_from":"2026-10-20","expect_date_to":"2026-10-20","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":491,"join_event_id":1029,"symbol":"ATNM","drug":"ATNM-400","modality":"radiopharma","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261020_080000_(ATNM)_yahoo_news_yahoo-81b762cbca9662e2162b7387dc66f72c-ATNM.txt","market_impact_date":"2026-10-20","day1_return":0.060606,"day2_return":-0.014286,"prior_1w_return":0.245283,"comments":"\"announced encouraging initial clinical results from the first-in-human Phase 1 study of ATNM-400 in metastatic castration-resistant prostate cancer (mCRPC). The findings, presented in an oral presentation on October 19 at the 39th Annual Congress of ... EANM ... in Vienna\". First public disclosure of the data; detailed figures not included in available text.","created_at":"2026-10-26 00:21:18","updated_at":"2026-10-26T00:21:52Z","company":"Actinium Pharmaceuticals Inc. (Delaware)","event_type":"data_presentation","expect_date_from":"2026-10-17","expect_date_to":"2026-10-21","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":453,"join_event_id":null,"symbol":"PALI","drug":"PALI-2108","modality":"small_molecule","area":"gi_hepatology","result_type":"data_presentation","news_source_file":"documents/20261020_080500_(PALI)_yahoo_news_yahoo-d8132184b8e3c2164ba177b5729596f0-PALI.txt","market_impact_date":"2026-10-20","day1_return":0.067164,"day2_return":-0.020979,"prior_1w_return":-0.157233,"comments":"UEG Week 2026 presentation (guided 2026-09-28): \"Five-patient Phase 1b Crohn's disease cohort showed a 47.5% reduction in mean endoscopic disease activity and a 58.8% reduction in mean fecal calprotectin after 14 days\", plus intestinal exposure/tissue analyses. Caveat: open-label n=5, no placebo; same 47.5% figure was first disclosed 2026-10-12 at ACG 2026. Source is company GlobeNewswire release carried by Yahoo (document is a truncated snippet).","created_at":"2026-10-25 15:58:57","updated_at":"2026-10-25T16:04:04Z","company":"Palisade Bio","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":226,"join_event_id":462,"symbol":"RAPP","drug":"RAP-219","modality":"small_molecule","area":"cns","result_type":"topline_results","news_source_file":"documents/20261020_060517_(RAPP)_sec_0001193125-26-425647-ex991.txt","market_impact_date":"2026-10-20","day1_return":0.026923,"day2_return":-0.146748,"prior_1w_return":-0.05141,"comments":"Phase 2 (n=253) in acute bipolar mania met primary endpoint: 3.1-point placebo-adjusted YMRS improvement at Week 3 (p=0.045; 15.4 vs 12.3) and CGI-BP severity 0.4 (p=0.024); well tolerated. Announced Oct 20, 2026 (SEC 8-K EX-99.1); Google News item same morning was an aggregator stub.","created_at":"2026-10-25 11:32:39","updated_at":"2026-10-25T12:10:27Z","company":"Rapport Therapeutics","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-10-31","event_closed":1,"tier":"Core","llm_prediction":"large_impact","llm_confidence":0.55,"llm_reason":"RAPP's ~$1.27B market cap is anchored on RAP-219 in focal epilepsy, and the October readout is a Phase 2 bipolar mania trial of an AMPA NAM. That is a high-risk psychiatric indication with a binary outcome. Success would add a major indication, while failure would also hurt confidence in the asset. Either result could plausibly move the stock 10% or more, so the size is clearer than the direction.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":219,"join_event_id":439,"symbol":"RCUS","drug":"casdatifan","modality":"small_molecule","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261020_083325_(RCUS)_sec_0001724521-26-000047.txt","market_impact_date":"2026-10-20","day1_return":0.072719,"day2_return":-0.195789,"prior_1w_return":-0.090386,"comments":"8-K reports ARC-20 data as of 2026-09-04 cutoff: 1L casdatifan+zimberelimab cORR 50%, 6/12-mo landmark PFS 86%/69%; 2L +cabozantinib mPFS 14.5 mo, 18-mo OS 77%; late-line mono mOS 35 mo, cORR 36%. \"On October 20, 2026, Arcus Biosciences, Inc. presented new data from the ARC-20 platform study\".","created_at":"2026-10-25 11:31:18","updated_at":"2026-10-25T12:10:26Z","company":"Arcus Biosciences","event_type":"data_presentation","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":51,"join_event_id":737,"symbol":"ODTX","drug":"OD-001","modality":"small_molecule","area":"gi_hepatology","result_type":"topline_results","news_source_file":"documents/20261020_070021_(ODTX)_sec_0001193125-26-425684-ex991.txt","market_impact_date":"2026-10-20","day1_return":0.049171,"day2_return":0.000527,"prior_1w_return":-0.008762,"comments":"Completed Phase 2a induction results (all 56 efficacy-evaluable patients) presented at UEG Week on 2026-10-20 and in the 8-K release: \"OD-001 met the trial's primary endpoint of change from baseline in modified Mayo score at the end of induction at Week 12 (mean reduction of 2.4 points; p<0.001).\" Clinical remission 27% at 20 mg BID (n=41). Open-label, no placebo control; data subject to change until database lock. Earlier 2026-10-21 Google News headline replaced by primary SEC exhibit.","created_at":"2026-10-25 10:35:07","updated_at":"2026-10-25T12:10:10Z","company":"Odyssey Therapeutics","event_type":"data_presentation","expect_date_from":"2026-10-20","expect_date_to":"2026-10-20","event_closed":1,"tier":"Core","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":527,"join_event_id":64,"symbol":"BCDA","drug":"Helix Catheter","modality":"other","area":"cardiovascular","result_type":"other","news_source_file":"documents/20261019_091523_(BCDA)_sec_0001437749-26-032887.txt","market_impact_date":"2026-10-19","day1_return":-0.021739,"day2_return":0.155556,"prior_1w_return":-0.115385,"comments":"8-K/GlobeNewswire Oct 19 2026: FDA \"has accepted its pre-submission package for marketing clearance of its Helix catheter\" under the De Novo pathway; \"FDA Substantive Review and Meeting Expected this Quarter.\" Acceptance of the Q-Submission package only - not a marketing authorization; the Q4 2026 review/meeting remains pending (event 64 kept open).","created_at":"2026-10-27T13:44:14","updated_at":"2026-10-27T17:46:32Z","company":"BioCardia","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":505,"join_event_id":1017,"symbol":"RIGL","drug":"pralsetinib","modality":"small_molecule","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261019_080500_(RIGL)_google_news_gnews-d0b570047cd45aef29727f8cf04c3b81-RIGL.txt","market_impact_date":"2026-10-19","day1_return":0.016315,"day2_return":0.029752,"prior_1w_return":-0.063366,"comments":"Pooled ARROW (NCT03037385) + TAPISTRY (NCT04589845) efficacy/safety in RET fusion-positive solid tumors presented in the ESMO 2026 rapid oral session on Sunday, Oct 25 (\"will be presented in a rapid oral session ... on Sunday, Octo[ber 25]\"). Source = company PR Newswire release (2026-10-19 08:05 ET, title states Oral and Poster Presentations). Response rate 53% per aggregator headlines (Stock Titan 08:05 \"A cancer drug produced responses in 53% of patients\"; Pluang 08:16 \"Pralsetinib shows 53% response rate in RET fusi...\"). Caveat: PR body in workspace is truncated at the session date.","created_at":"2026-10-26 14:46:41","updated_at":"2026-10-26T16:50:22Z","company":"Rigel Pharmaceuticals","event_type":"data_presentation","expect_date_from":"2026-10-25","expect_date_to":"2026-10-25","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":462,"join_event_id":null,"symbol":"URGN","drug":"UGN-103","modality":"small_molecule","area":"oncology","result_type":"other","news_source_file":"documents/20261019_103511_(URGN)_resolution_news_resolution_news-39d81c0b2898cc3db176178b357751c9.txt","market_impact_date":"2026-10-19","day1_return":-0.011863,"day2_return":0.025183,"prior_1w_return":-0.061635,"comments":"GuruFocus 2026-10-19 10:35: \"UroGen Pharma (URGN) FDA Accepts Marketing Application for UGN-1[03]\"; Urology Times 2026-10-19 13:22 \"FDA accepts new drug application for UGN-103 in recurrent LG-IR-NMIBC\". NDA accepted for filing; no PDUFA/action date disclosed. Caveat: aggregator-only items (Google News), no SEC exhibit or company wire release in hand. Earlier Stock Titan 08:00 item covers only the 77.8% 3-mo CR data.","created_at":"2026-10-25 16:08:34","updated_at":"2026-10-25T16:10:06Z","company":"UroGen Pharma","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":448,"join_event_id":786,"symbol":"IDYA","drug":"darovasertib","modality":"small_molecule","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261019_060000_(IDYA)_yahoo_news_yahoo-3808bfc66d359a9d6cf353345c56c6ed-IDYA.txt","market_impact_date":"2026-10-19","day1_return":0.029224,"day2_return":0.045844,"prior_1w_return":-0.09028,"comments":"Updated Phase 2 OptimUM-09 neoadjuvant darovasertib data disclosed 2026-10-19 ahead of ESMO 2026 (Oct 23-27, Madrid); coverage of the release reports \"a drug helped 57% of patients with eye melanoma keep their eyes\" (eye preservation). Feed copy truncated; data also presented at ESMO.","created_at":"2026-10-25 13:23:10","updated_at":"2026-10-25T13:23:40Z","company":"IDEAYA Biosciences","event_type":"data_presentation","expect_date_from":"2026-10-01","expect_date_to":"2026-10-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":447,"join_event_id":785,"symbol":"IDYA","drug":"darovasertib + crizotinib","modality":"small_molecule","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261019_060000_(IDYA)_yahoo_news_yahoo-3808bfc66d359a9d6cf353345c56c6ed-IDYA.txt","market_impact_date":"2026-10-19","day1_return":0.029224,"day2_return":0.045844,"prior_1w_return":-0.09028,"comments":"Updated OptimUM-01 (HLA-A*02:01-positive mUM) data disclosed 2026-10-19: release \"announced updated clinical data from three ongoing studies evaluating darovasertib in metastatic and primary uveal melanoma ... presented at ESMO Congress 2026, October 23-27 in Madrid\". Earliest public disclosure kept; doc truncated in feed.","created_at":"2026-10-25 13:23:07","updated_at":"2026-10-25T13:23:40Z","company":"IDEAYA Biosciences","event_type":"data_presentation","expect_date_from":"2026-10-01","expect_date_to":"2026-10-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":401,"join_event_id":966,"symbol":"CLNN","drug":"CNM-Au8","modality":"other","area":"cns","result_type":"other","news_source_file":"documents/20261019_080516_(CLNN)_sec_0001437749-26-032882.txt","market_impact_date":"2026-10-19","day1_return":0.06129,"day2_return":0.133739,"prior_1w_return":-0.196891,"comments":"8-K (Oct 19, 2026): \"issued a press release announcing its New Drug Application submission to the U.S. Food and Drug Administration (FDA) for CNM-Au8 for the treatment of ALS.\" Resolves the guided early-Q4 2026 NDA submission; submission, not approval.","created_at":"2026-10-25 08:07:40","updated_at":"2026-10-25T12:10:47Z","company":"Clene","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":320,"join_event_id":740,"symbol":"IRON","drug":"bitopertin","modality":"small_molecule","area":"rare_genetic","result_type":"topline_results","news_source_file":"documents/20261019_070808_(IRON)_sec_0001193125-26-424649-ex991.txt","market_impact_date":"2026-10-19","day1_return":0.388635,"day2_return":0.006968,"prior_1w_return":-0.084112,"comments":"APOLLO Phase 3 topline (n=183): met both co-primary endpoints (whole-blood PPIX -41.4% vs placebo, p<0.0001; +12.2 hours/month total time in light, p=0.0010) and all secondary endpoints; well-tolerated, no new safety signals. Company hosted webcast same morning.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:38Z","company":"Disc Medicine","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"large_upside","llm_confidence":0.45,"llm_reason":"The market cap (~$2.9B) is not far above cash (~$718M), which suggests the CRL left bitopertin risk heavily discounted. Bitopertin is the lead asset, and phase 2 data showed strong PPIX reductions. That points to a high probability of a positive APOLLO readout and a sizable rerating.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":72,"join_event_id":37,"symbol":"ANAB","drug":"dostarlimab","modality":"monoclonal_antibody","area":"oncology","result_type":"fda_approval","news_source_file":"documents/20261019_141800_(ANAB)_yahoo_news_yahoo-30ff83221afe4cf0f8e6ba401734738a-ANAB.txt","market_impact_date":"2026-10-19","day1_return":0.056426,"day2_return":-0.077376,"prior_1w_return":0.014363,"comments":"FDA granted (accelerated) approval Oct 19, 2026 for Jemperli (dostarlimab) monotherapy in previously untreated stage II/III dMMR/MSI-H locally advanced rectal cancer (AZUR-1): \"Jemperli (dostarlimab) Approved in the U.S. as First and Only Immunotherapy...\". Approval came before the Feb 2027 PDUFA date (CNPV). Source file is the Anaptys/GlobeNewswire release carried via Yahoo News; FDA press announcement dated October 19, 2026 corroborates.","created_at":"2026-10-25 10:38:18","updated_at":"2026-10-25T12:10:12Z","company":"AnaptysBio","event_type":"pdufa","expect_date_from":"2027-02-01","expect_date_to":"2027-02-28","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":50,"join_event_id":980,"symbol":"EYPT","drug":"DURAVYU","modality":"small_molecule","area":"ophthalmology","result_type":"topline_results","news_source_file":"documents/20261019_070519_(EYPT)_sec_0001193125-26-424644-ex991.txt","market_impact_date":"2026-10-19","day1_return":-0.852843,"day2_return":-0.068182,"prior_1w_return":-0.120588,"comments":"\"LUCIA did not achieve the primary endpoint of statistical non-inferiority in mean change in BCVA versus on-label aflibercept control, despite demonstrating visual improvement.\" Primary SEC 8-K exhibit (2026-10-19 07:05 ET); replaces the earlier Yahoo aggregator listing.","created_at":"2026-10-25T06:34:57","updated_at":"2026-10-25T12:10:10Z","company":"EyePoint","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.72,"llm_reason":"LUGANO missed its primary endpoint, and the market cap of about $37M suggests the stock has already collapsed. LUCIA is now a binary event: success could revive the filing path and send the stock sharply up, while a second miss would effectively end the wet AMD program. Either outcome likely moves the stock by 10% or more, but direction is uncertain.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":49,"join_event_id":813,"symbol":"MANE","drug":"VDPHL01","modality":"small_molecule","area":"dermatology","result_type":"topline_results","news_source_file":"documents/20261019_090614_(MANE)_sec_0001827635-26-000036-ex991.txt","market_impact_date":"2026-10-19","day1_return":0.12369,"day2_return":0.0395,"prior_1w_return":-0.168678,"comments":"8-K Ex-99.1 (Oct 19, 2026): Study '304' Part A met co-primary endpoints; non-vellus TAHC +28.6 hairs/cm2 (QD) and +36.4 (BID) vs +6.6 placebo at Month 6 (p<0.0001); 55.7% QD / 68.7% BID AAIRS improved/much improved vs 15.0% placebo. Primary SEC release; earlier Google News/Seeking Alpha slideshow (2026-10-21) was a later summary.","created_at":"2026-10-25 10:34:56","updated_at":"2026-10-25T12:10:09Z","company":"Veradermics","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.62,"llm_reason":"The 2H26 readout is likely the confirmatory Phase 3 '304' trial in men. Phase 2/3 '302' Part A was already positive, so the mechanism (oral minoxidil) is de-risked. The $5.8B valuation already prices in success, which makes a confirmatory hit likely a muted move. Downside risk remains if efficacy or safety disappoints.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":9,"join_event_id":23,"symbol":"EVAX","drug":"EVX-01","modality":"peptide","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261019_060007_(EVAX)_sec_0001171843-26-006678-ex991.txt","market_impact_date":"2026-10-19","day1_return":0.176678,"day2_return":0.216216,"prior_1w_return":-0.078176,"comments":"First disclosed Oct 19, 2026: \"All patients at three-year follow-up ... maintained the clinical responses observed at two-year follow-up, with no tumor progression.\" Oct 23 release added \"89% of the vaccine neoantigens generating potent specific T-cell responses\" and sustained T-cell responses. Later confirmed in ESMO poster Oct 24 and webinar Oct 29; earliest public announcement used.","created_at":"2026-10-25 09:53:57","updated_at":"2026-10-25T09:54:26Z","company":"Evaxion A/S American Depositary Share","event_type":"data_presentation","expect_date_from":"2026-10-24","expect_date_to":"2026-10-24","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":568,"join_event_id":null,"symbol":"RGNX","drug":"RGX-202","modality":"gene_therapy","area":"rare_genetic","result_type":"topline_results","news_source_file":"documents/20261016_030000_(RGNX)_google_news_google_news-658f833c80ec86c72bb93fe99d38c21c-RGN.txt","market_impact_date":"2026-10-16","day1_return":-0.032821,"day2_return":0.032491,"prior_1w_return":-0.114957,"comments":"Pivotal Phase III AFFINITY DUCHENNE met its primary endpoint: \"RGX-202 Meets Primary End Point in Phase 3 Duchenne Trial\" (NeurologyLive, 2026-10-16); Oct 20, 2026 Medical Daily adds \"New Data Detail Two Resolved Serious Side Effects\". First disclosure was the company's May 2026 topline release (per Q2 10-Q: \"In May 2026, we announced positive topline results from the pivotal Phase III AFFINITY DUCHENNE trial\"); both documents here are secondary coverage, no primary release or SEC exhibit in the set.","created_at":"2026-11-01T12:16:14","updated_at":"2026-11-01T17:17:41Z","company":"REGENXBIO","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":418,"join_event_id":null,"symbol":"IBRX","drug":"ANKTIVA","modality":"protein","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261016_030000_(IBRX)_google_news_gnews-1e54074928157fc71230ef38ce6985ab-IBRX.txt","market_impact_date":"2026-10-16","day1_return":-0.082,"day2_return":-0.082789,"prior_1w_return":0.009082,"comments":"Long-term Phase 2/3 QUILT-3.032 data published in the Journal of Urology (announced 2026-10-16): \"84% Cystectomy Avoidance at Three Years and Complete Responses Beyond 53 Months with ANKTIVA Plus BCG in BCG-Unresponsive NMIBC With CIS, With or Without Papillary Tumors.\" Company Business Wire release.","created_at":"2026-10-25 12:19:26","updated_at":"2026-10-25T12:20:07Z","company":"ImmunityBio","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":38,"join_event_id":null,"symbol":"AVXL","drug":"blarcamesine","modality":"small_molecule","area":"cns","result_type":"other","news_source_file":"documents/20261015_161827_(AVXL)_sec_0001731122-26-001348-ex991.txt","market_impact_date":"2026-10-16","day1_return":-0.114865,"day2_return":-0.045801,"prior_1w_return":-0.038961,"comments":"FDA cleared/opened the IND for blarcamesine (ANAVEX2-73) in Fragile X syndrome, enabling the planned Phase 2a study ANAVEX2-73-FXS-001: \"the Company may proceed with its planned clinical study under its Investigational New Drug Application (IND)\".","created_at":"2026-10-25 10:13:57","updated_at":"2026-10-25T10:14:02Z","company":"Anavex Life Sciences","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":11,"join_event_id":21,"symbol":"IRD","drug":"phentolamine ophthalmic solution 0.75%","modality":"small_molecule","area":"ophthalmology","result_type":"fda_approval","news_source_file":"documents/20261016_120000_(IRD)_yahoo_news_yahoo-1ac8a52d7ca593741e05d4c4c69ff026-IRD.txt","market_impact_date":"2026-10-16","day1_return":-0.051852,"day2_return":-0.005208,"prior_1w_return":-0.091928,"comments":"\"the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental New Drug Application (sNDA) for phentolamine ophthalmic solution 0.75% for the treatment of presbyopia in adults.\" Announced Oct 16, 2026 (GlobeNewswire release; earliest full-text copy for this symbol). Resolves PDUFA event 21 (Oct 17, 2026).","created_at":"2026-10-25 09:54:00","updated_at":"2026-10-25T09:54:26Z","company":"Opus Genetics","event_type":"pdufa","expect_date_from":"2026-10-17","expect_date_to":"2026-10-17","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":578,"join_event_id":null,"symbol":"AQST","drug":"Anaphylm (dibutepinephrine)","modality":"small_molecule","area":"immunology","result_type":"other","news_source_file":"documents/20261015_070000_(AQST)_yahoo_news_yahoo-1340f0bdefc0a7a11d2356f8c9a83a6f-AQST.txt","market_impact_date":"2026-10-15","day1_return":-0.119306,"day2_return":-0.068966,"prior_1w_return":-0.002164,"comments":"Oct 15, 2026 release: \"FDA accepted the resubmission as complete and classified it as a Class 2 response\" and \"PDUFA goal action date set for March 16, 2027\". Regulatory decision that establishes the PDUFA date tracked in event #34 (still open, not resolved). Earlier 07:00 ET GlobeNewswire copy; 8-K filed 07:21 ET.","created_at":"2026-11-02 17:57:59","updated_at":"2026-11-02T17:59:35Z","company":"Aquestive Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":542,"join_event_id":null,"symbol":"OCGN","drug":"OCU400","modality":"gene_therapy","area":"ophthalmology","result_type":"other","news_source_file":"documents/20261015_080105_(OCGN)_sec_0001104659-26-115970-ex991.txt","market_impact_date":"2026-10-15","day1_return":-0.032105,"day2_return":-0.041769,"prior_1w_return":-0.159,"comments":"Bahamas Regulatory Agency (LARTA) \"provided provisional approval and priority designation of OCU400\"; \"First approval of OCU400 for a broad RP indication\". Non-U.S. provisional approval under a regulated EAP; full LARTA approval and dosing \"expected within 90 days\". No date given for the provisional approval itself.","created_at":"2026-10-29 13:07:03","updated_at":"2026-10-29T13:08:39Z","company":"Ocugen","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":532,"join_event_id":null,"symbol":"ADMA","drug":null,"modality":"protein","area":"immunology","result_type":"safety_update","news_source_file":"documents/20261015_070000_(ADMA)_yahoo_news_yahoo-2f98d7c82b46ff6919803f56e5051873-ADMA.txt","market_impact_date":"2026-10-15","day1_return":0.037718,"day2_return":-0.00466,"prior_1w_return":0.019724,"comments":"Peer-reviewed publication (Oct 15, 2026): \"No Thromboembolic Events Were Reported for ADMA IVIG Products Manufactured Using the Optimized Process During the Postmarketing Surveillance Period Evaluated\". Caveat: manufacturing-process validation / postmarketing surveillance data on marketed IVIG products, not a new clinical trial readout; no product-specific drug named. No SEC or wire file in workspace; Yahoo carried the full GlobeNewswire release.","created_at":"2026-10-28T00:10:00","updated_at":"2026-10-28T18:33:38Z","company":"ADMA Biologics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":510,"join_event_id":null,"symbol":"IRD","drug":"OPGx-BEST1","modality":"gene_therapy","area":"rare_genetic","result_type":"data_presentation","news_source_file":"documents/20261015_172306_(IRD)_sec_0001140361-26-039781-ex991.txt","market_impact_date":"2026-10-15","day1_return":-0.012195,"day2_return":-0.051852,"prior_1w_return":-0.070295,"comments":"Data presented at Retina in Rio 2026: improved retinal sensitivity (microperimetry) in 3 of 4 evaluable low-dose Cohort 1 participants (75%), plus OCT-based structure/function analyses; cohort 1 had follow-up of 3-6 months, interim data. Earlier Cohort 1 topline disclosed 2026-09-09 (result #12).","created_at":"2026-10-26 18:57:37","updated_at":"2026-10-26T18:58:51Z","company":"Opus Genetics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":479,"join_event_id":397,"symbol":"RXRX","drug":"REC-1245","modality":"small_molecule","area":"oncology","result_type":"interim_analysis","news_source_file":"documents/20261015_082200_(RXRX)_yahoo_news_yahoo-a64f0ba387af5ba4cd3ea77e3dd1d98a-RXRX.txt","market_impact_date":"2026-10-15","day1_return":0.112299,"day2_return":-0.167067,"prior_1w_return":-0.124122,"comments":"REC-1245 (RBM39) Phase 1/2 DAHLIA dose-escalation update first disclosed in the Oct 15, 2026 release (\"Clinical Data Updates\"; company release carried by Yahoo; text truncated). Full detail in Nov 2, 2026 8-K: 2 confirmed + 1 unconfirmed partial responses (endometrial & liver cancer) at >=45 mg QD; 91.7% disease control rate (11/12); 45 mg selected for exploratory expansion.","created_at":"2026-10-25 20:16:05","updated_at":"2026-11-03T04:22:25Z","company":"Recursion Pharmaceuticals","event_type":"interim_analysis","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.68,"llm_reason":"The REC-1245 (RBM39 degrader) readout is additional Phase 1 dose-escalation data and gets only brief mention in the update. Early oncology safety/PK data at a $2B, platform-driven company rarely moves the stock 10% in one session, and the prior REC-1245 data drew a modest reaction.","llm_predicted_at":"2026-10-25T15:49:56Z","llm_source":"live"},{"id":478,"join_event_id":395,"symbol":"RXRX","drug":"REC-4881","modality":"small_molecule","area":"gi_hepatology","result_type":"interim_analysis","news_source_file":"documents/20261015_082200_(RXRX)_yahoo_news_yahoo-a64f0ba387af5ba4cd3ea77e3dd1d98a-RXRX.txt","market_impact_date":"2026-10-15","day1_return":0.112299,"day2_return":-0.167067,"prior_1w_return":-0.124122,"comments":"\"REC-4881 (MEK1/2) Phase 1b/2 TUPELO data update: deep, durable polyp burden reductions in expanded adult FAP population (18+), 47% median reduction after 12 weeks, 85% below baseline 12 weeks off treatment.\" First disclosed in the Oct 15, 2026 release (company release carried by Yahoo; text truncated). Full detail and new analyses (lower GI 50% median reduction; larger >5mm polyps) disclosed in the Nov 2, 2026 8-K and presented at CGA-IGC plenary (event 395).","created_at":"2026-10-25 20:16:05","updated_at":"2026-11-03T04:22:25Z","company":"Recursion Pharmaceuticals","event_type":"data_presentation","expect_date_from":"2026-11-02","expect_date_to":"2026-11-02","event_closed":1,"tier":"Core","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":360,"join_event_id":null,"symbol":"EDSA","drug":"EB06","modality":"monoclonal_antibody","area":"dermatology","result_type":"other","news_source_file":"documents/20261015_091514_(EDSA)_sec_0001171843-26-006647.txt","market_impact_date":"2026-10-15","day1_return":0.007547,"day2_return":-0.037453,"prior_1w_return":-0.320513,"comments":"Oct 15, 2026 8-K: \"the U.S. Food and Drug Administration (\\\"FDA\\\") has cleared the Company's Investigational New Drug (\\\"IND\\\") application for its Phase 2 clinical study of EB06 in vitiligo, enabling the Company to expand recruitment to the United States.\" Regulatory decision, not efficacy data.","created_at":"2026-10-25 12:01:50","updated_at":"2026-10-25T12:10:42Z","company":"Edesa Biotech","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":305,"join_event_id":1005,"symbol":"KRYS","drug":"KB113","modality":"gene_therapy","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261015_070230_(KRYS)_sec_0001711279-26-000064.txt","market_impact_date":"2026-10-15","day1_return":-0.002087,"day2_return":-0.040667,"prior_1w_return":0.018856,"comments":"8-K: press release (Oct 15, 2026) announced clinical data from the Gorlin Syndrome Pilot Study of KB113 in BCC patients with Gorlin syndrome; presented in poster at PeDRA Annual Conference Oct 15-17, 2026, Alexandria VA. Exhibit 99.1/99.2 only furnished separately; data details not in 8-K body.","created_at":"2026-10-25 11:49:17","updated_at":"2026-10-25T13:22:41Z","company":"Krystal Biotech","event_type":"data_presentation","expect_date_from":"2026-10-15","expect_date_to":"2026-10-17","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":46,"join_event_id":473,"symbol":"VNDA","drug":"VQW-765","modality":"small_molecule","area":"cns","result_type":"topline_results","news_source_file":"documents/20261014_170000_(VNDA)_yahoo_news_yahoo-a77c2b12bbe6f5db1462c5b0788cb1bf-VNDA.txt","market_impact_date":"2026-10-15","day1_return":0.004739,"day2_return":-0.049528,"prior_1w_return":-0.074561,"comments":"\"Vanda's Phase III clinical study, VP-VQW-765-3201 (Study 3201), which evaluated VQW-765 for the on-demand treatment of acute anxiety in adults with social anxiety disorder, did not meet its primary endpoint.\" Company release, first disclosure 2026-10-14 17:00 ET after the close. Later trade coverage (Clinical Trials Arena, 2026-10-15) headlined that Vanda put the anxiety program \"on ice\"; the release copy available here stops at the primary-endpoint miss.","created_at":"2026-10-25T06:34:49","updated_at":"2026-10-26T18:58:47Z","company":"Vanda Pharmaceuticals","event_type":"topline_results","expect_date_from":"2026-08-05","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.6,"llm_reason":"VQW-765 is one of several Phase III readouts in a diversified commercial-stage company. Social anxiety has historically high placebo response, so the drug is likely a low-weighted asset. Even with a ~$245M market cap, a positive or negative result probably moves the stock less than 10%, though the small cap raises some risk of a larger move.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":13,"join_event_id":null,"symbol":"IRD","drug":"OPGx-LCA5","modality":"gene_therapy","area":"rare_genetic","result_type":"data_presentation","news_source_file":"documents/20261015_172306_(IRD)_sec_0001140361-26-039781-ex991.txt","market_impact_date":"2026-10-15","day1_return":-0.051852,"day2_return":-0.005208,"prior_1w_return":-0.091928,"comments":"Presented at Retina in Rio 2026: sustained visual acuity and light-sensitivity gains in 3 adults through 24 months and 3 pediatric participants through six months (Phase 1/2). Interim data, subject to change.","created_at":"2026-10-25 09:54:00","updated_at":"2026-10-25T10:37:03Z","company":"Opus Genetics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":516,"join_event_id":1009,"symbol":"TRVI","drug":"Haduvio (nalbuphine ER) / CORAL","modality":"small_molecule","area":"respiratory","result_type":"data_presentation","news_source_file":"documents/20261013_073000_(TRVI)_yahoo_news_yahoo-e8fb8be97b3145984c2d5e118882a208-TRVI.txt","market_impact_date":"2026-10-14","day1_return":-0.018714,"day2_return":0.004146,"prior_1w_return":-0.067527,"comments":"Phase 2b CORAL (IPF-related chronic cough) patient-reported outcomes: \"will present on the patient-reported outcomes from the Phase 2b CORAL trial\"; oral presentation at CHEST 2026, Oct 18-21. Full-text company release only available via Yahoo syndication (no primary wire/SEC file on disk).","created_at":"2026-10-26 23:08:49","updated_at":"2026-11-04T01:15:29Z","company":"Trevi Therapeutics","event_type":"data_presentation","expect_date_from":"2026-10-18","expect_date_to":"2026-10-21","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":475,"join_event_id":null,"symbol":"ATRA","drug":"tabelecleucel","modality":"cell_therapy","area":"oncology","result_type":"other","news_source_file":"documents/20261014_030000_(ATRA)_resolution_news_resolution_news-e56b661e04307a5e0c1343a5b788fbb9.txt","market_impact_date":"2026-10-14","day1_return":0.027405,"day2_return":0.009414,"prior_1w_return":-0.045641,"comments":"Headline: \"Atara Biotherapeutics Reports that the Resubmitted Tabelecleucel (Tab-cel®) Biologics License Application Has Been Accepted by the U.S. Food and Drug Administration\" (Business Wire, 2026-10-14) - resubmitted BLA (sponsored by Pierre Fabre) accepted for review; no PDUFA/action date stated. Google News wire summary only (no SEC exhibit in workspace).","created_at":"2026-10-25 16:14:40","updated_at":"2026-10-25T20:16:11Z","company":"Atara Biotherapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":471,"join_event_id":394,"symbol":"RYTM","drug":"setmelanotide","modality":"peptide","area":"metabolic","result_type":"other","news_source_file":"documents/20261013_193000_(RYTM)_yahoo_news_yahoo-5d1a2023dc51efad7ee1e054f3133097-RYTM.txt","market_impact_date":"2026-10-14","day1_return":0.001155,"day2_return":0.014531,"prior_1w_return":-0.04583,"comments":"Japan MHLW approval of IMCIVREE (setmelanotide) for acquired hypothalamic obesity, followed by commercial launch and NHI price listing: \"Launch follows MHLW approval of IMCIVREE for acquired hypothalamic obesity and inclusion on Japan's National Health Insurance drug price list\"; \"IMCIVREE is the first approved therapy in Japan for patients living with acquired hypothalamic obesity.\" Exact approval date not stated in release (launch announced Oct 13, 2026).","created_at":"2026-10-25 20:14:01","updated_at":"2026-10-25T20:16:10Z","company":"Rhythm Pharmaceuticals","event_type":"other","expect_date_from":"2026-08-04","expect_date_to":"2026-12-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":470,"join_event_id":1019,"symbol":"ARWR","drug":"ARO-MAPT","modality":"sirna","area":"cns","result_type":"interim_analysis","news_source_file":"documents/20261014_073000_(ARWR)_yahoo_news_yahoo-a14167ea2753b361beff9f7f6a329217-ARWR.txt","market_impact_date":"2026-10-14","day1_return":0.004129,"day2_return":0.002227,"prior_1w_return":-0.055411,"comments":"\"today announced interim results from an ongoing Phase 1/2a study of ARO-MAPT ... first successful clinical validation of a platform to deliver siRNA across the blood-brain barrier and achieve substantial target gene knockdown in the brain\" (Oct 14, 2026, healthy volunteers). Coverage: mean ~73% CSF tau reduction at Day 105, up to 85% max. Source is Yahoo syndication of the company release (earliest available).","created_at":"2026-10-25 20:13:43","updated_at":"2026-10-25T20:16:10Z","company":"Arrowhead Pharmaceuticals","event_type":"data_presentation","expect_date_from":"2026-10-14","expect_date_to":"2026-10-14","event_closed":1,"tier":"Core","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":332,"join_event_id":793,"symbol":"IBRX","drug":"ANKTIVA","modality":"protein","area":"oncology","result_type":"fda_approval","news_source_file":"documents/20261014_171904_(IBRX)_sec_0001193125-26-421820-ex991.txt","market_impact_date":"2026-10-14","day1_return":0.009082,"day2_return":-0.082,"prior_1w_return":0.01641,"comments":"FDA expanded ANKTIVA plus BCG indication to BCG-unresponsive NMIBC with papillary-only tumors: \"FDA has expanded the approved indication ... to include patients with BCG-unresponsive NMIBC with papillary-only tumors\" (company release October 14, 2026; SEC 8-K EX-99.1 filed 2026-10-14 17:19 ET). Resolves the Jan 6, 2027 PDUFA ahead of the target date.","created_at":"2026-10-25 11:54:52","updated_at":"2026-10-26T04:26:04Z","company":"ImmunityBio","event_type":"pdufa","expect_date_from":"2027-01-06","expect_date_to":"2027-01-06","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":295,"join_event_id":null,"symbol":"LQDA","drug":"YUTREPIA (treprostinil) inhalation powder","modality":"small_molecule","area":"cardiovascular","result_type":"other","news_source_file":"documents/20261013_214911_(LQDA)_sec_0001104659-26-115672-ex991.txt","market_impact_date":"2026-10-14","day1_return":0.265946,"day2_return":0.02475,"prior_1w_return":0.034736,"comments":"\"global settlement agreement with United Therapeutics ... that resolves all pending litigation between the companies\"; YUTREPIA remains available in PAH, Liquidia to submit supplement removing PH-ILD indication, net $380.7M in installments 2026-2027. Announced Oct 13, 2026 (GlobeNewswire), earliest disclosure vs UTHR filing Oct 14.","created_at":"2026-10-25 11:47:25","updated_at":"2026-10-25T12:10:35Z","company":"Liquidia","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":19,"join_event_id":null,"symbol":"ALVO","drug":"AVT29","modality":"protein","area":"ophthalmology","result_type":"other","news_source_file":"documents/20261014_100507_(ALVO)_sec_0001171843-26-006617-ex991.txt","market_impact_date":"2026-10-14","day1_return":-0.039033,"day2_return":0.027079,"prior_1w_return":-0.123778,"comments":"Regulatory submission (not a data readout): \"AVT29 submitted to the European Medicines Agency as a line extension to the existing marketing authorization for Mynzepli (aflibercept 2 mg)\" — first known worldwide submission for an Eylea 8 mg biosimilar; announced Oct 14, 2026. No approval date guided.","created_at":"2026-10-25 10:04:43","updated_at":"2026-10-25T10:05:34Z","company":"Alvotech","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":10,"join_event_id":27,"symbol":"BMEA","drug":"BMF-650","modality":"small_molecule","area":"metabolic","result_type":"topline_results","news_source_file":"documents/20261013_160800_(BMEA)_yahoo_news_yahoo-e6af90d3bc06e2704d41ffa9b719846a-BMEA.txt","market_impact_date":"2026-10-14","day1_return":-0.338095,"day2_return":0.002398,"prior_1w_return":0.008,"comments":"GlobeNewswire release dated Oct 13, 2026 (syndicated copy published 16:08 ET, before the 4:30 p.m. ET call; also filed as SEC 8-K exhibit 99.1 at 17:35). Phase 1 GLP-131 MAD: mean Day 29 weight loss 1.5%-3.2% across Cohorts 1-4 vs 0.1% placebo; Cohort 5 (200 then 400 mg QD) -6.1% at Day 29, confounded (n=2 placebo ate ~33% of food). No severe/serious TEAEs.","created_at":"2026-10-25 05:53:24","updated_at":"2026-10-25T09:54:26Z","company":"Biomea Fusion","event_type":"topline_results","expect_date_from":"2026-10-13","expect_date_to":"2026-10-13","event_closed":1,"tier":"Core","llm_prediction":"large_impact","llm_confidence":0.6,"llm_reason":"A $42M microcap reporting Phase I oral GLP-1 data could easily move 10% or more either way. Oral GLP-1 Phase I readouts tend to provoke sharp reactions, but the weight-loss and tolerability bar set by orforglipron is high, so the direction is unclear.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":7,"join_event_id":14,"symbol":"VSTM","drug":"VS-7375","modality":"small_molecule","area":"oncology","result_type":"interim_analysis","news_source_file":"documents/20261014_060000_(VSTM)_yahoo_news_yahoo-0000d28c7f06a9e0ad950bce8f845d8c-VSTM.txt","market_impact_date":"2026-10-14","day1_return":0.034899,"day2_return":0.197146,"prior_1w_return":-0.03871,"comments":"Initial TARGET-D 101 Phase 1/2 data: \"50% Confirmed ORR in 2L Pancreatic Ductal Adenocarcinoma and Two Complete Responses in 2L+ Disease (One Confirmed)\"; activity also in mCRC/NSCLC. First public disclosure 2026-10-14 (Business Wire release).","created_at":"2026-10-25 09:52:58","updated_at":"2026-10-25T09:54:26Z","company":"Verastem","event_type":"interim_analysis","expect_date_from":"2026-10-01","expect_date_to":"2026-10-31","event_closed":1,"tier":"Core","llm_prediction":"large_impact","llm_confidence":0.5,"llm_reason":"VS-7375 is the main value driver at a ~$1.2B market cap, and the October update spans PDAC, NSCLC and CRC with more mature follow-up. The KRAS G12D space is competitive, so investors will compare the data closely against pan-RAS and other G12D programs. The June preliminary update was only described as 'encouraging', which leaves room for a sharp move either way.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":5,"join_event_id":null,"symbol":"TRDA","drug":"ENTR-601-44","modality":"aso","area":"rare_genetic","result_type":"interim_analysis","news_source_file":"documents/20261014_070000_(TRDA)_yahoo_news_yahoo-894cc11cb92cd49135547d22d405178f-TRDA.txt","market_impact_date":"2026-10-14","day1_return":-0.063786,"day2_return":0.050549,"prior_1w_return":-0.103321,"comments":"Company GlobeNewswire release via Yahoo: independent DMC reviewed all available safety and PK data from eight Cohort 2 participants and \"Recommends Initiation of Cohort 3 at the Top Dose of 18 mg/kg in ... ELEVATE-44-201.\" No data values disclosed.","created_at":"2026-10-25 09:52:41","updated_at":"2026-10-25T09:54:26Z","company":"Entrada Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":4,"join_event_id":3,"symbol":"TRDA","drug":"ENTR-601-45","modality":"aso","area":"rare_genetic","result_type":"topline_results","news_source_file":"documents/20261014_075200_(TRDA)_sec_0001689375-26-000057.txt","market_impact_date":"2026-10-14","day1_return":-0.063786,"day2_return":0.050549,"prior_1w_return":-0.103321,"comments":"8-K/PR: \"announced positive topline data from Cohort 1\" of ELEVATE-45-201; 5 mg/kg: favorable safety, 0.10% mean increase in dystrophin (n=6, nominal p=0.03) vs 0.02% decrease on placebo; no functional benefit expected/observed after three doses.","created_at":"2026-10-25 09:52:41","updated_at":"2026-10-25T09:54:26Z","company":"Entrada Therapeutics","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-10-31","event_closed":1,"tier":"Core","llm_prediction":"large_impact","llm_confidence":0.45,"llm_reason":"Market cap of about $184M is below the ~$223M in cash and securities, so the stock is priced near or below cash with little value given to the pipeline. ENTR-601-45 is a lead DMD exon-45 skipping program, and its topline dystrophin data is binary and pivotal for the EEV platform. That makes a move of 10% or more likely in either direction, and the deep discount to cash leaves room for a sharp rebound if data are good.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":480,"join_event_id":344,"symbol":"SNDX","drug":"axatilimab","modality":"monoclonal_antibody","area":"respiratory","result_type":"topline_results","news_source_file":"documents/20261012_160100_(SNDX)_yahoo_news_yahoo-938ad5d0982aa5e9e07f3da7c2250a01-SNDX.txt","market_impact_date":"2026-10-13","day1_return":-0.1571,"day2_return":-0.030108,"prior_1w_return":-0.071789,"comments":"MAXPIRe Phase 2 IPF topline (release Oct 12, 2026 16:01 ET, after close; first trading day Oct 13). \"Trial did not meet the primary endpoint of annualized rate of FVC decline\"; axatilimab well tolerated, safety comparable to placebo. Trade press (Fierce Pharma, Dealroom) reported development in IPF halted. GlobeNewswire release carried by Yahoo; no SEC exhibit.","created_at":"2026-10-26 00:19:06","updated_at":"2026-11-02T17:56:02Z","company":"Syndax Pharmaceuticals","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.6,"llm_reason":"The IPF Phase 2 (MAXPIRe) is a speculative add-on for a $1.2B company with two commercial drugs driving value. IPF expectations for CSF-1R are likely modest and the readout is shared 50/50 with Incyte, so the move is likely under 10% either way. A clear success could still exceed 10%.","llm_predicted_at":"2026-10-25T15:49:45Z","llm_source":"live"},{"id":474,"join_event_id":106,"symbol":"BEAM","drug":"BEAM-301","modality":"gene_therapy","area":"metabolic","result_type":"interim_analysis","news_source_file":"documents/20261013_070000_(BEAM)_yahoo_news_yahoo-b1eb2e2619437402243506dff006e220-BEAM.txt","market_impact_date":"2026-10-13","day1_return":-0.027855,"day2_return":-0.031928,"prior_1w_return":-0.021036,"comments":"GlobeNewswire release 2026-10-13: \"BEAM-301 Achieves Clinical Proof of Concept for Genetic Correction of R83C Mutation in GSDIa; Initial Phase 1/2 Data Show Restoration of Endogenous Glucose Production Following a Single Treatment, with Dose-Dependent Improvements.\" First disclosure 2026-10-13; same data presented at ESGCT 33rd Annual Congress (Hamburg, 2026-10-27..10-30) and investor webcast 2026-10-27 8:00 ET (GlobeNewswire/Yahoo 2026-10-27). Earliest date used.","created_at":"2026-10-25 20:14:53","updated_at":"2026-10-27T11:26:24Z","company":"Beam Therapeutics","event_type":"topline_results","expect_date_from":"2026-08-04","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.62,"llm_reason":"BEAM-301 for GSDIa is a smaller, earlier program. Its first-in-human data is unlikely to move a $2.5B multi-asset company 10% or more. Value is driven mainly by BEAM-302 and risto-cel, and the liver LNP platform is already partly validated by BEAM-302.","llm_predicted_at":"2026-10-25T15:48:39Z","llm_source":"live"},{"id":459,"join_event_id":503,"symbol":"TRAX","drug":"ANB033","modality":"monoclonal_antibody","area":"gi_hepatology","result_type":"topline_results","news_source_file":"documents/20261012_161016_(ANAB)_yahoo_news_yahoo-6e3b41c409ae656b73424bfef1a7a2cf-ANAB.txt","market_impact_date":"2026-10-13","day1_return":-0.069603,"day2_return":0.077336,"prior_1w_return":0.032131,"comments":"Yahoo News summary (tagged ANAB) reports First Tracks \"posted 'impressive' results for its celiac disease treatment Monday\" (Oct 12, 2026). No primary company wire/SEC copy exists in the workspace, so this aggregator is used and the timestamp may be later than first disclosure. Resolves Q4 2026 Cohort 1 top-line guidance.","created_at":"2026-10-25 16:00:56","updated_at":"2026-10-25T16:04:05Z","company":"First Tracks Biotherapeutics","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.6,"llm_reason":"The stock trades at about $1.8B against $168M cash, so nearly all the value rides on ANB033 in celiac disease. The Cohort 1 gluten-challenge readout (n=30, randomized vs placebo) is binary and lead-defining, so a 10%+ move either way is likely. The high expectations already priced in make the direction hard to call.","llm_predicted_at":"2026-10-25T15:50:25Z","llm_source":"live"},{"id":437,"join_event_id":858,"symbol":"ENTX","drug":"EB613","modality":"peptide","area":"metabolic","result_type":"data_presentation","news_source_file":"documents/20261013_030000_(ENTX)_resolution_news_resolution_news-eb7bd448ed8c3ded40b31232c78d32fd.txt","market_impact_date":"2026-10-13","day1_return":-0.060377,"day2_return":0.004016,"prior_1w_return":0.01145,"comments":"ASBMR 2026 plenary poster presented: \"Entera Presents Markedly Enhanced Anabolic Effects of EB613 (First-in-Class Oral PTH(1-34) Tablet) in Postmenopausal Women with Osteoporosis at High Risk of Fracture ... at ASBMR 2026 Annual Meeting.\" Caveat: only the GlobeNewswire headline via Google News is available in the workspace; full release/abstract not in documents. No quantitative data captured.","created_at":"2026-10-25 12:00:42","updated_at":"2026-10-25T12:48:04Z","company":"Entera Bio","event_type":"data_presentation","expect_date_from":"2026-10-09","expect_date_to":"2026-10-12","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":384,"join_event_id":916,"symbol":"CRVO","drug":"neflamapimod","modality":"small_molecule","area":"cns","result_type":"data_presentation","news_source_file":"documents/20261013_083631_(CRVO)_sec_0001437749-26-032502.txt","market_impact_date":"2026-10-13","day1_return":-0.095618,"day2_return":0.008811,"prior_1w_return":-0.241692,"comments":"\"On October 12, 2026, CervoMed Inc. ... issued a press release announcing initial data from the first 12 weeks of the Company's Phase 2a clinical trial in nonfluent variant primary progressive aphasia (nfvPPA), which were presented in a late-breaking oral presentation at the 15th International Society of Frontotemporal Dementias Annual Meeting in Philadelphia.\" Source is the 8-K (filed 10/13/26); underlying Ex. 99.1 press release dated 10/12/26 is not in the workspace.","created_at":"2026-10-25 12:05:22","updated_at":"2026-10-25T12:10:45Z","company":"CervoMed","event_type":"data_presentation","expect_date_from":"2026-10-08","expect_date_to":"2026-10-11","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":284,"join_event_id":632,"symbol":"MIRM","drug":"maralixibat","modality":"small_molecule","area":"gi_hepatology","result_type":"topline_results","news_source_file":"documents/20261013_080904_(MIRM)_sec_0001759425-26-000051.txt","market_impact_date":"2026-10-13","day1_return":-0.074831,"day2_return":0.00427,"prior_1w_return":0.056859,"comments":"8-K (event 2026-10-12): Phase 3 EXPAND met primary endpoint; ItchRO(Obs) -1.81 vs -0.83 placebo (p=0.0004); sBA -70.1% vs -3.5%. All 5 secondary endpoints met. sNDA planned 1H2027.","created_at":"2026-10-25 11:45:09","updated_at":"2026-10-25T12:10:33Z","company":"Mirum Pharmaceuticals","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.72,"llm_reason":"Maralixibat (Livmarli) is already approved and generating revenue. The Q4 2026 topline is likely an indication-expansion readout (e.g., EXPAND), so it is incremental for a ~$5.4B company whose value also rests on volixibat and brelovitug. A move of 10% or more is unlikely.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":262,"join_event_id":null,"symbol":"NRIX","drug":"zelebrudomide (NX-2127)","modality":"small_molecule","area":"oncology","result_type":"trial_discontinuation","news_source_file":"documents/20261013_062123_(NRIX)_sec_0001549595-26-000049.txt","market_impact_date":"2026-10-13","day1_return":-0.001354,"day2_return":0.069589,"prior_1w_return":-0.031469,"comments":"Disclosed in Q3 FY2026 10-Q: \"In August 2026, as part of a strategic prioritization of our wholly owned oncology portfolio, we decided to discontinue further clinical development of zelebrudomide.\" Existing patients may continue treatment. Decision dated August 2026; disclosed publicly in 10-Q filed 2026-10-13.","created_at":"2026-10-25T07:41:28","updated_at":"2026-10-25T12:10:31Z","company":"Nurix Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":197,"join_event_id":null,"symbol":"SABS","drug":"SAB-142","modality":"protein","area":"immunology","result_type":"other","news_source_file":"documents/20261013_083610_(SABS)_sec_0001193125-26-419769-ex991.txt","market_impact_date":"2026-10-13","day1_return":-0.053003,"day2_return":-0.070896,"prior_1w_return":-0.087097,"comments":"FDA granted Fast Track designation to SAB-142 for new-onset Stage 3 type 1 diabetes: \"the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SAB-142.\" Regulatory designation, not approval.","created_at":"2026-10-25 11:26:57","updated_at":"2026-10-25T12:10:24Z","company":"SAB Biotherapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":112,"join_event_id":1030,"symbol":"ZBIO","drug":"obexelimab","modality":"monoclonal_antibody","area":"immunology","result_type":"data_presentation","news_source_file":"documents/20261013_060128_(ZBIO)_sec_0001104659-26-115151-ex991.txt","market_impact_date":"2026-10-13","day1_return":-0.04697,"day2_return":-0.011924,"prior_1w_return":-0.051383,"comments":"New IgG4-RD data presented at the 6th International Symposium on IgG4-Related Disease (Oct 8-10, 2026): Phase 3 INDIGO OLE 12-month flare-free probability 0.93; GTI cumulative worsening score difference -11.4 (p=0.021) vs placebo at week 52; vaccine sub-study responses.","created_at":"2026-10-25 11:12:21","updated_at":"2026-10-26T00:21:24Z","company":"Zenas BioPharma","event_type":"data_presentation","expect_date_from":"2026-10-08","expect_date_to":"2026-10-10","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":583,"join_event_id":null,"symbol":"ZVRA","drug":"arimoclomol","modality":"small_molecule","area":"rare_genetic","result_type":"data_presentation","news_source_file":"documents/20261012_030000_(ZVRA)_google_news_google_news-67d49356eb96eb6e827ae661aa449dd2-ZVR.txt","market_impact_date":"2026-10-12","day1_return":-0.006146,"day2_return":-0.082155,"prior_1w_return":0.14014,"comments":"Google News (2026-10-12): \"Zevra Therapeutics shares new clinical findings for Niemann Pick disease type C\"; follow-up NeurologyLive (2026-10-14): \"Arimoclomol Plus Miglustat Shows Early, Sustained Slowing of Niemann-Pick Disease Type C Progression.\" Only aggregator headlines in workspace, no primary Zevra release; drug named in the Oct 14 item, date may lag first disclosure.","created_at":"2026-11-03T03:29:52","updated_at":"2026-11-03T08:31:06Z","company":"Zevra Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":572,"join_event_id":null,"symbol":"VRDN","drug":"elegrobart","modality":"monoclonal_antibody","area":"ophthalmology","result_type":"data_presentation","news_source_file":"documents/20261011_030000_(VRDN)_google_news_google_news-a163a182faa2be60cb19fe6c5611c1bb-VRD.txt","market_impact_date":"2026-10-12","day1_return":-0.019293,"day2_return":-0.004372,"prior_1w_return":-0.038144,"comments":"AAO 2026 conference item: \"AAO 2026: Elegrobart reduces proptosis in active thyroid eye disease.\" Conference presentation of subcutaneous anti-IGF-1R (REVEAL program) data. Caveat: only a Google News headline stub exists; no company wire/SEC exhibit available for this presentation and the exact presentation date is not stated.","created_at":"2026-11-02","updated_at":"2026-11-02T09:42:20Z","company":"Viridian Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":487,"join_event_id":1026,"symbol":"STOK","drug":"STK-002","modality":"aso","area":"ophthalmology","result_type":"data_presentation","news_source_file":"documents/20261012_080000_(STOK)_yahoo_news_yahoo-32c5c12acdf98c9e0ac32406b0db7bed-STOK.txt","market_impact_date":"2026-10-12","day1_return":-0.023848,"day2_return":-0.068323,"prior_1w_return":-0.034348,"comments":"\"today announced two presentations of data for STK-002 at the American Academy of Ophthalmology (AAO) 2026 Annual Meeting, taking place October 9-12 in New Orleans\", supporting the disease-modifying potential of STK-002 in ADOA. Company release carried via Yahoo Finance; no SEC/wire copy in workspace.","created_at":"2026-10-26 00:20:11","updated_at":"2026-10-26T00:21:52Z","company":"Stoke Therapeutics","event_type":"data_presentation","expect_date_from":"2026-10-09","expect_date_to":"2026-10-12","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":452,"join_event_id":null,"symbol":"PALI","drug":"PALI-2108","modality":"small_molecule","area":"gi_hepatology","result_type":"data_presentation","news_source_file":"documents/20261012_080500_(PALI)_yahoo_news_yahoo-7e74d37404ba472357f0a8fcab9ee112-PALI.txt","market_impact_date":"2026-10-12","day1_return":0.032468,"day2_return":-0.075472,"prior_1w_return":0.069444,"comments":"ACG 2026: \"Five presentations connect targeted intestinal exposure and sustained systemic drug exposure with PDE4 target engagement and early clinical activity\"; two Presidential Poster Awards. Same-day Stock Titan summary of the release: \"A Crohn's gut-exam score fell an average 47.5% in five people after 14 days. The study had no placebo group.\"","created_at":"2026-10-25 15:58:57","updated_at":"2026-10-25T16:04:04Z","company":"Palisade Bio","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":494,"join_event_id":null,"symbol":"ARQT","drug":"ZORYVE (roflumilast) cream 0.05%","modality":"small_molecule","area":"dermatology","result_type":"data_presentation","news_source_file":"documents/20261009_080000_(ARQT)_yahoo_news_yahoo-0bd10eeebd764664b7283d04af2ddeaa-ARQT.txt","market_impact_date":"2026-10-09","day1_return":0.085341,"day2_return":-0.013544,"prior_1w_return":-0.031633,"comments":"Company release \"Arcutis Presents ZORYVE (roflumilast) Data and Real-World Topical Corticosteroid Research at EADV and Fall Clinical\" (2026-10-09) reports presentation of Phase 2 INTEGUMENT-INFANT data for investigational ZORYVE cream 0.05% in infants 3 to <24 months, plus new ARRECTOR and DERMIS-1/2 analyses. Conference presentation, not a topline readout. Yahoo-syndicated copy of the company release; no SEC/wire original in workspace.","created_at":"2026-10-26 08:31:47","updated_at":"2026-10-26T08:33:26Z","company":"Arcutis Biotherapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":464,"join_event_id":1130,"symbol":"ALMS","drug":"envudeucitinib","modality":"small_molecule","area":"dermatology","result_type":"data_presentation","news_source_file":"documents/20261009_040000_(ALMS)_yahoo_news_yahoo-a02452a350ae5310bb86504f07a131af-ALMS.txt","market_impact_date":"2026-10-09","day1_return":0.02726,"day2_return":-0.013966,"prior_1w_return":-0.033287,"comments":"New Phase 3 ONWARD data announced Oct 9, 2026: \"Alumis Announces New Phase 3 Data Demonstrating Envudeucitinib Rapidly and Durably Improved Psoriasis Burden Across Scalp, Itch, and Quality of Life Measures\"; switchers from placebo/apremilast \"achieved rapid responses, comparable to those on continuous treatment at Week 48\". Only aggregator (Yahoo/GlobeNewswire syndication, truncated) available; no SEC exhibit in workspace.","created_at":"2026-10-25 16:09:02","updated_at":"2026-11-01T04:58:44Z","company":"Alumis","event_type":"data_presentation","expect_date_from":"2026-10-09","expect_date_to":"2026-10-09","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":456,"join_event_id":1007,"symbol":"SPTX","drug":"GlyphAgo","modality":"small_molecule","area":"cns","result_type":"data_presentation","news_source_file":"documents/20261009_070000_(SPTX)_yahoo_news_yahoo-af8d48236268d60935d203a3e65f6ca4-SPTX.txt","market_impact_date":"2026-10-09","day1_return":0.0134,"day2_return":-0.055096,"prior_1w_return":-0.054881,"comments":"Phase 1 PK data for GlyphAgo presented in a poster at ECNP Congress (Munich, Oct 10-13, 2026): \"The poster represents the first scientific presentation of data from the GlyphAgo Phase 1\" trial. Source is the company's own release (Oct 9, 2026); duplicate copies on Business Wire/Google News and Yahoo are later versions.","created_at":"2026-10-25 15:59:40","updated_at":"2026-10-25T16:04:05Z","company":"Seaport Therapeutics","event_type":"data_presentation","expect_date_from":"2026-10-10","expect_date_to":"2026-10-13","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":445,"join_event_id":null,"symbol":"MNKD","drug":"Furoscix ReadyFlow","modality":"small_molecule","area":"cardiovascular","result_type":"data_presentation","news_source_file":"documents/20261009_200000_(MNKD)_yahoo_news_yahoo-2bf2290e0255d13c2a768410c3999882-MNKD.txt","market_impact_date":"2026-10-09","day1_return":-0.048632,"day2_return":-0.025559,"prior_1w_return":-0.134211,"comments":"HFSA 2026 new analyses: \"Furoscix ReadyFlow PK/PD performance delivered via an autoinjector demonstrated comparable urine output to IV furosemide\" and consistent bioavailability/diuresis/natriuresis across injection sites. Company release (GlobeNewswire) syndicated; earliest copies 2026-10-09 (gnews), Yahoo 20:00 EDT. No SEC exhibit in workspace.","created_at":"2026-10-25 13:21:34","updated_at":"2026-10-29T15:12:48Z","company":"MannKind","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":558,"join_event_id":235,"symbol":"VERA","drug":"atacicept","modality":"protein","area":"renal","result_type":"data_presentation","news_source_file":"documents/20261008_111503_(VERA)_yahoo_news_yahoo-f4432456fcc9af6afe24ad4db914288f-VERA.txt","market_impact_date":"2026-10-08","day1_return":-0.01719,"day2_return":0.005045,"prior_1w_return":-0.063177,"comments":"Interim PIONEER Phase 2 results for atacicept: \"multiple company-sponsored abstracts, including final ORIGIN 3 efficacy data ... and interim PIONEER Phase 2 results, were presented as late-breaking sessions at ASN Kidney Week 2026 in Denver\" (2026-10-08 Yahoo summary; secondary source - no primary release in file set; abstracts presented Oct 22-25 2026).","created_at":"2026-10-30 18:07:05","updated_at":"2026-10-30T18:09:45Z","company":"Vera Therapeutics","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"","llm_prediction":"small_impact","llm_confidence":0.62,"llm_reason":"The drug already has accelerated approval, and the ORIGIN 3 final eGFR readout is largely de-risked by strong proteinuria data and the class precedent from Otsuka's sibeprenlimab and Vertex's povetacicept. The readout is confirmatory, so a sub-10% move is most likely.","llm_predicted_at":"2026-10-25T15:49:18Z","llm_source":"live"},{"id":485,"join_event_id":null,"symbol":"AGEN","drug":"botensilimab + balstilimab","modality":"monoclonal_antibody","area":"oncology","result_type":"other","news_source_file":"documents/20261008_073000_(AGEN)_yahoo_news_yahoo-312292a48de09da343d0a35ba531470d-AGEN.txt","market_impact_date":"2026-10-08","day1_return":-0.003963,"day2_return":0.017241,"prior_1w_return":-0.237664,"comments":"\"the Ministry of Health of the Republic of Armenia has granted marketing authorizations for Botvymo (botensilimab) and Evamplix (balstilimab)\" for previously treated MSS mCRC without active liver metastases - first country approval; ex-US regulatory decision, not an FDA action.","created_at":"2026-10-26 00:19:48","updated_at":"2026-10-26T00:21:51Z","company":"Agenus","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":362,"join_event_id":null,"symbol":"EDIT","drug":"EDIT-401","modality":"gene_therapy","area":"metabolic","result_type":"other","news_source_file":"documents/20261008_070433_(EDIT)_sec_0001650664-26-000093.txt","market_impact_date":"2026-10-08","day1_return":0.032727,"day2_return":0.021127,"prior_1w_return":0.070039,"comments":"Regulatory clearance to start first-in-human trial: \"received approval to initiate the Phase 1/2 Strive clinical trial of EDIT-401 in patients with heterozygous familial hypercholesterolemia in Australia\" (HREC approval and TGA CTN completed). No clinical data disclosed.","created_at":"2026-10-25 08:01:28","updated_at":"2026-10-25T12:10:43Z","company":"Editas Medicine","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":267,"join_event_id":null,"symbol":"NEOG","drug":"Vet HyCoat (Hyaluronate Sodium Sterile Solution)","modality":"other","area":"other","result_type":"safety_update","news_source_file":"documents/20261007_160232_(NEOG)_sec_0001193125-26-416954.txt","market_impact_date":"2026-10-08","day1_return":0.002568,"day2_return":0.011956,"prior_1w_return":-0.0875,"comments":"10-Q: \"On September 23, 2026, the FDA issued a Warning Letter to the Company following an inspection of the unaffiliated third-party contract manufacturer's facility and testing of the product by the FDA's laboratory which showed microbiological contamination.\" Relates to Jan 28, 2026 voluntary recall of all unexpired lots; product was third-party manufactured and Neogen served only as distributor. First public disclosure in the 10-Q filed 2026-10-07.","created_at":"2026-10-25T07:42:34","updated_at":"2026-10-25T12:10:32Z","company":"Neogen","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":132,"join_event_id":null,"symbol":"VIR","drug":"VIR-5500","modality":"bispecific","area":"oncology","result_type":"other","news_source_file":"documents/20261008_083838_(VIR)_sec_0001628280-26-065408.txt","market_impact_date":"2026-10-08","day1_return":-0.034722,"day2_return":0.052158,"prior_1w_return":0.030411,"comments":"8-K Item 8.01 (Oct 8, 2026): \"the U.S. Food and Drug Administration has granted Fast Track designation to VIR-5500, a PSMA-targeted PRO-XTEN dual-masked T-cell engager (TCE), for the treatment of late-line metastatic castration-resistant prostate cancer.\" Co-developed with Astellas; no prior guided event.","created_at":"2026-10-25 11:14:59","updated_at":"2026-10-25T12:10:18Z","company":"Vir Biotechnology","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":25,"join_event_id":null,"symbol":"CATX","drug":"PSV359","modality":"radiopharma","area":"oncology","result_type":"other","news_source_file":"documents/20261008_062819_(CATX)_sec_0001193125-26-417384-ex991.txt","market_impact_date":"2026-10-08","day1_return":0.101626,"day2_return":-0.01845,"prior_1w_return":-0.105455,"comments":"FDA granted Fast Track Designation for PSV359 in adult patients with locally advanced unresectable and/or metastatic FAP-positive solitary fibrous tumors. \"the U.S. Food and Drug Administration (the FDA) granted Fast Track Designation\"","created_at":"2026-10-25 10:12:39","updated_at":"2026-10-25T10:14:01Z","company":"Perspective Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":561,"join_event_id":1127,"symbol":"ARWR","drug":"plozasiran","modality":"sirna","area":"metabolic","result_type":"other","news_source_file":"documents/20261007_073000_(ARWR)_yahoo_news_yahoo-4076d9bbab20b8a3e04c723a7afd2061-ARWR.txt","market_impact_date":"2026-10-07","day1_return":-0.000975,"day2_return":-0.012036,"prior_1w_return":-0.071094,"comments":"Oct 7, 2026 company release: FDA granted plozasiran entry in the STAR (Split Real Time Application Review) pilot program for the upcoming sHTG sNDA. No clinical data or approval; a regulatory designation supporting the planned submission.","created_at":"2026-10-31 12:40:38","updated_at":"2026-10-31T12:41:16Z","company":"Arrowhead Pharmaceuticals","event_type":"other","expect_date_from":"2026-10-07","expect_date_to":"2026-10-07","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":482,"join_event_id":149,"symbol":"ARVN","drug":"ARV-102","modality":"small_molecule","area":"cns","result_type":"data_presentation","news_source_file":"documents/20261007_070000_(ARVN)_yahoo_news_yahoo-ebf95139051b95bc8e7944c07201e183-ARVN.txt","market_impact_date":"2026-10-07","day1_return":0.019152,"day2_return":0.008054,"prior_1w_return":-0.025333,"comments":"\"Data showed improvements in an objective measure of impaired eye movement associated with Parkinson's disease, with a correlation between reductions in LRRK2 cerebrospinal fluid (CSF) biomarkers to these changes in oculomotor function and changes in synaptic biomarkers.\" GlobeNewswire release of Oct 7, 2026 covering data presented at MDS (Oct 4-8, 2026); earliest available copy is the Yahoo reprint (no SEC/wire original in workspace).","created_at":"2026-10-25","updated_at":"2026-10-26T00:21:51Z","company":"Arvinas","event_type":"data_presentation","expect_date_from":"2026-10-04","expect_date_to":"2026-10-08","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":436,"join_event_id":443,"symbol":"RCKT","drug":"RP-A501","modality":"gene_therapy","area":"cardiovascular","result_type":"data_presentation","news_source_file":"documents/20261007_093600_(RCKT)_yahoo_news_yahoo-40a5955567150aa1e119792f2f080adb-RCKT.txt","market_impact_date":"2026-10-07","day1_return":0.022177,"day2_return":0.037475,"prior_1w_return":-0.042471,"comments":"Danon disease investor webinar (Oct 6, 2026, 4:30 p.m. ET) data disclosed: \"highlighted key findings and development milestones presented during its October 6 Danon disease investor webinar... highlighted sustained biological activity in longer-term Phase 1 follow-up and reported enco[ncouraging Phase 2 observations]\". Source is a syndicated copy of the company's Business Wire release (no standalone wire file in workspace); full text truncated in workspace copy, corroborated by MarketBeat 2026-10-06 22:02 summary of \"longer-term Phase I findings, preliminary Phase II observations\".","created_at":"2026-10-25 12:46:58","updated_at":"2026-10-25T12:48:04Z","company":"Rocket Pharmaceuticals","event_type":"data_presentation","expect_date_from":"2026-10-06","expect_date_to":"2026-10-06","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":388,"join_event_id":null,"symbol":"CRBU","drug":"CB-011","modality":"cell_therapy","area":"oncology","result_type":"trial_discontinuation","news_source_file":"documents/20261006_160710_(CRBU)_sec_0001193125-26-415559-ex991.txt","market_impact_date":"2026-10-07","day1_return":-0.456388,"day2_return":-0.220421,"prior_1w_return":-0.084677,"comments":"8-K Ex-99.1 (Oct 6, 2026): Caribou \"plans to discontinue further development activities\" for CB-011, its allogeneic anti-BCMA CAR-T for r/r multiple myeloma, alongside vispa-cel; workforce reduction expected mostly complete in Q4 2026.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:45Z","company":"Caribou Biosciences","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":387,"join_event_id":null,"symbol":"CRBU","drug":"vispa-cel","modality":"cell_therapy","area":"oncology","result_type":"trial_discontinuation","news_source_file":"documents/20261006_160710_(CRBU)_sec_0001193125-26-415559-ex991.txt","market_impact_date":"2026-10-07","day1_return":-0.456388,"day2_return":-0.220421,"prior_1w_return":-0.084677,"comments":"8-K Ex-99.1 (Oct 6, 2026): \"plans to discontinue further development activities for its two allogeneic CAR-T cell therapy programs, vispa-cel for the treatment of relapsed or refractory (r/r) B cell non-Hodgkin lymphoma and CB-011\"; company also exploring strategic alternatives, no timeline set.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:45Z","company":"Caribou Biosciences","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":296,"join_event_id":null,"symbol":"LPCN","drug":"TLANDO","modality":"small_molecule","area":"metabolic","result_type":"fda_approval","news_source_file":"documents/20261007_061001_(LPCN)_sec_0001493152-26-046060-ex991.txt","market_impact_date":"2026-10-07","day1_return":0.047619,"day2_return":-0.122727,"prior_1w_return":-0.027778,"comments":"Health Canada approved TLANDO (testosterone undecanoate) for testosterone replacement therapy via licensing partner Verity Pharma: \"Health Canada has approved TLANDO® ... for testosterone replacement therapy in adult males\". Non-US regulatory approval; Verity plans Canadian launch by end of 2026.","created_at":"2026-10-25 11:47:30","updated_at":"2026-10-25T12:10:35Z","company":"Lipocine","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":32,"join_event_id":1128,"symbol":"BCDA","drug":"CardiAMP HF II","modality":"cell_therapy","area":"cardiovascular","result_type":"data_presentation","news_source_file":"documents/20261007_090012_(BCDA)_sec_0001437749-26-032270.txt","market_impact_date":"2026-10-07","day1_return":0.028302,"day2_return":-0.027523,"prior_1w_return":0.029126,"comments":"8-K Oct 7 2026 (presented Oct 7 2026): \"BioCardia presents CardiAMP HF II Trial design at Heart Failure Society of America Annual Scientific Meeting.\" Trial design presentation only; no efficacy or safety data disclosed.","created_at":"2026-10-25","updated_at":"2026-11-01T00:54:32Z","company":"BioCardia","event_type":"data_presentation","expect_date_from":"2026-10-07","expect_date_to":"2026-10-07","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":603,"join_event_id":null,"symbol":"OSTX","drug":"OST-HER2","modality":"vaccine","area":"oncology","result_type":"topline_results","news_source_file":"documents/20261006_083000_(OSTX)_yahoo_news_yahoo-87f3a8309cf803feb987c9536937f93a-OSTX.txt","market_impact_date":"2026-10-06","day1_return":-0.06875,"day2_return":0.040268,"prior_1w_return":-0.030303,"comments":"Final 3-year OS from Phase 2b in pulmonary metastatic osteosarcoma: \"72.7 percent three-year overall survival vs. 45.8 percent comparable combined historical control (p = 0.0006)\". Company release (Newsfile, 2026-10-06 08:30 ET) via Yahoo; no SEC exhibit for this release, so aggregator copy used as earliest primary-text source.","created_at":"2026-11-04 17:48:45","updated_at":"2026-11-04T17:51:33Z","company":"OS Therapies","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":306,"join_event_id":696,"symbol":"KRRO","drug":"KRRO-121","modality":"aso","area":"metabolic","result_type":"other","news_source_file":"documents/20261005_161013_(KRRO)_sec_0001193125-26-414118-ex991.txt","market_impact_date":"2026-10-06","day1_return":-0.021063,"day2_return":0.074795,"prior_1w_return":0.04837,"comments":"\"First cohort of participants has been dosed in its Phase 1/2 clinical trial for KRRO-121\"; \"Part 1 SAD, which started in September 2026\". Trial initiation followed clearance to proceed, resolving the guided H2 2026 regulatory-approval milestone; no separate approval release was issued.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:36Z","company":"Korro Bio","event_type":"other","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":39,"join_event_id":343,"symbol":"AVBP","drug":"firmonertinib","modality":"small_molecule","area":"oncology","result_type":"topline_results","news_source_file":"documents/20261006_080709_(AVBP)_sec_0001104659-26-113898-ex991.txt","market_impact_date":"2026-10-06","day1_return":-0.469782,"day2_return":0.119284,"prior_1w_return":-0.028669,"comments":"Phase 3 FURVENT (NCT05607550) in 1L EGFR exon 20ins NSCLC \"did not meet its primary endpoint of progression free survival (PFS) by blinded independent central review (BICR)\"; BICR median PFS 11.0 mo (240mg) / 8.4 mo (160mg) vs 9.5 mo control, p=0.0654, HR 0.75. Investigator PFS and ORR favored firmonertinib; OS trend. Company evaluating development path.","created_at":"2026-10-25 10:34:05","updated_at":"2026-10-25T12:10:08Z","company":"ArriVent BioPharma","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.6,"llm_reason":"FURVENT is the lead pivotal readout for a ~$950M single-asset-driven company, so a large move is likely either way. Success odds look fairly good: the drug is approved in China, has Breakthrough designation, and the trial compares it against chemotherapy. But the readout is binary, and a modest PFS benefit could still disappoint, so the direction is uncertain.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":6,"join_event_id":9,"symbol":"SXTP","drug":"tafenoquine","modality":"small_molecule","area":"infectious","result_type":"interim_analysis","news_source_file":"documents/20261006_074542_(SXTP)_sec_0001213900-26-106979-ex991.txt","market_impact_date":"2026-10-06","day1_return":-0.229167,"day2_return":-0.009009,"prior_1w_return":0.152,"comments":"Interim analysis disclosed at 10/6/2026 webinar: DSMB \"recommended completing the originally planned study\"; \"No safety signal prevents use of tafenoquine in severe babesiosis as intended.\" Study remains blinded; 30 patients enrolled as of 10/1/2026, follow-up to early Jan 2027.","created_at":"2026-10-25 09:52:49","updated_at":"2026-10-25T09:54:26Z","company":"60 DEGREES PHARMACEUTICALS, INC","event_type":"interim_analysis","expect_date_from":"2026-07-29","expect_date_to":"2026-10-06","event_closed":1,"tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.55,"llm_reason":"SXTP is a micro-cap with about 3.5M shares, cash runway only to early October 2026, and repeated dilutive raises, so any interim tafenoquine readout is likely to move the stock by 10% or more. Direction is uncertain: positive data could spike the shares, while a likely follow-on financing could push them down.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":488,"join_event_id":555,"symbol":"STOK","drug":"zorevunersen","modality":"aso","area":"cns","result_type":"other","news_source_file":"documents/20261005_070000_(STOK)_yahoo_news_yahoo-9c152544b612bddeadd4585f37399898-STOK.txt","market_impact_date":"2026-10-05","day1_return":-0.01171,"day2_return":-0.03752,"prior_1w_return":0.033065,"comments":"Pre-NDA meeting held: \"announced the completion of a successful meeting with the U.S. Food and Drug Administration (FDA) intended to align on key aspects of the\" planned U.S. NDA for zorevunersen in Dravet syndrome (release dated Oct 5, 2026; same release also distributed by Business Wire). Meeting outcome, not a data readout.","created_at":"2026-10-26 00:20:14","updated_at":"2026-10-26T00:21:52Z","company":"Stoke Therapeutics","event_type":"other","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":483,"join_event_id":1023,"symbol":"AGEN","drug":"botensilimab + balstilimab","modality":"monoclonal_antibody","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261003_105000_(AGEN)_yahoo_news_yahoo-6c8703de69f41191cb5cd2c256d103cc-AGEN.txt","market_impact_date":"2026-10-05","day1_return":0.044258,"day2_return":-0.142039,"prior_1w_return":-0.021077,"comments":"\"today announced three-year follow-up results from the ovarian cancer cohort of its 400+ patient Phase 1b C-800-01 trial\"; 48% estimated three-year survival with BOT+BAL, presented at IGCS 2026.","created_at":"2026-10-26 00:19:46","updated_at":"2026-10-26T00:21:51Z","company":"Agenus","event_type":"data_presentation","expect_date_from":"2026-10-01","expect_date_to":"2026-10-03","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":247,"join_event_id":531,"symbol":"PCVX","drug":"VAX-31","modality":"vaccine","area":"infectious","result_type":"topline_results","news_source_file":"documents/20261005_080108_(PCVX)_sec_0001193125-26-413168-ex991.txt","market_impact_date":"2026-10-05","day1_return":0.307011,"day2_return":-0.096451,"prior_1w_return":0.004803,"comments":"Positive topline results from OPUS-1 pivotal adult Phase 3 trial: \"VAX-31 met all prespecified primary endpoints ... VAX-31 was well tolerated.\" Announced 2026-10-05.","created_at":"2026-10-25 11:36:55","updated_at":"2026-10-25T12:10:29Z","company":"Vaxcyte","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.55,"llm_reason":"VAX-31 is Vaxcyte's lead PCV asset, so topline data in late 2026 (likely Phase 3 adult immunogenicity vs PCV20) is binary-ish for a ~$10B company. Past VAX-31 readouts moved the stock more than 10%. Direction is uncertain given the high bar of noninferiority across all serotypes.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":200,"join_event_id":null,"symbol":"RZLT","drug":"ersodetug","modality":"monoclonal_antibody","area":"rare_genetic","result_type":"other","news_source_file":"documents/20261005_080015_(RZLT)_sec_0001104659-26-113503-ex991.txt","market_impact_date":"2026-10-05","day1_return":0.0798,"day2_return":-0.002309,"prior_1w_return":0.028205,"comments":"\"the U.S. Food and Drug Administration (FDA) recommended a pre-BLA meeting with the Company as a precursor to submitting a biologics license application (BLA)\" after reviewing sunRIZE data for congenital HI. Caveat: \"The Agency explicitly did not opine on the approvability of ersodetug for congenital HI.\"","created_at":"2026-10-25 11:27:13","updated_at":"2026-10-25T12:10:25Z","company":"Rezolute","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":87,"join_event_id":null,"symbol":"CBIO","drug":"CR-002","modality":"adc","area":"oncology","result_type":"other","news_source_file":"documents/20261005_073000_(CBIO)_yahoo_news_yahoo-4f0b3ed65aaaef1172dfd6b00bbba8ec-CBIO.txt","market_impact_date":"2026-10-05","day1_return":-0.026536,"day2_return":-0.026542,"prior_1w_return":0.023588,"comments":"FDA cleared/ allowed IND for CR-002, a PD-L1-targeted topoisomerase inhibitor ADC, for solid tumors (\"received allowance to proceed under an Investigational New Drug Application from the U.S. FDA\", per 8-K 2026-10-15). APOLLO Phase 1/2 on track to initiate Q4 2026. GlobeNewswire release 2026-10-05 03:00 ET; yahoo copy used (no SEC exhibit).","created_at":"2026-10-25 11:06:39","updated_at":"2026-10-25T12:10:14Z","company":"Crescent Biopharma","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":28,"join_event_id":53,"symbol":"BNTC","drug":"BB-301","modality":"gene_therapy","area":"rare_genetic","result_type":"other","news_source_file":"documents/20261005_080808_(BNTC)_sec_0001193125-26-413177-ex991.txt","market_impact_date":"2026-10-05","day1_return":0.02784,"day2_return":-0.024919,"prior_1w_return":-0.063608,"comments":"Company received \"formal feedback from the U.S. Food and Drug Administration (FDA) following the Type C meeting in 3Q 2026\"; FDA requested additional available data, including data from the Benitec-sponsored OPMD Natural History Study. Not an approval or CRL.","created_at":"2026-10-25 10:13:11","updated_at":"2026-10-25T10:14:01Z","company":"Benitec Biopharma","event_type":"other","expect_date_from":"2026-10-01","expect_date_to":"2026-10-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":167,"join_event_id":325,"symbol":"SRZN","drug":"SZN-8141","modality":"bispecific","area":"ophthalmology","result_type":"other","news_source_file":"documents/20261002_080548_(SRZN)_sec_0001193125-26-411298.txt","market_impact_date":"2026-10-02","day1_return":-0.022667,"day2_return":-0.00648,"prior_1w_return":-0.109264,"comments":"\"announced U.S. Food and Drug Administration (FDA) clearance of our Investigational New Drug (IND) application for SZN-8141, enabling us to advance the program into clinical development. The IND went into effect following the completion of the statutory 30-day review period.\"","created_at":"2026-10-25 11:22:08","updated_at":"2026-10-25T12:10:22Z","company":"Surrozen","event_type":"regulatory_submission","expect_date_from":"2026-08-06","expect_date_to":"2026-09-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":435,"join_event_id":207,"symbol":"WVE","drug":"WVE-006","modality":"aso","area":"rare_genetic","result_type":"other","news_source_file":"documents/20261001_030000_(WVE)_google_news_google_news-3a3a50127165bce7b4e07ce5df324637-WVE.txt","market_impact_date":"2026-10-01","day1_return":0.048649,"day2_return":-0.025773,"prior_1w_return":-0.063291,"comments":"Earliest disclosure: GlobeNewswire release (via Google News) at 2026-10-01 03:00 ET; same release republished by Yahoo at 07:30 (documents/20261001_073000_(WVE)_yahoo_news_yahoo-db7407020e93458c862f8bcd183a2885-WVE.txt) carries the body text: \"Following meeting with FDA, Wave plans for a single, two-year registrational trial, with a one-year interim analysis for potential accelerated approval based on AATD biomarkers.\" No SEC exhibit for this date.","created_at":"2026-10-25","updated_at":"2026-10-26T14:43:26Z","company":"Wave Life Sciences","event_type":"other","expect_date_from":"2026-08-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":353,"join_event_id":846,"symbol":"EVMN","drug":"EVO301","modality":"protein","area":"dermatology","result_type":"data_presentation","news_source_file":"documents/20261001_080158_(EVMN)_sec_0001193125-26-409865-ex991.txt","market_impact_date":"2026-10-01","day1_return":-0.127119,"day2_return":-0.040222,"prior_1w_return":-0.058153,"comments":"Late-breaking EADV oral presentation of Phase 2a AD data: primary endpoint met, 55% vs 22% LS mean EASI reduction at Week 12 (p<0.01), EASI-75 29% vs 9%. Presented 2026-10-01; does not itself close future Phase 2b readout planning.","created_at":"2026-10-25T07:59:11","updated_at":"2026-10-25T12:10:42Z","company":"Evommune","event_type":"data_presentation","expect_date_from":"2026-10-01","expect_date_to":"2026-10-01","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":346,"join_event_id":null,"symbol":"FHTX","drug":"FHD-909 (LY4050784)","modality":"small_molecule","area":"oncology","result_type":"trial_discontinuation","news_source_file":"documents/20261001_070121_(FHTX)_sec_0001628280-26-064102-ex991.txt","market_impact_date":"2026-10-01","day1_return":-0.182073,"day2_return":-0.308219,"prior_1w_return":-0.077519,"comments":"\"following a review of clinical data from the Phase 1 dose escalation trial of FHD-909 (LY4050784), Foghorn and Lilly have decided not to advance the program into the clinical development expansion phase.\" Efficacy not sufficient; Selective SMARCA2 degrader program also not advanced.","created_at":"2026-10-25 11:58:36","updated_at":"2026-10-25T12:10:41Z","company":"Foghorn Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":344,"join_event_id":833,"symbol":"GANX","drug":"rexaceract","modality":"small_molecule","area":"cns","result_type":"data_presentation","news_source_file":"documents/20261001_091602_(GANX)_sec_0001104659-26-112624.txt","market_impact_date":"2026-10-01","day1_return":-0.00578,"day2_return":-0.005814,"prior_1w_return":-0.059783,"comments":"Poster outlines long-term OLE data \"showing stabilization of MDS-UPDRS scores over 360 days (12 months) of dosing\"; 12 of 13 evaluable patients completed 12 months, one scheduled to complete dosing November 2026. Data described as preliminary.","created_at":"2026-10-25 11:58:31","updated_at":"2026-10-25T12:10:41Z","company":"Gain Therapeutics","event_type":"data_presentation","expect_date_from":"2026-10-04","expect_date_to":"2026-10-08","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":339,"join_event_id":823,"symbol":"GLUE","drug":"MRT-8102","modality":"small_molecule","area":"cardiovascular","result_type":"topline_results","news_source_file":"documents/20261001_073804_(GLUE)_sec_0001193125-26-409833-ex991.txt","market_impact_date":"2026-10-01","day1_return":-0.056161,"day2_return":-0.067496,"prior_1w_return":0.003364,"comments":"Positive GFORCE-1 Phase 1 data (n=108 obese subjects at elevated CVD risk): ~80-90% median NEK7 degradation across 5/20/40 mg, calprotectin -56%, S100A12 -46%, SAA -51%, hsCRP -85%, IL-6 -54%; no SAEs. Announced 2026-10-01 before market, webcast 8:00 a.m. ET.","created_at":"2026-10-25T07:57:04","updated_at":"2026-10-25T12:10:40Z","company":"Monte Rosa Therapeutics","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"large_downside","llm_confidence":0.5,"llm_reason":"Phase 1 biomarker readout building on an already-disclosed 85% CRP reduction, so the core signal is largely priced in. The added data (calprotectin, multiple doses) is incremental. Large cash runway and diversified pipeline limit downside, though a biomarker or safety surprise could still move the stock sharply.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":294,"join_event_id":null,"symbol":"LQDA","drug":"YUTREPIA (treprostinil) inhalation powder","modality":"small_molecule","area":"cardiovascular","result_type":"other","news_source_file":"documents/20260930_172708_(LQDA)_sec_0001104659-26-112420-ex991.txt","market_impact_date":"2026-10-01","day1_return":-0.075017,"day2_return":0.023223,"prior_1w_return":-0.551637,"comments":"\"Today, the Court ruled that claims 1 and 14 of the '327 patent ... are valid and infringed by Liquidia. The remaining claims ... were found to be invalid.\" U.S. District Court (D. Del.) Hatch-Waxman ruling on PH-ILD inhaled treprostinil; parties to submit proposed remedy/judgment within one week. Legal decision, not FDA action.","created_at":"2026-10-25 11:47:22","updated_at":"2026-10-25T12:10:35Z","company":"Liquidia","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":265,"join_event_id":null,"symbol":"NKTR","drug":"rezpegaldesleukin","modality":"protein","area":"dermatology","result_type":"data_presentation","news_source_file":"documents/20261001_075757_(NKTR)_sec_0001213900-26-105453-ex991.txt","market_impact_date":"2026-10-01","day1_return":-0.223947,"day2_return":-0.072569,"prior_1w_return":0.050121,"comments":"EADV 2026 oral presentations (Oct 1, 2026; AS-1732 and AS-1872) from the Oct 1 press release. REZOLVE-AA 52-wk data: SALT<=20 maintained in 75% (6/8) at 4 months and 63% (5/8) at 6 months off treatment; SALT<=10 deepened 7%->19% at 6 months off treatment. REZOLVE-AD wk 52 maintenance: EASI-100 rose 4%->22% (Q4W) and 9%->18% (Q12W). Quote: \"Off-Treatment Durability ... 63% (5/8) maintenance of SALT Score <=20 after 6 months off treatment\".","created_at":"2026-10-25 11:42:17","updated_at":"2026-10-25T12:10:31Z","company":"Nektar Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":149,"join_event_id":null,"symbol":"CADL","drug":"aglatimagene besadenovec","modality":"gene_therapy","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20261001_080500_(CADL)_yahoo_news_yahoo-b78cdc31f88810624fadc15087f077a7-CADL.txt","market_impact_date":"2026-10-01","day1_return":-0.02682,"day2_return":0.001969,"prior_1w_return":-0.075288,"comments":"Peer-reviewed publication (J Immunother Cancer) of phase 2a data: \"median overall survival of 24.5 months in advanced non-small cell lung cancer (NSCLC) patients with inadequate response to immune checkpoint inhibitors.\" No event created (no forward date); data were previously announced in March 2026 per the Q2 2026 8-K.","created_at":"2026-10-25 07:20:00","updated_at":"2026-10-25T12:10:20Z","company":"Candel Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":565,"join_event_id":null,"symbol":"AEON","drug":"ABP-450","modality":"protein","area":"cns","result_type":"other","news_source_file":"documents/20260930_080024_(AEON)_sec_0001837607-26-000064-ex991.txt","market_impact_date":"2026-09-30","day1_return":0.158301,"day2_return":-0.033333,"prior_1w_return":-0.01145,"comments":"Receipt of official minutes from FDA BPD Type 2b meeting: \"FDA indicated that comparative clinical studies previously conducted by Daewoong ... can be submitted for consideration as supportive evidence, subject to appropriate scientific bridging\"; no standalone comparative efficacy study planned at this time.","created_at":"2026-11-01 13:08:16","updated_at":"2026-11-01T13:10:51Z","company":"AEON Biopharma","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":489,"join_event_id":1027,"symbol":"SRPT","drug":"ELEVIDYS","modality":"gene_therapy","area":"rare_genetic","result_type":"data_presentation","news_source_file":"documents/20260930_083000_(SRPT)_yahoo_news_yahoo-6f2f1d76f0bf48fe5d30fadf049e978d-SRPT.txt","market_impact_date":"2026-09-30","day1_return":-0.022532,"day2_return":-0.035675,"prior_1w_return":-0.104277,"comments":"\"today presented new data at the 31st Annual Congress of the World Muscle Society (WMS) that provide evidence of clinically meaningful functional benefit of ELEVIDYS (delandistrogene moxeparvovec) in older ambulatory patients with Duchenne muscular dystrophy.\" Company wire release (Yahoo syndication); full text truncated at source.","created_at":"2026-10-25","updated_at":"2026-10-26T00:21:52Z","company":"Sarepta Therapeutics","event_type":"data_presentation","expect_date_from":"2026-09-29","expect_date_to":"2026-10-03","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":468,"join_event_id":1018,"symbol":"SGMT","drug":"denifanstat","modality":"small_molecule","area":"dermatology","result_type":"data_presentation","news_source_file":"documents/20260930_060000_(SGMT)_yahoo_news_yahoo-42081698b541113500aa09dda5643823-SGMT.txt","market_impact_date":"2026-09-30","day1_return":0.05895,"day2_return":-0.051619,"prior_1w_return":-0.158702,"comments":"Positive full 52-week results from Ascletis' Phase 3 OLE (ASC40-304): \"IGA success with a response rate of 57%, 72% reduction in total lesions, and 77% reduction in inflammatory lesions, and was generally well-tolerated\"; presented at EADV 2026. Same data repeated at Fall Clinical 2026-10-09. Source is the company release distributed via GlobeNewswire (Yahoo syndication).","created_at":"2026-10-25 20:13:24","updated_at":"2026-10-25T20:16:10Z","company":"Sagimet Biosciences Inc. Series A","event_type":"data_presentation","expect_date_from":"2026-09-30","expect_date_to":"2026-09-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":465,"join_event_id":1016,"symbol":"IMNM","drug":"IM-1340","modality":"adc","area":"oncology","result_type":"other","news_source_file":"documents/20260930_074500_(IMNM)_yahoo_news_yahoo-4149a7af97bbeff33711c6875b6357f8-IMNM.txt","market_impact_date":"2026-09-30","day1_return":-0.017359,"day2_return":-0.028824,"prior_1w_return":-0.149903,"comments":"\"today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for IM-1340, a potential first-in-class antibody-drug conjugate (ADC) for the treatment of advanced solid tumors\" — company release dated 2026-09-30 (full text carried by Yahoo Finance; no SEC exhibit found).","created_at":"2026-10-25T12:08:55","updated_at":"2026-10-25T16:10:07Z","company":"Immunome","event_type":"regulatory_submission","expect_date_from":"2026-06-01","expect_date_to":"2026-07-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":460,"join_event_id":474,"symbol":"VNDA","drug":"tasimelteon (HETLIOZ)","modality":"small_molecule","area":"cns","result_type":"topline_results","news_source_file":"documents/20260929_184500_(VNDA)_yahoo_news_yahoo-fe1cfe77c4bdf20e642c974714ca4f9c-VNDA.txt","market_impact_date":"2026-09-30","day1_return":-0.023857,"day2_return":-0.020367,"prior_1w_return":-0.034549,"comments":"\"positive topline results from its pivotal Phase III study of HETLIOZ (tasimelteon) 20 mg in adults with Delayed Sleep-Wake Phase Disorder (DSWPD)\"; company release text carried by Yahoo; Vanda plans sNDA submission.","created_at":"2026-10-25 16:06:54","updated_at":"2026-10-25T16:10:06Z","company":"Vanda Pharmaceuticals","event_type":"topline_results","expect_date_from":"2026-08-05","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.68,"llm_reason":"HETLIOZ is already facing generic erosion, so a DSPD label expansion adds limited value. Vanda also has multiple concurrent catalysts that would dilute the impact of this one readout, even at a ~$245M market cap.","llm_predicted_at":"2026-10-25T15:50:17Z","llm_source":"live"},{"id":430,"join_event_id":139,"symbol":"ATRA","drug":"tabelecleucel","modality":"cell_therapy","area":"oncology","result_type":"other","news_source_file":"documents/20260930_030000_(ATRA)_resolution_news_resolution_news-e8a922df597f449906f76b37c574e80c.txt","market_impact_date":"2026-09-30","day1_return":0.055901,"day2_return":-0.004706,"prior_1w_return":-0.098544,"comments":"\"Atara Biotherapeutics Reports that the Tabelecleucel Biologics License Application Has Been Resubmitted to the U.S. Food and Drug Administration\" (Business Wire, 2026-09-30) - BLA resubmitted by Pierre Fabre (BLA sponsor) under the FDA's third-quarter 2026 guidance; a later 2026-10-14 release reports the resubmission was accepted by FDA. Source is a Google News wire summary (no SEC exhibit or company-site release in the workspace), so details are limited to the headline.","created_at":"2026-10-25 12:44:27","updated_at":"2026-10-25T12:48:03Z","company":"Atara Biotherapeutics","event_type":"regulatory_submission","expect_date_from":"2026-07-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":396,"join_event_id":957,"symbol":"CNTB","drug":"rademikibart","modality":"monoclonal_antibody","area":"respiratory","result_type":"topline_results","news_source_file":"documents/20260930_070505_(CNTB)_sec_0001835268-26-000038.txt","market_impact_date":"2026-09-30","day1_return":0.108871,"day2_return":-0.109091,"prior_1w_return":-0.183539,"comments":"Phase 2 Seabreeze STAT COPD topline: treatment failure rate reduced 81% through Week 4 (p=0.0122); new moderate/severe exacerbations down 85% (p=0.030); ED visits/hospital admissions down 100% (p=0.0137); FEV1 +70 mL vs placebo at Week 4 (p=0.1607); well tolerated. 8-K/press release September 30, 2026.","created_at":"2026-10-25 08:07:10","updated_at":"2026-10-25T12:10:46Z","company":"Connect Biopharma Holdings","event_type":"topline_results","expect_date_from":"2026-09-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"Core","llm_prediction":"large_impact","llm_confidence":0.68,"llm_reason":"Rademikibart is essentially Connect's only asset, and the market cap of about $48M is close to its ~$31.5M cash. A Phase 2 topline readout in asthma or COPD exacerbation should move the stock at least 10% either way. Direction is uncertain.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":364,"join_event_id":879,"symbol":"DYN","drug":"z-basivarsen (DYNE-101)","modality":"aso","area":"rare_genetic","result_type":"data_presentation","news_source_file":"documents/20260929_161018_(DYN)_sec_0001818794-26-000009-ex991.txt","market_impact_date":"2026-09-30","day1_return":-0.006169,"day2_return":-0.018001,"prior_1w_return":-0.054259,"comments":"Additional 12-month ACHIEVE MAD data: pooled dose group (N=25-26) vHOT -3.2 s from baseline at 6 months vs +0.4 s placebo (3.6 s relative improvement); 5xSTS -1.2 s, 10MWR -0.3 s, QMT total and hand grip +4.8% predicted, MDHI total +25.2% at 12 months; favorable safety, no related SAEs. Note most participants did not receive registrational dose for full period.","created_at":"2026-10-25 08:02:00","updated_at":"2026-10-25T12:10:43Z","company":"Dyne Therapeutics","event_type":"data_presentation","expect_date_from":"2026-09-29","expect_date_to":"2026-10-03","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":357,"join_event_id":null,"symbol":"EPRX","drug":"EP-104GI","modality":"small_molecule","area":"gi_hepatology","result_type":"interim_analysis","news_source_file":"documents/20260930_080446_(EPRX)_sec_0001171843-26-006307-ex991.txt","market_impact_date":"2026-09-30","day1_return":0.095725,"day2_return":-0.13956,"prior_1w_return":-0.032051,"comments":"52-week data from highest dose cohorts of Phase 1b/2a RESOLVE: 64% (9/14) of patients in clinical remission at 52 weeks; Cohort 9 SDI reduction 3.0 at 52 wks; Cohort 8b EoEHSS Stage -0.26 / Grade -0.27 at 36 wks; no treatment-related SAEs. Open-label Phase 1b/2a data, not the Phase 2b interim.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:42Z","company":"Eupraxia Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":229,"join_event_id":478,"symbol":"QTTB","drug":"bempikibart","modality":"monoclonal_antibody","area":"dermatology","result_type":"data_presentation","news_source_file":"documents/20260930_092010_(QTTB)_sec_0001193125-26-408435-ex991.txt","market_impact_date":"2026-09-30","day1_return":-0.132214,"day2_return":-0.002418,"prior_1w_return":-0.098392,"comments":"\"Results from Part B ... presented across a late-breaking oral and poster presentation at the EADV Congress 2026\"; additional 36-week data and initial 16-week off-drug/Week 52 findings. First public disclosure at EADV on 2026-09-30.","created_at":"2026-10-25 11:33:22","updated_at":"2026-10-25T12:10:27Z","company":"Q32 Bio","event_type":"data_presentation","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":216,"join_event_id":432,"symbol":"RFL","drug":"Trappsol Cyclo","modality":"other","area":"rare_genetic","result_type":"topline_results","news_source_file":"documents/20260930_072327_(RFL)_sec_0001213900-26-104876-ex991.txt","market_impact_date":"2026-09-30","day1_return":-0.349754,"day2_return":0.136364,"prior_1w_return":0.015,"comments":"Phase 3 TransportNPC (n=94) topline: primary 4DNPCSS endpoint at Week 96 not statistically significant (LS mean change 0.46 vs 1.28; difference -0.81 [95% CI -2.04, 0.41]; p=0.19). Prespecified analysis in background miglustat/leucine patients (n=78) significant (p=0.046). Well tolerated; NDA planned Q4 2026.","created_at":"2026-10-25T07:30:22","updated_at":"2026-10-25T12:10:26Z","company":"Rafael Holdings","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.6,"llm_reason":"Binary pivotal Phase 3 readout for a ~$67M company that depends almost entirely on Trappsol Cyclo, so a move of 10% or more is likely either way. Direction is uncertain: prior HPβCD efficacy data are weak and uncontrolled, while the DMC's continuation decision is only a neutral signal.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":157,"join_event_id":null,"symbol":"TECX","drug":"TX2100","modality":"monoclonal_antibody","area":"rare_genetic","result_type":"other","news_source_file":"documents/20260929_171922_(TECX)_sec_0001193125-26-407823-ex991.txt","market_impact_date":"2026-09-30","day1_return":-0.002142,"day2_return":-0.026621,"prior_1w_return":-0.119245,"comments":"FDA granted Fast Track Designation for TX2100 in HHT in September 2026; FDA also cleared the IND for the Phase 1b trial in the U.S. (Aug 2026). \"In September 2026, the FDA granted TX2100 Fast Track Designation for the treatment of HHT.\"","created_at":"2026-10-25T07:20:01","updated_at":"2026-10-25T12:10:21Z","company":"Tectonic Therapeutic","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":156,"join_event_id":293,"symbol":"TECX","drug":"TX2100","modality":"monoclonal_antibody","area":"rare_genetic","result_type":"topline_results","news_source_file":"documents/20260929_171922_(TECX)_sec_0001193125-26-407823-ex991.txt","market_impact_date":"2026-09-30","day1_return":-0.002142,"day2_return":-0.026621,"prior_1w_return":-0.119245,"comments":"Phase 1a SAD topline: single ascending doses generally safe and well-tolerated across all six cohorts; no SAEs or severe TEAEs; PK consistent with TMDD/target engagement. ADA results pending. Detailed data to be presented at CureHHT conference Oct 12-16, 2026.","created_at":"2026-10-25T07:20:01","updated_at":"2026-10-25T12:10:21Z","company":"Tectonic Therapeutic","event_type":"topline_results","expect_date_from":"2026-08-06","expect_date_to":"2026-09-30","event_closed":1,"tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.8,"llm_reason":"The TX2100 readout is a Phase 1a single-ascending-dose study in healthy volunteers that measures safety and PK only, with no efficacy data. The stock's value rests mainly on TX45, whose APEX readout is due in early Q1 2027. Market cap (~$412M) is well above cash ($227M), so a routine safety readout is unlikely to move the stock 10% or more.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":146,"join_event_id":275,"symbol":"CADL","drug":"aglatimagene besadenovec","modality":"gene_therapy","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20260930_083000_(CADL)_yahoo_news_yahoo-9fafda48c3028020442079a9abe3b30f-CADL.txt","market_impact_date":"2026-09-30","day1_return":-0.040441,"day2_return":-0.02682,"prior_1w_return":-0.081857,"comments":"Second ASTRO 2026 release (same day): \"Novel systemic immune data demonstrated T-cell activation following local administration of aglatimagene. Together with recently disclosed evidence of persistent local immune remodeling...\" Also biodistribution and shedding data from PrTK05 phase 2 trial.","created_at":"2026-10-25 07:20:00","updated_at":"2026-10-25T12:10:20Z","company":"Candel Therapeutics","event_type":"data_presentation","expect_date_from":"2026-07-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":145,"join_event_id":275,"symbol":"CADL","drug":"aglatimagene besadenovec","modality":"gene_therapy","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20260930_080500_(CADL)_yahoo_news_yahoo-be6ff66fc5bf085c31bd9af348fac9bb-CADL.txt","market_impact_date":"2026-09-30","day1_return":-0.040441,"day2_return":-0.02682,"prior_1w_return":-0.081857,"comments":"ASTRO 2026 data: \"AI-enabled digital pathology analysis shows aglatimagene significantly increased lymphocyte infiltration and immune engagement with tumor cells compared to standard-of-care radiotherapy alone two years after treatment.\" GlobeNewswire release republished by Yahoo (primary wire text).","created_at":"2026-10-25 07:20:00","updated_at":"2026-10-25T12:10:20Z","company":"Candel Therapeutics","event_type":"data_presentation","expect_date_from":"2026-07-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":328,"join_event_id":null,"symbol":"IMMX","drug":"NXC-201","modality":"cell_therapy","area":"hematology","result_type":"interim_analysis","news_source_file":"documents/20260929_070021_(IMMX)_sec_0001493152-26-044761-ex991.txt","market_impact_date":"2026-09-29","day1_return":-0.081081,"day2_return":-0.012808,"prior_1w_return":-0.080192,"comments":"Interim update across all 45 NEXICART-2 patients: 89% (40/45) CR by independent review committee; 100% (25/25) new patients in CR or MRD-negative; no relapses in CR/MRD-negative patients; no neurotoxicity or enterocolitis. Conference call same day 8:00am ET.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:39Z","company":"Immix Biopharma","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":317,"join_event_id":735,"symbol":"IVVD","drug":"VYD2311","modality":"monoclonal_antibody","area":"infectious","result_type":"topline_results","news_source_file":"documents/20260929_072646_(IVVD)_sec_0001193125-26-406007-ex991.txt","market_impact_date":"2026-09-29","day1_return":-0.105263,"day2_return":0.023529,"prior_1w_return":-0.068627,"comments":"Positive topline LIBERTY Phase 3: VYD2311 safety/tolerability \"clinically and statistically superior\" to mRNA COVID-19 vaccine (6-day TEAE/ISR/hypersensitivity 56.5% vs 91.4%, P<0.0001; 56-day 60.9% vs 91.4%, P<0.0001); no interference with vaccine neutralizing titers. Company release 2026-09-29.","created_at":"2026-10-25 11:51:21","updated_at":"2026-10-25T12:10:37Z","company":"Invivyd","event_type":"topline_results","expect_date_from":"2026-09-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"Core","llm_prediction":"large_impact","llm_confidence":0.6,"llm_reason":"Binary pivotal Phase 3 efficacy readout for the company's lead asset. Market cap of about $180M is close to its $160M cash, and PEMGARDA's EUA is ending. VYD2311 is essentially the whole value story, so a big move either way is likely. Direction is uncertain: the parent antibody has prior efficacy, but COVID attack rates are variable and a sample-size re-estimation was needed.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":227,"join_event_id":469,"symbol":"QURE","drug":"ifezuntirgene inilparvovec (AMT-130)","modality":"gene_therapy","area":"cns","result_type":"topline_results","news_source_file":"documents/20260929_090532_(QURE)_sec_0001104659-26-111654-ex991.txt","market_impact_date":"2026-09-29","day1_return":-0.373306,"day2_return":-0.01428,"prior_1w_return":-0.117355,"comments":"48-month Phase I/II data (cutoff June 30, 2026) presented 2026-09-29: 44% slowing of cUHDRS progression vs Enroll-HD B (p=0.144, nominal) and 61% slowing on TFC (p=0.008, nominal); high-dose generally well-tolerated.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:27Z","company":"uniQure","event_type":"topline_results","expect_date_from":"2026-09-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"Core","llm_prediction":"large_impact","llm_confidence":0.55,"llm_reason":"Four-year follow-up data come from an existing open-label cohort whose three-year results are already known, and the FDA has already aligned on an accelerated-approval BLA. The readout is largely de-risked, so a modest move is likely, though a disappointment on durability could still cause a sharp drop.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":222,"join_event_id":460,"symbol":"ALDX","drug":"reproxalap","modality":"small_molecule","area":"ophthalmology","result_type":"other","news_source_file":"documents/20260929_070115_(ALDX)_sec_0001193125-26-405954-ex991.txt","market_impact_date":"2026-09-29","day1_return":0.137931,"day2_return":-0.068182,"prior_1w_return":-0.140741,"comments":"Type D meeting held: \"Aldeyra met with the Division of Ophthalmology and the Office of Specialty Medicine at an End of Review Type A meeting and again at a Type D meeting to present arguments supportive of the totality of evidence. Based on the outcome of the meetings, Aldeyra intends to submit a Formal Dispute Resolution Request (FDRR) to the Office of New Drugs (OND).\"","created_at":"2026-10-25 11:32:19","updated_at":"2026-10-25T12:10:27Z","company":"Aldeyra Therapeutics","event_type":"other","expect_date_from":"2026-07-15","expect_date_to":"2026-09-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":211,"join_event_id":null,"symbol":"RNAC","drug":"Descartes-08","modality":"cell_therapy","area":"cns","result_type":"interim_analysis","news_source_file":"documents/20260929_073310_(RNAC)_sec_0001453687-26-000105.txt","market_impact_date":"2026-09-29","day1_return":0.004161,"day2_return":-0.004144,"prior_1w_return":-0.09194,"comments":"8-K/PR 2026-09-29: additional retreatment data from Ph2 MG trial; \"Retreated patients observed an average MG-ADL reduction of 6.6 (±4.2) points from baseline at Month 12\"; no new safety concerns, no SAEs.","created_at":"2026-10-25 07:28:32","updated_at":"2026-10-25T12:10:26Z","company":"Cartesian Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":26,"join_event_id":null,"symbol":"BYSI","drug":"Plinabulin","modality":"small_molecule","area":"oncology","result_type":"other","news_source_file":"documents/20260929_070338_(BYSI)_sec_0001171843-26-006273-ex991.txt","market_impact_date":"2026-09-29","day1_return":-0.309821,"day2_return":-0.003881,"prior_1w_return":0.513514,"comments":"FDA granted Fast Track designation to Plinabulin + docetaxel in advanced/metastatic non-squamous NSCLC without AGAs after anti-PD-(L)1 and platinum chemo (2L/3L). Release dated Sept 29, 2026; designation, not approval — no efficacy data. Interim analysis of DUBLIN-4 (221 PFS events) has no stated date, so no event created.","created_at":"2026-10-25T06:12:44","updated_at":"2026-10-25T10:14:01Z","company":"BeyondSpring","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":490,"join_event_id":null,"symbol":"ALXO","drug":"evorpacept","modality":"protein","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20260928_080000_(ALXO)_yahoo_news_yahoo-fe5e521fcfb7769a86b7c4f2bb65c817-ALXO.txt","market_impact_date":"2026-09-28","day1_return":0.061069,"day2_return":-0.028777,"prior_1w_return":-0.229412,"comments":"Nature Medicine publication of ASPEN-06 Phase 2 data: ORR 40.3% with evorpacept + trastuzumab/ramucirumab/paclitaxel vs 26.6% control; 63.6% vs 23.1% in high CD47 expression. Peer-reviewed publication of previously reported data; no SEC exhibit or company wire full text available, aggregator copy used.","created_at":"2026-10-26 00:20:47","updated_at":"2026-10-26T00:21:52Z","company":"ALX Oncology Holdings","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":476,"join_event_id":486,"symbol":"PVLA","drug":"QTORIN rapamycin","modality":"small_molecule","area":"dermatology","result_type":"other","news_source_file":"documents/20260928_073000_(PVLA)_yahoo_news_yahoo-e2f958f201a7a7b1332fdb185aa0327a-PVLA.txt","market_impact_date":"2026-09-28","day1_return":0.012087,"day2_return":-0.005936,"prior_1w_return":-0.082359,"comments":"NDA submission completed: \"NDA submission completed following positive Phase 3 SELVA results; potential U.S. commercial launch in the first half of 2027, if approved.\" 505(b)(2) NDA for microcystic lymphatic malformations via rolling review; first module June 2026. Source is the GlobeNewswire release carried by Yahoo Finance (no SEC exhibit for this announcement in the doc set).","created_at":"2026-10-25 20:15:23","updated_at":"2026-10-25T20:16:11Z","company":"Palvella Therapeutics","event_type":"regulatory_submission","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":376,"join_event_id":909,"symbol":"CV","drug":"AI Highlights","modality":"other","area":"gi_hepatology","result_type":"fda_approval","news_source_file":"documents/20260928_110333_(CV)_sec_0001378325-26-000045-ex991.txt","market_impact_date":"2026-09-28","day1_return":0.040602,"day2_return":-0.033237,"prior_1w_return":-0.007463,"comments":"AI Highlights(TM), the AI-assisted reading tool for CapsoCam Plus, \"received clearance from the U.S. Food and Drug Administration (FDA) on September 25, 2026\"; announced publicly September 28, 2026. Resolves the guided Q3 2026 clearance expectation.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:44Z","company":"CapsoVision","event_type":"other","expect_date_from":"2026-08-13","expect_date_to":"2026-09-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":348,"join_event_id":840,"symbol":"FDMT","drug":"4D-150","modality":"gene_therapy","area":"ophthalmology","result_type":"topline_results","news_source_file":"documents/20260928_080505_(FDMT)_sec_0001193125-26-403424.txt","market_impact_date":"2026-09-28","day1_return":0.00622,"day2_return":-0.004808,"prior_1w_return":-0.049277,"comments":"\"reported 2-year data from the SPECTRA clinical trial\" (8-K, Sept 28, 2026; data cutoff Mar 12, 2026). Phase 3 dose n=9: +10.8 letters BCVA, -176 um CST, 61% treatment burden reduction. Reported ahead of guided Q4 2026 window.","created_at":"2026-10-25 11:59:04","updated_at":"2026-10-25T12:10:41Z","company":"4D Molecular Therapeutics","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.72,"llm_reason":"Q4 2026 event is likely SPECTRA DME 2-year Phase 2 update, an incremental follow-up of known data; the pivotal wet AMD Phase 3 readouts are in 2027.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":310,"join_event_id":703,"symbol":"KOD","drug":"KSI-501","modality":"bispecific","area":"ophthalmology","result_type":"topline_results","news_source_file":"documents/20260928_085356_(KOD)_sec_0001193125-26-403481-ex991.txt","market_impact_date":"2026-09-28","day1_return":1.779598,"day2_return":0.013345,"prior_1w_return":-0.011006,"comments":"DAYBREAK: \"Tabirafusp alfa tedromer (tabirafusp-ted) met the vision primary endpoint (p-value of 0.0036) and anatomical key secondary endpoint (p-value of <0.0001)\"; 0.4% intraocular inflammation.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:36Z","company":"Kodiak Sciences","event_type":"topline_results","expect_date_from":"2026-09-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"Core","llm_prediction":"large_impact","llm_confidence":0.6,"llm_reason":"DAYBREAK is a binary Phase 3 wet AMD readout for both KSI-501 and tarcocimab. The company has a going concern warning and about $126M in cash, so its ~$5.4B valuation rests heavily on these programs. A large move is likely in either direction, and the outcome is hard to call.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":309,"join_event_id":702,"symbol":"KOD","drug":"tarcocimab tedromer","modality":"monoclonal_antibody","area":"ophthalmology","result_type":"topline_results","news_source_file":"documents/20260928_085356_(KOD)_sec_0001193125-26-403481-ex991.txt","market_impact_date":"2026-09-28","day1_return":1.779598,"day2_return":0.013345,"prior_1w_return":-0.011006,"comments":"DAYBREAK Phase 3 met one-year primary endpoint: Zenkuda non-inferior to aflibercept in vision gains (p=0.0007); 54% of patients on 24-week dosing; 0% intraocular inflammation. Announced 2026-09-28 with same-day webcast.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:36Z","company":"Kodiak Sciences","event_type":"topline_results","expect_date_from":"2026-09-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"Core","llm_prediction":"large_impact","llm_confidence":0.6,"llm_reason":"The $5.4B valuation leaves Kodiak heavily dependent on the DAYBREAK readout of two drugs in one study, with cash of $126M only reaching into 2027. A binary non-inferiority result in a high-expectation setup makes a move of at least 10% likely. Direction is uncertain: Zenkuda has a prior wet AMD miss (DAYLIGHT met non-inferiority only at monthly dosing), offset by a de-risked trial design.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":286,"join_event_id":625,"symbol":"MIRM","drug":"zilurgisertib","modality":"small_molecule","area":"rare_genetic","result_type":"fda_approval","news_source_file":"documents/20260928_080247_(MIRM)_sec_0001759425-26-000049.txt","market_impact_date":"2026-09-28","day1_return":-0.019398,"day2_return":-0.004775,"prior_1w_return":-0.023195,"comments":"8-K: FDA approved Atebrioz (zilurgisertib) on 2026-09-25 to reduce total new HO volume in FOP patients aged 12+; PDUFA was 2026-09-26. Announced by Mirum and Incyte.","created_at":"2026-10-25 11:45:09","updated_at":"2026-10-25T12:10:33Z","company":"Mirum Pharmaceuticals","event_type":"pdufa","expect_date_from":"2026-09-26","expect_date_to":"2026-09-26","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":285,"join_event_id":634,"symbol":"MIRM","drug":"brelovitug","modality":"monoclonal_antibody","area":"infectious","result_type":"topline_results","news_source_file":"documents/20260928_080247_(MIRM)_sec_0001759425-26-000049.txt","market_impact_date":"2026-09-28","day1_return":-0.019398,"day2_return":-0.004775,"prior_1w_return":-0.023195,"comments":"8-K (event 2026-09-28): Phase 3 AZURE-1 met primary endpoint; 56% (300mg QW) and 45% (900mg Q4W) vs 0% delayed treatment (p<0.0001). 48-week Phase 2b data also reported.","created_at":"2026-10-25 11:45:09","updated_at":"2026-10-25T12:10:33Z","company":"Mirum Pharmaceuticals","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"Watch","llm_prediction":"large_upside","llm_confidence":0.45,"llm_reason":"Brelovitug's Phase 3 hepatitis delta readout is a key value driver for MIRM, but the company already has commercial revenue at a $5.4B market cap, which cushions moves. Phase 2 data were strong, so success is likely and could still lift the stock 10% or more given the program's weight in the valuation. The involuntary CMO change shortly before topline adds some uncertainty.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":209,"join_event_id":null,"symbol":"RNAZ","drug":"TTX-MC138","modality":"other","area":"oncology","result_type":"interim_analysis","news_source_file":"documents/20260928_081610_(RNAZ)_sec_0001104659-26-111170-ex991.txt","market_impact_date":"2026-09-28","day1_return":0.011834,"day2_return":-0.046784,"prior_1w_return":0.024242,"comments":"Updated Phase 1a data (cutoff Sept 1, 2026): 71.4% stable disease (10/14), DCR 57.1% at C3D1; no DLTs, primary endpoint met. \"today announced updated clinical data from its Phase 1a clinical trial of TTX-MC138\" — press release dated September 28, 2026.","created_at":"2026-10-25T07:30:00","updated_at":"2026-10-25T12:10:25Z","company":"TransCode Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":21,"join_event_id":86,"symbol":"ACET","drug":"prula-cel","modality":"cell_therapy","area":"immunology","result_type":"interim_analysis","news_source_file":"documents/20260928_081531_(ACET)_sec_0001720580-26-000060-ex991.txt","market_impact_date":"2026-09-28","day1_return":-0.296009,"day2_return":0.075591,"prior_1w_return":-0.017429,"comments":"Phase 1 SLE/LN data cut 2026-08-28: \"At the 12-month mark, 50% of evaluable lupus nephritis patients achieved a complete renal response (CRR) and 54% of evaluable patients achieved DORIS remission\"; no CRS >Grade 2, no ICANS/IEC-HS (24 safety-evaluable pts). Announced via press release/webcast 2026-09-28.","created_at":"2026-10-25 10:05:15","updated_at":"2026-10-25T10:37:44Z","company":"Adicet Bio","event_type":"interim_analysis","expect_date_from":"2026-09-28","expect_date_to":"2026-09-28","event_closed":1,"tier":"Core","llm_prediction":"large_downside","llm_confidence":0.5,"llm_reason":"Prula-cel is effectively the whole company, and the market cap (~$40M) is well below the ~$118M in cash and investments. That makes a ≥10% move on the interim autoimmune data likely. Direction is uncertain: the cash cushion limits downside, but early cell-therapy data have historically disappointed.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":537,"join_event_id":null,"symbol":"RGNX","drug":"surabgene lomparvovec","modality":"gene_therapy","area":"ophthalmology","result_type":"data_presentation","news_source_file":"documents/20260924_191700_(RGNX)_yahoo_news_yahoo-14ca17f5f3cd4a6853f4e631504bc52f-RGNX.txt","market_impact_date":"2026-09-25","day1_return":0.022099,"day2_return":0.009459,"prior_1w_return":-0.118685,"comments":"\"announced positive long-term follow-up data from the Phase II ALTITUDE study\" in diabetic retinopathy (suprachoroidal delivery), presented Sep 24, 2026 at the Retina Society 59th Annual Scientific Meeting. Source is Yahoo News; no company/SEC release in the document set.","created_at":"2026-10-28 14:21:20","updated_at":"2026-10-28T14:23:36Z","company":"REGENXBIO","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":23,"join_event_id":126,"symbol":"CCCC","drug":"cemsidomide","modality":"small_molecule","area":"hematology","result_type":"data_presentation","news_source_file":"documents/20260925_070425_(CCCC)_sec_0001628280-26-063497.txt","market_impact_date":"2026-09-25","day1_return":-0.016502,"day2_return":0.045302,"prior_1w_return":-0.112738,"comments":"\"On September 25, 2026, the Company announced new biomarker data from its Phase 1 clinical trial of cemsidomide in combination with dexamethasone ... being presented in a poster presentation at the 23rd International Myeloma Society (IMS) Annual Meeting\"; also preliminary biomarker data (as of June 22, 2026) from first two patients in Phase 1b with elranatamab. Biomarker data, not efficacy topline.","created_at":"2026-10-25 10:12:34","updated_at":"2026-10-25T11:05:44Z","company":"C4 Therapeutics","event_type":"interim_analysis","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"","llm_prediction":"large_impact","llm_confidence":0.45,"llm_reason":"Cemsidomide (IKZF1/3 degrader) is C4's lead asset in a ~$390M small cap. Interim MM/NHL data could move the stock strongly either way. Past cemsidomide data updates have driven big swings, but the direction is hard to call.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":1,"join_event_id":1,"symbol":"ACAD","drug":"remlifanserin","modality":"small_molecule","area":"cns","result_type":"topline_results","news_source_file":"documents/20260924_171107_(ACAD)_sec_0001193125-26-401157-ex991.txt","market_impact_date":"2026-09-25","day1_return":-0.067628,"day2_return":-0.007253,"prior_1w_return":-0.191985,"comments":"Phase 3 enabling topline results from Phase 2 RADIANT in ADP: 60 mg once daily SAPS-H+D change -12.6 vs -10.4 placebo at week 6 (ES 0.26, p=0.0603, narrowly missed primary); CGI-S-ADP -1.3 vs -0.9 (ES 0.37, p=0.0077 nominal); favorable safety. Acadia to continue Phase 3, removing the 30 mg arm.","created_at":"2026-10-25 05:52:00","updated_at":"2026-10-25T09:54:26Z","company":"ACADIA Pharmaceuticals","event_type":"topline_results","expect_date_from":"2026-09-01","expect_date_to":"2026-10-31","event_closed":1,"tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.55,"llm_reason":"Management calls the Phase 2 Alzheimer's psychosis readout 'potentially transformational' for a $3.5B company. ADP is a large market where pimavanserin has a mixed history, so either a clear win or a miss could move the stock 10% or more. Direction is uncertain because of the high-placebo-response setting.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":477,"join_event_id":1020,"symbol":"ANNX","drug":"vonaprument","modality":"monoclonal_antibody","area":"ophthalmology","result_type":"data_presentation","news_source_file":"documents/20260924_080000_(ANNX)_yahoo_news_yahoo-d7012a6519af43c6ebe3b0b78f9dfdad-ANNX.txt","market_impact_date":"2026-09-24","day1_return":-0.018088,"day2_return":-0.042105,"prior_1w_return":-0.015267,"comments":"Baseline characteristics of the Phase 3 ARCHER II geographic atrophy population presented at the Retina Society 59th Annual Scientific Meeting, highlighting a Phase 3 population consistent with Phase 2; no efficacy data disclosed. Confirmation of presentation via Investing.com headline (2026-09-24) \"Annexon presents vonaprument data at retina meeting\".","created_at":"2026-10-25T16:16:00","updated_at":"2026-10-25T20:16:11Z","company":"Annexon","event_type":"data_presentation","expect_date_from":"2026-09-24","expect_date_to":"2026-09-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":455,"join_event_id":null,"symbol":"NVCT","drug":"NXP200","modality":"small_molecule","area":"oncology","result_type":"other","news_source_file":"documents/20260924_080000_(NVCT)_yahoo_news_yahoo-c1d7b2dd39424feacecc6bf592faba26-NVCT.txt","market_impact_date":"2026-09-24","day1_return":0.026578,"day2_return":-0.065187,"prior_1w_return":-0.03658,"comments":"\"NXP200 (HSK42360), an oral, brain-penetrant, paradox-breaker BRAF inhibitor, has been granted Breakthrough Therapy Designation (BTD) for the treatment of patients with BRAF V600-mutant, recurrent or progressive, high-grade glioma\" in China. Regulatory designation, announced Sept. 24, 2026. Note: document text truncated after ~1000 chars; no FDA (U.S.) action. Duplicate headline-only item on google_news at 03:00 same day.","created_at":"2026-10-25 15:59:33","updated_at":"2026-10-25T16:04:04Z","company":"Nuvectis Pharma","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":432,"join_event_id":499,"symbol":"PRME","drug":"PM647","modality":"gene_therapy","area":"rare_genetic","result_type":"other","news_source_file":"documents/20260924_030000_(PRME)_resolution_news_resolution_news-ca749673cc100048b932bff54a96f709.txt","market_impact_date":"2026-09-24","day1_return":-0.019169,"day2_return":-0.055375,"prior_1w_return":0.043333,"comments":"GlobeNewswire, 2026-09-24: \"Prime Medicine Announces U.S. FDA Clearance of\" (headline truncated in available copy); AllSci 2026-09-28 confirms: \"Prime Medicine receives FDA clearance for PM647 in alpha-1 antitrypsin deficiency\". IND clearance is a regulatory decision, not a marketing approval; exact clearance date not stated. Resolves guided 3Q 2026 IND/CTA submission.","created_at":"2026-10-25","updated_at":"2026-10-25T12:48:03Z","company":"Prime Medicine","event_type":"regulatory_submission","expect_date_from":"2026-07-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":338,"join_event_id":820,"symbol":"GOSS","drug":"seralutinib","modality":"small_molecule","area":"cardiovascular","result_type":"other","news_source_file":"documents/20260923_160541_(GOSS)_sec_0001728117-26-000104.txt","market_impact_date":"2026-09-24","day1_return":-0.005459,"day2_return":0.000915,"prior_1w_return":0.002737,"comments":"Company announced it \"submitted a New Drug Application ('NDA') to the U.S. Food and Drug Administration ('FDA') in September 2026 for seralutinib for the treatment of pulmonary arterial hypertension\"; first NDA submission, supported by Phase 3 PROSERA plus Phase 2 TORREY.","created_at":"2026-10-25 11:57:22","updated_at":"2026-10-25T12:10:40Z","company":"Gossamer Bio","event_type":"regulatory_submission","expect_date_from":"2026-09-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":303,"join_event_id":682,"symbol":"KYTX","drug":"mivocabtagene autoleucel","modality":"cell_therapy","area":"cns","result_type":"topline_results","news_source_file":"documents/20260924_060027_(KYTX)_sec_0001193125-26-400062-ex991.txt","market_impact_date":"2026-09-24","day1_return":-0.011315,"day2_return":-0.025751,"prior_1w_return":0.024638,"comments":"Press release with two topline readouts: (1) KYSA-8 SPS one-year durability (db lock July 2026, n=26): T25FW median improvement 49% at month 12, p<0.0001, 92% off chronic immunotherapies, no high-grade CRS/ICANS - resolves Q3 2026 guided 12-month topline; (2) KYSA-6 Phase 2 gMG longer-term follow-up (cut-off June 2026, n=7): 100% with clinically meaningful MG-ADL/QMG improvement at 24 weeks, benefits maintained >=1 year, MSE 57% - matches Q3 2026 guidance. One row per schema key (symbol+drug+type+file).","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:36Z","company":"Kyverna Therapeutics","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.6,"llm_reason":"The Q3 2026 topline readouts are 12-month follow-up from the KYSA-8 SPS trial and longer-term Phase 2 gMG data. Primary SPS results have already been disclosed and a BLA is underway, so this is incremental durability data with limited surprise potential. Market cap is about $354M, so a modest move is likely.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":277,"join_event_id":null,"symbol":"MSLE","drug":"forazapadin","modality":"small_molecule","area":"rare_genetic","result_type":"other","news_source_file":"documents/20260924_070005_(MSLE)_sec_0001171843-26-006202-ex991.txt","market_impact_date":"2026-09-24","day1_return":0.035672,"day2_return":-0.001148,"prior_1w_return":-0.095699,"comments":"Sep 24, 2026 release: \"FDA has cleared its Investigational New Drug (IND) application for forazapadin for the treatment of facioscapulohumeral muscular dystrophy (FSHD)\". Company plans Phase 2 start in Q4 2026.","created_at":"2026-10-25 11:44:30","updated_at":"2026-10-25T12:10:33Z","company":"Satellos Bioscience","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":444,"join_event_id":767,"symbol":"IMVT","drug":"IMVT-1402","modality":"monoclonal_antibody","area":"dermatology","result_type":"topline_results","news_source_file":"documents/20260923_070000_(IMVT)_yahoo_news_yahoo-0059eaefc94409994015cdf3a89f5a9d-IMVT.txt","market_impact_date":"2026-09-23","day1_return":-0.073746,"day2_return":-0.015634,"prior_1w_return":0.017462,"comments":"Period 1 CLE proof-of-concept topline: \"did not achieve statistical significance on the primary endpoint of ... CLASI-A percent change from baseline at Week 12\"; \"the study did not meet Immunovant's internal bar to continue development\" — program halted. No SEC/company-wire copy available; used the GlobeNewswire syndication (Yahoo), an aggregator. Earlier 03:00 ET Google News items carry the same headline, consistent disclosure 2026-09-23.","created_at":"2026-10-25 13:21:00","updated_at":"2026-10-25T13:23:40Z","company":"Immunovant","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.68,"llm_reason":"The CLE readout is only a proof-of-concept trial in one of six IMVT-1402 indications at a $6B company. Valuation rests mainly on the registrational Graves' disease and myasthenia gravis trials reading out in 2027. FcRn inhibition in CLE is speculative, so a single-session move of 10% or more is unlikely.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":431,"join_event_id":558,"symbol":"ORKA","drug":"ORKA-001","modality":"monoclonal_antibody","area":"dermatology","result_type":"interim_analysis","news_source_file":"documents/20260923_030000_(ORKA)_resolution_news_resolution_news-a3adbfef82d4f2ce2411e10e3fdba50e.txt","market_impact_date":"2026-09-23","day1_return":-0.048863,"day2_return":-0.049372,"prior_1w_return":0.025488,"comments":"\"Oruka Therapeutics Announces Positive Week 28 Data for [ORKA-001]\" (GlobeNewswire, 2026-09-23 03:00 EDT). Week 28 EVERLAST-A Phase 2a data in moderate-to-severe plaque psoriasis reported positive. Caveat: workspace copy is a headline-only wire stub (no full body, no SEC exhibit available); details corroborated by same-time Yahoo headline.","created_at":"2026-10-25","updated_at":"2026-10-25T12:48:03Z","company":"Oruka Therapeutics","event_type":"interim_analysis","expect_date_from":"2026-09-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"Core","llm_prediction":"small_impact","llm_confidence":0.62,"llm_reason":"Week 28 EVERLAST-A is a follow-up to strong, already-disclosed Week 16 data in a validated IL-23 mechanism. For a $5.4B, well-funded company, maintenance data are likely confirmatory, and the bigger catalysts (EVERLAST-B, 52-week data) come later.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":429,"join_event_id":362,"symbol":"ARCT","drug":"ARCT-810","modality":"other","area":"rare_genetic","result_type":"interim_analysis","news_source_file":"documents/20260923_030000_(ARCT)_resolution_news_resolution_news-2af35fd1fe9d8ee2c48983141182df70.txt","market_impact_date":"2026-09-23","day1_return":-0.075104,"day2_return":0.061654,"prior_1w_return":-0.092172,"comments":"Earliest public disclosure of ARCT-810 OTC deficiency Phase 2 interim data: Business Wire release 2026-09-23 (03:00 EDT) \"Arcturus Therapeutics Announces Interim OTC Deficiency Phase 2 Results and Introduces LUNAR 2.0 Next-Generation mRNA Delivery Platform\". Same event re-reported later same day (Seeking Alpha 03:00, Kalkine 19:47) and 2026-09-24 (Benzinga); one result, earliest source kept. Caveat: full release text not captured in workspace; 8-K Ex-99.1 (Sep 23) has no body text.","created_at":"2026-10-25","updated_at":"2026-10-25T20:15:25Z","company":"Arcturus Therapeutics Holdings","event_type":"topline_results","expect_date_from":"2026-08-06","expect_date_to":"2026-09-30","event_closed":1,"tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.5,"llm_reason":"ARCT trades near cash (~$305M cap vs $191M cash). The ARCT-810 Phase 2 readout is paired with a regulatory plan, and prior interim data already reduced uncertainty. Market focus is on ARCT-032 in CF, so a modest move is most likely, though small caps can swing sharply.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":56,"join_event_id":906,"symbol":"IONS","drug":"sefaxersen","modality":"aso","area":"renal","result_type":"interim_analysis","news_source_file":"documents/20260923_060320_(IONS)_sec_0001140361-26-037371-ex991.txt","market_impact_date":"2026-09-23","day1_return":-0.039781,"day2_return":-0.002732,"prior_1w_return":-0.031746,"comments":"Earliest disclosure: 2026-09-23 Ionis release \"positive prespecified interim results from the ongoing Phase 3 IMAgINATION study ... met its primary endpoint\" (proteinuria reduction vs placebo at 37 weeks). Detailed 43.1% reduction (95% CI 32.5-52.0, p<0.0001) first quantified in the 2026-10-23 release accompanying the ASN Kidney Week late-breaking oral presentation.","created_at":"2026-10-25T06:36:00","updated_at":"2026-10-25T12:10:11Z","company":"Ionis Pharmaceuticals","event_type":"interim_analysis","expect_date_from":"2026-01-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.8,"llm_reason":"Sefaxersen is a Roche-partnered complement factor B ASO in IgAN. The IMAGINATION interim (proteinuria) readout is one of many pipeline events for a ~$7B company with diversified commercial assets, and the IgAN field is crowded. A large first-session move is unlikely.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":20,"join_event_id":512,"symbol":"ACIU","drug":"ACI-7104","modality":"vaccine","area":"cns","result_type":"topline_results","news_source_file":"documents/20260923_070005_(ACIU)_sec_0001651625-26-000020-ex991.txt","market_impact_date":"2026-09-23","day1_return":0.03663,"day2_return":-0.060071,"prior_1w_return":0.018657,"comments":"Part 1 of VacSYn Phase 2 (n=34) week-100: \"All primary endpoints of the study were met\" - safety/tolerability/immunogenicity; 100% antibody response after three immunizations, CSF antibody penetration. Part 1 only, not designed for clinical outcomes.","created_at":"2026-10-25 10:05:10","updated_at":"2026-10-25T11:35:16Z","company":"AC Immune","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.5,"llm_reason":"Week-100 Part 1 results come from a small open-label safety and immunogenicity study whose positive interim data are already known. Biomarker signals may be ambiguous, so a muted reaction is more likely. Small-cap volatility still allows a large move.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":472,"join_event_id":null,"symbol":"RYTM","drug":"setmelanotide","modality":"peptide","area":"metabolic","result_type":"other","news_source_file":"documents/20260922_080000_(RYTM)_yahoo_news_yahoo-5cfcff320cb9f4671bff4430575ca22c-RYTM.txt","market_impact_date":"2026-09-22","day1_return":0.004452,"day2_return":-0.010376,"prior_1w_return":-0.03524,"comments":"Health Canada approved IMCIVREE (setmelanotide) for the additional indication of weight management in adults and pediatric patients 4 years and older with acquired hypothalamic obesity: \"Health Canada has approved IMCIVREE® (setmelanotide) for the additional indication of weight management in adult and pediatric patients\"; \"First targeted therapy approved in Canada\" for acquired HO. Announced Sept 22, 2026 (GlobeNewswire, also 03:00 ET GlobeNewswire copy).","created_at":"2026-10-25 20:14:03","updated_at":"2026-10-25T20:16:10Z","company":"Rhythm Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":454,"join_event_id":908,"symbol":"IONS","drug":"ulefnersen","modality":"aso","area":"cns","result_type":"topline_results","news_source_file":"documents/20260922_030000_(IONS)_google_news_gnews-b1d16195e8c5ffb4a08cea0d3e988303-IONS.txt","market_impact_date":"2026-09-22","day1_return":0.018931,"day2_return":-0.039781,"prior_1w_return":-0.127138,"comments":"Ionis announced \"positive topline results from Phase 3 FUSION study of ulefnersen\" in FUS-ALS; partner Otsuka also reported \"transformative Phase 3 FUSION Results\" the same day. Headline/summary via Google News (BioSpace) only; no full company release in workspace. Earliest disclosure 2026-09-22.","created_at":"2026-10-25 15:59:12","updated_at":"2026-10-25T16:04:04Z","company":"Ionis Pharmaceuticals","event_type":"topline_results","expect_date_from":"2026-01-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.8,"llm_reason":"Ulefnersen targets FUS-ALS, an ultra-rare indication with small commercial value relative to Ionis's ~$7B market cap. The company has a diversified portfolio, and the pelacarsen HORIZON readout is the dominant stock driver. A FUSION result in either direction likely moves shares less than 10%.","llm_predicted_at":"2026-10-25T15:52:01Z","llm_source":"live"},{"id":450,"join_event_id":548,"symbol":"PALI","drug":"PALI-2108","modality":"small_molecule","area":"gi_hepatology","result_type":"fda_approval","news_source_file":"documents/20260922_083500_(PALI)_yahoo_news_yahoo-962e5adaefe96dc86168d4b470afc513-PALI.txt","market_impact_date":"2026-09-22","day1_return":0.0,"day2_return":-0.053254,"prior_1w_return":-0.17561,"comments":"FDA cleared the IND for PALI-2108 in Crohn's disease, expanding Phase 2 across IBD: \"Phase 2 ASCENTRA-CD clinical trial in patients with moderate to severe Crohn's disease\"; \"First patient dosing targeted for Q1 2027; primary efficacy readout (Week 12 endoscopic response) targeted for Q1 2028\". Resolves the guided 2H 2026 IND submission (#548). Source is the company GlobeNewswire release carried by Yahoo (no SEC exhibit in this document set).","created_at":"2026-10-25 15:58:52","updated_at":"2026-10-25T16:04:04Z","company":"Palisade Bio","event_type":"regulatory_submission","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":397,"join_event_id":958,"symbol":"CMPX","drug":"tovecimig","modality":"bispecific","area":"oncology","result_type":"other","news_source_file":"documents/20260922_083016_(CMPX)_sec_0001171843-26-006162-ex991.txt","market_impact_date":"2026-09-22","day1_return":-0.318681,"day2_return":-0.056452,"prior_1w_return":-0.071429,"comments":"FDA feedback: \"The FDA recommended that Compass conduct a trial to demonstrate a survival benefit prior to submitting a BLA for tovecimig.\" Company disagrees a new trial is warranted and will continue engaging FDA; no new efficacy data disclosed. Earliest disclosure of this feedback (PR dated 2026-09-22).","created_at":"2026-10-25 12:07:47","updated_at":"2026-10-25T12:10:46Z","company":"Compass Therapeutics","event_type":"other","expect_date_from":"2026-07-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":343,"join_event_id":null,"symbol":"FLNA","drug":"simufilam","modality":"small_molecule","area":"cns","result_type":"clinical_hold","news_source_file":"documents/20260922_080040_(FLNA)_sec_0001171843-26-006161-ex991.txt","market_impact_date":"2026-09-22","day1_return":0.391892,"day2_return":-0.15534,"prior_1w_return":0.027778,"comments":"FDA lifted the full clinical hold on the simufilam IND, enabling a planned Phase 2a study in TSC-related epilepsy. Quote: \"the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Company's investigational new drug (IND) application.\" Patient screening expected by Q1 2027 (not a catalyst date).","created_at":"2026-10-25 11:58:29","updated_at":"2026-10-25T12:10:41Z","company":"Filana Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":271,"join_event_id":615,"symbol":"NAMS","drug":"obicetrapib","modality":"small_molecule","area":"metabolic","result_type":"fda_approval","news_source_file":"documents/20260921_163015_(NAMS)_sec_0001193125-26-396716.txt","market_impact_date":"2026-09-22","day1_return":0.032772,"day2_return":-0.027444,"prior_1w_return":0.009839,"comments":"\"the European Commission ('EC') has granted marketing authorization for Ubeslo (obicetrapib 10 mg monotherapy) and Evlarco (obicetrapib 10 mg plus ezetimibe FDC)\"; first regulatory approval of obicetrapib worldwide (EU, not FDA). Announced with partner Menarini.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:32Z","company":"NewAmsterdam Pharma","event_type":"other","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":249,"join_event_id":null,"symbol":"PDSB","drug":"PDS0101","modality":"vaccine","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20260922_080508_(PDSB)_sec_0001140361-26-037298-ex991.txt","market_impact_date":"2026-09-22","day1_return":0.08076,"day2_return":-0.094506,"prior_1w_return":1.110276,"comments":"VERSATILE-002 Phase 2 results (PDS0101 + pembrolizumab, HPV16+ R/M HNSCC) published online Sept 17, 2026 in JAMA Oncology: \"mOS was 39.3 months (95% CI, 23.9 to NE)\" in ICI-naive CPS>=1; ORR 36%.","created_at":"2026-10-25 11:37:07","updated_at":"2026-10-25T12:10:29Z","company":"PDS Biotechnology","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":245,"join_event_id":525,"symbol":"PHAR","drug":"leniolisib","modality":"small_molecule","area":"immunology","result_type":"topline_results","news_source_file":"documents/20260922_060249_(PHAR)_sec_0001828316-26-000039.txt","market_impact_date":"2026-09-22","day1_return":0.041628,"day2_return":-0.043517,"prior_1w_return":-0.000924,"comments":"\"announced that a late-breaking abstract highlighting positive topline data from its Phase II trial with leniolisib in genetically identifiable PIDs ... has been accepted at the ... ESID\" (Sept 22, 2026); data included mean 26.4% spleen volume reduction. Poster presented at ESID Oct 14-17, 2026.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:29Z","company":"Pharming Group","event_type":"data_presentation","expect_date_from":"2026-10-14","expect_date_to":"2026-10-17","event_closed":1,"tier":"Core","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":131,"join_event_id":226,"symbol":"VKTX","drug":"VK2735","modality":"peptide","area":"metabolic","result_type":"topline_results","news_source_file":"documents/20260922_070619_(VKTX)_sec_0001193125-26-397219-ex991.txt","market_impact_date":"2026-09-22","day1_return":0.356692,"day2_return":0.019584,"prior_1w_return":-0.045036,"comments":"Positive topline results from Phase 1 maintenance dosing study (VK2735-102): after 21-week weekly induction (16-19% weight loss), up to 97% of weight loss maintained with every-other-week and up to 90% with monthly dosing vs 61% placebo at Week 33; 22% placebo-adjusted weight loss at Week 33 with 17.5 mg weekly; GI AE rates similar to placebo.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:18Z","company":"Viking Therapeutics","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.55,"llm_reason":"The expected 3Q26 readout is a Phase 1 maintenance dosing study in about 180 patients. Its primary endpoints are safety and PK, and weight change is only exploratory. That makes it a lower-stakes event than the Phase 3 VANQUISH data. VKTX is volatile, but a sub-10% first-session move is more likely.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":97,"join_event_id":null,"symbol":"ANAB","drug":"dostarlimab","modality":"monoclonal_antibody","area":"oncology","result_type":"interim_analysis","news_source_file":"documents/20260921_162000_(ANAB)_sec_0001193125-26-396690-ex991.txt","market_impact_date":"2026-09-22","day1_return":-0.018208,"day2_return":-0.05842,"prior_1w_return":0.014969,"comments":"AZUR-1 pivotal Phase 2 (dostarlimab monotherapy, untreated stage II/III dMMR/MSI-H locally advanced rectal cancer) met its primary objective: \"In July 2026, GSK announced positive interim results from the trial, which met its primary objective by demonstrating a meaningful and sustained clinical complete response rate for 12 months (cCR12)\". First disclosed by GSK in July 2026; earliest source in workspace is this Anaptys 8-K exhibit.","created_at":"2026-10-25 11:09:17","updated_at":"2026-10-25T12:10:12Z","company":"AnaptysBio","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":8,"join_event_id":22,"symbol":"CLDX","drug":"barzolvolimab","modality":"monoclonal_antibody","area":"dermatology","result_type":"topline_results","news_source_file":"documents/20260922_070901_(CLDX)_sec_0001104659-26-109465-ex991.txt","market_impact_date":"2026-09-22","day1_return":-0.115598,"day2_return":-0.071322,"prior_1w_return":-0.032925,"comments":"Positive topline results: EMBARQ-CSU1 and -CSU2 met primary endpoint (UAS7 change at Week 12, p<.00001) and all key secondary endpoints; well tolerated through 24 weeks. Company \"plans to submit a Biologics License Application (BLA) to the FDA in 2027\".","created_at":"2026-10-25 09:53:51","updated_at":"2026-10-25T09:54:26Z","company":"Celldex Therapeutics","event_type":"topline_results","expect_date_from":"2026-09-01","expect_date_to":"2026-10-31","event_closed":1,"tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.55,"llm_reason":"Phase 3 CSU topline for the lead asset at a ~$2.3B company is a binary, value-defining event. The strong Phase 2 data and an April raise suggest high expectations are priced in, so a clean beat could still move the stock up 10% or more. The real risks are the competitive bar against dupilumab and remibrutinib, plus safety signals such as hair and skin color changes, which could drive a sharp drop. A move of at least 10% is likely in either direction.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":378,"join_event_id":911,"symbol":"CUE","drug":"CUE-221","modality":"monoclonal_antibody","area":"immunology","result_type":"topline_results","news_source_file":"documents/20260921_080017_(CUE)_sec_0001193125-26-396094-ex991.txt","market_impact_date":"2026-09-21","day1_return":-0.236977,"day2_return":0.093031,"prior_1w_return":0.289144,"comments":"Positive Phase 2 CSU topline: primary endpoint HSS7=0 at week 12 met at all doses (54%/53%/43% vs 11% placebo, p<0.005); key secondary UAS7=0 met at 4 mg/kg (46% vs 11%, p<0.05); favorable safety. Release dated Sept 20, 2026, filed 8-K 2026-09-21 08:00 EDT; call 8:00 a.m. EDT Sept 21.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:44Z","company":"Cue Biopharma","event_type":"topline_results","expect_date_from":"2026-07-10","expect_date_to":"2026-09-30","event_closed":1,"tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.6,"llm_reason":"CUE-221, the anti-IgE lead asset, is now the main value driver for a ~$137M company, so the Phase 2 CSU readout from partner Ascendant in China is binary. A $50M PIPE led by specialist funds ahead of data hints at a positive lean, but the direction remains uncertain.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":18,"join_event_id":null,"symbol":"ALKS","drug":"ALKS 7290","modality":"small_molecule","area":"cns","result_type":"topline_results","news_source_file":"documents/20260921_071039_(ALKS)_sec_0001193125-26-396065-ex991.txt","market_impact_date":"2026-09-21","day1_return":0.018207,"day2_return":-0.020145,"prior_1w_return":-0.056124,"comments":"Positive phase 1b proof-of-concept topline results in adults with ADHD: day 14 median AISRS reductions of 14.0 (20 mg) and 19.0 (50 mg) points; generally well tolerated, no serious TEAEs. Exploratory endpoints; study not powered for statistical significance.","created_at":"2026-10-25","updated_at":"2026-10-25T10:05:34Z","company":"Alkermes","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":463,"join_event_id":null,"symbol":"XENE","drug":"azetukalner","modality":"small_molecule","area":"cns","result_type":"clinical_hold","news_source_file":"documents/20260918_030000_(XENE)_resolution_news_resolution_news-ffb34b1bbb6a07db6efe9cb6aadd8fd6.txt","market_impact_date":"2026-09-18","day1_return":-0.306888,"day2_return":-0.019119,"prior_1w_return":-0.02466,"comments":"Earliest available item (BioSpace, 2026-09-18): \"Xenon tumbles on voluntary psychiatry hold\"; same-day FirstWord (16:56): \"Safety signals jolt Xenon's azetukalner neuropsychiatry trials.\" Aggregator headline only - no company release or SEC exhibit in documents; scope/duration of the voluntary hold not disclosed.","created_at":"2026-10-25T12:08:29","updated_at":"2026-10-25T16:10:06Z","company":"Xenon Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":416,"join_event_id":951,"symbol":"CORT","drug":"relacorilant","modality":"small_molecule","area":"oncology","result_type":"other","news_source_file":"documents/20260918_030000_(CORT)_google_news_gnews-29779cec0d40676f2116118b09424384-CORT.txt","market_impact_date":"2026-09-18","day1_return":-0.039788,"day2_return":0.031463,"prior_1w_return":-0.000522,"comments":"CHMP positive opinion recommending EU marketing authorization for Lifyorli (relacorilant) + nab-paclitaxel in platinum-resistant ovarian cancer, disclosed 2026-09-18 (\"Corcept Announces CHMP Opinion Recommending EU Marketing Authorization for Lifyorli\"). Headline-only wire copy; formal EC decision still pending, so event 951 stays open.","created_at":"2026-10-25 12:18:18","updated_at":"2026-10-25T12:20:07Z","company":"Corcept Therapeutics","event_type":"regulatory_submission","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":345,"join_event_id":null,"symbol":"FENC","drug":"PEDMARK (sodium thiosulfate)","modality":"small_molecule","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20260917_160317_(FENC)_sec_0001104659-26-108565-ex991.txt","market_impact_date":"2026-09-18","day1_return":-0.014842,"day2_return":0.027307,"prior_1w_return":-0.046018,"comments":"Oral presentation of detailed investigator-initiated Ph2 STS-J01 results in Japan at SIOP 2026 on 2026-09-17: ASHA-defined hearing loss 24.0% (6/25) vs 56.4% historical benchmark (P=0.001); 84% Brock Grade 0, no Grade 3/4; ORR 23/24 (95.8%). \"The data will be presented today during the 58th Annual International Society of Pediatric Oncology (SIOP) Annual Meeting\". Earlier topline disclosed Dec 2025 per 10-Q.","created_at":"2026-10-25 11:58:35","updated_at":"2026-10-25T12:10:41Z","company":"Fennec Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":571,"join_event_id":1140,"symbol":"OSTX","drug":"OST-HER2","modality":"vaccine","area":"oncology","result_type":"other","news_source_file":"documents/20260917_030000_(OSTX)_resolution_news_resolution_news-39a26c62a13a3ae4d0b4d9dc3affc9a6.txt","market_impact_date":"2026-09-17","day1_return":0.045714,"day2_return":-0.032787,"prior_1w_return":-0.05914,"comments":"Earliest disclosure of the outcome; aggregator headline only (no company release in workspace): \"OS Therapies Achieves Incremental Alignment With FDA and Accepts Project Orbis Invitation From MHRA on OST-HER2\"; 9/21 headline: \"Completes FDA Type C Statistical Methods Meeting ... Under Project Orbis\". Regulatory alignment/meeting outcome, not data or an FDA decision.","created_at":"2026-11-02 01:28:28","updated_at":"2026-11-02T01:31:04Z","company":"OS Therapies","event_type":"other","expect_date_from":"2026-09-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":473,"join_event_id":null,"symbol":"AXSM","drug":"dextromethorphan-bupropion","modality":"small_molecule","area":"cns","result_type":"data_presentation","news_source_file":"documents/20260917_030000_(AXSM)_google_news_google_news-665f12aa5668a0ef50967812cbb8dff9-AXS.txt","market_impact_date":"2026-09-17","day1_return":0.010898,"day2_return":-0.030334,"prior_1w_return":0.006362,"comments":"\"Axsome Therapeutics Presents Ten Posters ... at Psych Congress 2026\" - company release (syndicated copy, Manila Times via Google News); Yahoo (2026-09-19) confirms \"new clinical data in major depressive disorder and Alzheimer's disease agitation, including outcomes for its dextromethorphan-bupropion therapy\". Conference date passed; no numeric data in available sources.","created_at":"2026-10-25 20:14:09","updated_at":"2026-10-25T20:16:11Z","company":"Axsome Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":442,"join_event_id":203,"symbol":"XENE","drug":"azetukalner","modality":"small_molecule","area":"cns","result_type":"other","news_source_file":"documents/20260917_030000_(XENE)_resolution_news_resolution_news-d8a0eb1e22015f3462c2f45a8967438a.txt","market_impact_date":"2026-09-17","day1_return":0.010395,"day2_return":-0.306888,"prior_1w_return":-0.03764,"comments":"\"Xenon Announces Azetukalner NDA Submission to FDA for Focal\" (GlobeNewswire, 2026-09-17) — NDA for azetukalner in focal onset seizures confirmed submitted; later 2026-09-21 AllSci/NeurologyLive copies confirm filing. Source is the company wire release as carried by Google News (no SEC exhibit in documents).","created_at":"2026-10-25 12:50:00","updated_at":"2026-10-25T13:07:44Z","company":"Xenon Pharmaceuticals","event_type":"regulatory_submission","expect_date_from":"2026-07-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":224,"join_event_id":456,"symbol":"RARE","drug":"rebisufligene etisparvovec (UX111)","modality":"gene_therapy","area":"rare_genetic","result_type":"fda_approval","news_source_file":"documents/20260917_142643_(TRAX)_fda_press_fda_press-http-www.fda.gov-news-events-press-ann.txt","market_impact_date":"2026-09-17","day1_return":0.125776,"day2_return":0.00069,"prior_1w_return":-0.09993,"comments":"FDA news release, 2026-09-17 14:26 ET: \"FDA today approved Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with MPS IIIA\"; \"FDA granted Fayuvi approval to Ultragenyx Pharmaceutical, Inc.\" Earliest disclosure; company 8-K (15:55 ET) confirms standard full approval and a PRV.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:27Z","company":"Ultragenyx Pharmaceutical","event_type":"pdufa","expect_date_from":"2026-09-19","expect_date_to":"2026-09-19","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":493,"join_event_id":null,"symbol":"COGT","drug":"bezuclastinib","modality":"small_molecule","area":"hematology","result_type":"other","news_source_file":"documents/20260915_080000_(COGT)_yahoo_news_yahoo-b820481790ae7b118325e4cecd7ac7ad-COGT.txt","market_impact_date":"2026-09-15","day1_return":-0.020054,"day2_return":-0.006109,"prior_1w_return":-0.038838,"comments":"FDA decision 2026-09-15: company release (GlobeNewswire, republished via Yahoo) says FDA \"has accepted\" the NDA for bezuclastinib in Advanced SM, with \"PDUFA target action date set for June 29, 2027\", no advisory committee planned and no review issues flagged. Filing acceptance, not an approval; approval tracked as open PDUFA event #993.","created_at":"2026-10-26","updated_at":"2026-10-26T04:27:49Z","company":"Cogent Biosciences","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":469,"join_event_id":1057,"symbol":"ARWR","drug":"ARO-DIMER-PA","modality":"sirna","area":"cardiovascular","result_type":"topline_results","news_source_file":"documents/20260915_030000_(ARWR)_google_news_gnews-723bd26ad423a954e172fc4694cdbcfc-ARWR.txt","market_impact_date":"2026-09-15","day1_return":-0.123962,"day2_return":-0.069053,"prior_1w_return":-0.065671,"comments":"Company announced \"Interim Topline Clinical Data for the First Dual-Functional RNAi Therapeutic for the Treatment of Mixed Hyperlipidemia\" (ARO-DIMER-PA, Phase 1/2a) on Sep 15, 2026. Google News listing used: only a headline-level document is present in the workspace; no primary release text available.","created_at":"2026-10-25 20:13:41","updated_at":"2026-10-26T18:58:00Z","company":"Arrowhead Pharmaceuticals","event_type":"topline_results","expect_date_from":"2026-09-15","expect_date_to":"2026-09-15","event_closed":1,"tier":"Core","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":428,"join_event_id":301,"symbol":"BIVI","drug":"Bezisterim","modality":"small_molecule","area":"infectious","result_type":"topline_results","news_source_file":"documents/20260915_030000_(BIVI)_resolution_news_resolution_news-a9afa1b3d557ba695f18a306a36fb7d1.txt","market_impact_date":"2026-09-15","day1_return":-0.146341,"day2_return":-0.017143,"prior_1w_return":0.025,"comments":"GlobeNewswire headline 2026-09-15 03:00 EDT: \"BioVie Announces Topline Results from Phase 2 ADDRESS-LC\". Same-day Proactive coverage: \"BioVie Phase 2 trial shows bezisterim eases fatigue, cognitive symptoms in severe Long COVID cases\". Only headline/summary text available (no SEC 8-K or full release text in workspace); no quantitative data captured.","created_at":"2026-10-25 12:44:04","updated_at":"2026-10-25T12:48:03Z","company":"BioVie","event_type":"topline_results","expect_date_from":"2026-08-01","expect_date_to":"2026-09-22","event_closed":1,"tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.6,"llm_reason":"The readout is the Phase 2 ADDRESS-LC long COVID trial of bezisterim, expected late summer 2026. BioVie is a ~$11M microcap with heavy dilution and financing risk, so a binary readout will likely move the stock 10% or more. Direction is unclear: long COVID trials have mostly failed, and the company tends to spin results on nominal endpoints.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":395,"join_event_id":957,"symbol":"CNTB","drug":"rademikibart","modality":"monoclonal_antibody","area":"respiratory","result_type":"topline_results","news_source_file":"documents/20260915_070634_(CNTB)_sec_0001835268-26-000034-ex991.txt","market_impact_date":"2026-09-15","day1_return":-0.321739,"day2_return":0.059829,"prior_1w_return":-0.0625,"comments":"Phase 2 Seabreeze STAT asthma topline: post-BD FEV1 +250 mL vs +120 mL placebo at Day 7 (p=0.023); treatment failure reduced ~66% at 28 days (p=0.153, not significant); 50% fewer ED/unscheduled visits; well tolerated. Press release Exhibit 99.1 to 8-K, September 15, 2026.","created_at":"2026-10-25 08:07:10","updated_at":"2026-10-25T12:10:46Z","company":"Connect Biopharma Holdings","event_type":"topline_results","expect_date_from":"2026-09-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"Core","llm_prediction":"large_impact","llm_confidence":0.68,"llm_reason":"Rademikibart is essentially Connect's only asset, and the market cap of about $48M is close to its ~$31.5M cash. A Phase 2 topline readout in asthma or COPD exacerbation should move the stock at least 10% either way. Direction is uncertain.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":379,"join_event_id":null,"symbol":"CTNM","drug":"JNJ-5120/PIPE-307","modality":"small_molecule","area":"cns","result_type":"topline_results","news_source_file":"documents/20260914_160712_(CTNM)_sec_0001628280-26-061834-ex991.txt","market_impact_date":"2026-09-15","day1_return":-0.067476,"day2_return":-0.004341,"prior_1w_return":-0.112575,"comments":"Phase 2 MOONLIGHT-1 (NCT06785012) in MDD did not meet primary endpoint: \"the MOONLIGHT-1 trial did not achieve its primary efficacy endpoint\" (change in MADRS total score at Day 5 vs placebo). Well-tolerated, no new safety signals; J&J evaluating exploratory endpoints and next steps. Announced by Contineum; drug licensed to J&J.","created_at":"2026-10-25 12:04:29","updated_at":"2026-10-25T12:10:44Z","company":"Contineum Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":221,"join_event_id":442,"symbol":"RCKT","drug":"RP-A501","modality":"gene_therapy","area":"cardiovascular","result_type":"other","news_source_file":"documents/20260915_070651_(RCKT)_sec_0001140361-26-036563-ex991.txt","market_impact_date":"2026-09-15","day1_return":-0.005831,"day2_return":0.020528,"prior_1w_return":-0.111399,"comments":"\"FDA confirms pivotal efficacy population of 12 patients... FDA review of initial safety data supports continued enrollment and dosing under modified protocol\" — resolves the guided H2 2026 regulatory pathway update. No further regulatory update expected from this event; additional Danon dosing/readout tracked separately.","created_at":"2026-10-25 11:31:51","updated_at":"2026-10-25T12:10:27Z","company":"Rocket Pharmaceuticals","event_type":"other","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":188,"join_event_id":367,"symbol":"SION","drug":"SION-719","modality":"small_molecule","area":"rare_genetic","result_type":"other","news_source_file":"documents/20260914_161018_(SION)_sec_0001193125-26-390577-ex991.txt","market_impact_date":"2026-09-15","day1_return":-0.16707,"day2_return":0.023256,"prior_1w_return":0.150418,"comments":"Post hoc analysis of PreciSION CF: excluding three PK-outlier participants, \"mean placebo-adjusted sweat chloride change of -8.6 mmol/L using the secondary analysis\"; company believes SION-719 was biologically active but confounding factors blunted the signal. Exploratory post hoc data.","created_at":"2026-10-25 07:24:36","updated_at":"2026-10-25T12:10:23Z","company":"Sionna Therapeutics","event_type":"topline_results","expect_date_from":"2026-06-01","expect_date_to":"2026-08-31","event_closed":1,"tier":"","llm_prediction":"large_impact","llm_confidence":0.6,"llm_reason":"The SION-719 add-on proof-of-concept readout in CF patients is a binary, pivotal event for a single-platform NBD1 company. Expectations look elevated (recent option grants near $39), so either a beat or a miss on sweat chloride likely moves the stock 10% or more. The direction is unclear.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":134,"join_event_id":233,"symbol":"VERA","drug":"atacicept","modality":"protein","area":"renal","result_type":"topline_results","news_source_file":"documents/20260915_064534_(VERA)_sec_0001193125-26-391280-ex991.txt","market_impact_date":"2026-09-15","day1_return":-0.01116,"day2_return":-0.05643,"prior_1w_return":-0.051268,"comments":"ORIGIN 3 final efficacy analysis (428 patients) met all prespecified endpoints: 52-wk eGFR change -0.1 vs -5.7 mL/min/1.73m2; annualized eGFR slope through 104 wks -0.6 vs -5.6; composite kidney progression 11 vs 38 events (HR 0.24, 76% risk reduction), p<0.0001. Also presented 2026-10-22 as late-breaking oral presentation at ASN Kidney Week 2026 and published in NEJM (later disclosure of same dataset).","created_at":"2026-10-25 07:14:56","updated_at":"2026-10-25T16:07:29Z","company":"Vera Therapeutics","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.68,"llm_reason":"The drug already has accelerated approval, and the ORIGIN 3 eGFR confirmatory analysis is likely to succeed given the strong proteinuria data. The mechanism is validated by peers, so a positive result is largely priced in at a ~$2B market cap. A miss is possible but less likely.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":30,"join_event_id":248,"symbol":"BLSM","drug":"BH-30643","modality":"small_molecule","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20260915_073006_(BLSM)_sec_0001193125-26-391328-ex991.txt","market_impact_date":"2026-09-15","day1_return":0.019779,"day2_return":0.184032,"prior_1w_return":-0.012267,"comments":"Updated Phase 1/2 SOLARA data presented in mini-oral at IASLC 2026 WCLC (Seoul): C797S-positive NSCLC ORR 45% (18/40), DCR 88% (35/40), data cutoff 2026-05-12, efficacy follow-up through 2026-08-10. Low rate of TR-ae dose reductions (9%)/discontinuations (3%). First disclosure.","created_at":"2026-10-25","updated_at":"2026-10-25T11:16:23Z","company":"BlossomHill Therapeutics","event_type":"data_presentation","expect_date_from":"2026-09-15","expect_date_to":"2026-09-15","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":457,"join_event_id":null,"symbol":"TNYA","drug":"TN-401","modality":"gene_therapy","area":"cardiovascular","result_type":"other","news_source_file":"documents/20260914_083000_(TNYA)_yahoo_news_yahoo-388a69283a28cae4ad69511dedf90566-TNYA.txt","market_impact_date":"2026-09-14","day1_return":0.082813,"day2_return":-0.031746,"prior_1w_return":-0.079137,"comments":"FDA granted RMAT designation for TN-401 in PKP2-associated ARVC, per GlobeNewswire release (Sept 14, 2026): \"Tenaya Therapeutics Granted U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for TN-401\". No SEC exhibit available; Yahoo/Google mirror of the company wire used as source. Title says additional data/regulatory updates anticipated 4Q 2026.","created_at":"2026-10-25 16:00:14","updated_at":"2026-10-25T16:04:05Z","company":"Tenaya Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":441,"join_event_id":526,"symbol":"PHIO","drug":"PH-762","modality":"sirna","area":"oncology","result_type":"other","news_source_file":"documents/20260914_085936_(PHIO)_sec_0001437749-26-030236.txt","market_impact_date":"2026-09-14","day1_return":0.0,"day2_return":-0.009709,"prior_1w_return":-0.072072,"comments":"FDA submission confirmed: 2026-09-14 8-K \"announcing a key development milestone for PH-762, including the submission of materials to the FDA to support the next phase of clinical development in cutaneous cell carcinoma and a planned Phase 2b neoadjuvant study.\" Briefing package submission; FDA guidance/outcome not yet disclosed.","created_at":"2026-10-25 13:10:00","updated_at":"2026-10-25T13:07:44Z","company":"Phio Pharmaceuticals","event_type":"regulatory_submission","expect_date_from":"2026-07-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":419,"join_event_id":null,"symbol":"MDWD","drug":"EscharEx","modality":"protein","area":"other","result_type":"interim_analysis","news_source_file":"documents/20260914_070000_(MDWD)_yahoo_news_yahoo-3c38e618f018a9f161e7196b50f63bb8-MDWD.txt","market_impact_date":"2026-09-14","day1_return":0.058734,"day2_return":-0.029539,"prior_1w_return":-0.00757,"comments":"DSMB completed its pre-specified review of the Phase III VALUE trial (VLUs) and recommended it continue without modification: \"DSMB did not identify safety concerns in pre-specified review; interim assessment and enrollment completion remain on track for end of the first quarter of 2027.\" Only a Yahoo/GlobeNewswire syndication copy is in the workspace; the release is otherwise truncated. No numbers disclosed; interim sample size reassessment not yet reported.","created_at":"2026-10-25 12:19:48","updated_at":"2026-10-25T12:20:08Z","company":"MediWound","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":405,"join_event_id":null,"symbol":"CGEM","drug":"zipalertinib","modality":"small_molecule","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20260914_072942_(CGEM)_sec_0001193125-26-389844-ex991.txt","market_impact_date":"2026-09-14","day1_return":-0.009228,"day2_return":0.006863,"prior_1w_return":-0.070848,"comments":"Full REZILIENT3 results presented in Presidential Symposium 2 at IASLC WCLC 2026, session September 14, 2026 8 a.m. KST: mPFS 14.5 vs 8.5 mo (HR 0.50; P=0.00015), ORR 65.0% vs 40.3%.","created_at":"2026-10-25 12:08:48","updated_at":"2026-10-25T12:10:47Z","company":"Cullinan Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":390,"join_event_id":937,"symbol":"CRBP","drug":"CRB-913","modality":"small_molecule","area":"metabolic","result_type":"topline_results","news_source_file":"documents/20260914_070627_(CRBP)_sec_0001193125-26-389829-ex991.txt","market_impact_date":"2026-09-14","day1_return":-0.004926,"day2_return":-0.143564,"prior_1w_return":-0.291449,"comments":"Positive CANYON-1 Phase 1b topline: LS mean weight loss 5.0% at 60 mg vs 0.0% placebo at week 12 (p<0.0001), all doses significant, no plateau; generally well tolerated, psychiatric AEs broadly in line with GLP-1s. Later copies (Oct 15 deck) support details.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:45Z","company":"Corbus Pharmaceuticals Holdings","event_type":"topline_results","expect_date_from":"2026-09-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"Core","llm_prediction":"large_downside","llm_confidence":0.62,"llm_reason":"The market cap (~$80M) is below the company's cash (~$118M), so a lot of downside is already priced in, but the 240-patient obesity readout is a binary catalyst. A strong weight-loss result with clean neuropsychiatric safety could send the stock sharply higher. A weak efficacy signal or CB1-related safety issues could cause a large drop. A move of at least 10% is likely in either direction.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":368,"join_event_id":891,"symbol":"DFTX","drug":"DT120 ODT","modality":"small_molecule","area":"cns","result_type":"topline_results","news_source_file":"documents/20260914_080240_(DFTX)_sec_0001104659-26-107275-ex991.txt","market_impact_date":"2026-09-14","day1_return":0.03497,"day2_return":-0.085217,"prior_1w_return":0.023421,"comments":"Positive Phase 3 Panorama topline in GAD: HAM-A LS mean change -9.8 vs -4.7 placebo, difference -5.1 (p<0.0001, d=0.64) at Week 12; primary and all key secondary endpoints met; no new safety signals.","created_at":"2026-10-25 12:03:03","updated_at":"2026-10-25T12:10:43Z","company":"Definium Therapeutics","event_type":"topline_results","expect_date_from":"2026-09-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"Core","llm_prediction":"large_downside","llm_confidence":0.45,"llm_reason":"The stock has re-rated from about $13 to $47 and the company raised $805M at $34, likely after a positive first Phase 3. A confirmatory DT120 readout is probably largely priced in. Downside risk remains if the trial misses, though the large cash position cushions it.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":297,"join_event_id":672,"symbol":"LPCN","drug":"LPCN 1154","modality":"small_molecule","area":"cns","result_type":"other","news_source_file":"documents/20260914_061526_(LPCN)_sec_0001493152-26-042466-ex991.txt","market_impact_date":"2026-09-14","day1_return":-0.022026,"day2_return":-0.015766,"prior_1w_return":-0.061984,"comments":"Q3 2026 FDA guidance meeting occurred; BLOOM Phase 3 design \"incorporates feedback from a recent meeting with the U.S. Food and Drug Administration (FDA)\". Feedback informed the new placebo-controlled PPD study.","created_at":"2026-10-25 11:47:30","updated_at":"2026-10-25T12:10:35Z","company":"Lipocine","event_type":"other","expect_date_from":"2026-07-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":258,"join_event_id":null,"symbol":"NSRX","drug":"NS002","modality":"small_molecule","area":"immunology","result_type":"other","news_source_file":"documents/20260914_081515_(NSRX)_sec_0001493152-26-042488-ex991.txt","market_impact_date":"2026-09-14","day1_return":0.071953,"day2_return":-0.016438,"prior_1w_return":-0.092,"comments":"9/14/2026 6-K: \"the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for NS002, its investigational intranasal epinephrine powder for the treatment of anaphylaxis.\" Company plans pivotal study in Q4 2026, topline Q1 2027.","created_at":"2026-10-25 07:41:06","updated_at":"2026-10-25T12:10:31Z","company":"Nasus Pharma","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":168,"join_event_id":327,"symbol":"SRRK","drug":"apitegromab","modality":"monoclonal_antibody","area":"rare_genetic","result_type":"fda_approval","news_source_file":"documents/20260914_080027_(SRRK)_sec_0001104659-26-107273-ex991.txt","market_impact_date":"2026-09-14","day1_return":-0.064248,"day2_return":-0.03568,"prior_1w_return":-0.009474,"comments":"\"FDA has approved ISEMBYLD (apitegromab-mstn) for the treatment of spinal muscular atrophy (SMA) in adults and children two years of age and older who are currently receiving an SMN2-targeted treatment.\" Press release dated Sep 11, 2026; filed as 8-K exhibit Sep 14, 2026. Later 8-K (2026-09-15) clarifies FDA required a pregnancy safety study and 15-day alert reports for fractures.","created_at":"2026-10-25 07:21:55","updated_at":"2026-10-25T12:10:22Z","company":"Scholar Rock Holding","event_type":"pdufa","expect_date_from":"2026-09-30","expect_date_to":"2026-09-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":31,"join_event_id":318,"symbol":"BFRI","drug":"Ameluz (aminolevulinic acid HCl) topical gel 10% + BF-RhodoLED","modality":"small_molecule","area":"dermatology","result_type":"fda_approval","news_source_file":"documents/20260914_092943_(BFRI)_sec_0001493152-26-042508-ex991.txt","market_impact_date":"2026-09-14","day1_return":-0.122581,"day2_return":-0.125,"prior_1w_return":0.02649,"comments":"FDA approved sNDA for Ameluz with BF-RhodoLED PDT for superficial basal cell carcinoma in adults: \"the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental New Drug Application (sNDA) for Ameluz\". Ph3: 66% complete response vs 5% vehicle. Announced 2026-09-14 09:29 EDT.","created_at":"2026-10-25","updated_at":"2026-10-25T11:21:37Z","company":"Biofrontera","event_type":"pdufa","expect_date_from":"2026-09-16","expect_date_to":"2026-09-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":17,"join_event_id":null,"symbol":"ARMP","drug":"AP-SA02","modality":"other","area":"infectious","result_type":"other","news_source_file":"documents/20260914_071201_(ARMP)_sec_0001104659-26-107253-ex991.txt","market_impact_date":"2026-09-14","day1_return":0.031599,"day2_return":-0.207207,"prior_1w_return":-0.025362,"comments":"FDA granted Breakthrough Therapy designation to AP-SA02 for adjunct treatment of complicated S. aureus bacteremia (MSSA or MRSA): \"the U.S. Food and Drug Administration ... has granted Breakthrough Therapy designation to AP-SA02\". Designation supported by Phase 1b/2a diSArm data; not an approval.","created_at":"2026-10-25 10:04:20","updated_at":"2026-10-25T10:05:34Z","company":"Armata Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":244,"join_event_id":522,"symbol":"PHAR","drug":"leniolisib","modality":"small_molecule","area":"immunology","result_type":"fda_approval","news_source_file":"documents/20260911_145934_(PHAR)_sec_0001828316-26-000037.txt","market_impact_date":"2026-09-11","day1_return":0.037483,"day2_return":-0.03479,"prior_1w_return":-0.035268,"comments":"\"FDA has approved its supplemental New Drug Application (sNDA) for 40 mg and 50 mg twice-daily dosing of Joenja ... for children aged 4 to 11 years weighing at least 27 kg with APDS\" - approval Sept 11, 2026, ahead of the Oct 24, 2026 PDUFA date.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:29Z","company":"Pharming Group","event_type":"pdufa","expect_date_from":"2026-10-24","expect_date_to":"2026-10-24","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":321,"join_event_id":741,"symbol":"IRON","drug":"DISC-3405","modality":"monoclonal_antibody","area":"hematology","result_type":"data_presentation","news_source_file":"documents/20260910_084826_(IRON)_sec_0001193125-26-387351-ex991.txt","market_impact_date":"2026-09-10","day1_return":-0.030976,"day2_return":-0.055031,"prior_1w_return":-0.027456,"comments":"Initial RESTORE-PV Phase 2 results in PV presented in a poster at the 2026 SOHO annual meeting: hematocrit controlled <45% through week 26, mean phlebotomy events fell from 4.0 to 0.6 (p<0.0001), 61.5% phlebotomy-free; oral presentation followed on September 10.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:38Z","company":"Disc Medicine","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"","llm_prediction":"small_impact","llm_confidence":0.68,"llm_reason":"DISC-3405 is an early-stage anti-TMPRSS6 antibody for PV and SCD. Hepcidin-mechanism data are already fairly de-risked by peers such as rusfertide. Disc's ~$2.9B valuation rests mainly on bitopertin, so an early PV readout is unlikely to move the stock 10% or more.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":233,"join_event_id":null,"symbol":"PRLD","drug":"PRT13722","modality":"small_molecule","area":"oncology","result_type":"other","news_source_file":"documents/20260910_072955_(PRLD)_sec_0001193125-26-387232-ex991.txt","market_impact_date":"2026-09-10","day1_return":-0.082515,"day2_return":-0.017131,"prior_1w_return":-0.07286,"comments":"FDA cleared the IND for PRT13722 (oral KAT6A selective degrader), allowing the Phase 1 study in HR+/HER2- breast cancer to proceed: \"FDA cleared the Company to proceed with a Phase 1 study under its Investigational New Drug Application (IND)\". Company expects to begin enrolling in Q4 2026 (trial start, not a catalyst).","created_at":"2026-10-25 11:34:41","updated_at":"2026-10-25T12:10:28Z","company":"Prelude Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":29,"join_event_id":null,"symbol":"BHVN","drug":"BHV-7000","modality":"small_molecule","area":"cns","result_type":"clinical_hold","news_source_file":"documents/20260909_215518_(BHVN)_sec_0001935979-26-000077.txt","market_impact_date":"2026-09-10","day1_return":-0.147333,"day2_return":-0.006255,"prior_1w_return":-0.047014,"comments":"FDA \"issued a partial clinical hold letter on September 4, 2026 that pauses new patient enrollment pending the results of additional nonclinical data regarding the metabolite\"; dosing continues for >600 randomized patients; BHV7000-303 fully enrolled.","created_at":"2026-10-25 10:13:21","updated_at":"2026-10-25T10:14:01Z","company":"Biohaven","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":351,"join_event_id":844,"symbol":"EVMN","drug":"EVO756","modality":"small_molecule","area":"dermatology","result_type":"topline_results","news_source_file":"documents/20260908_180532_(EVMN)_sec_0001193125-26-385430-ex991.txt","market_impact_date":"2026-09-09","day1_return":-0.171254,"day2_return":-0.02583,"prior_1w_return":0.033175,"comments":"Phase 2b in moderate-to-severe AD (N=121) \"did not meet the primary and secondary endpoints in any of the doses studied\"; company does not plan to advance EVO756 in AD. Announced 2026-09-08.","created_at":"2026-10-25T07:59:11","updated_at":"2026-10-25T12:10:42Z","company":"Evommune","event_type":"topline_results","expect_date_from":"2026-09-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"Core","llm_prediction":"large_impact","llm_confidence":0.6,"llm_reason":"The company trades at a $189M market cap against $288M in cash, so the market assigns little value to EVO756 after the June CSU Phase 2b failure. The AD Phase 2b readout is binary for the lead asset. Positive data could drive a large rebound from the depressed valuation. A miss could still push the stock well below cash, though cash support may limit the fall. A large move is likely, but the direction is uncertain.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":327,"join_event_id":762,"symbol":"INBX","drug":"INBRX-106","modality":"protein","area":"oncology","result_type":"topline_results","news_source_file":"documents/20260908_160151_(INBX)_sec_0002007919-26-000047-ex991.txt","market_impact_date":"2026-09-09","day1_return":-0.012944,"day2_return":-0.012759,"prior_1w_return":-0.097553,"comments":"Primary endpoint results from randomized Phase 2 HexAgon: cORR 48.3% vs 26.5% for pembrolizumab alone; median PFS 9.6 vs 4.9 months (data cutoff 2026-08-19). \"today announced the primary endpoint results from the randomized and controlled Phase 2 portion of the HexAgon study\" (September 8, 2026).","created_at":"2026-10-25T07:53:09","updated_at":"2026-10-25T12:10:39Z","company":"Inhibrx Biosciences","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"Watch","llm_prediction":"large_downside","llm_confidence":0.55,"llm_reason":"Randomized Phase 2 PFS readout of INBRX-106 (OX40 agonist) plus pembrolizumab in HNSCC is a binary event for a ~$1.4B company that is otherwise driven by ozekibart. Prior OX40 agonist failures raise downside risk, but a positive randomized result could move the stock sharply up, so direction is uncertain.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":256,"join_event_id":593,"symbol":"NTLA","drug":"lonvoguran ziclumeran","modality":"gene_therapy","area":"rare_genetic","result_type":"other","news_source_file":"documents/20260908_160515_(NTLA)_sec_0001193125-26-385194-ex991.txt","market_impact_date":"2026-09-09","day1_return":-0.041601,"day2_return":-0.022932,"prior_1w_return":0.000786,"comments":"FDA accepted the BLA for lonvo-z in HAE and granted Priority Review (PDUFA March 10, 2027); FDA not currently planning an advisory committee. Regulatory acceptance decision, not approval.","created_at":"2026-10-25 11:41:09","updated_at":"2026-10-25T12:10:30Z","company":"Intellia Therapeutics","event_type":"regulatory_submission","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":231,"join_event_id":481,"symbol":"PYXS","drug":"micvotabart pelidotin (MICVO)","modality":"adc","area":"oncology","result_type":"interim_analysis","news_source_file":"documents/20260909_073445_(PYXS)_sec_0001193125-26-385901-ex991.txt","market_impact_date":"2026-09-09","day1_return":-0.131105,"day2_return":-0.032544,"prior_1w_return":0.200617,"comments":"Updated Phase 1 monotherapy data (cutoff 18-Aug-2026, N=33 evaluable, 5.4 mg/kg with dose cap): cORR 36% (12/33), DCR 94%, mPFS 6.2 months, 12-month OS probability 79%, median OS not reached; no new safety signals. More mature OS data still expected 1H 2027.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:28Z","company":"Pyxis Oncology","event_type":"interim_analysis","expect_date_from":"2026-09-01","expect_date_to":"2026-11-30","event_closed":1,"tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.6,"llm_reason":"The ~$200M single-asset company has its value concentrated in MICVO. A Fall 2026 update on 2L+ HNSCC monotherapy with dose-cap safety analyses is a binary-ish readout that likely moves the stock 10% or more. Direction is uncertain: the dose cap hints at tolerability issues, while the BVF/RTW-led financing signals insider confidence.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":190,"join_event_id":null,"symbol":"SER","drug":"SER-252","modality":"small_molecule","area":"cns","result_type":"interim_analysis","news_source_file":"documents/20260909_074319_(SER)_sec_0001708599-26-000054.txt","market_impact_date":"2026-09-09","day1_return":0.028,"day2_return":-0.027237,"prior_1w_return":0.033058,"comments":"Independent Safety Monitoring Committee \"completed its blinded review of Cohort 1 ... and has recommended that the study advance to Cohort 2\"; Cohort 1 showed a PK profile consistent with sustained apomorphine exposure and sustained motor improvement on exploratory measures. Topline SAD data still guided to 1H 2027.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:23Z","company":"Serina Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":155,"join_event_id":290,"symbol":"TENX","drug":"TNX-103 (oral levosimendan)","modality":"small_molecule","area":"cardiovascular","result_type":"data_presentation","news_source_file":"documents/20260909_080012_(TENX)_sec_0001193125-26-385910-ex991.txt","market_impact_date":"2026-09-09","day1_return":0.075758,"day2_return":-0.084507,"prior_1w_return":0.076087,"comments":"Comprehensive LEVEL results update; deck states \"Comprehensive results update: 09 September 2026\" and data presented by Dr. Sanjiv Shah at ESC Congress 2026 on August 29, 2026. Includes subgroup, biomarker and safety analyses.","created_at":"2026-10-25T07:19:02","updated_at":"2026-10-25T12:10:20Z","company":"Tenax Therapeutics","event_type":"data_presentation","expect_date_from":"2026-08-29","expect_date_to":"2026-08-29","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":139,"join_event_id":null,"symbol":"TYRA","drug":"dabogratinib","modality":"small_molecule","area":"oncology","result_type":"other","news_source_file":"documents/20260909_071006_(TYRA)_sec_0001193125-26-385886.txt","market_impact_date":"2026-09-09","day1_return":-0.176581,"day2_return":0.069514,"prior_1w_return":0.067918,"comments":"Initial observation from SURF303 (LG-UTUC): \"the first patient treated achieved a complete response at the 3-month assessment with 60 mg QD, with no observed TEAEs\" as of 2026-08-31 cutoff. Single participant; does not resolve the 2027 initial-results event.","created_at":"2026-10-25 11:16:37","updated_at":"2026-10-25T12:10:18Z","company":"Tyra Biosciences","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":138,"join_event_id":253,"symbol":"TYRA","drug":"dabogratinib","modality":"small_molecule","area":"oncology","result_type":"topline_results","news_source_file":"documents/20260909_071006_(TYRA)_sec_0001193125-26-385886.txt","market_impact_date":"2026-09-09","day1_return":-0.176581,"day2_return":0.069514,"prior_1w_return":0.067918,"comments":"Initial SURF302 Ph2 results (data cutoff 2026-08-31): 60 mg QD ORR 79% (11/14), CR 57%; 50 mg QD ORR 67% (8/12); no Gr4/5 TEAEs; 60 mg QD selected for adjuvant development.","created_at":"2026-10-25 11:16:37","updated_at":"2026-10-25T12:10:18Z","company":"Tyra Biosciences","event_type":"topline_results","expect_date_from":"2026-09-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"Core","llm_prediction":"large_impact","llm_confidence":0.55,"llm_reason":"The first SURF302 efficacy readout in IR NMIBC (about 20 evaluable patients) is a key value driver for a $1.4B company built around a single asset. The bar is set by competitors such as TAR-210 and by FGFR toxicity, so either beating or missing expectations could move the stock 10% or more. The new $250M ATM adds some dilution risk, but the direction is still uncertain.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":80,"join_event_id":121,"symbol":"BBOT","drug":"BBO-8520","modality":"small_molecule","area":"oncology","result_type":"interim_analysis","news_source_file":"documents/20260908_161906_(BBOT)_sec_0001193125-26-385225-ex991.txt","market_impact_date":"2026-09-09","day1_return":-0.237585,"day2_return":-0.182828,"prior_1w_return":0.006818,"comments":"ONKORAS-101 Ph1 (cutoff Jun 1, 2026): BBO-8520 + pembrolizumab ORR 75% at 500 mg QD (53% across doses, N=17) in 2L+ KRAS G12C inhibitor-experienced NSCLC; monotherapy ORR 63% (26/41), DCR 100%, no grade 3 liver enzyme elevations.","created_at":"2026-10-25 11:05:16","updated_at":"2026-10-25T12:10:13Z","company":"BridgeBio Oncology Therapeutics","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.5,"llm_reason":"BBO-8520, a KRAS G12C ON inhibitor, is a lead asset of a small-cap company whose market cap (~$228M) sits below its ~$344M cash. That gap means low expectations are priced in, so strong data could drive a sharp rebound and weak data could still hurt. Either way, a move of 10% or more is likely, but the direction is unclear.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":12,"join_event_id":1089,"symbol":"IRD","drug":"OPGx-BEST1","modality":"gene_therapy","area":"rare_genetic","result_type":"topline_results","news_source_file":"documents/20260909_073047_(IRD)_sec_0001140361-26-035979-ex991.txt","market_impact_date":"2026-09-09","day1_return":0.320276,"day2_return":0.059337,"prior_1w_return":0.198895,"comments":"Low-dose Cohort 1 (n=5) 3- and 6-month results: no SAEs/DLTs; all 5 had clinically meaningful visual function improvement; 3/4 evaluable met >=3 dB microperimetry; FDA aligned on potential pivotal endpoint. First disclosed 2026-09-09 8-K; same data re-presented at Retina in Rio 2026-10-15.","created_at":"2026-10-25 09:54:00","updated_at":"2026-10-29T09:00:45Z","company":"Opus Genetics","event_type":"topline_results","expect_date_from":"2026-09-07","expect_date_to":"2026-09-13","event_closed":1,"tier":"Core","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":427,"join_event_id":243,"symbol":"UPB","drug":"verekitug","modality":"monoclonal_antibody","area":"respiratory","result_type":"data_presentation","news_source_file":"documents/20260908_030000_(UPB)_resolution_news_resolution_news-e69cff62278861a64aaad4611531e923.txt","market_impact_date":"2026-09-08","day1_return":0.02995,"day2_return":-0.037157,"prior_1w_return":-0.101644,"comments":"Phase 2 VALIANT severe asthma results presented at ERS Congress 2026 (Sept 5-9, Barcelona). Evidence: headline \"Upstream Bio Presents Results from the Phase 2 VALIANT\" (GlobeNewswire, 2026-09-08). Caveat: only the Google News/GlobeNewswire aggregator item is available; no primary release or SEC exhibit in workspace.","created_at":"2026-10-25T08:43:35","updated_at":"2026-10-25T12:48:03Z","company":"Upstream Bio","event_type":"data_presentation","expect_date_from":"2026-09-05","expect_date_to":"2026-09-09","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":425,"join_event_id":103,"symbol":"BEAM","drug":"BEAM-302","modality":"gene_therapy","area":"rare_genetic","result_type":"data_presentation","news_source_file":"documents/20260908_030000_(BEAM)_resolution_news_resolution_news-ae2c3a134188425b9764ce0335f4b516.txt","market_impact_date":"2026-09-08","day1_return":-0.095415,"day2_return":-0.061685,"prior_1w_return":0.011596,"comments":"Updated Phase 1/2 BEAM-302 data presented at ERS on 2026-09-08. Primary GlobeNewswire release (\"Beam Therapeutics Presents Updated Clinical Data from the Phase 1/2 Trial of BEAM-302 in AATD at the ERS Congress 2026\"), 2026-09-08 03:00 EDT, first disclosure; body not in workspace, details from Yahoo summary 2026-09-10: 38 patients treated by Aug 17, efficacy analysis of 29 single-dose patients at June 24 cutoff, biomarker results to 18 months.","created_at":"2026-10-25 12:43:30","updated_at":"2026-10-25T12:48:02Z","company":"Beam Therapeutics","event_type":"data_presentation","expect_date_from":"2026-09-05","expect_date_to":"2026-09-09","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":374,"join_event_id":905,"symbol":"IONS","drug":"pelacarsen","modality":"aso","area":"cardiovascular","result_type":"topline_results","news_source_file":"documents/20260904_170039_(IONS)_sec_0001140361-26-035802-ex991.txt","market_impact_date":"2026-09-08","day1_return":-0.023756,"day2_return":-0.012167,"prior_1w_return":-0.048485,"comments":"\"the pelacarsen Phase 3 Lp(a)HORIZON study ... did not meet its primary endpoint of reducing the risk of cardiovascular events\"; Lp(a) substantially lowered and safety acceptable. \"The full Lp(a)HORIZON data will be presented at an upcoming medical congress\" (congress date not stated). Novartis-partnered; Ionis discovered the drug.","created_at":"2026-10-25T08:09:00","updated_at":"2026-10-25T12:10:11Z","company":"Ionis Pharmaceuticals","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.6,"llm_reason":"Pelacarsen is Novartis-partnered, so Ionis earns only royalties. Ionis has a diversified commercial portfolio (TRYNGOLZA, DAWNZERA, WAINUA) and a large market cap, which likely limits the first-session move from the Lp(a) HORIZON outcome to under 10%.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":369,"join_event_id":null,"symbol":"DFTX","drug":"DT120 ODT","modality":"small_molecule","area":"cns","result_type":"other","news_source_file":"documents/20260908_080015_(DFTX)_sec_0001193125-26-384403-ex991.txt","market_impact_date":"2026-09-08","day1_return":0.003675,"day2_return":-0.006278,"prior_1w_return":-0.070522,"comments":"FDA granted Breakthrough Therapy designation for DT120 ODT in MDD, supported by Phase 3 Emerge results; second BTD for DT120 (first in GAD).","created_at":"2026-10-25 12:03:03","updated_at":"2026-10-25T12:10:43Z","company":"Definium Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":241,"join_event_id":517,"symbol":"PHVS","drug":"deucrictibant XR","modality":"small_molecule","area":"immunology","result_type":"topline_results","news_source_file":"documents/20260908_065109_(PHVS)_sec_0001193125-26-384339-ex991.txt","market_impact_date":"2026-09-08","day1_return":0.073475,"day2_return":-0.002643,"prior_1w_return":-0.001982,"comments":"CHAPTER-3 pivotal Phase 3 topline: primary endpoint met, 83% reduction in mean monthly HAE attack rate vs placebo (p<0.0001); 87% in HAE Type 1/2 (n=80); all secondary endpoints significant; well tolerated. Same-day slide deck filed at 09:00 EDT supports details.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:29Z","company":"Pharvaris","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.45,"llm_reason":"CHAPTER-1 Phase 2 already validated XR prophylaxis, and the B2 mechanism is de-risked by RAPIDe-3, so a positive readout is largely expected and priced in at a $2.1B cap. The key uncertainty is the size of the attack reduction versus injectables like garadacimab and lanadelumab. That makes a large move in either direction possible, but a modest move is most likely.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":115,"join_event_id":201,"symbol":"XFOR","drug":"mavorixafor","modality":"small_molecule","area":"hematology","result_type":"other","news_source_file":"documents/20260908_071554_(XFOR)_sec_0001501697-26-000072.txt","market_impact_date":"2026-09-08","day1_return":-0.132426,"day2_return":0.027104,"prior_1w_return":0.0,"comments":"8-K item 8.01, Sept 8, 2026: \"X4 Pharmaceuticals, Inc. announced the positive outcome of the Company's Type C Meeting with the U.S. Food and Drug Administration related to the global 4WARD Phase 3 clinical trial.\" FDA meeting outcome (regulatory); press release exhibit not in workspace.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:17Z","company":"X4 Pharmaceuticals","event_type":"other","expect_date_from":"2026-08-06","expect_date_to":"2026-09-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":372,"join_event_id":903,"symbol":"IONS","drug":"zilganersen","modality":"aso","area":"cns","result_type":"fda_approval","news_source_file":"documents/20260904_060159_(IONS)_sec_0001140361-26-035657-ex991.txt","market_impact_date":"2026-09-04","day1_return":-0.000688,"day2_return":-0.023756,"prior_1w_return":-0.068877,"comments":"\"FDA has approved ZANVASTRO (zilganersen) for the treatment of Alexander disease (AxD) in pediatric and adult patients\" - first disease-modifying treatment, Priority Review Voucher awarded. Release dated Sept. 3, 2026; 8-K exhibit filed 2026-09-04 06:01 ET.","created_at":"2026-10-25T08:08:00","updated_at":"2026-10-25T12:10:11Z","company":"Ionis Pharmaceuticals","event_type":"pdufa","expect_date_from":"2026-09-22","expect_date_to":"2026-09-22","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":334,"join_event_id":null,"symbol":"MIST","drug":"etripamil","modality":"small_molecule","area":"cardiovascular","result_type":"other","news_source_file":"documents/20260903_160358_(MIST)_sec_0001104659-26-105052-ex991.txt","market_impact_date":"2026-09-04","day1_return":-0.008264,"day2_return":-0.0625,"prior_1w_return":0.016807,"comments":"\"China's NMPA has approved etripamil nasal spray for the treatment of PSVT in adults\" (Sept 3, 2026). First etripamil approval outside the US; triggers $2.0M milestone from Everest Medicines. Not an FDA action.","created_at":"2026-10-25 07:54:57","updated_at":"2026-10-25T12:10:39Z","company":"Milestone Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":293,"join_event_id":null,"symbol":"LTGO","drug":"onzotrigine","modality":"small_molecule","area":"pain_anesthesia","result_type":"data_presentation","news_source_file":"documents/20260903_161539_(LTGO)_sec_0001193125-26-381912-ex991.txt","market_impact_date":"2026-09-04","day1_return":0.024911,"day2_return":0.029948,"prior_1w_return":-0.1008,"comments":"NEJM published positive abdominoplasty trial results: \"The study met its primary endpoint of the Summed Pain Intensity Difference over 48 hours versus placebo with high statistical significance.\" Caveat: peer-reviewed publication of data previously reported by the company; no new topline readout.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:35Z","company":"Latigo Biotherapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":298,"join_event_id":null,"symbol":"LQDA","drug":"YUTREPIA (treprostinil) inhalation powder","modality":"small_molecule","area":"cardiovascular","result_type":"other","news_source_file":"documents/20260903_080031_(LQDA)_sec_0001104659-26-104929-ex991.txt","market_impact_date":"2026-09-03","day1_return":-0.015069,"day2_return":0.000437,"prior_1w_return":-0.023543,"comments":"\"FDA has granted Fast Track designation to YUTREPIA ... for the treatment of Raynaud's phenomenon associated with systemic sclerosis (SSc-RP).\" Announced Sept 3, 2026. Caveat: designation only; safety/efficacy not evaluated and approval not guaranteed. RE-WARM Phase 2a trial start (Oct 2026) is a trial start, not recorded as a catalyst.","created_at":"2026-10-25 11:47:32","updated_at":"2026-10-25T12:10:35Z","company":"Liquidia","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":225,"join_event_id":457,"symbol":"RARE","drug":"apazunersen (GTX-102)","modality":"aso","area":"cns","result_type":"topline_results","news_source_file":"documents/20260902_160405_(RARE)_sec_0001193125-26-380165.txt","market_impact_date":"2026-09-03","day1_return":-0.440256,"day2_return":0.030303,"prior_1w_return":0.003404,"comments":"Phase 3 Aspire (Angelman syndrome) did not achieve the primary endpoint (Bayley-4 cognitive raw score) nor the key secondary MDRI net response; safety consistent with Phase 1/2. Company will decide on program disposition.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:27Z","company":"Ultragenyx Pharmaceutical","event_type":"topline_results","expect_date_from":"2026-09-01","expect_date_to":"2026-10-31","event_closed":1,"tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.72,"llm_reason":"With a market cap of about $1.6B, the Phase 3 Aspire GTX-102 readout in Angelman is a major binary event that could swing the stock 10% or more either way. RARE has fallen heavily, likely after setbacks such as the Phase 3 setrusumab failure, and cash is down to $436M, so the stock is sensitive to this result. Success could send it sharply up, while failure would hurt the path to profitability.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":86,"join_event_id":null,"symbol":"ATTO","drug":"ATTO-1310","modality":"protein","area":"gi_hepatology","result_type":"other","news_source_file":"documents/20260902_161718_(ATTO)_sec_0001193125-26-380215-ex991.txt","market_impact_date":"2026-09-03","day1_return":0.04626,"day2_return":0.055785,"prior_1w_return":0.18312,"comments":"\"Received IND clearance for Phase 1b trial in patients with cholestatic pruritus associated with primary biliary cholangitis (PBC) or primary sclerosing cholangitis (PSC) in China in less than 30 working days via NMPA's new expedited review pathway.\" Regulatory decision (NMPA, not FDA); no specific clearance date given, so release date used.","created_at":"2026-10-25 11:06:28","updated_at":"2026-10-25T12:10:14Z","company":"Attovia Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":85,"join_event_id":132,"symbol":"ATTO","drug":"ATTO-1310","modality":"protein","area":"dermatology","result_type":"interim_analysis","news_source_file":"documents/20260902_161718_(ATTO)_sec_0001193125-26-380215-ex991.txt","market_impact_date":"2026-09-03","day1_return":0.04626,"day2_return":0.055785,"prior_1w_return":0.18312,"comments":"\"Preliminary results showed that a single dose of ATTO-1310 was followed by rapid, deep itch relief in both patient populations, and consistent lesion control was demonstrated in patients with high-itch AD, providing clinical proof of concept.\" Earliest primary source in this workspace; complete Phase 1b data still expected Q4 2026, so the event remains open.","created_at":"2026-10-25 11:06:28","updated_at":"2026-10-25T12:10:14Z","company":"Attovia Therapeutics","event_type":"topline_results","expect_date_from":"2026-10-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.45,"llm_reason":"Newly IPO'd ~$660M biotech whose lead dermatology biologic ATTO-1310 readout is a key catalyst, so a 10%+ move is likely. The 8-K is administrative and gives no hint of direction.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":234,"join_event_id":null,"symbol":"PMVP","drug":"rezatapopt","modality":"small_molecule","area":"oncology","result_type":"interim_analysis","news_source_file":"documents/20260831_160601_(PMVP)_sec_0001193125-26-376723-ex991.txt","market_impact_date":"2026-09-01","day1_return":0.066116,"day2_return":-0.023256,"prior_1w_return":-0.072797,"comments":"Updated interim ovarian cancer data from PYNNACLE Phase 2 (data cutoff 2026-05-14): \"ORR of 46% (35/76 patients...)\" with median DOR 10.0 months; announced 2026-08-31 press release (8-K Ex-99.1). Primary analysis of ovarian cohort still expected at a Q4 2026 medical conference.","created_at":"2026-10-25 11:35:06","updated_at":"2026-10-25T12:10:28Z","company":"PMV Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":98,"join_event_id":163,"symbol":"ALMS","drug":"envudeucitinib","modality":"small_molecule","area":"immunology","result_type":"topline_results","news_source_file":"documents/20260901_083046_(ALMS)_sec_0001104659-26-104145-ex991.txt","market_impact_date":"2026-09-01","day1_return":-0.565795,"day2_return":0.092925,"prior_1w_return":-0.052974,"comments":"Phase 2b LUMUS did not meet primary (BICLA) or secondary endpoints in the overall population; robust responses in prespecified IFNGS-high subgroup (BICLA, CLASI-50, SRI-4, LLDAS) support Phase 3; \"no new safety signals\". Announced 8:30 am ET Sept 1, 2026; no earlier version found.","created_at":"2026-10-25 11:09:33","updated_at":"2026-10-25T12:10:15Z","company":"Alumis","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.6,"llm_reason":"The Q3 2026 readout is the Phase 2b LUMUS trial in lupus (SLE), which has a history of high trial failure rates. Its endpoint is the noisy BICLA composite. LUMUS is billed as potentially pivotal and could enable an accelerated path, and the ~$880M market cap with ~$570M cash means SLE value is a meaningful share of the price. A large move in either direction is likely; a clear win could drive +10% or more, a miss -10% or more.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":443,"join_event_id":188,"symbol":"ZYME","drug":"zanidatamab","modality":"bispecific","area":"oncology","result_type":"topline_results","news_source_file":"documents/20260831_030000_(ZYME)_resolution_news_resolution_news-9e7979d857f9be267db66b65e1ac4280.txt","market_impact_date":"2026-08-31","day1_return":0.040325,"day2_return":0.008841,"prior_1w_return":-0.013952,"comments":"OncLive headline 2026-08-31: \"Zanidatamab Plus Chemotherapy Improves OS at Second Interim Analysis of HERIZON-GEA-01 in First-Line HER2+ GEA.\" Headline-only Google News aggregator; no primary company/wire release found, so exact OS statistics unavailable. CancerNetwork 2026-09-02 headline corroborates (\"Extends OS\").","created_at":"2026-10-25","updated_at":"2026-10-25T13:14:59Z","company":"Zymeworks","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.62,"llm_reason":"The catalyst is the second interim OS analysis of the HERIZON-GEA-01 doublet arm. The primary PFS and OS results are already published in NEJM and the PDUFA is set, so a positive outcome is largely priced in. ZYME is now a diversified royalty company with buybacks, which dampens volatility. A miss on the doublet would mainly affect label breadth, not the triplet.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":423,"join_event_id":144,"symbol":"ARWR","drug":"plozasiran","modality":"sirna","area":"metabolic","result_type":"data_presentation","news_source_file":"documents/20260830_113157_(ARWR)_resolution_news_resolution_news-e7ee209e3d9bbfa6e9eee82468200860.txt","market_impact_date":"2026-08-31","day1_return":-0.029679,"day2_return":0.004248,"prior_1w_return":-0.025255,"comments":"ESC 2026 HOT LINE Late Breaker (Aug 30, 2026) SHASTA-3/SHASTA-4 sHTG data presented: \"Presents Phase 3 SHASTA-3 and SHASTA-4 Data Demonstrating Plozasiran Reduced Acute Pancreatitis Events in Patients with Severe Hypertriglyceridemia.\" First public disclosure; Google News summary used as no primary release in workspace.","created_at":"2026-10-25 12:43:05","updated_at":"2026-10-25T12:48:02Z","company":"Arrowhead Pharmaceuticals","event_type":"data_presentation","expect_date_from":"2026-08-30","expect_date_to":"2026-08-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":193,"join_event_id":null,"symbol":"ALVO","drug":"AVT80","modality":"monoclonal_antibody","area":"immunology","result_type":"other","news_source_file":"documents/20260831_080007_(ALVO)_sec_0001171843-26-005793-ex991.txt","market_impact_date":"2026-08-31","day1_return":0.048485,"day2_return":0.009634,"prior_1w_return":0.117381,"comments":"Regulatory milestone (not a data readout): \"FDA has accepted for review a Biologics License Application (BLA) for AVT80, a proposed interchangeable biosimilar to Entyvio (vedolizumab)\" prefilled syringe/autoinjector for subcutaneous use; announced Aug 31, 2026. No approval date guided.","created_at":"2026-10-25 07:25:39","updated_at":"2026-10-25T12:10:24Z","company":"Alvotech","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":440,"join_event_id":917,"symbol":"CRSP","drug":"CTX310","modality":"gene_therapy","area":"cardiovascular","result_type":"data_presentation","news_source_file":"documents/20260828_030000_(CRSP)_resolution_news_resolution_news-04408faffc3ec5a4fc1cf6d23d07ed32.txt","market_impact_date":"2026-08-28","day1_return":-0.027792,"day2_return":-0.012821,"prior_1w_return":0.021507,"comments":"Phase 1a durability data presented at ESC Congress 2026 (Aug 28): \"CRISPR Therapeutics Presents Phase 1a Data for CTX310®\" (GlobeNewswire, 2026-08-28, earliest disclosure found); HCPLive 2026-08-29: \"CTX310 Gene Editing Sustains ANGPTL3, LDL Reductions at 1 Year\". Only aggregator headline/summary files available; no SEC exhibit or full wire body for this release.","created_at":"2026-10-25T09:05:16","updated_at":"2026-10-25T13:07:43Z","company":"CRISPR Therapeutics","event_type":"data_presentation","expect_date_from":"2026-08-28","expect_date_to":"2026-08-28","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":424,"join_event_id":488,"symbol":"PTGX","drug":"rusfertide","modality":"peptide","area":"hematology","result_type":"fda_approval","news_source_file":"documents/20260828_030000_(PTGX)_resolution_news_resolution_news-43452e0d4da248db60c0717513672cbe.txt","market_impact_date":"2026-08-28","day1_return":-0.034582,"day2_return":0.023696,"prior_1w_return":-0.007897,"comments":"FDA approved MIMRYLO (rusfertide) for polycythemia vera, per release dated 2026-08-28: \"Protagonist Therapeutics Announces U.S. FDA Approval of Hepcidin Mimetic Peptide MIMRYLO(TM) (rusfertide) for Polycythemia Vera.\" No SEC exhibit or company wire original in workspace; only the Google News aggregated headline/lead text is available, so the aggregator copy is the source.","created_at":"2026-10-25 12:43:13","updated_at":"2026-10-25T12:48:02Z","company":"Protagonist Therapeutics","event_type":"pdufa","expect_date_from":"2026-08-01","expect_date_to":"2026-08-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":370,"join_event_id":901,"symbol":"CYTK","drug":"aficamten","modality":"small_molecule","area":"cardiovascular","result_type":"data_presentation","news_source_file":"documents/20260828_092149_(CYTK)_sec_0001193125-26-372456-ex991.txt","market_impact_date":"2026-08-28","day1_return":-0.074583,"day2_return":-0.016368,"prior_1w_return":0.009329,"comments":"ACACIA-HCM (nHCM, Ph3) primary results presented in ESC 2026 Hot Line Session on 2026-08-28 and published in NEJM: both dual primary endpoints met — KCCQ-CSS +3.0 vs placebo (p=0.021), pVO2 +0.67 mL/kg/min (p=0.003). Topline was announced earlier; this is the first document in the file set with the data.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:43Z","company":"Cytokinetics","event_type":"data_presentation","expect_date_from":"2026-08-01","expect_date_to":"2026-08-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":105,"join_event_id":177,"symbol":"ACET","drug":"ADI-212","modality":"cell_therapy","area":"oncology","result_type":"other","news_source_file":"documents/20260827_160000_(ACET)_yahoo_news_yahoo-0b7396a0d1b2005c6b3d12e31319aab8-ACET.txt","market_impact_date":"2026-08-28","day1_return":0.005549,"day2_return":-0.039735,"prior_1w_return":-0.039446,"comments":"FDA cleared Adicet's IND application for ADI-212 in metastatic castration-resistant prostate cancer (mCRPC); announced 2026-08-27. IND clearance is a regulatory decision, not a marketing approval.","created_at":"2026-10-25 11:10:40","updated_at":"2026-10-25T12:10:16Z","company":"Adicet Bio","event_type":"regulatory_submission","expect_date_from":"2026-07-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":341,"join_event_id":830,"symbol":"GENB","drug":"GB-0895","modality":"monoclonal_antibody","area":"respiratory","result_type":"data_presentation","news_source_file":"documents/20260825_192857_(GENB)_sec_0001193125-26-365556-ex991.txt","market_impact_date":"2026-08-26","day1_return":-0.208047,"day2_return":-0.022924,"prior_1w_return":0.267413,"comments":"ERS 2026 abstracts filed as 8-K Ex-99.1 on 2026-08-25 (first public disclosure). Asthma: \"Unblinded data from Parts A and B ... in asthma participants are presented here\" - well tolerated, ~98-day half-life, maximal PD biomarker suppression (BEC/FeNO/IL-5/IL-13) for >=6 months at 300 mg (cutoff 26Jan2026). COPD Part C data blinded (cutoff 27Jul2026). Two separate ERS posters.","created_at":"2026-10-25 11:58:03","updated_at":"2026-10-25T12:10:40Z","company":"Generate Biomedicines","event_type":"data_presentation","expect_date_from":"2026-09-08","expect_date_to":"2026-09-08","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":336,"join_event_id":null,"symbol":"GYRE","drug":"CG001419","modality":"small_molecule","area":"pain_anesthesia","result_type":"data_presentation","news_source_file":"documents/20260826_090044_(GYRE)_sec_0001140361-26-034401-ex991.txt","market_impact_date":"2026-08-26","day1_return":-0.004491,"day2_return":0.004511,"prior_1w_return":-0.04298,"comments":"First disclosure found of CG001419 Phase 1 results in this document set: \"DC50 = 2.1 ng/mL; DC90 = 16 ng/mL\" and \"Single and multiple oral doses were well tolerated up to the highest tested dose levels.\" Healthy-volunteer Phase 1 (NCT06636500). Repeated in the 2026-09-01 presentation; earlier date used.","created_at":"2026-10-25 11:56:58","updated_at":"2026-10-25T12:10:40Z","company":"Gyre Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":215,"join_event_id":429,"symbol":"RGNX","drug":"clemidsogene lanparvovec","modality":"gene_therapy","area":"rare_genetic","result_type":"clinical_hold","news_source_file":"documents/20260824_172014_(RGNX)_sec_0001193125-26-363786-ex991.txt","market_impact_date":"2026-08-25","day1_return":0.106145,"day2_return":0.05275,"prior_1w_return":-0.289056,"comments":"\"FDA placed a clinical hold on RGX-121 following the discovery of asymptomatic spine MRI findings in five participants in the CAMPSIITE study\"; company does not expect to resubmit the BLA in the near term.","created_at":"2026-10-25 11:30:19","updated_at":"2026-10-25T12:10:26Z","company":"REGENXBIO","event_type":"regulatory_submission","expect_date_from":"2026-07-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":185,"join_event_id":364,"symbol":"ARCT","drug":"ARCT-810","modality":"other","area":"rare_genetic","result_type":"data_presentation","news_source_file":"documents/20260825_060033_(ARCT)_sec_0001193805-26-001130.txt","market_impact_date":"2026-08-25","day1_return":0.076708,"day2_return":0.025259,"prior_1w_return":0.761671,"comments":"Poster presented Aug 25, 2026 at the SSIEM 2026 Annual Symposium (Helsinki): \"Impact of ARCT-810 mRNA Therapy on Dietary Intake and Biochemical Data in Adolescents and Adults with Ornithine Transcarbamylase Deficiency\"; poster furnished as Exhibit 99.1 to the 8-K. No data values in the filing text.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:23Z","company":"Arcturus Therapeutics Holdings","event_type":"data_presentation","expect_date_from":"2026-08-25","expect_date_to":"2026-08-25","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":108,"join_event_id":187,"symbol":"ZYME","drug":"zanidatamab","modality":"bispecific","area":"oncology","result_type":"fda_approval","news_source_file":"documents/20260825_105411_(ZYME)_sec_0001937653-26-000051.txt","market_impact_date":"2026-08-25","day1_return":-0.045186,"day2_return":0.0668,"prior_1w_return":0.136705,"comments":"\"Zymeworks' partner, Jazz Pharmaceuticals, has received FDA approval for two Ziihera (zanidatamab-hrii)-containing regimens for the first-line treatment of adults with unresectable locally advanced or metastatic HER2+ GEA.\" Approval earned a $250M milestone.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:16Z","company":"Zymeworks","event_type":"pdufa","expect_date_from":"2026-08-25","expect_date_to":"2026-08-25","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":355,"join_event_id":null,"symbol":"ERAS","drug":"ERAS-0015","modality":"small_molecule","area":"oncology","result_type":"other","news_source_file":"documents/20260824_081514_(ERAS)_sec_0001193125-26-361895.txt","market_impact_date":"2026-08-24","day1_return":-0.001702,"day2_return":0.009091,"prior_1w_return":-0.040805,"comments":"FDA granted Fast Track Designation: \"FDA has granted Fast Track Designation (\"FTD\") to ERAS-0015 for the treatment of patients with metastatic pancreatic adenocarcinoma.\" (8-K, 2026-08-24)","created_at":"2026-10-25 12:00:08","updated_at":"2026-10-25T12:10:42Z","company":"Erasca","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":237,"join_event_id":null,"symbol":"ACIU","drug":"ACI-19764","modality":"small_molecule","area":"cns","result_type":"interim_analysis","news_source_file":"documents/20260820_070004_(ACIU)_sec_0001651625-26-000018-ex991.txt","market_impact_date":"2026-08-20","day1_return":0.023256,"day2_return":0.098485,"prior_1w_return":-0.015267,"comments":"Positive preliminary Phase 1 SAD/MAD data in healthy volunteers: \"safe and well-tolerated ... including doses up to 20mg per day (SAD)\", no SAEs, CSF penetration, dose-dependent IL-1beta inhibition; therapeutic dose expected <=10mg QD.","created_at":"2026-10-25 10:30:00","updated_at":"2026-10-25T12:10:28Z","company":"AC Immune","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":223,"join_event_id":455,"symbol":"RARE","drug":"pariglasgene brecaparvovec (DTX401)","modality":"gene_therapy","area":"metabolic","result_type":"fda_approval","news_source_file":"documents/20260819_172444_(RARE)_sec_0001193125-26-357185.txt","market_impact_date":"2026-08-20","day1_return":-0.035061,"day2_return":0.020142,"prior_1w_return":-0.023083,"comments":"\"FDA granted accelerated approval for GENGLYCOS (pariglasgene brecaparvovec-opnr), also known as DTX401, in adult and pediatric patients eight years and older with GSDIa.\" Approved ahead of the 2026-08-23 PDUFA date; based on Phase 3 GlucoGene cornstarch reduction (p<0.001).","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:27Z","company":"Ultragenyx Pharmaceutical","event_type":"pdufa","expect_date_from":"2026-08-23","expect_date_to":"2026-08-23","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":580,"join_event_id":null,"symbol":"BLSM","drug":"BH-30643","modality":"small_molecule","area":"oncology","result_type":"other","news_source_file":"documents/20260818_070000_(BLSM)_yahoo_news_yahoo-b5fdf5ac0e98ec8213e8ab6b408663cf-BLSM.txt","market_impact_date":"2026-08-18","day1_return":-0.017094,"day2_return":0.004348,"prior_1w_return":0.02439,"comments":"August 18, 2026 release: \"the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BH-30643 for the treatment of adult patients with advanced or metastatic EGFR C797S-positive NSCLC after prior treatment with a third-generation EGFR TKI.\" Later corroborated in the Sep 18 8-K/10-Q. No prior guided event.","created_at":"2026-11-03 00:16:12","updated_at":"2026-11-03T00:16:17Z","company":"BlossomHill Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":79,"join_event_id":112,"symbol":"AMLX","drug":"avexitide","modality":"peptide","area":"metabolic","result_type":"topline_results","news_source_file":"documents/20260818_070958_(AMLX)_sec_0001193125-26-354716-ex991.txt","market_impact_date":"2026-08-18","day1_return":0.638357,"day2_return":0.099402,"prior_1w_return":-0.054698,"comments":"Phase 3 LUCIDITY met primary endpoint: \"55% reduction in the composite rate of Level 2 and Level 3 hypoglycemic events compared to placebo (p=0.000003)\"; all secondary endpoints met; generally well-tolerated. Announced 2026-08-18 via SEC 8-K Ex-99.1.","created_at":"2026-10-25 11:05:00","updated_at":"2026-10-25T12:10:13Z","company":"Amylyx Pharmaceuticals","event_type":"topline_results","expect_date_from":"2026-08-15","expect_date_to":"2026-09-15","event_closed":1,"tier":"Core","llm_prediction":"large_impact","llm_confidence":0.6,"llm_reason":"Binary pivotal Phase 3 readout for Amylyx's lead asset, and the ~$3.6B market cap prices in substantial success. Strong prior Phase 2 data and Breakthrough designation favor a positive result, but much of that is already priced in. A miss would likely cause a sharp drop, so a 10%+ move either way is likely.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":514,"join_event_id":null,"symbol":"CTOR","drug":"LYMPHIR (denileukin diftitox-cxdl)","modality":"protein","area":"oncology","result_type":"topline_results","news_source_file":"documents/20260814_163517_(CTOR)_sec_0001213900-26-090182-ex991.txt","market_impact_date":"2026-08-17","day1_return":-0.186813,"day2_return":-0.05,"prior_1w_return":0.208499,"comments":"10-Q: \"On March 10, 2026, we announced positive topline results from a completed investigator-initiated Phase 1 clinical trial ... LYMPHIR in combination with the PD-1 immune checkpoint inhibitor pembrolizumab ... in patients with recurrent or refractory gynecologic cancers.\" Primary March release not in file set; 8-K Ex-99.1 (8/14/26) details: 24% ORR overall, 33% ORR in r/r endometrial cancer, 20.5-mo mPFS; data presented at 2026 ASCO.","created_at":"2026-10-26 21:03:00","updated_at":"2026-10-26T21:04:40Z","company":"Citius Oncology","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":513,"join_event_id":null,"symbol":"CTOR","drug":"LYMPHIR (denileukin diftitox-cxdl)","modality":"protein","area":"oncology","result_type":"topline_results","news_source_file":"documents/20260814_163536_(CTOR)_sec_0001213900-26-090184.txt","market_impact_date":"2026-08-17","day1_return":-0.186813,"day2_return":-0.05,"prior_1w_return":0.208499,"comments":"10-Q: \"On March 4, 2026, we announced positive topline safety and efficacy results from an investigator-initiated Phase 1 trial evaluating LYMPHIR administered prior to commercial CD19 directed CAR T therapy in patients with high risk relapsed or refractory DLBCL.\" Primary disclosure was a March 2026 company release not in file set; per ASCO/ASTCT data later reported 86% ORR (57% CR).","created_at":"2026-10-26 21:02:54","updated_at":"2026-10-26T21:04:40Z","company":"Citius Oncology","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":434,"join_event_id":242,"symbol":"URGN","drug":"UGN-103","modality":"small_molecule","area":"oncology","result_type":"other","news_source_file":"documents/20260817_030000_(URGN)_resolution_news_resolution_news-9bd4e88f469a134f7ea691e13a1101cf.txt","market_impact_date":"2026-08-17","day1_return":0.019079,"day2_return":-0.004477,"prior_1w_return":0.026831,"comments":"GlobeNewswire 2026-08-17: \"UroGen Submits NDA for UGN-103, an Investigational Treatment of Recurrent LG-IR-NMIBC\" - NDA submitted within the Q3 2026 guided window. Caveat: aggregator (Google News) item only; no company exhibit for the submission in hand. FDA subsequently accepted the application for filing (reported 2026-10-19, Urology Times / GuruFocus).","created_at":"2026-10-25 12:45:55","updated_at":"2026-10-25T12:48:04Z","company":"UroGen Pharma","event_type":"regulatory_submission","expect_date_from":"2026-07-01","expect_date_to":"2026-09-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":414,"join_event_id":979,"symbol":"EYPT","drug":"DURAVYU","modality":"small_molecule","area":"ophthalmology","result_type":"topline_results","news_source_file":"documents/20260817_085021_(EYPT)_sec_0001193125-26-353308-ex991.txt","market_impact_date":"2026-08-17","day1_return":-0.669831,"day2_return":0.123203,"prior_1w_return":0.061915,"comments":"\"primary endpoint ... was not achieved in the full dataset\"; DURAVYU non-inferior in ad hoc analysis excluding a 4% asymmetric cohort (nominal p=0.0096). Key secondary endpoints met (42% reduction in treatment burden). First pivotal Phase 3 wet AMD readout.","created_at":"2026-10-25T08:08:58","updated_at":"2026-10-25T12:10:10Z","company":"EyePoint","event_type":"topline_results","expect_date_from":"2026-08-01","expect_date_to":"2026-08-31","event_closed":1,"tier":"Core","llm_prediction":"large_downside","llm_confidence":0.55,"llm_reason":"The LUGANO Phase 3 readout is a binary event for a company that depends on one asset, so a move of at least 10% is very likely. Direction is the uncertain part. The listed market cap (~$37M) sits far below the $180M cash balance. That gap may reflect metadata already showing a post-readout collapse, or the market pricing in failure risk. Either way it tilts the call toward downside.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":381,"join_event_id":null,"symbol":"CTXR","drug":"LYMPHIR (denileukin diftitox-cxdl)","modality":"protein","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20260814_163517_(CTXR)_sec_0001213900-26-090181-ex991.txt","market_impact_date":"2026-08-17","day1_return":-0.256614,"day2_return":0.017794,"prior_1w_return":0.108504,"comments":"Investigator-initiated Phase 1 data disclosed in Q3 FY26 release. ASCO 2026 (with pembrolizumab, r/r gynecologic): \"24% overall response rate (ORR) and a 48% clinical benefit rate\". ASTCT/CIBMTR 2026 (pre-CAR-T, r/r DLBCL): \"86% ORR, including 57% complete response (CR)\". Meeting dates not given in this filing.","created_at":"2026-10-25 12:04:34","updated_at":"2026-10-25T12:10:44Z","company":"Citius Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":196,"join_event_id":null,"symbol":"ALLR","drug":"stenoparib","modality":"small_molecule","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20260814_163517_(ALLR)_sec_0001213900-26-090183-ex991.txt","market_impact_date":"2026-08-17","day1_return":-0.021898,"day2_return":0.007463,"prior_1w_return":-0.014388,"comments":"Q2 2026 release: \"AACR 2026 data linked higher stenoparib DRP scores with enhanced overall survival in advanced ovarian cancer\" - Phase 2 exploratory analysis showing extended OS in platinum-resistant/refractory ovarian cancer, greatest in high DRP scores. Caveat: data first presented at AACR 2026 (April); this 8-K summarizes them.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:24Z","company":"Allarity Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":371,"join_event_id":null,"symbol":"DARE","drug":"Ovaprene","modality":"other","area":"womens_health","result_type":"interim_analysis","news_source_file":"documents/20260813_160219_(DARE)_sec_0001493152-26-037737-ex991.txt","market_impact_date":"2026-08-14","day1_return":-0.321168,"day2_return":-0.129032,"prior_1w_return":0.030075,"comments":"Q2 2026 release: \"Reported positive interim results from the ongoing pivotal Phase 3 study and the independent Data Safety Monitoring Board's recommendation that the study continue without modification.\" No quantified data or guided readout window given.","created_at":"2026-10-25 12:03:35","updated_at":"2026-10-25T12:10:44Z","company":"Dare Bioscience","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":363,"join_event_id":873,"symbol":"ELDN","drug":"tegoprubart","modality":"monoclonal_antibody","area":"renal","result_type":"data_presentation","news_source_file":"documents/20260813_160848_(ELDN)_sec_0001193125-26-349170-ex991.txt","market_impact_date":"2026-08-14","day1_return":-0.043243,"day2_return":0.011299,"prior_1w_return":0.069364,"comments":"Q2 8-K recaps two June 2026 presentations (single row per source/type). ATC: \"At 18 months, the eGFR curves showed a statistically significant separation (p<0.05), with mean eGFR approximately 12 mL/min/1.73 m2 higher for tegoprubart compared with tacrolimus (approximately 74 vs. 61)\"; no BPAR after 6 months vs 7 tacrolimus events. ADA islet: \"All 12 patients with T1D achieved insulin independence and HbA1c below 6.5%\". First disclosed at the conferences; this is the earnings recap.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:43Z","company":"Eledon Pharmaceuticals","event_type":"data_presentation","expect_date_from":"2026-06-01","expect_date_to":"2026-06-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":361,"join_event_id":null,"symbol":"EDSA","drug":"paridiprubart","modality":"monoclonal_antibody","area":"respiratory","result_type":"other","news_source_file":"documents/20260813_162017_(EDSA)_sec_0001171843-26-005499-ex991.txt","market_impact_date":"2026-08-14","day1_return":-0.014733,"day2_return":0.056075,"prior_1w_return":0.075247,"comments":"Aug 13, 2026 fiscal Q3 release: exploratory analysis in \"a population of 101 ARDS patients from our Phase 2 and 3 studies who presented with AKI at baseline, paridiprubart plus standard of care treatments was associated with significant mortality reductions supported by concordant improvements in the kidney-specific MAKE30 composite endpoint.\" Post-hoc subgroup analysis, not a topline readout.","created_at":"2026-10-25 12:01:52","updated_at":"2026-10-25T12:10:42Z","company":"Edesa Biotech","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":301,"join_event_id":null,"symbol":"KYNB","drug":"roxadustat","modality":"small_molecule","area":"hematology","result_type":"data_presentation","news_source_file":"documents/20260813_160516_(KYNB)_sec_0001193125-26-349141-ex991.txt","market_impact_date":"2026-08-14","day1_return":0.00142,"day2_return":-0.034043,"prior_1w_return":0.008452,"comments":"Post hoc analysis of Phase 3 MATTERHORN presented at EHA Congress 2026: \"patients treated with roxadustat showed a clinically meaningful improvement in transfusion independence (TI) in patients with LR-MDS and HTB compared to placebo,\" with similar TI rates in RS+ and RS- disease. Exact EHA presentation date not stated in filing.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:35Z","company":"Kyntra Bio","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":274,"join_event_id":null,"symbol":"MPLT","drug":"ML-004","modality":"small_molecule","area":"cns","result_type":"topline_results","news_source_file":"documents/20260813_165137_(MPLT)_sec_0001193125-26-349490-ex991.txt","market_impact_date":"2026-08-14","day1_return":0.01468,"day2_return":-0.042979,"prior_1w_return":-0.128012,"comments":"Phase 2 IRIS topline in ASD: \"did not meet its primary endpoint in social communication\"; prespecified analysis showed clinically meaningful improvements in irritability in adolescents with moderate+ baseline irritability. Results were originally announced June 2026; this 8-K exhibit is the earliest primary source available in this file set.","created_at":"2026-10-25 11:44:01","updated_at":"2026-10-25T12:10:32Z","company":"MapLight Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":263,"join_event_id":null,"symbol":"NMRA","drug":"navacaprant","modality":"small_molecule","area":"cns","result_type":"trial_discontinuation","news_source_file":"documents/20260814_072350_(NMRA)_sec_0001193125-26-350370.txt","market_impact_date":"2026-08-14","day1_return":-0.075145,"day2_return":-0.05,"prior_1w_return":0.054878,"comments":"10-Q: \"Following results from the Phase 3 KOASTAL program in June 2026 the Company is discontinuing development of navacaprant in major depressive disorder (MDD)\". KOASTAL topline was disclosed in June 2026; that original release is not in the workspace, so the 10-Q is cited.","created_at":"2026-10-25 11:41:54","updated_at":"2026-10-25T12:10:31Z","company":"Neumora Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":404,"join_event_id":976,"symbol":"CGEM","drug":"zipalertinib","modality":"small_molecule","area":"oncology","result_type":"topline_results","news_source_file":"documents/20260812_193550_(CGEM)_sec_0001193125-26-347400-ex991.txt","market_impact_date":"2026-08-13","day1_return":0.002041,"day2_return":0.035642,"prior_1w_return":0.113004,"comments":"\"REZILIENT3 ... met its primary endpoint of progression-free survival (PFS) at a planned interim analysis ... statistically significant and clinically meaningful improvement in PFS in the zipalertinib containing arm.\" IDMC recommended unblinding; numbers not disclosed at this date.","created_at":"2026-10-25 12:08:48","updated_at":"2026-10-25T12:10:47Z","company":"Cullinan Therapeutics","event_type":"topline_results","expect_date_from":"2026-08-06","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"small_impact","llm_confidence":0.68,"llm_reason":"The REZILIENT3 1L topline for zipalertinib is a partnered asset run by Taiho. CGEM's valuation (~$960M) is driven mainly by its T cell engager pipeline, and the company holds $356M cash. Zipalertinib carries a 50/50 US profit share and a $100M milestone, but the ex20ins market is small and competitive with amivantamab and sunvozertinib. A positive readout is largely expected, so the move is likely under 10%.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":400,"join_event_id":965,"symbol":"CING","drug":"CTx-1301","modality":"small_molecule","area":"cns","result_type":"crl","news_source_file":"documents/20260813_084015_(CING)_sec_0001493152-26-037605-ex991.txt","market_impact_date":"2026-08-13","day1_return":-0.042227,"day2_return":0.02004,"prior_1w_return":0.054656,"comments":"FDA issued a Complete Response Letter for the CTx-1301 NDA on June 1, 2026 (announced June 2, 2026 per 10-Q); CRL \"identified specific requests for additional CMC information and did not identify any concerns regarding the clinical safety or efficacy of CTx-1301.\" Earliest primary source in workspace; original June 2 release not available.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:46Z","company":"Cingulate","event_type":"pdufa","expect_date_from":"2026-05-31","expect_date_to":"2026-05-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":399,"join_event_id":null,"symbol":"CLRB","drug":"iopofosine I 131","modality":"radiopharma","area":"hematology","result_type":"data_presentation","news_source_file":"documents/20260813_072527_(CLRB)_sec_0001104659-26-095460-ex991.txt","market_impact_date":"2026-08-13","day1_return":-0.046154,"day2_return":0.048387,"prior_1w_return":0.031746,"comments":"CLOVER WaM data in r/r WM \"presented ... at the American Society of Clinical Oncology 2026 Annual Meeting\": evaluable patients (n=24) 87.5% ORR, 79.2% MRR, median DOR 16 months. First disclosed at ASCO 2026; this Q2 8-K recaps it (ASCO release not in workspace).","created_at":"2026-10-25 08:07:28","updated_at":"2026-10-25T12:10:46Z","company":"Cellectar Biosciences","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":358,"join_event_id":null,"symbol":"EPRX","drug":"EP-104GI","modality":"small_molecule","area":"gi_hepatology","result_type":"interim_analysis","news_source_file":"documents/20260813_081002_(EPRX)_sec_0001171843-26-005479-ex991.txt","market_impact_date":"2026-08-13","day1_return":0.029321,"day2_return":0.007496,"prior_1w_return":0.0,"comments":"New analysis of Phase 1b/2a RESOLVE symptom severity (Cohorts 7-9): moderate-severe odynophagia fell from 62% at baseline to 25% at 24-52 weeks; no severe odynophagia at 24/52 wks; moderate-severe dysphagia 77% -> 25%. >130 patients treated with no treatment-emergent or procedure-related SAEs. Company continued to guide Phase 2b interim readout in Q4 2026.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:42Z","company":"Eupraxia Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":340,"join_event_id":null,"symbol":"GNLX","drug":"Olvi-Vec","modality":"other","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20260813_130541_(GNLX)_sec_0001493152-26-037667.txt","market_impact_date":"2026-08-13","day1_return":-0.025926,"day2_return":0.041825,"prior_1w_return":0.075697,"comments":"Q2 2026 10-Q: \"In June 2026, we announced the publication of translational and clinical findings from our Phase 1b/2 VIRO-15 trial of Olvi-Vec-primed immunochemotherapy in heavily pretreated patients with platinum-resistant/refractory ovarian cancer. The data were presented in Gynecologic Oncology Reports, a peer-reviewed journal.\" Publication, not a topline readout; original June 2026 announcement not in document set.","created_at":"2026-10-25 11:57:56","updated_at":"2026-10-25T12:10:40Z","company":"Genelux","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":325,"join_event_id":null,"symbol":"INDP","drug":"Decoy20","modality":"other","area":"oncology","result_type":"trial_discontinuation","news_source_file":"documents/20260813_073016_(INDP)_sec_0001493152-26-037574-ex991.txt","market_impact_date":"2026-08-13","day1_return":0.039216,"day2_return":0.009434,"prior_1w_return":-0.233083,"comments":"Q2 2026 release: \"The Company has discontinued further enrollment in its combination study, has no participants remaining in any ongoing Decoy20 clinical study and currently has no active clinical development programs.\" Previously guided programs wound down pending strategic review.","created_at":"2026-10-25 11:53:12","updated_at":"2026-10-25T12:10:38Z","company":"Indaptus Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":324,"join_event_id":null,"symbol":"INKT","drug":"agenT-797","modality":"cell_therapy","area":"respiratory","result_type":"data_presentation","news_source_file":"documents/20260813_074044_(INKT)_sec_0001193125-26-347907-ex991.txt","market_impact_date":"2026-08-13","day1_return":-0.03169,"day2_return":0.024545,"prior_1w_return":-0.02906,"comments":"Initial Day 28 observations from randomized Phase 2 C-1300-02 (NCT07615010) presented at MHSRS: first agenT-797 patients alive/afebrile at Day 28, improved oxygenation, ventilator/vasopressor liberation, reduced inflammatory markers; no major SAEs attributed to agenT-797. Company calls these preliminary, uncontrolled observations in a small number of patients in an ongoing blinded trial.","created_at":"2026-10-25 11:53:07","updated_at":"2026-10-25T12:10:38Z","company":"MiNK Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":252,"join_event_id":null,"symbol":"OMER","drug":"narsoplimab","modality":"monoclonal_antibody","area":"hematology","result_type":"other","news_source_file":"documents/20260812_161232_(OMER)_sec_0001437749-26-027318.txt","market_impact_date":"2026-08-13","day1_return":0.2655,"day2_return":-0.009222,"prior_1w_return":0.083795,"comments":"CHMP negative opinion on EU MAA for narsoplimab in TA-TMA: \"In June 2026, the Committee for Medicinal Products for Human Use (CHMP) of the EMA adopted a negative opinion on our marketing authorization application (MAA) for narsoplimab in TA-TMA. We believe the clinical evidence supports approval and have requested re-examination.\" Caveat: opinion adopted June 2026; earliest primary release not in workspace, disclosure is 10-Q (2026-08-12).","created_at":"2026-10-25T07:38:38","updated_at":"2026-10-25T12:10:30Z","company":"Omeros","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":232,"join_event_id":null,"symbol":"PRQR","drug":"AX-0810","modality":"aso","area":"gi_hepatology","result_type":"interim_analysis","news_source_file":"documents/20260813_070008_(PRQR)_sec_0001104659-26-095422-ex991.txt","market_impact_date":"2026-08-13","day1_return":-0.005376,"day2_return":0.037838,"prior_1w_return":-0.055838,"comments":"Positive AX-0810 Phase 1 target engagement data in healthy volunteers: up to 8-fold increase in total serum bile acids (6 mg/kg) vs 2-fold pre-defined threshold, dose-dependent conjugated bile acid changes, no SAEs or pruritus, ~8-week half-life. Caveat: first announced in June 2026; the June release is not in the document set, this Q2 2026 release reiterates the findings.","created_at":"2026-10-25 11:34:33","updated_at":"2026-10-25T12:10:28Z","company":"ProQR Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":189,"join_event_id":null,"symbol":"SGMT","drug":"denifanstat","modality":"small_molecule","area":"dermatology","result_type":"other","news_source_file":"documents/20260813_070506_(SGMT)_sec_0001193125-26-347854.txt","market_impact_date":"2026-08-13","day1_return":-0.011715,"day2_return":0.136854,"prior_1w_return":0.086806,"comments":"8-K Item 8.01 (2026-08-13): FDA \"cleared the Investigational New Drug application and issued a Study May Proceed letter for the Company's Phase 3 clinical trial of fatty acid synthase inhibitor denifanstat in moderate to severe acne.\"","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:23Z","company":"Sagimet Biosciences Inc. Series A","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":169,"join_event_id":null,"symbol":"SPRO","drug":"tebipenem pivoxil","modality":"small_molecule","area":"infectious","result_type":"fda_approval","news_source_file":"documents/20260812_160926_(SPRO)_sec_0001193125-26-346855-ex991.txt","market_impact_date":"2026-08-13","day1_return":0.042017,"day2_return":-0.008065,"prior_1w_return":-0.055556,"comments":"FDA approved Utebzi (tebipenem pivoxil), first oral carbapenem for cUTI incl. pyelonephritis; 10-Q states \"On June 17, 2026, the Company and GSK announced that the FDA approved Utebzi\" (approval announced June 17, 2026; earliest SPRO document in workspace). GSK holds US/EU commercial rights.","created_at":"2026-10-25 11:22:55","updated_at":"2026-10-25T12:10:22Z","company":"Spero Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":113,"join_event_id":null,"symbol":"ZBIO","drug":"obexelimab","modality":"monoclonal_antibody","area":"immunology","result_type":"other","news_source_file":"documents/20260813_070549_(ZBIO)_sec_0001104659-26-095437-ex991.txt","market_impact_date":"2026-08-13","day1_return":-0.066795,"day2_return":0.010616,"prior_1w_return":-0.017891,"comments":"\"In August, the U.S. Food and Drug Administration (FDA) accepted the Company's Biologics License Application (BLA) for obexelimab for the treatment of IgG4-RD\"; PDUFA target action date May 27, 2027.","created_at":"2026-10-25 11:12:21","updated_at":"2026-10-25T12:10:17Z","company":"Zenas BioPharma","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":107,"join_event_id":null,"symbol":"ADCT","drug":"ZYNLONTA + rituximab","modality":"adc","area":"hematology","result_type":"other","news_source_file":"documents/20260813_091434_(ADCT)_sec_0000950103-26-012287-ex991.txt","market_impact_date":"2026-08-13","day1_return":-0.146342,"day2_return":-0.038095,"prior_1w_return":0.149533,"comments":"Pre-sBLA meeting outcome (disclosed 2026-08-13): \"the FDA noted substantial concerns regarding the benefit-risk or verification of clinical benefit observed in this trial based on the imbalance in Grade 5 events, when assessed in the context of a marginal treatment benefit.\" Company \"assessing the best regulatory path forward\"; no timing given.","created_at":"2026-10-25 11:20:00","updated_at":"2026-10-25T12:10:16Z","company":"ADC Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":106,"join_event_id":null,"symbol":"ADCT","drug":"ZYNLONTA + rituximab","modality":"adc","area":"hematology","result_type":"topline_results","news_source_file":"documents/20260813_091434_(ADCT)_sec_0000950103-26-012287-ex991.txt","market_impact_date":"2026-08-13","day1_return":-0.146342,"day2_return":-0.038095,"prior_1w_return":0.149533,"comments":"LOTIS-5 Phase 3 (r/r DLBCL): \"In June 2026, the Company announced topline results from the LOTIS-5 Phase 3 confirmatory trial of ZYNLONTA in combination with rituximab, which met the trial's primary endpoint of progression-free survival (PFS).\" 10-Q adds HR=0.73, p=0.008. Original June 2026 release is not in the workspace; this 8-K is the primary source available.","created_at":"2026-10-25 11:20:00","updated_at":"2026-10-25T12:10:16Z","company":"ADC Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":101,"join_event_id":null,"symbol":"ALLO","drug":"cema-cel","modality":"cell_therapy","area":"oncology","result_type":"interim_analysis","news_source_file":"documents/20260812_161718_(ALLO)_sec_0001628280-26-056213.txt","market_impact_date":"2026-08-13","day1_return":-0.043478,"day2_return":0.035354,"prior_1w_return":0.061538,"comments":"Restated in 10-Q: \"On April 13, 2026, we announced results from the planned interim futility analysis of the first 24 randomized patients\" in ALPHA3 - MRD negativity 58.3% (7/12) cema-cel vs 16.7% (2/12) observation; ctDNA median -97.7% vs +26.6%. First disclosed 2026-04-13; that release is not in the archive, so date-sensitive use caveat applies.","created_at":"2026-10-25 11:09:51","updated_at":"2026-10-25T12:10:16Z","company":"Allogene Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":82,"join_event_id":null,"symbol":"AVIR","drug":"bemnifosbuvir/ruzasvir (BEM/RZR)","modality":"small_molecule","area":"gi_hepatology","result_type":"topline_results","news_source_file":"documents/20260812_161536_(AVIR)_sec_0001193125-26-346888-ex991.txt","market_impact_date":"2026-08-13","day1_return":0.001976,"day2_return":0.009862,"prior_1w_return":0.065263,"comments":"Phase 3 C-BEYOND topline (announced July 2026): mITT SVR 93.9% BEM/RZR vs 94.8% SOF/VEL, primary non-inferiority endpoint met; 8-week regimen in non-cirrhotics. First primary disclosure was the July 2026 release (not in workspace); this Q2 2026 8-K exhibit restates it.","created_at":"2026-10-25 11:05:57","updated_at":"2026-10-25T12:10:14Z","company":"Atea Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":466,"join_event_id":null,"symbol":"ABSI","drug":"ABS-201","modality":"monoclonal_antibody","area":"dermatology","result_type":"interim_analysis","news_source_file":"documents/20260811_160614_(ABSI)_sec_0001672688-26-000134-ex991.txt","market_impact_date":"2026-08-12","day1_return":0.009564,"day2_return":-0.004211,"prior_1w_return":0.10967,"comments":"Interim Phase 1 HEADLINE data in pattern hair loss: \"positive interim Phase 1 data from the HEADLINE trial of ABS-201\" with \"estimated half-life of at least 65 days\" and favorable safety across blinded SAD cohorts. First disclosed June 2026 (June PR not in workspace); earliest source here is the Aug-11 8-K exhibit; Oct-24 Yahoo recap repeats it. Distinct from the H2-2026 interim PoC readout (event 181).","created_at":"2026-10-25T12:09:02","updated_at":"2026-10-25T16:10:07Z","company":"Absci","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":389,"join_event_id":null,"symbol":"CRDF","drug":"onvansertib","modality":"small_molecule","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20260811_161116_(CRDF)_sec_0001193125-26-344645-ex991.txt","market_impact_date":"2026-08-12","day1_return":-0.057143,"day2_return":-0.010101,"prior_1w_return":0.129032,"comments":"CRDF-004 randomized Phase 2 (1L RAS-mut mCRC) data: 30 mg onvansertib+FOLFIRI/bev confirmed ORR 72.2% (13/18) vs 42.1% (8/19) SoC; PFS HR 0.55 (BICR). \"Data highlights ... were presented at the ASCO Meeting on June 2, 2026, using a data cut of March 18, 2026.\" First public disclosure was the ASCO presentation; this later Q2 release summarizes it (earlier ASCO release not in workspace).","created_at":"2026-10-25 12:05:56","updated_at":"2026-10-25T12:10:45Z","company":"Cardiff Oncology","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":377,"join_event_id":null,"symbol":"CYPH","drug":"sirexatamab","modality":"monoclonal_antibody","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20260812_071023_(CYPH)_sec_0001104659-26-094445-ex991.txt","market_impact_date":"2026-08-12","day1_return":-0.032353,"day2_return":-0.015198,"prior_1w_return":-0.014493,"comments":"Full DeFianCe (NCT05480306) Phase 2 efficacy/safety/biomarker analyses published in Clinical Cancer Research: \"the prespecified primary endpoint was not met in the intent-to-treat population,\" but benefit of sirexatamab increases with baseline plasma DKK1; defines DKK1-high mCRC population. Journal publication, no new topline; no publication date stated.","created_at":"2026-10-25 12:03:58","updated_at":"2026-10-25T12:10:44Z","company":"Cypherpunk Technologies","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":367,"join_event_id":890,"symbol":"DFTX","drug":"DT120 ODT","modality":"small_molecule","area":"cns","result_type":"topline_results","news_source_file":"documents/20260812_080537_(DFTX)_sec_0001104659-26-094528-ex991.txt","market_impact_date":"2026-08-12","day1_return":0.045955,"day2_return":0.025941,"prior_1w_return":-0.033318,"comments":"Positive Phase 3 Voyage topline in GAD: HAM-A LS mean change -11.6 vs -6.2 placebo, difference -5.4 (p<0.0001, d=0.81) at Week 12; primary and all key secondary endpoints met; generally well tolerated.","created_at":"2026-10-25 12:03:03","updated_at":"2026-10-25T12:10:43Z","company":"Definium Therapeutics","event_type":"topline_results","expect_date_from":"2026-08-10","expect_date_to":"2026-08-16","event_closed":1,"tier":"Core","llm_prediction":"large_impact","llm_confidence":0.45,"llm_reason":"Definium (formerly MindMed) has its Phase 3 Voyage GAD readout due the week of August 10. GAD is the lead indication. The $4.8B valuation already prices in success after positive Phase 2b GAD data and a strong Emerge MDD result. A clear win could be a modest move, but a miss or a disappointing effect size against high expectations would likely drop the stock more than 10%. The direction is uncertain, but a large move in either direction is plausible.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":304,"join_event_id":null,"symbol":"KYTX","drug":"mivocabtagene autoleucel","modality":"cell_therapy","area":"cns","result_type":"other","news_source_file":"documents/20260811_160443_(KYTX)_sec_0001193125-26-344572-ex991.txt","market_impact_date":"2026-08-12","day1_return":0.003741,"day2_return":0.003727,"prior_1w_return":0.030848,"comments":"FDA granted RMAT designation for miv-cel in non-active secondary progressive MS (naSPMS) based on investigator-initiated trial data from Stanford and UCSF. Regulatory designation, not a data readout.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:36Z","company":"Kyverna Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":291,"join_event_id":null,"symbol":"LXEO","drug":"LX2020","modality":"gene_therapy","area":"cardiovascular","result_type":"other","news_source_file":"documents/20260812_070257_(LXEO)_sec_0001193125-26-345722-ex991.txt","market_impact_date":"2026-08-12","day1_return":0.018828,"day2_return":0.018481,"prior_1w_return":0.0839,"comments":"\"In August 2026, Lexeo received Regenerative Medicine Advanced Therapy (RMAT) designation for LX2020 from the FDA based on recent interim data\" in PKP2-ACM. Regulatory designation, no new data disclosed.","created_at":"2026-10-25 11:46:39","updated_at":"2026-10-25T12:10:34Z","company":"Lexeo Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":282,"join_event_id":null,"symbol":"MLYS","drug":"lorundrostat","modality":"small_molecule","area":"respiratory","result_type":"topline_results","news_source_file":"documents/20260811_171847_(MLYS)_sec_0001933414-26-000114.txt","market_impact_date":"2026-08-12","day1_return":-0.010245,"day2_return":-0.03549,"prior_1w_return":0.031321,"comments":"\"On March 9, 2026, we announced topline data from our exploratory Phase 2 Explore-OSA trial\" in OSA/hypertension; lorundrostat 50 mg missed a clinically meaningful AHI effect vs placebo (primary endpoint), though BP fell 11.1 mmHg vs 1.0 mmHg placebo. First disclosure was March 9, 2026; no primary release in workspace, so this 10-Q is the source relied on. Subsequent endpoints may be reported later.","created_at":"2026-10-25T07:44:21","updated_at":"2026-10-25T12:10:33Z","company":"Mineralys Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":257,"join_event_id":599,"symbol":"NTHI","drug":"NEO100","modality":"small_molecule","area":"oncology","result_type":"topline_results","news_source_file":"documents/20260812_083057_(NTHI)_sec_0001829126-26-008654-ex991.txt","market_impact_date":"2026-08-12","day1_return":-0.204598,"day2_return":-0.072254,"prior_1w_return":0.268222,"comments":"Phase 2a of NEO100-01 met primary endpoint: 6-month PFS 48.9% vs 20% benchmark (p=0.0047); median OS 26.09 months; ORR 8.3% (2/24); no major toxicities. Single-arm, open-label, 24 patients. First disclosure 2026-08-12 08:30 ET 8-K exhibit (webcast same morning).","created_at":"2026-10-25 11:41:25","updated_at":"2026-10-25T12:10:30Z","company":"NeOnc Technologies Holdings","event_type":"topline_results","expect_date_from":"2026-08-12","expect_date_to":"2026-08-12","event_closed":1,"tier":"Core","llm_prediction":"large_downside","llm_confidence":0.5,"llm_reason":"Micro-cap company with only $2M cash and heavy dependence on dilutive financing is reporting a small, uncontrolled Phase 2a in recurrent glioma. A big move is very likely either way, but sell-the-news selling plus expected dilution after the readout tilts it toward a large decline.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":213,"join_event_id":null,"symbol":"ABUS","drug":"imdusiran","modality":"sirna","area":"infectious","result_type":"other","news_source_file":"documents/20260812_073119_(ABUS)_sec_0001171843-26-005442-ex991.txt","market_impact_date":"2026-08-12","day1_return":-0.017131,"day2_return":-0.002179,"prior_1w_return":0.056561,"comments":"Q2 2026 release (Aug 12, 2026): \"In April 2026, the FDA granted Fast Track designation for imdusiran for the treatment of chronic hepatitis B (cHBV).\" Regulatory designation only; no trial start, readout or action date guided.","created_at":"2026-10-25 11:29:09","updated_at":"2026-10-25T12:10:26Z","company":"Arbutus Biopharma","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":208,"join_event_id":411,"symbol":"ACHV","drug":"cytisinicline","modality":"small_molecule","area":"cns","result_type":"crl","news_source_file":"documents/20260811_160440_(ACHV)_sec_0001193125-26-344571-ex991.txt","market_impact_date":"2026-08-12","day1_return":-0.011817,"day2_return":0.083707,"prior_1w_return":0.046368,"comments":"\"On June 20, 2026, Achieve received a Complete Response Letter (CRL) from the FDA regarding the New Drug Application (NDA) for cytisinicline.\" CRL relates to cGMP observations at prior third-party facility (OAI) and incomplete labeling; no efficacy/safety deficiencies. Company disclosed the anticipated outcome in April 2026.","created_at":"2026-10-25 07:27:48","updated_at":"2026-10-25T12:10:25Z","company":"Achieve Life Sciences","event_type":"pdufa","expect_date_from":"2026-06-20","expect_date_to":"2026-06-20","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":165,"join_event_id":null,"symbol":"STRO","drug":"STRO-004","modality":"adc","area":"oncology","result_type":"interim_analysis","news_source_file":"documents/20260812_071523_(STRO)_sec_0001193125-26-345733-ex991.txt","market_impact_date":"2026-08-12","day1_return":-0.149361,"day2_return":0.000469,"prior_1w_return":-0.024542,"comments":"Early Phase 1 (STRIVE-01) dose-escalation data, cutoff 2026-07-24: \"Multiple responses, including confirmed and ongoing unconfirmed partial responses, across three tumor types\"; dose optimization ongoing 4-5 mg/kg, MTD not defined. Result disclosed with Q2 earnings 8-K (same day as 10-Q).","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:21Z","company":"Sutro Biopharma","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":142,"join_event_id":null,"symbol":"TSHA","drug":"TSHA-102","modality":"gene_therapy","area":"cns","result_type":"data_presentation","news_source_file":"documents/20260811_160548_(TSHA)_sec_0001193125-26-344594-ex991.txt","market_impact_date":"2026-08-12","day1_return":-0.041168,"day2_return":-0.064793,"prior_1w_return":0.077419,"comments":"\"Four poster presentations were delivered at the 2026 International Rett Syndrome Foundation (IRSF) Rett Syndrome Scientific Meeting\": longer-term REVEAL Part A data (May 2026 cutoff) with functional gains through >=12 months and 83% response at 6 months / 100% at 12 months; 10-Q adds detail. Exact poster date not stated in the release; disclosure first surfaced via this 8-K exhibit.","created_at":"2026-10-25 11:17:20","updated_at":"2026-10-25T12:10:19Z","company":"Taysha Gene Therapies","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":137,"join_event_id":246,"symbol":"UNCY","drug":"oxylanthanum carbonate","modality":"small_molecule","area":"renal","result_type":"crl","news_source_file":"documents/20260812_063054_(UNCY)_sec_0001213900-26-088013.txt","market_impact_date":"2026-08-12","day1_return":0.078,"day2_return":0.001855,"prior_1w_return":-0.032882,"comments":"\"On June 30, 2026, we announced that we received a CRL from the FDA regarding the resubmitted NDA for OLC.\" CRL cited the same third-party manufacturing deficiencies; no clinical efficacy/safety concerns and no additional data requested.","created_at":"2026-10-25 11:16:21","updated_at":"2026-10-25T12:10:18Z","company":"Unicycive Therapeutics","event_type":"pdufa","expect_date_from":"2026-06-29","expect_date_to":"2026-06-29","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":114,"join_event_id":null,"symbol":"XLO","drug":"XTX501","modality":"bispecific","area":"oncology","result_type":"other","news_source_file":"documents/20260812_073526_(XLO)_sec_0001193125-26-345753-ex991.txt","market_impact_date":"2026-08-12","day1_return":-0.014161,"day2_return":-0.00442,"prior_1w_return":0.009901,"comments":"FDA cleared IND for XTX501 (bispecific PD-1 / masked IL-2) to proceed to a Phase 1/2 trial: \"Xilio received clearance from the U.S. Food and Drug Administration (FDA) for the company's investigational new drug application (IND) to proceed to a Phase 1/2 clinical trial for XTX501.\" Announced with Q2 2026 results.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:17Z","company":"Xilio Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":415,"join_event_id":null,"symbol":"DMAC","drug":"DM199","modality":"protein","area":"womens_health","result_type":"interim_analysis","news_source_file":"documents/20260810_163706_(DMAC)_sec_0001437749-26-026792.txt","market_impact_date":"2026-08-11","day1_return":0.033083,"day2_return":-0.004367,"prior_1w_return":0.019939,"comments":"Part 1a extension cohort data (released August 2026, described in 10-Q): \"In the combined final, highest-dose cohorts, which consisted of 15 PE subjects... DM199 produced clinically meaningful and statistically significant, sustained reductions in maternal blood pressure\" 5 minutes post-IV; SBP <160 mmHg over 24h. Investigator-sponsored Phase 2 in preeclampsia; first disclosure predates this 10-Q.","created_at":"2026-10-25 12:10:02","updated_at":"2026-10-25T12:10:47Z","company":"DiaMedica Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":394,"join_event_id":null,"symbol":"COAG","drug":"sutacimig","modality":"bispecific","area":"hematology","result_type":"other","news_source_file":"documents/20260811_071107_(COAG)_sec_0001193125-26-343421-ex991.txt","market_impact_date":"2026-08-11","day1_return":0.037498,"day2_return":0.03363,"prior_1w_return":0.108222,"comments":"Regulatory feedback (July 2026): \"The FDA has endorsed the Company's clinical data package as sufficient to proceed to a Phase 3 pivotal trial in GT with a dose of 0.2 mg/kg once weekly.\" Company plans to initiate Phase 3 in 2H 2026; trial start not recorded as a catalyst.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:46Z","company":"Hemab Therapeutics Holdings","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":393,"join_event_id":null,"symbol":"COAG","drug":"HMB-002","modality":"monoclonal_antibody","area":"hematology","result_type":"data_presentation","news_source_file":"documents/20260811_071107_(COAG)_sec_0001193125-26-343421-ex991.txt","market_impact_date":"2026-08-11","day1_return":0.037498,"day2_return":0.03363,"prior_1w_return":0.108222,"comments":"First-in-human VELORA Pioneer Phase 1/2 data in VWD presented at ISTH 2026 (July 2026): >=2.4-fold peak increase in VWF and FVIII, normalization of peak thrombin generation; 8 of 9 evaluable patients with zero treated bleeds (mean ATBR 1.6 vs baseline 20.1). Descriptive SAD observations only.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:46Z","company":"Hemab Therapeutics Holdings","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":392,"join_event_id":null,"symbol":"COAG","drug":"sutacimig","modality":"bispecific","area":"hematology","result_type":"data_presentation","news_source_file":"documents/20260811_071107_(COAG)_sec_0001193125-26-343421-ex991.txt","market_impact_date":"2026-08-11","day1_return":0.037498,"day2_return":0.03363,"prior_1w_return":0.108222,"comments":"Phase 2 long-term extension data in Glanzmann thrombasthenia presented at ISTH 2026 (July 2026): sustained bleed reduction in 34 participants, mean high-intensity ATBR reduced 62% (low-dose weekly cohort ~84%); 3 Grade 2 thromboembolic events. Earliest available document is the Aug 11 Q2 8-K exhibit; presentation itself was in July 2026.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:46Z","company":"Hemab Therapeutics Holdings","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":322,"join_event_id":null,"symbol":"INTS","drug":"INT230-6","modality":"small_molecule","area":"oncology","result_type":"interim_analysis","news_source_file":"documents/20260811_074055_(INTS)_sec_0001567264-26-000061-ex991.txt","market_impact_date":"2026-08-11","day1_return":-0.020979,"day2_return":-0.009524,"prior_1w_return":0.007042,"comments":"Preliminary data from first 14 patients in Phase 2 INVINCIBLE-4 (TNBC): \"71% pathological complete response in Cohort A (INT230-6 before SOC) and 42% pCR in Cohort B (SOC alone)\", plus 44% reduction in grade 3 AEs. Preliminary/early data; also disclosed in Form 10-Q filed 2026-08-11 07:17. No event date had been guided.","created_at":"2026-10-25T07:52:15","updated_at":"2026-10-25T12:10:38Z","company":"Intensity Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":248,"join_event_id":null,"symbol":"PDSB","drug":"PDS0101","modality":"vaccine","area":"oncology","result_type":"trial_discontinuation","news_source_file":"documents/20260811_083033_(PDSB)_sec_0001140361-26-032142-ex991.txt","market_impact_date":"2026-08-11","day1_return":-0.648427,"day2_return":-0.058366,"prior_1w_return":0.02381,"comments":"Strategic refocus: \"we will cease further internal investment in the PDS0101 Phase 3 VERSATILE-003 trial, including the discontinuation of the VERSATILE-003 Phase 3 trial.\" No data-driven safety/efficacy failure cited.","created_at":"2026-10-25 11:37:07","updated_at":"2026-10-25T12:10:29Z","company":"PDS Biotechnology","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":239,"join_event_id":null,"symbol":"ACIU","drug":"ACI-7104","modality":"vaccine","area":"cns","result_type":"other","news_source_file":"documents/20260811_070002_(ACIU)_sec_0001651625-26-000016-ex991.txt","market_impact_date":"2026-08-11","day1_return":0.114035,"day2_return":0.031496,"prior_1w_return":0.027027,"comments":"FDA granted Fast Track designation and cleared the IND for ACI-7104 in early-stage Parkinson's disease, enabling US site expansion of VacSYn; company also cites $4M grant for 2-year Part 1 extension.","created_at":"2026-10-25 10:30:00","updated_at":"2026-10-25T12:10:28Z","company":"AC Immune","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":195,"join_event_id":null,"symbol":"SANA","drug":"UP421","modality":"cell_therapy","area":"metabolic","result_type":"data_presentation","news_source_file":"documents/20260810_160940_(SANA)_sec_0001193125-26-342371-ex991.txt","market_impact_date":"2026-08-11","day1_return":0.049862,"day2_return":-0.005277,"prior_1w_return":0.13522,"comments":"14-month IST results: \"Results of the study through 14 months after cell transplantation demonstrated the survival and function of pancreatic beta cells\"; no safety issues. NEJM Letter (DOI 10.1056/NEJMc2604408); 14-mo data first presented at ISSCR July 2026.","created_at":"2026-10-25 11:26:38","updated_at":"2026-10-25T12:10:24Z","company":"Sana Biotechnology","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":166,"join_event_id":null,"symbol":"STTK","drug":"SL-325","modality":"monoclonal_antibody","area":"immunology","result_type":"topline_results","news_source_file":"documents/20260811_065717_(STTK)_sec_0001628280-26-055483.txt","market_impact_date":"2026-08-11","day1_return":0.005602,"day2_return":0.043175,"prior_1w_return":-0.020576,"comments":"\"In June 2026, we shared the following data from our Phase 1 trial of SL-325.\" Phase 1 SAD/MAD in 72 healthy volunteers: well tolerated (only Grade 1 TRAEs), complete TL1A/DR3 blockade at all doses, RO >76 days at >=1 mg/kg, ADA 3.7% (2/54). Caveat: first disclosed June 2026; exact June date not in available documents, so this 10-Q (2026-08-11) is the earliest source on file.","created_at":"2026-10-25 11:22:04","updated_at":"2026-10-25T12:10:22Z","company":"Shattuck Labs","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":161,"join_event_id":null,"symbol":"TARA","drug":"TARA-002","modality":"cell_therapy","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20260811_081059_(TARA)_sec_0001213900-26-087508.txt","market_impact_date":"2026-08-11","day1_return":-0.048662,"day2_return":-0.005115,"prior_1w_return":0.035265,"comments":"\"In May 2026, we presented additional updated interim data from our ongoing Phase 2 open-label ADVANCED-2 trial demonstrating meaningful and durable activity in BCG-Naive NMIBC patients\"; April 5, 2026 cutoff, CR 66.7% (18/27) at 6 months. Data first public in May 2026; 10-Q retells it.","created_at":"2026-10-25 07:20:46","updated_at":"2026-10-25T12:10:21Z","company":"Protara Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":160,"join_event_id":null,"symbol":"TARA","drug":"TARA-002","modality":"cell_therapy","area":"rare_genetic","result_type":"data_presentation","news_source_file":"documents/20260811_080536_(TARA)_sec_0001213900-26-087506-ex991.txt","market_impact_date":"2026-08-11","day1_return":-0.048662,"day2_return":-0.005115,"prior_1w_return":0.035265,"comments":"\"In May 2026, we presented updated interim safety and durability data from STARBORN-1 at the International Society for the Study of Vascular Anomalies World Congress\"; April 10, 2026 cutoff: clinical success 100% (10/10) evaluable, 83% (10/12) completed treatment, no SAEs. Data first public at the May 2026 poster; this 8-K/10-Q retells it.","created_at":"2026-10-25 07:20:46","updated_at":"2026-10-25T12:10:21Z","company":"Protara Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":99,"join_event_id":164,"symbol":"ALMS","drug":"envudeucitinib","modality":"small_molecule","area":"dermatology","result_type":"topline_results","news_source_file":"documents/20260810_160606_(ALMS)_sec_0001104659-26-093353-ex991.txt","market_impact_date":"2026-08-11","day1_return":-0.07846,"day2_return":0.007095,"prior_1w_return":0.053982,"comments":"ONWARD3 LTE topline: \"75% and 54% of patients achieved PASI 90 and PASI 100, respectively\" after up to 48 weeks (n=773); safety consistent with ONWARD1/2. First disclosure Aug 10, 2026 (repeated in Aug 13 8-K/10-Q).","created_at":"2026-10-25 11:09:33","updated_at":"2026-10-25T12:10:15Z","company":"Alumis","event_type":"topline_results","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.45,"llm_reason":"The likely readout is a binary envudeucitinib topline result, possibly the lupus Phase 2b, for a roughly $880M company. That makes a move of 10% or more plausible, but direction is unclear. The document itself is only an annual meeting vote filing and offers no evidence on the trial.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":84,"join_event_id":null,"symbol":"AURA","drug":"bel-sar","modality":"other","area":"oncology","result_type":"interim_analysis","news_source_file":"documents/20260811_070526_(AURA)_sec_0001193125-26-343408-ex991.txt","market_impact_date":"2026-08-11","day1_return":0.044156,"day2_return":-0.03607,"prior_1w_return":0.09375,"comments":"Interim Phase 1b/2 NMIBC data: \"81% of patients achieved an objective response at 3 months, including 69% with a complete response\"; 100% of evaluable patients disease-free at 9/12 months; all TRAEs Grade 1. First disclosure in the Aug 11, 2026 release; program being deprioritized.","created_at":"2026-10-25 11:06:16","updated_at":"2026-10-25T12:10:14Z","company":"Aura Biosciences","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":73,"join_event_id":null,"symbol":"CBLL","drug":"Ceribell Clarity (Epileptiform Abnormality Detection and Artifact Reduction algorithms)","modality":"other","area":"cns","result_type":"fda_approval","news_source_file":"documents/20260810_162700_(CBLL)_sec_0001193125-26-342463-ex991.txt","market_impact_date":"2026-08-11","day1_return":0.104145,"day2_return":0.075082,"prior_1w_return":0.054069,"comments":"Q2 2026 8-K earnings release: \"Received U.S. Food and Drug Administration 510(k) clearances for Epileptiform Abnormality Detection algorithm and Artifact Reduction algorithm\"; 10-Q dates it \"In June 2026\". Exact clearance day not stated. Device/software, not a drug.","created_at":"2026-10-25 11:03:16","updated_at":"2026-10-25T12:10:12Z","company":"CeriBell","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":402,"join_event_id":null,"symbol":"CLNN","drug":"CNM-Au8","modality":"other","area":"cns","result_type":"other","news_source_file":"documents/20260810_080737_(CLNN)_sec_0001437749-26-026653.txt","market_impact_date":"2026-08-10","day1_return":-0.022727,"day2_return":-0.153101,"prior_1w_return":0.051793,"comments":"8-K (Aug 10, 2026): \"issued a press release announcing biomarker analyses to be included in the Company's NDA submission supporting ALS accelerated approval.\" 10-Q details post hoc NfL analyses from two completed Phase 2 ALS trials (exploratory).","created_at":"2026-10-25 08:07:40","updated_at":"2026-10-25T12:10:47Z","company":"Clene","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":313,"join_event_id":null,"symbol":"JBIO","drug":"JADE101","modality":"monoclonal_antibody","area":"renal","result_type":"interim_analysis","news_source_file":"documents/20260810_071338_(JBIO)_sec_0001193125-26-341229-ex991.txt","market_impact_date":"2026-08-10","day1_return":-0.010474,"day2_return":0.028532,"prior_1w_return":0.111899,"comments":"Positive interim Phase 1 data: \"Mean IgA reductions reached approximately 70% from baseline after a single 700 mg dose,\" supporting Q12W dosing; well tolerated across doses. Per the 10-Q, data were initially announced in June 2026 (release not in workspace) and subsequently presented at the 63rd ERA Congress; this 8-K exhibit is the earliest primary source available.","created_at":"2026-10-25 11:50:42","updated_at":"2026-10-25T12:10:37Z","company":"Jade Biosciences","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":290,"join_event_id":null,"symbol":"MAIA","drug":"ateganosine","modality":"small_molecule","area":"oncology","result_type":"interim_analysis","news_source_file":"documents/20260810_090037_(MAIA)_sec_0001493152-26-036764.txt","market_impact_date":"2026-08-10","day1_return":-0.007042,"day2_return":-0.021277,"prior_1w_return":0.136,"comments":"Announced July 8, 2026: \"initial efficacy results from Part C of the Phase 2 THIO-101 clinical trial. As of July 6, 2026, among the 21 efficacy-evaluable patients ... DCR of 90.5% (19 of 21)\" with ateganosine + cemiplimab in 3L NSCLC (10-Q recap; primary release not in file set). Initial/interim efficacy, not topline.","created_at":"2026-10-25 11:46:22","updated_at":"2026-10-25T12:10:34Z","company":"MAIA Biotechnology","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":283,"join_event_id":null,"symbol":"MLTX","drug":"sonelokimab","modality":"bispecific","area":"immunology","result_type":"topline_results","news_source_file":"documents/20260810_071514_(MLTX)_sec_0001213900-26-086939-ex991.txt","market_impact_date":"2026-08-10","day1_return":-0.050931,"day2_return":-0.042701,"prior_1w_return":-0.009761,"comments":"Aug 10, 2026 release: Phase 3 IZAR-1 (PsA) \"met all clinical endpoints at Week 16 for 60 mg sonelokimab\"; ACR50 42.1%, ACR20 66.5%, MDA 41.2%, PASI90 61%; blinded safety, no new signals. Placebo comparisons remain blinded until trial completion (Week 52).","created_at":"2026-10-25 11:45:02","updated_at":"2026-10-25T12:10:33Z","company":"MoonLake Immunotherapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":250,"join_event_id":null,"symbol":"PASG","drug":"PBFT02","modality":"gene_therapy","area":"cns","result_type":"trial_discontinuation","news_source_file":"documents/20260810_071552_(PASG)_sec_0001104659-26-093021.txt","market_impact_date":"2026-08-10","day1_return":-0.018182,"day2_return":0.041667,"prior_1w_return":-0.01566,"comments":"Company wound down its PBFT02 clinical development program: \"In April 2026, we determined to wind-down our clinical development programs related to PBFT02.\" Disclosed historically in Q2 2026 10-Q; original April 2026 announcement not in workspace. Related: notice to terminate PBFT02 Penn license (June 23, 2026).","created_at":"2026-10-25 11:37:37","updated_at":"2026-10-25T12:10:29Z","company":"Passage Bio","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":230,"join_event_id":null,"symbol":"QNTM","drug":"Lucid-21-302 (Lucid-MS)","modality":"small_molecule","area":"cns","result_type":"fda_approval","news_source_file":"documents/20260810_070007_(QNTM)_sec_0001171843-26-005370-ex991.txt","market_impact_date":"2026-08-10","day1_return":0.002899,"day2_return":0.026012,"prior_1w_return":0.193772,"comments":"FDA approved the IND application: \"the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational New Drug (IND) application for Lucid-MS (Lucid-21-302), enabling Quantum BioPharma to immediately advance ... into Phase 2 clinical development.\" No dated enrollment/data guidance given. Restated 2026-09-15 and 2026-10-06.","created_at":"2026-10-25 11:33:45","updated_at":"2026-10-25T12:10:28Z","company":"Quantum Biopharma Ltd. Class B Subordinate Voting Shares","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":210,"join_event_id":415,"symbol":"ABCL","drug":"ABCL635","modality":"monoclonal_antibody","area":"womens_health","result_type":"topline_results","news_source_file":"documents/20260810_074917_(ABCL)_sec_0001703057-26-000053.txt","market_impact_date":"2026-08-10","day1_return":0.347763,"day2_return":0.044968,"prior_1w_return":0.21366,"comments":"8-K (Aug 10, 2026): company \"issued a press release announcing positive top-line results from the Phase 2 portion of its Phase 1/2 clinical trial evaluating ABCL635\" (NK3R antagonist antibody) for moderate-to-severe VMS due to menopause; investor call held same day. Press release exhibit not in file set; earliest disclosure is the Aug 10 8-K.","created_at":"2026-10-25T07:28:08","updated_at":"2026-10-25T12:10:26Z","company":"AbCellera Biologics","event_type":"topline_results","expect_date_from":"2026-08-01","expect_date_to":"2026-08-31","event_closed":1,"tier":"Core","llm_prediction":"large_impact","llm_confidence":0.55,"llm_reason":"ABCL635 (NK3R antagonist antibody for menopausal hot flashes) is AbCellera's lead internal asset, and its Phase 2 topline is expected in August 2026. The $3.7B valuation trades well above roughly $540M in cash, so much of the premium likely rides on this readout. A binary Phase 2 result for the lead asset makes a move of 10% or more likely, but the document gives no basis for picking a direction.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":187,"join_event_id":368,"symbol":"SION","drug":"SION-451","modality":"small_molecule","area":"rare_genetic","result_type":"topline_results","news_source_file":"documents/20260810_071506_(SION)_sec_0001193125-26-341230-ex991.txt","market_impact_date":"2026-08-10","day1_return":-0.911834,"day2_return":0.133333,"prior_1w_return":0.082962,"comments":"Phase 1 dual combination trial (SION-451 with SION-2222 or SION-109) \"achieved the safety, tolerability, and pharmacokinetic (PK) objectives\"; \"SION-451 + SION-2222 was identified as the preferred dual combination.\" 120 participants dosed.","created_at":"2026-10-25 07:24:36","updated_at":"2026-10-25T12:10:23Z","company":"Sionna Therapeutics","event_type":"topline_results","expect_date_from":"2026-06-01","expect_date_to":"2026-08-31","event_closed":1,"tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.55,"llm_reason":"At a ~$172M market cap, Sionna depends heavily on its CF NBD1 stabilizer franchise. A SION-451 topline readout is likely binary against the Vertex benchmark, so a 10%+ move is likely, but the direction is unclear.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":186,"join_event_id":367,"symbol":"SION","drug":"SION-719","modality":"small_molecule","area":"rare_genetic","result_type":"topline_results","news_source_file":"documents/20260810_071506_(SION)_sec_0001193125-26-341230-ex991.txt","market_impact_date":"2026-08-10","day1_return":-0.911834,"day2_return":0.133333,"prior_1w_return":0.082962,"comments":"\"The PreciSION CF trial did not meet its key activity endpoint, with a -1.0 mmol/L mean placebo-adjusted sweat chloride change (p=0.7).\" Generally well tolerated; company does not plan to advance SION-719 as add-on to SOC. Topline data received Friday, 2026-08-07.","created_at":"2026-10-25 07:24:36","updated_at":"2026-10-25T12:10:23Z","company":"Sionna Therapeutics","event_type":"topline_results","expect_date_from":"2026-06-01","expect_date_to":"2026-08-31","event_closed":1,"tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.6,"llm_reason":"The SION-719 add-on proof-of-concept readout in CF patients is a binary, pivotal event for a single-platform NBD1 company. Expectations look elevated (recent option grants near $39), so either a beat or a miss on sweat chloride likely moves the stock 10% or more. The direction is unclear.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":183,"join_event_id":360,"symbol":"SLN","drug":"divesiran","modality":"sirna","area":"hematology","result_type":"topline_results","news_source_file":"documents/20260810_075719_(SLN)_sec_0001193125-26-341293-ex991.txt","market_impact_date":"2026-08-10","day1_return":0.291213,"day2_return":-0.046014,"prior_1w_return":0.13918,"comments":"Phase 2 SANRECO topline (36-wk, n=48 PV): primary endpoint met, 88% vs 19% clinical responders (p<0.0001); Q6W 93.8%, Q12W 81.3%; phlebotomy rate 0.2 vs 2.1 (p<0.0001); well tolerated. Full results to be presented at an upcoming congress (no date stated).","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:23Z","company":"Silence Therapeutics Plc American Depository Share","event_type":"topline_results","expect_date_from":"2026-08-01","expect_date_to":"2026-08-31","event_closed":1,"tier":"Core","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":154,"join_event_id":289,"symbol":"TENX","drug":"TNX-103 (oral levosimendan)","modality":"small_molecule","area":"cardiovascular","result_type":"topline_results","news_source_file":"documents/20260810_071906_(TENX)_sec_0001193125-26-341236-ex991.txt","market_impact_date":"2026-08-10","day1_return":-0.897693,"day2_return":0.178182,"prior_1w_return":-0.018978,"comments":"Topline LEVEL results: primary 6MWD endpoint not met (LS mean difference 3.5 m, p=0.63); 49% NT-proBNP reduction vs placebo (nominal p<0.0001); prespecified subgroup baseline 6MWD <333 m showed +26.3 m (95% CI 6.0-46.7; nominal p=0.0112).","created_at":"2026-10-25T07:19:02","updated_at":"2026-10-25T12:10:20Z","company":"Tenax Therapeutics","event_type":"topline_results","expect_date_from":"2026-08-01","expect_date_to":"2026-08-31","event_closed":1,"tier":"Core","llm_prediction":"large_impact","llm_confidence":0.8,"llm_reason":"Market cap (~$66M) sits well below the $118M cash balance, so the company is valued below cash and the binary Phase 3 LEVEL readout of its sole asset should move the stock sharply either way. Success could re-rate it substantially; failure could still cut it sharply despite the cash cushion. Direction is uncertain.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":152,"join_event_id":null,"symbol":"AQST","drug":"Anaphylm (dibutepinephrine)","modality":"small_molecule","area":"immunology","result_type":"topline_results","news_source_file":"documents/20260810_070544_(AQST)_sec_0001398733-26-000035.txt","market_impact_date":"2026-08-10","day1_return":0.088832,"day2_return":0.027972,"prior_1w_return":0.066306,"comments":"8-K (Aug 10, 2026): \"issued a press release announcing the results from its human factors validation study and pharmacokinetic study for Anaphylm (dibutepinephrine) sublingual film.\" Q2 release: PK study \"met its primary endpoints\" (preliminary data), no administration errors, no SAEs; human factors showed improvement across each CRL deficiency. Studies support the NDA resubmission.","created_at":"2026-10-25 11:18:57","updated_at":"2026-10-25T12:10:20Z","company":"Aquestive Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":590,"join_event_id":null,"symbol":"OCS","drug":"OCS-01","modality":"small_molecule","area":"ophthalmology","result_type":"topline_results","news_source_file":"documents/20260806_161537_(OCS)_sec_0001193125-26-338054-ex991.txt","market_impact_date":"2026-08-07","day1_return":0.024233,"day2_return":0.006309,"prior_1w_return":0.104371,"comments":"Q2-2026 financials restate the outcome: \"Oculis' legacy asset, OCS-01, had topline results announced in May 2026. The primary endpoint of the two Phase 3 trials was not met, and the Company decided not to pursue an FDA NDA regulatory filing for OCS-01 in diabetic macular edema (DME).\" Readout (DIAMOND-1/-2) occurred May 2026; the original May 2026 release is not in the file set, so this 6-K is the primary source available. Not linked to an event (no previously guided window in calendar).","created_at":"2026-11-03 23:09:53","updated_at":"2026-11-03T23:11:38Z","company":"Oculis Holding","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":562,"join_event_id":null,"symbol":"NXTC","drug":"SIM0505","modality":"adc","area":"oncology","result_type":"trial_discontinuation","news_source_file":"documents/20260806_162551_(NXTC)_sec_0001104659-26-092050.txt","market_impact_date":"2026-08-07","day1_return":0.044723,"day2_return":0.171233,"prior_1w_return":0.111332,"comments":"Announced July 14, 2026 (8-K, items 7.01/8.01), restated in 10-Q: \"On July 14, 2026, the Company announced that it had informed all U.S. clinical trial sites to stop screening, consenting, enrolling, and delivering first doses to new patients in the SIM0505 study\"; no expansion into Europe/Canada; patients to cease treatment and transition. Source here is the 10-Q because the July 14 8-K exhibit in the file set (merger release) does not itself describe the action.","created_at":"2026-10-31 16:44:22","updated_at":"2026-10-31T16:46:20Z","company":"NextCure","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":382,"join_event_id":null,"symbol":"CRVS","drug":"soquelitinib","modality":"small_molecule","area":"immunology","result_type":"data_presentation","news_source_file":"documents/20260806_160232_(CRVS)_sec_0001171843-26-005317-ex991.txt","market_impact_date":"2026-08-07","day1_return":0.004329,"day2_return":-0.012931,"prior_1w_return":0.050796,"comments":"8-K release: final Phase 1 atopic dermatitis data \"were presented in two oral sessions at the Society for Investigative Dermatology (SID) Annual Meeting\"; 10-Q specifies May 2026. Cohort 4 EASI 75 75% vs 20% placebo.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:45Z","company":"Corvus Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":366,"join_event_id":null,"symbol":"DNLI","drug":"DNL151 (BIIB122)","modality":"small_molecule","area":"cns","result_type":"topline_results","news_source_file":"documents/20260806_160319_(DNLI)_sec_0001714899-26-000096-ex991.txt","market_impact_date":"2026-08-07","day1_return":0.004044,"day2_return":0.006847,"prior_1w_return":0.015606,"comments":"\"In May 2026, Denali and Biogen announced that the global Phase 2b LUMA study of DNL151 did not meet its primary or secondary endpoints in early-stage Parkinson's disease. Based on these results, Denali and Biogen decided to discontinue further development of DNL151 in idiopathic Parkinson's disease.\" First announced May 2026 (original release not in workspace); repeated in Q2 2026 release and 10-Q. BEACON Phase 2a continues.","created_at":"2026-10-25T08:06:00","updated_at":"2026-10-25T12:10:43Z","company":"Denali Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":302,"join_event_id":681,"symbol":"LCTX","drug":"RG6501 (OpRegen)","modality":"cell_therapy","area":"ophthalmology","result_type":"data_presentation","news_source_file":"documents/20260806_161142_(LCTX)_sec_0001193125-26-338020-ex991.txt","market_impact_date":"2026-08-07","day1_return":-0.026549,"day2_return":0.027273,"prior_1w_return":0.018018,"comments":"3-year Phase 1/2a results: mean BCVA above baseline at 12/24/36 months in Cohort 4 (n=12); 5 patients with extensive OpRegen coverage showed mean BCVA change +9.0 letters at 36 months vs +7.4 at 24 months; OCT suggests partial retinal restoration. Data first disclosed at the Retinal Therapeutics Innovation Summit (May 2026); earliest source file available here is the Aug 6, 2026 8-K exhibit reporting the encore.","created_at":"2026-10-25 11:48:48","updated_at":"2026-10-25T12:10:35Z","company":"Lineage Cell Therapeutics","event_type":"data_presentation","expect_date_from":"2026-05-01","expect_date_to":"2026-05-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":264,"join_event_id":605,"symbol":"NRXP","drug":"preservative-free ketamine","modality":"small_molecule","area":"cns","result_type":"other","news_source_file":"documents/20260807_070032_(NRXP)_sec_0001437749-26-026428.txt","market_impact_date":"2026-08-07","day1_return":0.158576,"day2_return":-0.064246,"prior_1w_return":-0.009615,"comments":"First-round ANDA review outcome: \"The FDA advised the Company on July 30, 2026 of a final determination on first-round review that there were no major deficiencies related to the drug components of the product\" but found a major deficiency on the vial luer-lock cap; review to be reinitiated. Disclosed in 8-K filed 2026-08-07.","created_at":"2026-10-25 07:41:26","updated_at":"2026-10-25T12:10:31Z","company":"NRX Pharmaceuticals","event_type":"pdufa","expect_date_from":"2026-11-10","expect_date_to":"2026-11-10","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":218,"join_event_id":435,"symbol":"REPL","drug":"RP1 (vusolimogene oderparepvec)","modality":"gene_therapy","area":"oncology","result_type":"fda_approval","news_source_file":"documents/20260806_212749_(REPL)_sec_0001104659-26-092246-ex991.txt","market_impact_date":"2026-08-07","day1_return":-0.062208,"day2_return":0.133499,"prior_1w_return":1.377079,"comments":"FDA granted accelerated approval to TUDRIQEV (vusolimogene oderparepvec-wtpg) + nivolumab for unresectable advanced cutaneous melanoma after anti-PD-1 progression; ORR 24.2%, median DoR 14.1 months (announced 2026-08-06).","created_at":"2026-10-25 07:30:26","updated_at":"2026-10-25T12:10:26Z","company":"Replimune Group","event_type":"pdufa","expect_date_from":"2026-08-02","expect_date_to":"2026-08-02","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":129,"join_event_id":null,"symbol":"VRCA","drug":"VP-315 (ruxotemitide)","modality":"peptide","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20260806_163451_(VRCA)_sec_0001193125-26-338273-ex991.txt","market_impact_date":"2026-08-07","day1_return":-0.052239,"day2_return":0.007874,"prior_1w_return":0.019011,"comments":"Phase 2 BCC data on abscopal effects presented at the 2026 SID Annual Meeting; \"On May 5, 2026, the Company announced the presentation of Phase 2 clinical data highlighting the potential abscopal effects of its novel oncolytic peptide, VP-315 (ruxotemitide) ... at the 2026 SID Annual Meeting.\" May 5, 2026 announcement date per this later release; original release not in workspace.","created_at":"2026-10-25 11:14:27","updated_at":"2026-10-25T12:10:17Z","company":"Verrica Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":110,"join_event_id":null,"symbol":"ZYME","drug":"ZW191","modality":"adc","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20260806_160905_(ZYME)_sec_0001937653-26-000046-ex991.txt","market_impact_date":"2026-08-07","day1_return":0.017726,"day2_return":0.026338,"prior_1w_return":0.018494,"comments":"Dose-escalation Phase 1 data: \"In June 2026, we presented new clinical data ... at the European Society for Medical Oncology Gynaecological Cancers Congress 2026\"; cORR 78.6% FRa-positive and 47.4% FRa-negative platinum-resistant ovarian cancer. First disclosed at the June 14, 2026 congress presentation; details per 8-K exhibit dated 2026-08-06.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:16Z","company":"Zymeworks","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":507,"join_event_id":null,"symbol":"ACRS","drug":"ATI-052","modality":"bispecific","area":"immunology","result_type":"topline_results","news_source_file":"documents/20260806_071515_(ACRS)_sec_0001104659-26-091629-ex991.txt","market_impact_date":"2026-08-06","day1_return":-0.042453,"day2_return":-0.029557,"prior_1w_return":0.242188,"comments":"\"Provided Positive Full Top Line Results of Phase 1a Single (SAD) and Multiple Ascending Dose (MAD) Trial of ... ATI-052\": well tolerated, favorable safety, sustained PK/PD supporting potential up to quarterly dosing. Reported in the Q2 2026 8-K; the standalone release was issued earlier (not in workspace), so this is the earliest primary source available.","created_at":"2026-10-26 16:51:09","updated_at":"2026-10-26T16:52:38Z","company":"Aclaris Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":359,"join_event_id":867,"symbol":"ELVN","drug":"relcobatinib","modality":"small_molecule","area":"hematology","result_type":"data_presentation","news_source_file":"documents/20260805_161016_(ELVN)_sec_0001193125-26-335101-ex991.txt","market_impact_date":"2026-08-06","day1_return":0.009548,"day2_return":0.003152,"prior_1w_return":0.127053,"comments":"EHA Congress oral presentation (June 2026): \"61% overall major molecular response (MMR) and 48% MMR achievement by 24 weeks in the 80 mg once daily (QD) Phase 1b cohort\"; 67% MMR in patients with only 1-2 prior TKIs; 161 patients enrolled, median treatment 35 weeks, data cutoff March 10, 2026. First company release was June 2026 (not in workspace); this 8-K recap is the earliest primary source available.","created_at":"2026-10-25 12:01:11","updated_at":"2026-10-25T12:10:42Z","company":"Enliven Therapeutics","event_type":"data_presentation","expect_date_from":"2026-06-01","expect_date_to":"2026-06-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":349,"join_event_id":null,"symbol":"EWTX","drug":"EDG-7500","modality":"small_molecule","area":"cardiovascular","result_type":"topline_results","news_source_file":"documents/20260806_080535_(EWTX)_sec_0001104659-26-091671-ex991.txt","market_impact_date":"2026-08-06","day1_return":-0.01267,"day2_return":-0.020261,"prior_1w_return":0.131824,"comments":"Q2 2026 8-K recaps: \"announced positive top-line results from the 12-week Phase 2 Part D CIRRUS-HCM open label trial of EDG-7500 in obstructive and nonobstructive HCM.\" Actual disclosure was the company's June 2026 press release (not in workspace); exact June date unknown, so this later SEC recap is used.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:41Z","company":"Edgewise Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":319,"join_event_id":null,"symbol":"IRWD","drug":"LINZESS (linaclotide)","modality":"peptide","area":"gi_hepatology","result_type":"fda_approval","news_source_file":"documents/20260806_071223_(IRWD)_sec_0001104659-26-091625-ex991.txt","market_impact_date":"2026-08-06","day1_return":0.026506,"day2_return":0.014084,"prior_1w_return":0.16573,"comments":"Q2 2026 8-K: \"In May 2026, the U.S. Food and Drug Administration (FDA) approved the use of LINZESS in pediatric patients 2 years of age and older with functional constipation (FC).\" Caveat: approval occurred May 2026; this 8-K is the earliest primary source in the workspace. 10-Q confirms \"In June 2023 and May 2026, the U.S. FDA approved LINZESS ... for pediatric patients ages 6-17 and 2-5 with FC.\" PDL/partner AbbVie co-commercializes.","created_at":"2026-10-25T07:51:26","updated_at":"2026-10-25T12:10:37Z","company":"Ironwood Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":299,"join_event_id":674,"symbol":"LNTH","drug":"LNTH-2501","modality":"peptide","area":"oncology","result_type":"crl","news_source_file":"documents/20260806_080122_(LNTH)_sec_0001193125-26-336795.txt","market_impact_date":"2026-08-06","day1_return":-0.004236,"day2_return":-0.001187,"prior_1w_return":0.015,"comments":"\"on June 26, 2026, the Company announced that the FDA issued a Complete Response Letter (CRL) regarding the NDA for LNTH-2501 ... due to unresolved third-party facility manufacturing-related conditions.\" Caveat: CRL was first announced June 26, 2026 (release not in file set); source here is the Aug 6, 2026 10-Q.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:35Z","company":"Lantheus Holdings","event_type":"pdufa","expect_date_from":"2026-06-29","expect_date_to":"2026-06-29","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":281,"join_event_id":null,"symbol":"MNKD","drug":"MNKD-201 (nintedanib DPI)","modality":"small_molecule","area":"respiratory","result_type":"topline_results","news_source_file":"documents/20260805_160326_(MNKD)_sec_0001193125-26-335016-ex991.txt","market_impact_date":"2026-08-06","day1_return":-0.051219,"day2_return":0.056555,"prior_1w_return":0.064935,"comments":"\"Topline data readout of U.S. Phase 1b INFLO-1 demonstrates safety and tolerability in IPF patients\"; headline bullet calls it \"Positive nintedanib DPI Phase 1b data in IPF patients\". Phase 2 INFLO-2 enrolling.","created_at":"2026-10-25 11:44:37","updated_at":"2026-10-25T12:10:33Z","company":"MannKind","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":280,"join_event_id":null,"symbol":"MNKD","drug":"Afrezza","modality":"protein","area":"metabolic","result_type":"fda_approval","news_source_file":"documents/20260805_160326_(MNKD)_sec_0001193125-26-335016-ex991.txt","market_impact_date":"2026-08-06","day1_return":-0.051219,"day2_return":0.056555,"prior_1w_return":0.064935,"comments":"\"Received FDA approval of Afrezza on May 29, 2026 for use in children and adolescents ages 6 and older living with diabetes\"; pediatric launch noted in same Q2 2026 release.","created_at":"2026-10-25 11:44:34","updated_at":"2026-10-25T12:10:33Z","company":"MannKind","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":279,"join_event_id":null,"symbol":"MNKD","drug":"Furoscix ReadyFlow","modality":"small_molecule","area":"cardiovascular","result_type":"fda_approval","news_source_file":"documents/20260805_160326_(MNKD)_sec_0001193125-26-335016-ex991.txt","market_impact_date":"2026-08-06","day1_return":-0.051219,"day2_return":0.056555,"prior_1w_return":0.064935,"comments":"\"Received FDA approval of Furoscix ReadyFlow on July 23, 2026, the first and only autoinjector delivering IV-equivalent diuretic therapy for the treatment of edema in adults with heart failure (HF) or chronic kidney disease (CKD)\". 10-Q confirms Milestone 1 achieved on July 23, 2026.","created_at":"2026-10-25 11:44:34","updated_at":"2026-10-25T12:10:33Z","company":"MannKind","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":255,"join_event_id":null,"symbol":"NUVB","drug":"safusidenib","modality":"small_molecule","area":"oncology","result_type":"topline_results","news_source_file":"documents/20260806_073008_(NUVB)_sec_0001193125-26-336751-ex991.txt","market_impact_date":"2026-08-06","day1_return":-0.040816,"day2_return":0.080196,"prior_1w_return":-0.033384,"comments":"Updated long-term Phase 2 (J201) data in chemo-/RT-naive grade 2 IDH1-mutant glioma at median 38.8 mo follow-up: RANO-LGG ORR 51.9%, mPFS not reached, 36-mo PFS 79.1%, only 1 progressor. Company says it announced these data in July 2026; this Q2 release is the earliest primary document in the workspace (July notice not available), so actual first-disclosure date is July 2026.","created_at":"2026-10-25 11:41:02","updated_at":"2026-10-25T12:10:30Z","company":"Nuvation Bio","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":246,"join_event_id":null,"symbol":"PEPG","drug":"PGN-EDODM1","modality":"aso","area":"cns","result_type":"safety_update","news_source_file":"documents/20260806_074021_(PEPG)_sec_0001193125-26-336767-ex991.txt","market_impact_date":"2026-08-06","day1_return":0.217172,"day2_return":0.182573,"prior_1w_return":0.157895,"comments":"\"Based on the review of available safety data from the 10 mg/kg MAD cohort and the open-label extension (OLE) study, an independent DSMB recommended advancing the FREEDOM2 trial into the third and highest dose cohort (12.5 mg/kg). The DSMB also approved dose escalation in the OLE study from 5 mg/kg to 10 mg/kg.\" No new data values disclosed.","created_at":"2026-10-25 11:36:37","updated_at":"2026-10-25T12:10:29Z","company":"PepGen","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":236,"join_event_id":null,"symbol":"PRAX","drug":"elsunersen","modality":"aso","area":"cns","result_type":"topline_results","news_source_file":"documents/20260806_083228_(PRAX)_sec_0001689548-26-000083.txt","market_impact_date":"2026-08-06","day1_return":0.15954,"day2_return":-0.025394,"prior_1w_return":0.096897,"comments":"10-Q: \"we announced positive topline results in April 2026 from the EMBRAVE Part A study evaluating the safety and efficacy of elsunersen versus sham procedure for treating SCN2A gain-of-function DEE.\" Original April 2026 release not in workspace; 10-Q is earliest available primary source.","created_at":"2026-10-25 11:35:07","updated_at":"2026-10-25T12:10:28Z","company":"Praxis Precision Medicines","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":235,"join_event_id":null,"symbol":"PRAX","drug":"vormatrigine","modality":"small_molecule","area":"cns","result_type":"topline_results","news_source_file":"documents/20260806_083228_(PRAX)_sec_0001689548-26-000083.txt","market_impact_date":"2026-08-06","day1_return":0.15954,"day2_return":-0.025394,"prior_1w_return":0.096897,"comments":"10-Q: \"In June 2026, we announced that the primary endpoint was not met in our POWER1 study, a double-blind, placebo-controlled, 12-week study in FOS.\" Enrollment in POWER2 paused. Original June 2026 press release not in workspace; 10-Q is earliest available primary source.","created_at":"2026-10-25 11:35:07","updated_at":"2026-10-25T12:10:28Z","company":"Praxis Precision Medicines","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":192,"join_event_id":null,"symbol":"ALXO","drug":"evorpacept","modality":"protein","area":"oncology","result_type":"data_presentation","news_source_file":"documents/20260806_080522_(ALXO)_sec_0001193125-26-336843-ex991.txt","market_impact_date":"2026-08-06","day1_return":0.098958,"day2_return":-0.004739,"prior_1w_return":-0.012854,"comments":"Exploratory biomarker analyses of the Phase 1b/2 zanidatamab + evorpacept trial \"presented at ESMO Breast Cancer 2026\" in May 2026: cORR 60% and mPFS 8.3 mo in ccHER2-positive (n=10); 5/5 ccHER2+/CD47-high responded (mPFS 22.1 mo). Presentation predates this 8-K (earliest document available).","created_at":"2026-10-25 11:25:53","updated_at":"2026-10-25T12:10:24Z","company":"ALX Oncology Holdings","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":159,"join_event_id":null,"symbol":"BIVI","drug":"Bezisterim","modality":"small_molecule","area":"cns","result_type":"topline_results","news_source_file":"documents/20260806_073524_(BIVI)_sec_0001520138-26-000312-ex991.txt","market_impact_date":"2026-08-06","day1_return":-0.338235,"day2_return":-0.26,"prior_1w_return":0.619048,"comments":"Phase 2b SUNRISE-PD topline: met primary pharmacodynamic endpoint (composite neuroinflammation -0.28 vs +0.19, nominal p=0.0018); EPNIC-15 -0.04 vs +0.18, p=0.0006. Company called them exploratory; 57 patients, 12 weeks. Public via 8-K exhibit Aug 6, 2026.","created_at":"2026-10-25 11:21:00","updated_at":"2026-10-25T12:10:21Z","company":"BioVie","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":148,"join_event_id":null,"symbol":"TNYA","drug":"TN-401","modality":"gene_therapy","area":"cardiovascular","result_type":"data_presentation","news_source_file":"documents/20260805_161004_(TNYA)_sec_0001193125-26-335098-ex991.txt","market_impact_date":"2026-08-06","day1_return":-0.075159,"day2_return":0.001377,"prior_1w_return":0.068027,"comments":"Recap of interim RIDGE-1 data presented May 2026 at ASGCT (April 2026 cutoff); not first disclosure. PVCs \"decreased in all patients by a mean of 64% from baseline\"; no DLTs; all patients off immunosuppressives.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:20Z","company":"Tenaya Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":147,"join_event_id":null,"symbol":"TNYA","drug":"TN-201","modality":"gene_therapy","area":"cardiovascular","result_type":"interim_analysis","news_source_file":"documents/20260805_161004_(TNYA)_sec_0001193125-26-335098-ex991.txt","market_impact_date":"2026-08-06","day1_return":-0.075159,"day2_return":0.001377,"prior_1w_return":0.068027,"comments":"Recap of interim MyPEAK-1 data first shared June 2026 (May 2026 cutoff); this 8-K is not the first disclosure. \"all six evaluable patients achieved reductions in one or more echocardiographic measures of hypertrophy\"; 5/6 improved >=1 NYHA class; no DLTs; enrollment complete for dose selection.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:20Z","company":"Tenaya Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":109,"join_event_id":null,"symbol":"ZVRA","drug":"arimoclomol","modality":"small_molecule","area":"rare_genetic","result_type":"crl","news_source_file":"documents/20260805_171900_(ZVRA)_sec_0001434647-26-000068.txt","market_impact_date":"2026-08-06","day1_return":0.128205,"day2_return":-0.026936,"prior_1w_return":0.076687,"comments":"CHMP negative opinion on the EU Marketing Authorisation Application for arimoclomol in NPC, adopted July 2026; Zevra requested a re-examination. \"In July 2026, the Committee for Medicinal Products for Human Use (CHMP) ... adopted a negative opinion regarding the MAA.\" No primary July 2026 release in workspace; this 10-Q is the earliest available source, so market-impact date is not the first disclosure.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:16Z","company":"Zevra Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":95,"join_event_id":null,"symbol":"ANNX","drug":"tanruprubart","modality":"monoclonal_antibody","area":"immunology","result_type":"interim_analysis","news_source_file":"documents/20260806_081710_(ANNX)_sec_0001193125-26-336867-ex991.txt","market_impact_date":"2026-08-06","day1_return":0.042831,"day2_return":-0.033929,"prior_1w_return":0.104938,"comments":"Initial cohort (n=10) of open-label FORWARD study: \"clinically meaningful and rapid improvement in strength and reduced disability within days of a single infusion of 30 mg/kg tanruprubart\"; all patients improved within four days and drug was generally well tolerated. Not a topline readout of the full study.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:15Z","company":"Annexon","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":89,"join_event_id":null,"symbol":"ARQT","drug":"ZORYVE (roflumilast) cream 0.3%","modality":"small_molecule","area":"dermatology","result_type":"fda_approval","news_source_file":"documents/20260805_161424_(ARQT)_sec_0001787306-26-000049-ex991.txt","market_impact_date":"2026-08-06","day1_return":-0.024723,"day2_return":-0.043133,"prior_1w_return":-0.027279,"comments":"FDA approved sNDA expanding ZORYVE cream 0.3% to treat children with plaque psoriasis down to age 2 \"in June 2026\"; seventh FDA approval since 2022. Only available source is the Q2 2026 release; exact June date not stated.","created_at":"2026-10-25 11:07:00","updated_at":"2026-10-25T12:10:14Z","company":"Arcutis Biotherapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":83,"join_event_id":null,"symbol":"AVTX","drug":"abdakibart","modality":"monoclonal_antibody","area":"dermatology","result_type":"topline_results","news_source_file":"documents/20260806_070135_(AVTX)_sec_0001534120-26-000048-ex991.txt","market_impact_date":"2026-08-06","day1_return":-0.007431,"day2_return":-0.020321,"prior_1w_return":-0.008943,"comments":"Q2 2026 release: \"We delivered positive topline Phase 2 LOTUS results for abdakibart in HS.\" Actual disclosure was May 2026 per 10-Q (\"release of topline data in May 2026\"); that earlier primary release is not in the workspace, so this later copy is used.","created_at":"2026-10-25 11:06:00","updated_at":"2026-10-25T12:10:14Z","company":"Avalo Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":365,"join_event_id":null,"symbol":"DNTH","drug":"claseprubart","modality":"monoclonal_antibody","area":"immunology","result_type":"interim_analysis","news_source_file":"documents/20260804_160521_(DNTH)_sec_0001690585-26-000033-ex991.txt","market_impact_date":"2026-08-05","day1_return":0.019022,"day2_return":-0.022933,"prior_1w_return":0.086507,"comments":"Interim Responder Analysis, first 40 participants completing Part A of Phase 3 CAPTIVATE (CIDP): \"75% response rate observed ... exceeding the target response rate of 50% or greater\"; well tolerated. Caveat: 10-Q states this was first announced in June 2026; this 8-K/10-Q repeats it.","created_at":"2026-10-25 12:02:38","updated_at":"2026-10-25T12:10:43Z","company":"Dianthus Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":330,"join_event_id":null,"symbol":"IMA","drug":"olevaprubart","modality":"monoclonal_antibody","area":"dermatology","result_type":"interim_analysis","news_source_file":"documents/20260805_080510_(IMA)_sec_0001193125-26-333912-ex991.txt","market_impact_date":"2026-08-05","day1_return":0.007005,"day2_return":-0.02087,"prior_1w_return":-0.008681,"comments":"\"The Independent Data Monitoring Committee (IDMC) for the ADAPTIVE study recommended the study proceed with no changes to the protocol or monitoring on July 23, 2026.\" First disclosure in the Aug 5, 2026 Q2 release; no numeric data disclosed. Also notes no Kaposi sarcoma cases as of July 31, 2026.","created_at":"2026-10-25 07:53:54","updated_at":"2026-10-25T12:10:39Z","company":"ImageneBio","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":272,"join_event_id":null,"symbol":"NAGE","drug":"NB4168","modality":"small_molecule","area":"rare_genetic","result_type":"other","news_source_file":"documents/20260804_160329_(NAGE)_sec_0001386570-26-000042-ex991.txt","market_impact_date":"2026-08-05","day1_return":-0.146974,"day2_return":0.027027,"prior_1w_return":0.054711,"comments":"\"NB4168 received the Rare Pediatric Disease (RPD) designation ... from the U.S. Food and Drug Administration, and Orphan Medicinal Product Designation (OMPD) from the European Medicines Agency\" for Ataxia-Telangiectasia. Designations granted after the July 2026 program introduction; first disclosure available to us is this 2026-08-04 release.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:32Z","company":"Niagen Bioscience","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":91,"join_event_id":null,"symbol":"ARVN","drug":"ARV-102","modality":"small_molecule","area":"cns","result_type":"clinical_hold","news_source_file":"documents/20260804_160823_(ARVN)_sec_0001628280-26-052554.txt","market_impact_date":"2026-08-05","day1_return":-0.066667,"day2_return":0.033333,"prior_1w_return":0.097561,"comments":"\"Following the 30-day review period, prior to authorizing the initiation of the Phase 1b clinical trial in the U.S. in patients with PSP, the FDA requested additional information ... the planned Phase 1b clinical trial, in which we have not yet dosed any patients, is on clinical hold\".","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:15Z","company":"Arvinas","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":90,"join_event_id":145,"symbol":"ARVN","drug":"vepdegestrant","modality":"small_molecule","area":"oncology","result_type":"fda_approval","news_source_file":"documents/20260804_160823_(ARVN)_sec_0001628280-26-052554.txt","market_impact_date":"2026-08-05","day1_return":-0.066667,"day2_return":0.033333,"prior_1w_return":0.097561,"comments":"Q3 2026 10-Q: \"In the second quarter of 2026, the U.S. Food and Drug Administration, or FDA, approved VEPPANU (vepdegestrant)\" for ER+/HER2- ESR1-mutated advanced/metastatic breast cancer; first FDA-approved PROTAC. Nov 2026 corporate presentation (11/3/26) states \"FDA approved VEPPANU (vepdegestrant) on May 1, 2026\" - ahead of the June 5, 2026 PDUFA date.","created_at":"2026-10-25","updated_at":"2026-11-04T05:24:49Z","company":"Arvinas","event_type":"pdufa","expect_date_from":"2026-06-05","expect_date_to":"2026-06-05","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":88,"join_event_id":null,"symbol":"ARWR","drug":"plozasiran","modality":"sirna","area":"metabolic","result_type":"topline_results","news_source_file":"documents/20260804_160302_(ARWR)_sec_0000879407-26-000058-ex991.txt","market_impact_date":"2026-08-05","day1_return":-0.029914,"day2_return":-0.012427,"prior_1w_return":0.044416,"comments":"Phase 3 SHASTA-3/SHASTA-4 in sHTG met primary endpoint: median TG reductions 79% and 81% vs placebo, 78% reduction in acute pancreatitis events, no new safety signals. Release says topline was \"recently announced\"; this Aug 4, 2026 8-K is the earliest sourced document available.","created_at":"2026-10-25 11:06:59","updated_at":"2026-10-25T12:10:14Z","company":"Arrowhead Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":528,"join_event_id":null,"symbol":"NVCT","drug":"ciprocopan (NXP100)","modality":"small_molecule","area":"hematology","result_type":"other","news_source_file":"documents/20260804_082532_(NVCT)_sec_0001104659-26-090094-ex991.txt","market_impact_date":"2026-08-04","day1_return":-0.069444,"day2_return":-0.041791,"prior_1w_return":0.105425,"comments":"Marketing approval in China (partner Haisco) for PNH patients previously untreated with complement inhibitors: \"ciprocopan (NXP100), a Complement Factor B inhibitor for once-daily, oral administration, was approved in China in July 2026\"; disclosed by Nuvectis in its Aug 4, 2026 Q2 release (\"Approximately two weeks ago, ciprocopan received its first marketing approval in China\"). China NMPA decision, not FDA. Second China PNH application (post-anti-C5) under review.","created_at":"2026-10-28 00:00:25","updated_at":"2026-10-28T00:02:37Z","company":"Nuvectis Pharma","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":383,"join_event_id":null,"symbol":"CRSP","drug":"CASGEVY (exagamglogene autotemcel)","modality":"gene_therapy","area":"hematology","result_type":"fda_approval","news_source_file":"documents/20260803_162423_(CRSP)_sec_0001193125-26-330644-ex991.txt","market_impact_date":"2026-08-04","day1_return":0.070607,"day2_return":-0.011683,"prior_1w_return":0.060775,"comments":"Q2 2026 release: \"The U.S. FDA recently approved CASGEVY in children 2 years of age and older with SCD or TDT ... achieved in just 53 days post filing\"; the 10-Q notes the FDA approval occurred in July 2026. Exact approval date not stated in these documents.","created_at":"2026-10-25 12:05:21","updated_at":"2026-10-25T12:10:45Z","company":"CRISPR Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":335,"join_event_id":null,"symbol":"HRMY","drug":"BP-205","modality":"small_molecule","area":"cns","result_type":"topline_results","news_source_file":"documents/20260804_080512_(HRMY)_sec_0001104659-26-090086-ex991.txt","market_impact_date":"2026-08-04","day1_return":0.089326,"day2_return":-0.013925,"prior_1w_return":-0.011386,"comments":"Phase 1 SAD topline data in healthy volunteers: Tmax 30-75 min, mean t1/2 ~25h, dose-proportional exposure, no serious/severe TEAEs. \"Phase 1 SAD Data for BP-205 Demonstrate Favorable PK and Safety/Tolerability Profiles\"","created_at":"2026-10-25 11:55:42","updated_at":"2026-10-25T12:10:40Z","company":"Harmony Biosciences Holdings","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":331,"join_event_id":null,"symbol":"IDYA","drug":"darovasertib","modality":"small_molecule","area":"oncology","result_type":"topline_results","news_source_file":"documents/20260804_060139_(IDYA)_sec_0001193125-26-331381-ex991.txt","market_impact_date":"2026-08-04","day1_return":0.020056,"day2_return":-0.001939,"prior_1w_return":-0.037259,"comments":"OptimUM-02 (1L HLA*A2:01-negative mUM) met primary endpoint: BICR median PFS 6.9 vs 3.1 mo (HR 0.42; p<0.0001), n=313, cutoff Jan 23 2026. Caveat: 10-Q states \"In April 2026, we reported positive topline data\" and full data were presented at ASCO 2026, so the first disclosure predates this 8-K.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:39Z","company":"IDEAYA Biosciences","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":326,"join_event_id":null,"symbol":"INDV","drug":"INDV-6001","modality":null,"area":"cns","result_type":"trial_discontinuation","news_source_file":"documents/20260803_162435_(INDV)_sec_0001628280-26-051895.txt","market_impact_date":"2026-08-04","day1_return":-0.023281,"day2_return":0.061096,"prior_1w_return":-0.06645,"comments":"Q2 2026 10-Q: \"During the six months ended June 30, 2026, Indivior made the decision to cease Phase 3 development of INDV-6001 and not advance INDV-2000 internally. The Company is not currently pursuing any pipeline activities.\" Decision described as made \"earlier in the year\"; no separate announcement date given in this filing.","created_at":"2026-10-25 11:53:18","updated_at":"2026-10-25T12:10:38Z","company":"Indivior Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":199,"join_event_id":null,"symbol":"RYTM","drug":"RM-718","modality":"peptide","area":"metabolic","result_type":"interim_analysis","news_source_file":"documents/20260804_074913_(RYTM)_sec_0001628280-26-052170.txt","market_impact_date":"2026-08-04","day1_return":0.029189,"day2_return":0.046606,"prior_1w_return":-0.031565,"comments":"Preliminary data from ongoing open-label Phase 2 Part C trial in acquired hypothalamic obesity (n=11): \"-11.6% reduction in mean BMI from baseline (n=7) at 16 weeks of RM-718\"; two mild injection-site hyperpigmentation events; 2 discontinuations due to AEs. Announced Aug 4, 2026 (8-K Item 8.01); mirrored in 10-Q.","created_at":"2026-10-25 11:27:11","updated_at":"2026-10-25T12:10:25Z","company":"Rhythm Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":253,"join_event_id":null,"symbol":"OCUL","drug":"AXPAXLI","modality":"small_molecule","area":"ophthalmology","result_type":"other","news_source_file":"documents/20260803_070736_(OCUL)_sec_0001104659-26-089443-ex991.txt","market_impact_date":"2026-08-03","day1_return":0.028152,"day2_return":0.022619,"prior_1w_return":-0.039389,"comments":"New post-hoc analysis of SOL-1 (Phase 3, wet AMD) reported Aug 3, 2026: 66.5% of AXPAXLI subjects rescue-free at Week 52 under SOL-R rescue criteria, \"up to an estimated 72% reduction in treatment burden over 60 weeks\" vs projected on-label aflibercept 2 mg q8w. Analysis of previously reported SOL-1 data; not new topline results.","created_at":"2026-10-25 11:39:46","updated_at":"2026-10-25T12:10:30Z","company":"Ocular Therapeutix","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":220,"join_event_id":null,"symbol":"RCKT","drug":"RP-A501","modality":"gene_therapy","area":"cardiovascular","result_type":"safety_update","news_source_file":"documents/20260803_074133_(RCKT)_sec_0001140361-26-030568-ex991.txt","market_impact_date":"2026-08-03","day1_return":0.096463,"day2_return":0.008798,"prior_1w_return":-0.025078,"comments":"\"Rocket Pharmaceuticals Announces Positive Clinical Safety Update from Initial Three Patients Treated with RP-A501 Under Modified Phase 2 Protocol\": \"no thrombotic microangiopathy (TMA), capillary leak syndrome, or other significant safety concerns have been observed\". First disclosure of this safety data.","created_at":"2026-10-25 11:31:51","updated_at":"2026-10-25T12:10:27Z","company":"Rocket Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":380,"join_event_id":null,"symbol":"CTNM","drug":"PIPE-791","modality":"small_molecule","area":"pain_anesthesia","result_type":"topline_results","news_source_file":"documents/20260730_160807_(CTNM)_sec_0001628280-26-051051-ex991.txt","market_impact_date":"2026-07-31","day1_return":-0.016508,"day2_return":0.028405,"prior_1w_return":0.096033,"comments":"Phase 1b exploratory trial in chronic osteoarthritis pain / chronic low back pain (NCT06810245): \"On April 30, 2026, the Company reported positive topline data...\" Met primary safety/tolerability objective; pain improvements numerically greater than placebo. Note: first disclosed 2026-04-30; that release is not in this workspace, so this Q2 8-K exhibit is cited.","created_at":"2026-10-25 12:04:29","updated_at":"2026-10-25T12:10:44Z","company":"Contineum Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":342,"join_event_id":null,"symbol":"FULC","drug":"pociredir","modality":"small_molecule","area":"hematology","result_type":"trial_discontinuation","news_source_file":"documents/20260730_160537_(FULC)_sec_0001193125-26-326098.txt","market_impact_date":"2026-07-31","day1_return":-0.037634,"day2_return":0.036313,"prior_1w_return":-0.010638,"comments":"10-Q: \"On June 1, 2026, the Company announced the discontinuation of its pociredir program for the treatment of sickle cell disease\" after FDA end-of-phase meeting minutes reflected benefit-risk concerns and no viable path forward. First public disclosure 2026-06-01 per filing.","created_at":"2026-10-25T07:58:01","updated_at":"2026-10-25T12:10:41Z","company":"Fulcrum Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":333,"join_event_id":null,"symbol":"IBRX","drug":"ANKTIVA","modality":"protein","area":"oncology","result_type":"other","news_source_file":"documents/20260730_171945_(IBRX)_sec_0001326110-26-000071-ex991.txt","market_impact_date":"2026-07-31","day1_return":-0.037584,"day2_return":-0.002789,"prior_1w_return":0.006757,"comments":"UAE Emirates Drug Establishment granted marketing authorization for ANKTIVA in BCG-unresponsive NMIBC (CIS and papillary disease) and metastatic NSCLC: \"the Emirates Drug Establishment (EDE) of the United Arab Emirates (UAE) has granted Marketing Authorization for ANKTIVA across two indications\"; first registration 24 July 2026. Non-U.S. regulatory approval.","created_at":"2026-10-25 11:54:52","updated_at":"2026-10-25T12:10:39Z","company":"ImmunityBio","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":308,"join_event_id":null,"symbol":"KPTI","drug":"selinexor","modality":"small_molecule","area":"oncology","result_type":"topline_results","news_source_file":"documents/20260731_083033_(KPTI)_sec_0001193125-26-326995.txt","market_impact_date":"2026-07-31","day1_return":-0.726106,"day2_return":0.026042,"prior_1w_return":-0.011283,"comments":"Phase 3 XPORT-EC-042 (selinexor maintenance vs placebo, TP53 wild-type advanced/recurrent endometrial cancer) announced July 30, 2026 did not meet primary endpoint of PFS: mITT (n=236) median PFS 12.75 vs 7.43 months, HR=0.76 (95% CI 0.51, 1.12), one-sided p=0.0791. Safety consistent with known profile. Full data to be presented at a future medical meeting.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:36Z","company":"Karyopharm Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":217,"join_event_id":434,"symbol":"REPL","drug":"RP1 (vusolimogene oderparepvec)","modality":"gene_therapy","area":"oncology","result_type":"adcom_outcome","news_source_file":"documents/20260730_200223_(REPL)_sec_0001104659-26-088857-ex991.txt","market_impact_date":"2026-07-31","day1_return":1.07024,"day2_return":0.063393,"prior_1w_return":-0.482792,"comments":"CTGTAC voted 10 to 3 that \"the efficacy results from IGNYTE [are] evaluable and clinically meaningful\" at the 2026-07-30 meeting on the RP1 BLA resubmission.","created_at":"2026-10-25 07:30:26","updated_at":"2026-10-25T12:10:26Z","company":"Replimune Group","event_type":"adcom","expect_date_from":"2026-07-20","expect_date_to":"2026-07-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":151,"join_event_id":null,"symbol":"TLSA","drug":"foralumab","modality":"monoclonal_antibody","area":"cns","result_type":"interim_analysis","news_source_file":"documents/20260731_070005_(TLSA)_sec_0001213900-26-083604-ex991.txt","market_impact_date":"2026-07-31","day1_return":0.061856,"day2_return":-0.058252,"prior_1w_return":-0.04902,"comments":"Quantitative PET imaging from third MSA patient completing dosing in Phase 2: \"up to 34% reduction in standardized uptake value (SUV) and 26% reduction in standardized uptake value ratio (SUVR)\"; open-label, single-patient imaging data.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:20Z","company":"Tiziana Life Sciences","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":78,"join_event_id":null,"symbol":"BHC","drug":"rifaximin soluble solid dispersion","modality":"small_molecule","area":"gi_hepatology","result_type":"topline_results","news_source_file":"documents/20260730_161133_(BHC)_sec_0000885590-26-000107.txt","market_impact_date":"2026-07-31","day1_return":0.14262,"day2_return":0.015965,"prior_1w_return":0.355056,"comments":"10-Q: \"In January 2026, the Company received the results for the double-blind Phase 3 clinical trials for two global RED-C clinical programs evaluating its rifaximin soluble solid dispersion formulation... both clinical trials failed to achieve their primary endpoints.\" Safe/well tolerated; results first disclosed Jan 2026 (earlier release not in this workspace); drove $1,426M Salix goodwill impairment.","created_at":"2026-10-25T07:04:11","updated_at":"2026-10-25T12:10:13Z","company":"Bausch Health Companies","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":74,"join_event_id":89,"symbol":"CAPR","drug":"Deramiocel","modality":"cell_therapy","area":"rare_genetic","result_type":"adcom_outcome","news_source_file":"documents/20260730_160511_(CAPR)_sec_0001104659-26-088667-ex991.txt","market_impact_date":"2026-07-31","day1_return":-0.081146,"day2_return":0.090909,"prior_1w_return":-0.788704,"comments":"\"the ... Cellular, Tissue and Gene Therapies Advisory Committee voted that available evidence did not support the effectiveness of Deramiocel for the treatment of cardiomyopathy in patients with Duchenne muscular dystrophy (3 for, 9 against, 0 abstain). The Committee's vote is non-binding.\"","created_at":"2026-10-25 07:06:00","updated_at":"2026-10-25T12:10:12Z","company":"Capricor Therapeutics","event_type":"adcom","expect_date_from":"2026-07-29","expect_date_to":"2026-07-29","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":439,"join_event_id":237,"symbol":"VCEL","drug":"MACI","modality":"cell_therapy","area":"other","result_type":"other","news_source_file":"documents/20260730_080354_(VCEL)_sec_0001628280-26-050815-ex991.txt","market_impact_date":"2026-07-30","day1_return":0.021236,"day2_return":-0.034657,"prior_1w_return":0.04623,"comments":"Q2 2026 8-K exhibit (7/30/2026): \"MACI marketing authorization application submitted to U.K. MHRA.\" MAA confirmed submitted; no MHRA decision date disclosed.","created_at":"2026-10-25 09:05:07","updated_at":"2026-10-25T13:07:43Z","company":"Vericel","event_type":"regulatory_submission","expect_date_from":"2026-07-30","expect_date_to":"2026-07-30","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":104,"join_event_id":null,"symbol":"AGIO","drug":"tebapivat","modality":"small_molecule","area":"hematology","result_type":"trial_discontinuation","news_source_file":"documents/20260730_063237_(AGIO)_sec_0001439222-26-000115-ex991.txt","market_impact_date":"2026-07-30","day1_return":-0.064553,"day2_return":-0.083359,"prior_1w_return":-0.028849,"comments":"8-K: \"will not advance tebapivat in sickle cell disease following results from the company's Phase 2 trial. ... did not demonstrate a sufficiently differentiated profile relative to other PK activators.\" 10-Q: announced July 2026; earlier primary release not in file set.","created_at":"2026-10-25 11:10:24","updated_at":"2026-10-25T12:10:16Z","company":"Agios Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":103,"join_event_id":null,"symbol":"AGIO","drug":"tebapivat","modality":"small_molecule","area":"hematology","result_type":"topline_results","news_source_file":"documents/20260730_063237_(AGIO)_sec_0001439222-26-000115-ex991.txt","market_impact_date":"2026-07-30","day1_return":-0.064553,"day2_return":-0.083359,"prior_1w_return":-0.028849,"comments":"8-K: \"will not advance tebapivat in LR-MDS following results from the company's Phase 2b trial ... did not demonstrate clinical benefit in a sufficient proportion of patients or any patient subgroup.\" 10-Q: announced May 2026; earlier primary release not in file set.","created_at":"2026-10-25 11:10:24","updated_at":"2026-10-25T12:10:16Z","company":"Agios Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":102,"join_event_id":null,"symbol":"AGIO","drug":"AG-236","modality":"sirna","area":"hematology","result_type":"topline_results","news_source_file":"documents/20260730_063237_(AGIO)_sec_0001439222-26-000115-ex991.txt","market_impact_date":"2026-07-30","day1_return":-0.064553,"day2_return":-0.083359,"prior_1w_return":-0.028849,"comments":"8-K: \"Results from Agios' Phase 1 trial of AG-236 in healthy volunteers demonstrated sustained hepcidin control and effects on iron regulation biomarkers without the need for titration.\" 10-Q: topline results were first announced in June 2026 (\"dose-dependent hepcidin induction, sustained activity across doses ... no dose-limiting toxicities\"); earlier primary release not in file set.","created_at":"2026-10-25 11:10:24","updated_at":"2026-10-25T12:10:16Z","company":"Agios Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":75,"join_event_id":null,"symbol":"CAPR","drug":"Deramiocel","modality":"cell_therapy","area":"rare_genetic","result_type":"data_presentation","news_source_file":"documents/20260729_100521_(CAPR)_sec_0001104659-26-087891-ex991.txt","market_impact_date":"2026-07-29","day1_return":0.0,"day2_return":-0.362253,"prior_1w_return":-0.668014,"comments":"The Lancet published full HOPE-3 Phase 3 dataset (n=106) July 29, 2026: PUL 2.0 p=0.03, 54% slowing of upper limb decline. Peer-reviewed publication of previously announced topline data; later Q2 release notes revised LVEF analysis (p=0.09) under SAP 3.0.","created_at":"2026-10-25 07:06:00","updated_at":"2026-10-25T12:10:12Z","company":"Capricor Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":337,"join_event_id":819,"symbol":"GRCE","drug":"GTx-104","modality":"small_molecule","area":"cns","result_type":"crl","news_source_file":"documents/20260728_071615_(GRCE)_sec_0001140361-26-029837-ex991.txt","market_impact_date":"2026-07-28","day1_return":-0.021739,"day2_return":-0.075556,"prior_1w_return":-0.053498,"comments":"FDA issued a CRL for the GTx-104 NDA on April 23, 2026: \"the Complete Response Letter (CRL) issued on April 23, 2026\"; \"The CRL did not identify any clinical safety or efficacy deficiencies and did not request additional clinical data\" - items are CMC/cGMP facility-level, leachables and excipient toxicology. Earliest CRL announcement document not in workspace; this July 28, 2026 release (Type A minutes) is the earliest available copy.","created_at":"2026-10-25 11:57:01","updated_at":"2026-10-25T12:10:40Z","company":"Grace Therapeutics","event_type":"pdufa","expect_date_from":"2026-04-23","expect_date_to":"2026-04-23","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":307,"join_event_id":null,"symbol":"KNSA","drug":"KPL-387","modality":"monoclonal_antibody","area":"cardiovascular","result_type":"interim_analysis","news_source_file":"documents/20260728_073348_(KNSA)_sec_0001730430-26-000031-ex991.txt","market_impact_date":"2026-07-28","day1_return":0.250335,"day2_return":0.01863,"prior_1w_return":0.01526,"comments":"Q2 2026 8-K release: \"Kiniksa today announced data from an interval analysis of the ongoing KPL-387 Phase 2/3 trial in recurrent pericarditis\" - 300 mg SC monthly group showed time to treatment response 4.0 (3.0, 6.0) days, time to CRP normalization 8.0 (7.0, 9.0) days; generally well-tolerated. Dose selected for Phase 3 PASTORALE.","created_at":"2026-10-25T07:49:41","updated_at":"2026-10-25T12:10:36Z","company":"Kiniksa Pharmaceuticals International","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":240,"join_event_id":null,"symbol":"PMN","drug":"PMN310","modality":"monoclonal_antibody","area":"cns","result_type":"interim_analysis","news_source_file":"documents/20260728_060527_(PMN)_sec_0001104659-26-087269-ex991.txt","market_impact_date":"2026-07-28","day1_return":0.238908,"day2_return":-0.03168,"prior_1w_return":-0.222812,"comments":"Blinded six-month interim safety/biomarker data from PRECISE-AD Phase 1b (n=136): \"No ARIA-E and 4.4% total ARIA (all mild and asymptomatic... ARIA-H)\"; 68.5% pTau217 decline, 62.5% CSF MTBR-tau243 decline. Trial remains blinded; not an efficacy determination.","created_at":"2026-10-25 11:35:19","updated_at":"2026-10-25T12:10:28Z","company":"ProMIS Neurosciences","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":194,"join_event_id":null,"symbol":"ALT","drug":"pemvidutide","modality":"peptide","area":"cns","result_type":"topline_results","news_source_file":"documents/20260728_070440_(ALT)_sec_0001326190-26-000044-ex991.txt","market_impact_date":"2026-07-28","day1_return":0.010135,"day2_return":-0.023411,"prior_1w_return":0.053381,"comments":"RECLAIM Ph2 AUD topline: HDD/week -4.20 vs -2.75 placebo (p=0.0014), primary endpoint met; 2-level WHO-RDL 64.4% vs 34.8% (p=0.0049); zero HDD 42.2% vs 17.4%. Company plans End-of-Phase 2 FDA meeting.","created_at":"2026-10-25 11:26:08","updated_at":"2026-10-25T12:10:24Z","company":"Altimmune","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":273,"join_event_id":null,"symbol":"MPLT","drug":"ML-007C-MA","modality":"small_molecule","area":"cns","result_type":"topline_results","news_source_file":"documents/20260727_070727_(MPLT)_sec_0001193125-26-316820-ex991.txt","market_impact_date":"2026-07-27","day1_return":-0.729076,"day2_return":0.242807,"prior_1w_return":-0.034592,"comments":"Phase 2 ZEPHYR topline in schizophrenia: 210/3 mg BID met primary endpoint (PANSS total LS mean diff -4.5 vs placebo, p=0.015, ES 0.37); cognitive composite ES 0.51 (p=0.041); generally well tolerated. 8-K exhibit 99.1 topline data presentation, July 27, 2026.","created_at":"2026-10-25 11:44:01","updated_at":"2026-10-25T12:10:32Z","company":"MapLight Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":251,"join_event_id":1184,"symbol":"OTLK","drug":"LYTENAVA (bevacizumab-vikg)","modality":"monoclonal_antibody","area":"ophthalmology","result_type":"fda_approval","news_source_file":"documents/20260724_170105_(OTLK)_sec_0001104659-26-086685-ex991.txt","market_impact_date":"2026-07-27","day1_return":-0.241993,"day2_return":-0.151174,"prior_1w_return":0.010791,"comments":"Company press release (8-K Ex-99.1) dated July 24, 2026: \"today announced that the U.S. Food and Drug Administration (FDA) has approved LYTENAVA (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (nAMD)\". First public disclosure; 10-Q confirms FDA approval on July 24, 2026.","created_at":"2026-10-25 11:37:55","updated_at":"2026-11-04T05:25:42Z","company":"Outlook Therapeutics","event_type":"pdufa","expect_date_from":"2026-07-23","expect_date_to":"2026-07-31","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":153,"join_event_id":null,"symbol":"CAMP","drug":"CMP-002","modality":"aso","area":"cns","result_type":"other","news_source_file":"documents/20260727_070141_(CAMP)_sec_0001628280-26-049661-ex991.txt","market_impact_date":"2026-07-27","day1_return":0.082278,"day2_return":0.0,"prior_1w_return":-0.148248,"comments":"Regulatory clearance: \"received clearance from Australia's Therapeutic Goods Administration (TGA) and local Human Research Ethics Committee (HREC) to initiate the Company's Phase 1/2 clinical trial of CMP-002\" in SYNGAP1-related disorder (announced 2026-07-27). 10-Q of 2026-08-13 also discloses subsequent ANMAT (Argentina) clearance. Site-opening clearance only; no data.","created_at":"2026-10-25 11:19:25","updated_at":"2026-10-25T12:10:20Z","company":"CAMP4 Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":329,"join_event_id":null,"symbol":"IKT","drug":"IKT-001","modality":"small_molecule","area":"cardiovascular","result_type":"other","news_source_file":"documents/20260723_083245_(IKT)_sec_0001193125-26-313400-ex991.txt","market_impact_date":"2026-07-23","day1_return":0.073733,"day2_return":0.0,"prior_1w_return":0.053398,"comments":"July 23, 2026: FDA granted Orphan Drug Designation to IKT-001 (imatinib active moiety) for treatment of PAH; a regulatory designation, not an approval.","created_at":"2026-10-25 11:54:15","updated_at":"2026-10-25T12:10:39Z","company":"Inhibikase Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":92,"join_event_id":null,"symbol":"CLDX","drug":"barzolvolimab","modality":"monoclonal_antibody","area":"dermatology","result_type":"topline_results","news_source_file":"documents/20260721_185247_(CLDX)_yahoo_news_yahoo-566fc81bad8d1819009dea918bcdea17-CLDX.txt","market_impact_date":"2026-07-22","day1_return":-0.024958,"day2_return":0.018694,"prior_1w_return":-0.065758,"comments":"Phase 2 prurigo nodularis study failed: \"barzolvolimab missed key goals in a mid-stage study for prurigo nodularis\" (Stocktwits/Yahoo, after-hours 2026-07-21). Q2 8-K later confirmed \"trial did not meet primary or key secondary endpoints\" and Phase 2 PN study discontinued. Earliest available source is an aggregator; no company wire/SEC release of the top-line in corpus.","created_at":"2026-10-25 11:08:00","updated_at":"2026-10-25T12:10:15Z","company":"Celldex Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":347,"join_event_id":null,"symbol":"FDMT","drug":"4D-150","modality":"gene_therapy","area":"ophthalmology","result_type":"data_presentation","news_source_file":"documents/20260720_083005_(FDMT)_sec_0001193125-26-308409.txt","market_impact_date":"2026-07-20","day1_return":0.009099,"day2_return":0.025699,"prior_1w_return":-0.10723,"comments":"\"reported positive 2-year data from the PRISM Phase 2b clinical trial\"; Q2 release notes data presented at ASRS Annual Meeting on July 18, 2026 (earlier public date). 78% treatment burden reduction overall; 87% recently diagnosed subgroup.","created_at":"2026-10-25 11:59:04","updated_at":"2026-10-25T12:10:41Z","company":"4D Molecular Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":312,"join_event_id":709,"symbol":"KLRS","drug":"TH103","modality":"protein","area":"ophthalmology","result_type":"data_presentation","news_source_file":"documents/20260717_070541_(KLRS)_sec_0001193125-26-306737-ex991.txt","market_impact_date":"2026-07-17","day1_return":-0.049892,"day2_return":-0.086758,"prior_1w_return":0.026726,"comments":"Expanded Phase 1a SAD dataset (17 treatment-naive + 3 treatment-experienced nAMD patients, 6-month follow-up): 41% first retreatment at >=4 months, 29% no additional anti-VEGF over 6 months; no IOI at 2.5 mg. First disclosure 2026-07-17 07:05 EDT 8-K exhibit; later 8-K only repeats (\"recently released\").","created_at":"2026-10-25 07:49:53","updated_at":"2026-10-25T12:10:37Z","company":"Kalaris Therapeutics","event_type":"data_presentation","expect_date_from":"2026-07-17","expect_date_to":"2026-07-17","event_closed":1,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":385,"join_event_id":null,"symbol":"CRVO","drug":"neflamapimod","modality":"small_molecule","area":"cns","result_type":"data_presentation","news_source_file":"documents/20260714_162127_(CRVO)_sec_0001437749-26-023538.txt","market_impact_date":"2026-07-15","day1_return":-0.003247,"day2_return":0.022801,"prior_1w_return":-0.099415,"comments":"\"On July 14, 2026, CervoMed Inc. ... issued a press release announcing clinical, plasma biomarker, and imaging data presented at the Alzheimer's Association International Conference 2026 in London, England related to ... neflamapimod, in the treatment of patients with dementia with Lewy bodies.\" Details are in Ex. 99.1, which is not in the workspace.","created_at":"2026-10-25 12:05:22","updated_at":"2026-10-25T12:10:45Z","company":"CervoMed","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":212,"join_event_id":null,"symbol":"RNA","drug":"ATR 1072","modality":"sirna","area":"rare_genetic","result_type":"other","news_source_file":"documents/20260714_171428_(RNA)_sec_0001193125-26-303393-ex991.txt","market_impact_date":"2026-07-15","day1_return":0.006547,"day2_return":-0.011382,"prior_1w_return":-0.077039,"comments":"\"FDA has cleared its Investigational New Drug (IND) application\" for ATR 1072, allowing the Corventis Ph 1/2 trial in PRKAG2 syndrome to proceed; Health Canada No Objection Letter also noted in the 8/13/26 release. Regulatory decision, not data.","created_at":"2026-10-25 07:28:35","updated_at":"2026-10-25T12:10:26Z","company":"Atrium Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":386,"join_event_id":null,"symbol":"CRDL","drug":"CardiolRx","modality":"small_molecule","area":"cardiovascular","result_type":"data_presentation","news_source_file":"documents/20260714_073758_(CRDL)_sec_0001279569-26-000670-ex991.txt","market_impact_date":"2026-07-14","day1_return":0.084906,"day2_return":-0.034783,"prior_1w_return":-0.009346,"comments":"Phase II MAvERIC results published in the Journal of the American Heart Association: \"rapid and sustained reductions in pericarditis pain and inflammation\". Findings previously presented at AHA Scientific Sessions; this is the peer-reviewed publication, not new topline data.","created_at":"2026-10-25 12:05:42","updated_at":"2026-10-25T12:10:45Z","company":"Cardiol Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":354,"join_event_id":null,"symbol":"ERAS","drug":"ERAS-0015","modality":"small_molecule","area":"oncology","result_type":"interim_analysis","news_source_file":"documents/20260713_161936_(ERAS)_sec_0001193125-26-302045.txt","market_impact_date":"2026-07-14","day1_return":0.089385,"day2_return":0.090256,"prior_1w_return":-0.050398,"comments":"Updated preliminary AURORAS-1 Ph1 data (DCO 2026-05-25): \"57% uORR8wk (N=7) at recommended dose for expansion (RDE) of 32 mg once daily (QD)\" in 2L+ KRAS G12X PDAC; no DLTs, no TRAE discontinuations; 16 mg panitumumab combination cohort cleared. Interim/preliminary data.","created_at":"2026-10-25 12:00:08","updated_at":"2026-10-25T12:10:42Z","company":"Erasca","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":311,"join_event_id":null,"symbol":"KMDA","drug":"CYTOGAM","modality":"protein","area":"infectious","result_type":"data_presentation","news_source_file":"documents/20260713_074616_(KMDA)_sec_0001213900-26-077360-ex991.txt","market_impact_date":"2026-07-13","day1_return":0.007023,"day2_return":0.013947,"prior_1w_return":-0.050667,"comments":"Kamada highlighted investigator-initiated study results \"recently presented at the 2026 International Society for Heart and Lung Transplant (ISHLT) annual meeting, held in Toronto, Canada\" as three posters: CMV high-risk lung transplant recipients on CMVIG prophylaxis had improved outcomes. Exact presentation date not stated; company release July 13, 2026. Full publication expected \"later this year\" (no date).","created_at":"2026-10-25 11:50:04","updated_at":"2026-10-25T12:10:37Z","company":"Kamada","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":228,"join_event_id":null,"symbol":"QTTB","drug":"bempikibart","modality":"monoclonal_antibody","area":"dermatology","result_type":"topline_results","news_source_file":"documents/20260713_070959_(QTTB)_sec_0001193125-26-301464-ex991.txt","market_impact_date":"2026-07-13","day1_return":0.907226,"day2_return":-0.136576,"prior_1w_return":-0.143621,"comments":"Positive 36-week topline results from Part B of SIGNAL-AA Phase 2a; mean SALT reduction 35.3% (mITT), SALT-20 40.0% mITT / 30.3% ITT; \"positive 36-week topline results from Part B of the SIGNAL-AA Phase 2a clinical trial evaluating bempikibart\". No prior event on file for this readout.","created_at":"2026-10-25 11:33:20","updated_at":"2026-10-25T12:10:27Z","company":"Q32 Bio","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":191,"join_event_id":null,"symbol":"AGEN","drug":"botensilimab + balstilimab","modality":"monoclonal_antibody","area":"oncology","result_type":"trial_discontinuation","news_source_file":"documents/20260713_063023_(AGEN)_sec_0001193125-26-301414-ex991.txt","market_impact_date":"2026-07-13","day1_return":0.826866,"day2_return":-0.169935,"prior_1w_return":-0.040115,"comments":"Agenus discontinued financial support for the CCTG-sponsored BATTMAN Phase 3 (late-line MSS mCRC); CCTG formally terminated the study. 10-Q: decision \"was not driven by enrollment performance, efficacy or safety findings, or an interim analysis.\"","created_at":"2026-10-25 11:25:35","updated_at":"2026-10-25T12:10:23Z","company":"Agenus","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":184,"join_event_id":null,"symbol":"ARMP","drug":"AP-SA02","modality":"other","area":"infectious","result_type":"other","news_source_file":"documents/20260713_071125_(ARMP)_sec_0001104659-26-082850-ex991.txt","market_impact_date":"2026-07-13","day1_return":-0.068075,"day2_return":-0.012594,"prior_1w_return":-0.27674,"comments":"FDA agreement on an Agreed Initial Pediatric Study Plan (iPSP) for AP-SA02: \"has received agreement from the U.S. Food and Drug Administration ... on an Agreed Initial Pediatric Study Plan\". Regulatory milestone, not a data readout or approval; pediatric studies deferred until adult Phase 3 data.","created_at":"2026-10-25 07:24:12","updated_at":"2026-10-25T12:10:23Z","company":"Armata Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":375,"join_event_id":null,"symbol":"IONS","drug":"eplontersen","modality":"aso","area":"cardiovascular","result_type":"topline_results","news_source_file":"documents/20260709_145522_(IONS)_sec_0001140361-26-028092-ex991.txt","market_impact_date":"2026-07-09","day1_return":-0.239048,"day2_return":-0.093667,"prior_1w_return":0.065204,"comments":"\"CARDIO-TTRansform Phase 3 trial for eplontersen in patients with ATTR-CM did not meet the primary efficacy endpoint\" of CV mortality and recurrent CV events vs placebo; prespecified monotherapy subgroup nominal HR 0.71 and favorable safety. Full data to be shared at ESC Congress in August 2026.","created_at":"2026-10-25T08:09:00","updated_at":"2026-10-25T12:10:11Z","company":"Ionis Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":289,"join_event_id":null,"symbol":"MCRB","drug":"SER-155","modality":"other","area":"oncology","result_type":"topline_results","news_source_file":"documents/20260708_080009_(MCRB)_sec_0001193125-26-298005-ex991.txt","market_impact_date":"2026-07-08","day1_return":-0.12285,"day2_return":-0.056022,"prior_1w_return":0.044929,"comments":"8-K Ex.99.1 (Jul 8, 2026): \"today announced encouraging top-line results from an IST evaluating SER-155 in patients with irEC\"; 12/15 (80%) immunosuppressive-free clinical response at Day 15 (primary endpoint); well tolerated, no related SAEs. IST at MSK, NCT06801067. Repeated in Aug 5 Q2 release/10-Q.","created_at":"2026-10-25 11:45:57","updated_at":"2026-10-25T12:10:34Z","company":"Seres Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":275,"join_event_id":621,"symbol":"MSLE","drug":"forazapadin","modality":"small_molecule","area":"rare_genetic","result_type":"interim_analysis","news_source_file":"documents/20260708_063004_(MSLE)_sec_0001171843-26-004525-ex991.txt","market_impact_date":"2026-07-08","day1_return":0.093788,"day2_return":0.051225,"prior_1w_return":0.040558,"comments":"Jul 8, 2026 release (drug then called SAT-3247): \"six-month interim data from TRAILHEAD\" in four DMD adults showed reduced muscle fat fraction, increased total effort, stable strength, lower CK and a favorable safety profile. Also webcast same day.","created_at":"2026-10-25 11:44:30","updated_at":"2026-10-25T12:10:33Z","company":"Satellos Bioscience","event_type":"interim_analysis","expect_date_from":"2026-07-01","expect_date_to":"2026-12-31","event_closed":1,"tier":"Watch","llm_prediction":"large_impact","llm_confidence":0.55,"llm_reason":"Satellos is a ~$140M single-asset company, and the 2H26 interim data on SAT-3247 (forazapadin) in Duchenne is binary for the stock. An open-label TRAILHEAD update or a BASECAMP interim likely moves shares at least 10%, but the document gives no basis for calling the direction.","llm_predicted_at":"2026-10-25T15:53:03Z","llm_source":"backtest"},{"id":254,"join_event_id":null,"symbol":"OKYO","drug":"urcosimod","modality":"peptide","area":"ophthalmology","result_type":"other","news_source_file":"documents/20260708_070015_(OKYO)_sec_0001493152-26-032407-ex991.txt","market_impact_date":"2026-07-08","day1_return":-0.051429,"day2_return":0.012048,"prior_1w_return":0.151316,"comments":"Announced \"positive feedback from its U.S. Food and Drug Administration (FDA) Type D meeting, validating the Company's regulatory and clinical path forward for urcosimod\"; FDA aligned on a single-dose Phase 3 design and potential single-trial registration pathway.","created_at":"2026-10-25 11:40:11","updated_at":"2026-10-25T12:10:30Z","company":"OKYO Pharma","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":96,"join_event_id":null,"symbol":"AMPH","drug":null,"modality":null,"area":"other","result_type":"other","news_source_file":"documents/20260707_200350_(AMPH)_sec_0001297184-26-000041.txt","market_impact_date":"2026-07-08","day1_return":-0.059761,"day2_return":0.007415,"prior_1w_return":-0.03042,"comments":"FDA warning letter to subsidiary International Medication Systems (South El Monte, CA facility) received July 2, 2026, disclosed in 8-K filed July 7, 2026: \"On July 2, 2026, International Medication Systems, Limited (\"IMS\") ... received a warning letter ... from the FDA.\" Cites cGMP violations (investigation procedures, environmental monitoring, equipment); does not require ceasing distribution. No drug named; no resolution timing given.","created_at":"2026-10-25 11:08:46","updated_at":"2026-10-25T12:10:15Z","company":"Amphastar Pharmaceuticals","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":398,"join_event_id":null,"symbol":"CMPS","drug":"COMP360","modality":"small_molecule","area":"cns","result_type":"data_presentation","news_source_file":"documents/20260707_063323_(CMPS)_sec_0001816590-26-000047-ex991.txt","market_impact_date":"2026-07-07","day1_return":0.011682,"day2_return":0.075058,"prior_1w_return":-0.133603,"comments":"Phase 3 COMP006 Part B 26-week results: \"26-week data demonstrate rapid onset and remarkable durability through at least 6 months\"; 25mg separated from control through week 26; AEs mostly transient on dosing day. Disclosed via 8-K item 7.01 presentation/webcast on July 7, 2026; 10-Q confirms \"In July 2026, we announced Part B results from our ongoing Phase 3 COMP006 trial\".","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:46Z","company":"COMPASS Pathways Plc American Depository Shares","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":141,"join_event_id":null,"symbol":"TTRX","drug":"GX-03","modality":"other","area":"dermatology","result_type":"interim_analysis","news_source_file":"documents/20260707_080525_(TTRX)_sec_0001213900-26-075757-ex991.txt","market_impact_date":"2026-07-07","day1_return":0.262679,"day2_return":-0.053553,"prior_1w_return":0.109668,"comments":"Turn announced completion of the comprehensive Stage 1 interim analysis of the adaptive Phase 2 AD trial: EASI 1.1-7.0 subgroup Week 4 vIGA-AD success 71.4% vs 33.3%; representative subgroup Week 4 vIGA-AD success 61.5% (8/13) vs 8.3% (1/12). No treatment-related SAEs. Same data repeated in 2026-08-12 release.","created_at":"2026-10-25","updated_at":"2026-10-25T12:10:19Z","company":"Turn Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":140,"join_event_id":null,"symbol":"TVRD","drug":"TTI-109","modality":"small_molecule","area":"immunology","result_type":"topline_results","news_source_file":"documents/20260707_070235_(TVRD)_sec_0001104659-26-080930-ex991.txt","market_impact_date":"2026-07-07","day1_return":0.542289,"day2_return":0.612903,"prior_1w_return":0.34,"comments":"First disclosure July 7, 2026 8-K: Phase 1 healthy volunteer study of TTI-109 confirmed prodrug conversion, TTI-101-equivalent exposure, improved tolerability (diarrhea 0.46 vs 3.35 days) and up to 60% reductions in STAT3-driven Th17/Tfh/B cell subsets. Repeated in later filings.","created_at":"2026-10-25 11:16:57","updated_at":"2026-10-25T12:10:19Z","company":"Tvardi Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":133,"join_event_id":null,"symbol":"VERA","drug":"atacicept","modality":"protein","area":"renal","result_type":"fda_approval","news_source_file":"documents/20260707_124557_(VERA)_sec_0001193125-26-297211.txt","market_impact_date":"2026-07-07","day1_return":0.070521,"day2_return":-0.012337,"prior_1w_return":-0.054875,"comments":"8-K (2026-07-07): FDA granted accelerated approval to TRUTAKNA (atacicept-vymj) to reduce proteinuria in adults with primary IgAN at risk of progression; based on prespecified ORIGIN 3 interim analysis (42% proteinuria reduction vs placebo at 36 weeks).","created_at":"2026-10-25 07:14:56","updated_at":"2026-10-25T12:10:18Z","company":"Vera Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":318,"join_event_id":null,"symbol":"IVVD","drug":"pemivibart","modality":"monoclonal_antibody","area":"infectious","result_type":"other","news_source_file":"documents/20260706_071145_(IVVD)_sec_0001193125-26-295539-ex991.txt","market_impact_date":"2026-07-06","day1_return":-0.067114,"day2_return":0.129496,"prior_1w_return":0.017065,"comments":"FDA sent Invivyd a Notice of Termination of the PEMGARDA EUA after HHS advance notice of termination of the COVID-19 EUA declaration; EUA \"set to terminate on June 29, 2027\" after a twelve-month transition period. Company release 2026-07-06.","created_at":"2026-10-25 11:51:21","updated_at":"2026-10-25T12:10:37Z","company":"Invivyd","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":268,"join_event_id":null,"symbol":"NCEL","drug":"NCEL-101","modality":"cell_therapy","area":"metabolic","result_type":"other","news_source_file":"documents/20260701_093001_(NCEL)_sec_0001213900-26-074040-ex991.txt","market_impact_date":"2026-07-01","day1_return":0.051913,"day2_return":0.0,"prior_1w_return":0.033898,"comments":"Earliest disclosure of FDA outcome: \"announced the successful completion of its Type B Pre-IND meeting with the U.S. Food and Drug Administration\"; agency gave \"constructive feedback and alignment on the Company's proposed development strategy\" for NCEL-101 + Eledon tegoprubart in T1D, allowing progression toward IND-enabling activities. No IND date guided.","created_at":"2026-10-25 11:42:58","updated_at":"2026-10-25T12:10:32Z","company":"NewcelX","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":76,"join_event_id":null,"symbol":"SXTP","drug":"tafenoquine","modality":"small_molecule","area":"infectious","result_type":"interim_analysis","news_source_file":"documents/20260701_080200_(SXTP)_yahoo_news_yahoo-5f1189a8ad8372ded74044131d6c3ad9-SXTP.txt","market_impact_date":"2026-07-01","day1_return":-0.005682,"day2_return":-0.022857,"prior_1w_return":0.047619,"comments":"B-FREE Phase 2 chronic babesiosis study (Icahn School of Medicine at Mount Sinai): independent DSMB \"identifies no safety concerns and recommends continuation of the clinical trial.\" No efficacy data disclosed. Source is a syndicated GlobeNewswire item via Yahoo (document truncated); no SEC exhibit or primary wire file available.","created_at":"2026-10-25 07:02:50","updated_at":"2026-10-25T12:10:13Z","company":"60 DEGREES PHARMACEUTICALS, INC","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":278,"join_event_id":null,"symbol":"MNPR","drug":"ALXN1840","modality":"small_molecule","area":"rare_genetic","result_type":"other","news_source_file":"documents/20260630_080016_(MNPR)_sec_0001437749-26-022086.txt","market_impact_date":"2026-06-30","day1_return":-0.020833,"day2_return":0.026353,"prior_1w_return":0.377221,"comments":"8-K (June 30, 2026): \"FDA granted Rare Pediatric Disease designation to ALXN1840 (tiomolibdate choline).\" Designation, not approval; gives potential for a pediatric Priority Review Voucher at NDA approval.","created_at":"2026-10-25 11:44:31","updated_at":"2026-10-25T12:10:33Z","company":"Monopar Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":238,"join_event_id":null,"symbol":"ACIU","drug":"ACI-24","modality":"vaccine","area":"cns","result_type":"interim_analysis","news_source_file":"documents/20260630_090312_(ACIU)_sec_0000950103-26-009745-ex991.txt","market_impact_date":"2026-06-30","day1_return":-0.105263,"day2_return":0.0,"prior_1w_return":0.064,"comments":"Interim 12-month data from cohorts AD1-AD3 (n=74) of Phase 1b/2 ABATE in prodromal AD: \"generally safe and well tolerated, with no evidence of amyloid-related imaging abnormalities-edema (ARIA-E)\"; anti-Abeta antibody dose-response at all dose levels.","created_at":"2026-10-25 10:30:00","updated_at":"2026-10-25T12:10:28Z","company":"AC Immune","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":198,"join_event_id":null,"symbol":"AKBA","drug":"vadadustat","modality":"small_molecule","area":"renal","result_type":"interim_analysis","news_source_file":"documents/20260630_080511_(AKBA)_sec_0001517022-26-000047-ex991.txt","market_impact_date":"2026-06-30","day1_return":0.027027,"day2_return":0.061404,"prior_1w_return":0.018349,"comments":"VOICE trial (USRC-sponsored, TIW vadadustat vs ESA) planned interim analysis, data cutoff June 1, 2026, met stopping criteria: win odds 1.16 (95% CI 1.06-1.28, p=0.0016); \"Primary Investigator to stop trial on recommendation from Independent Data Monitoring Committee\"; full data to be submitted to upcoming scientific meeting (no date given).","created_at":"2026-10-25T07:30:00","updated_at":"2026-10-25T12:10:24Z","company":"Akebia Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":352,"join_event_id":null,"symbol":"EVMN","drug":"EVO756","modality":"small_molecule","area":"dermatology","result_type":"topline_results","news_source_file":"documents/20260629_083215_(EVMN)_sec_0001193125-26-286918-ex991.txt","market_impact_date":"2026-06-29","day1_return":-0.402303,"day2_return":-0.116944,"prior_1w_return":0.178839,"comments":"Phase 2b in chronic spontaneous urticaria (N=160) \"did not meet the primary endpoint of mean change in a patients Urticaria Activity Score over seven days (UAS7) at 12 weeks at any dose.\" No prior guided-window event on file.","created_at":"2026-10-25T07:59:11","updated_at":"2026-10-25T12:10:42Z","company":"Evommune","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":292,"join_event_id":null,"symbol":"LRMR","drug":"nomlabofusp","modality":"protein","area":"rare_genetic","result_type":"topline_results","news_source_file":"documents/20260629_063336_(LRMR)_sec_0001193125-26-286780-ex991.txt","market_impact_date":"2026-06-29","day1_return":-0.125683,"day2_return":-0.046875,"prior_1w_return":0.005495,"comments":"Company announced positive long-term open label data: \"a mean 1.0-point improvement in mFARS with nomlabofusp treatment compared to a mean 1.6-point worsening in FACOMS\"; 100% (9/9) reached skin FXN levels comparable to carriers at 1 year; 10/41 anaphylaxis. First disclosed June 29, 2026 (webcast 7:45 a.m. EDT).","created_at":"2026-10-25 07:46:30","updated_at":"2026-10-25T12:10:34Z","company":"Larimar Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":276,"join_event_id":null,"symbol":"MSLE","drug":"forazapadin","modality":"small_molecule","area":"rare_genetic","result_type":"other","news_source_file":"documents/20260629_070009_(MSLE)_sec_0001171843-26-004332-ex991.txt","market_impact_date":"2026-06-29","day1_return":0.114407,"day2_return":-0.014575,"prior_1w_return":0.23993,"comments":"Jun 29, 2026 release: \"FDA has granted Fast Track designation to SAT-3247 for the treatment of Duchenne\" (DMD). Regulatory designation; drug now named forazapadin.","created_at":"2026-10-25 11:44:30","updated_at":"2026-10-25T12:10:33Z","company":"Satellos Bioscience","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":266,"join_event_id":null,"symbol":"NGNE","drug":"NGN-401","modality":"gene_therapy","area":"cns","result_type":"interim_analysis","news_source_file":"documents/20260629_080050_(NGNE)_sec_0001404644-26-000046.txt","market_impact_date":"2026-06-29","day1_return":0.007805,"day2_return":-0.025712,"prior_1w_return":0.015858,"comments":"\"press release announcing positive, updated clinical data from its Phase 1/2 trial evaluating NGN-401 gene therapy\" for Rett syndrome; data cutoff June 16, 2026 (10-Q, 2026-08-11): 10/10 improved CGI-I and gained milestones, up to 30 months. Announced via 8-K/conference call.","created_at":"2026-10-25 11:42:31","updated_at":"2026-10-25T12:10:32Z","company":"Neurogene","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"Watch","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null},{"id":128,"join_event_id":null,"symbol":"VRDN","drug":"veligrotug","modality":"monoclonal_antibody","area":"ophthalmology","result_type":"fda_approval","news_source_file":"documents/20260626_181831_(VRDN)_sec_0001193125-26-286273-ex991.txt","market_impact_date":"2026-06-29","day1_return":0.049721,"day2_return":-0.022352,"prior_1w_return":0.076368,"comments":"FDA approved Lumvoa (veligrotug-vvze) for thyroid eye disease on June 26, 2026, ahead of target PDUFA date; immediate U.S. launch; first commercial product for Viridian.","created_at":"2026-10-25 11:14:25","updated_at":"2026-10-25T12:10:17Z","company":"Viridian Therapeutics","event_type":null,"expect_date_from":null,"expect_date_to":null,"event_closed":null,"tier":"","llm_prediction":null,"llm_confidence":null,"llm_reason":null,"llm_predicted_at":null,"llm_source":null}]