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Biotech catalysts, dated precisely.

2026-11-05 09:29 ET
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Recent results

Announced data, decisions, and holds. Returns run from the first session that could react.

Impact date▼ Symbol Drug Result Tier LLM predict Day 1 Day 2 Prior 1w Event window Source Notes
2026-11-05 IOVAIovance Biotherapeutics lifileucel cell therapy · oncology interim_analysis Watch — — — — — document 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.
2026-11-05 MLYSMineralys Therapeutics lorundrostat small molecule · respiratory topline_results Watch — — — — — document 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.
2026-11-04 HRMYHarmony Biosciences Holdings BP-205 small molecule · cns topline_resultsevent closed Watch small impact 78% confidence -7.04% — -2.45% 2026-10-01 → 2026-12-31 document 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."
2026-11-04 CORTCorcept Therapeutics miricorilant small molecule · gi hepatology topline_resultsevent closed Watch small impact 80% confidence -3.31% — -6.46% 2026-07-29 → 2026-12-31 document 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.
2026-11-03 CMPSCOMPASS Pathways Plc American Depository Shares COMP360 small molecule · cns topline_results Watch — +2.14% +0.12% -23.89% — document 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.
2026-11-02 TLSATiziana Life Sciences foralumab monoclonal antibody · cns topline_resultsevent closed Watch large impact 55% confidence -16.25% +3.00% -15.79% 2026-10-01 → 2026-12-31 document 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.
2026-11-02 SPTXSeaport Therapeutics GlyphAllo small molecule · cns topline_resultsevent closed Watch small impact 72% confidence +2.09% +0.95% -4.90% 2026-07-01 → 2026-12-31 document 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.
2026-10-30 ABOSAcumen Pharmaceuticals sabirnetug monoclonal antibody · cns topline_resultsevent closed Core large impact 80% confidence -90.83% +14.14% +11.16% 2026-11-01 → 2026-11-30 document 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.
2026-10-30 IOVAIovance Biotherapeutics lifileucel cell therapy · oncology topline_resultsevent closed Core large upside 50% confidence -11.30% -5.42% -32.39% 2026-10-29 document 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.
2026-10-29 CHRSCoherus Oncology tagmokitug monoclonal antibody · oncology interim_analysisevent closed Core large impact 50% confidence -22.59% -0.09% +13.73% 2026-10-28 document 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.
2026-10-28 ECORelectroCore Quell other · oncology topline_resultsevent closed Core — +8.51% -3.68% +3.60% 2026-10-28 document 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%.
2026-10-28 MLYSMineralys Therapeutics lorundrostat small molecule · renal topline_results Watch — +1.18% -0.65% -2.09% — document 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.
2026-10-27 ONCYOncolytics Biotech pelareorep other · oncology topline_resultsevent closed Watch small impact 68% confidence -2.13% -3.76% -6.00% 2026-10-14 → 2026-12-31 document 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.
2026-10-27 VNDAVanda Pharmaceuticals tradipitant (NEREUS) small molecule · gi hepatology topline_resultsevent closed Watch small impact 60% confidence +1.27% -2.88% -3.67% 2026-08-05 → 2026-12-31 document "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.
2026-10-27 SXTP60 DEGREES PHARMACEUTICALS, INC tafenoquine small molecule · infectious interim_analysisevent closed Core — -14.75% +12.82% +4.96% 2026-11-01 → 2026-11-30 document 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.
2026-10-27 ACRSAclaris Therapeutics ATI-052 bispecific · immunology topline_resultsevent closed Watch large impact 50% confidence +0.00% +4.49% +8.91% 2026-07-01 → 2026-12-31 document 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.
2026-10-26 CORTCorcept Therapeutics relacorilant small molecule · oncology topline_resultsevent closed Watch — +1.48% +0.53% -22.06% 2026-07-29 → 2026-12-31 document 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.
2026-10-26 ORKAOruka Therapeutics ORKA-001 monoclonal antibody · dermatology topline_resultsevent closed Core small impact 60% confidence +12.70% +6.42% +11.43% 2026-10-26 document 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.
2026-10-26 MIRMMirum Pharmaceuticals zilurgisertib small molecule · rare genetic topline_results Watch — +3.58% +0.73% +0.31% — document 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.
2026-10-23 CPIXCumberland Pharmaceuticals ifetroban small molecule · immunology topline_results Watch — +0.12% -48.76% +12.47% — document 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.
2026-10-23 XBITXBiotech — oncology topline_results Watch — -2.03% -4.15% -8.80% — document 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.
2026-10-23 HUMAHumacyte ATEV (Symvess) other · renal interim_analysisevent closed Core — +5.33% -7.82% -6.14% 2026-10-22 document 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.
2026-10-23 ELTXElicio Therapeutics camupepimut (ELI-002 7P) peptide · oncology topline_resultsevent closed Core — -2.06% -10.53% +8.99% 2026-10-23 document 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).
2026-10-23 CATXPerspective Therapeutics VMT-alpha-NET radiopharma · oncology interim_analysisevent closed Core — -28.76% -24.84% -3.42% 2026-10-23 → 2026-10-27 document 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"
2026-10-23 AARDAardvark Therapeutics ARD-101 small molecule · rare genetic interim_analysisevent closed Watch large impact 45% confidence · backtest -64.81% -22.30% +2.33% 2026-07-01 → 2026-09-30 document 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.
2026-10-22 SCYXSCYNEXIS SCY-247 small molecule · infectious topline_resultsevent closed Watch large downside 45% confidence · backtest +0.66% -0.66% -4.42% 2026-07-01 → 2026-09-30 document 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.
2026-10-20 RAPPRapport Therapeutics RAP-219 small molecule · cns topline_resultsevent closed Core large impact 55% confidence · backtest +2.69% -14.67% -5.14% 2026-10-01 → 2026-10-31 document 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.
2026-10-20 ODTXOdyssey Therapeutics OD-001 small molecule · gi hepatology topline_resultsevent closed Core — +4.92% +0.05% -0.88% 2026-10-20 document 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.
2026-10-19 IRONDisc Medicine bitopertin small molecule · rare genetic topline_resultsevent closed Watch large upside 45% confidence · backtest +38.86% +0.70% -8.41% 2026-10-01 → 2026-12-31 document 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.
2026-10-19 EYPTEyePoint DURAVYU small molecule · ophthalmology topline_resultsevent closed Watch large impact 72% confidence · backtest -85.28% -6.82% -12.06% 2026-10-01 → 2026-12-31 document "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.
2026-10-19 MANEVeradermics VDPHL01 small molecule · dermatology topline_resultsevent closed Watch small impact 62% confidence · backtest +12.37% +3.95% -16.87% 2026-07-01 → 2026-12-31 document 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.
2026-10-16 RGNXREGENXBIO RGX-202 gene therapy · rare genetic topline_results Watch — -3.28% +3.25% -11.50% — document 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.
2026-10-15 RXRXRecursion Pharmaceuticals REC-1245 small molecule · oncology interim_analysisevent closed Watch small impact 68% confidence +11.23% -16.71% -12.41% 2026-07-01 → 2026-12-31 document 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.
2026-10-15 RXRXRecursion Pharmaceuticals REC-4881 small molecule · gi hepatology interim_analysisevent closed Core — +11.23% -16.71% -12.41% 2026-11-02 document "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).
2026-10-15 VNDAVanda Pharmaceuticals VQW-765 small molecule · cns topline_resultsevent closed Watch small impact 60% confidence · backtest +0.47% -4.95% -7.46% 2026-08-05 → 2026-12-31 document "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.
2026-10-14 ARWRArrowhead Pharmaceuticals ARO-MAPT sirna · cns interim_analysisevent closed Core — +0.41% +0.22% -5.54% 2026-10-14 document "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).
2026-10-14 BMEABiomea Fusion BMF-650 small molecule · metabolic topline_resultsevent closed Core large impact 60% confidence · backtest -33.81% +0.24% +0.80% 2026-10-13 document 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.
2026-10-14 VSTMVerastem VS-7375 small molecule · oncology interim_analysisevent closed Core large impact 50% confidence · backtest +3.49% +19.71% -3.87% 2026-10-01 → 2026-10-31 document 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).
2026-10-14 TRDAEntrada Therapeutics ENTR-601-44 aso · rare genetic interim_analysis Watch — -6.38% +5.05% -10.33% — document 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.
2026-10-14 TRDAEntrada Therapeutics ENTR-601-45 aso · rare genetic topline_resultsevent closed Core large impact 45% confidence · backtest -6.38% +5.05% -10.33% 2026-10-01 → 2026-10-31 document 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.
2026-10-13 SNDXSyndax Pharmaceuticals axatilimab monoclonal antibody · respiratory topline_resultsevent closed Watch small impact 60% confidence -15.71% -3.01% -7.18% 2026-10-01 → 2026-12-31 document 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.
2026-10-13 BEAMBeam Therapeutics BEAM-301 gene therapy · metabolic interim_analysisevent closed Watch small impact 62% confidence -2.79% -3.19% -2.10% 2026-08-04 → 2026-12-31 document 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.
2026-10-13 TRAXFirst Tracks Biotherapeutics ANB033 monoclonal antibody · gi hepatology topline_resultsevent closed Watch large impact 60% confidence -6.96% +7.73% +3.21% 2026-10-01 → 2026-12-31 document 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.
2026-10-13 MIRMMirum Pharmaceuticals maralixibat small molecule · gi hepatology topline_resultsevent closed Watch small impact 72% confidence · backtest -7.48% +0.43% +5.69% 2026-10-01 → 2026-12-31 document 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.
2026-10-06 OSTXOS Therapies OST-HER2 vaccine · oncology topline_results Watch — -6.88% +4.03% -3.03% — document 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.
2026-10-06 AVBPArriVent BioPharma firmonertinib small molecule · oncology topline_resultsevent closed Watch large impact 60% confidence · backtest -46.98% +11.93% -2.87% 2026-07-01 → 2026-12-31 document 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.
2026-10-06 SXTP60 DEGREES PHARMACEUTICALS, INC tafenoquine small molecule · infectious interim_analysisevent closed Watch large impact 55% confidence · backtest -22.92% -0.90% +15.20% 2026-07-29 → 2026-10-06 document 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.
2026-10-05 PCVXVaxcyte VAX-31 vaccine · infectious topline_resultsevent closed Watch large impact 55% confidence · backtest +30.70% -9.65% +0.48% 2026-10-01 → 2026-12-31 document 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.
2026-10-01 GLUEMonte Rosa Therapeutics MRT-8102 small molecule · cardiovascular topline_resultsevent closed Watch large downside 50% confidence · backtest -5.62% -6.75% +0.34% 2026-07-01 → 2026-12-31 document 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.
2026-09-30 VNDAVanda Pharmaceuticals tasimelteon (HETLIOZ) small molecule · cns topline_resultsevent closed Watch small impact 68% confidence -2.39% -2.04% -3.45% 2026-08-05 → 2026-12-31 document "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.
2026-09-30 CNTBConnect Biopharma Holdings rademikibart monoclonal antibody · respiratory topline_resultsevent closed Core large impact 68% confidence · backtest +10.89% -10.91% -18.35% 2026-09-01 → 2026-09-30 document 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.
2026-09-30 EPRXEupraxia Pharmaceuticals EP-104GI small molecule · gi hepatology interim_analysis Watch — +9.57% -13.96% -3.21% — document 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.
2026-09-30 RFLRafael Holdings Trappsol Cyclo other · rare genetic topline_resultsevent closed Watch large impact 60% confidence · backtest -34.98% +13.64% +1.50% 2026-07-01 → 2026-12-31 document 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.
2026-09-30 TECXTectonic Therapeutic TX2100 monoclonal antibody · rare genetic topline_resultsevent closed Watch small impact 80% confidence · backtest -0.21% -2.66% -11.92% 2026-08-06 → 2026-09-30 document 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.
2026-09-29 IMMXImmix Biopharma NXC-201 cell therapy · hematology interim_analysis Watch — -8.11% -1.28% -8.02% — document 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.
2026-09-29 IVVDInvivyd VYD2311 monoclonal antibody · infectious topline_resultsevent closed Core large impact 60% confidence · backtest -10.53% +2.35% -6.86% 2026-09-01 → 2026-09-30 document 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.
2026-09-29 QUREuniQure ifezuntirgene inilparvovec (AMT-130) gene therapy · cns topline_resultsevent closed Core large impact 55% confidence · backtest -37.33% -1.43% -11.74% 2026-09-01 → 2026-09-30 document 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.
2026-09-29 RNACCartesian Therapeutics Descartes-08 cell therapy · cns interim_analysis Watch — +0.42% -0.41% -9.19% — document 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.
2026-09-28 FDMT4D Molecular Therapeutics 4D-150 gene therapy · ophthalmology topline_resultsevent closed Watch small impact 72% confidence · backtest +0.62% -0.48% -4.93% 2026-10-01 → 2026-12-31 document "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.
2026-09-28 KODKodiak Sciences KSI-501 bispecific · ophthalmology topline_resultsevent closed Core large impact 60% confidence · backtest +177.96% +1.33% -1.10% 2026-09-01 → 2026-09-30 document 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.
2026-09-28 KODKodiak Sciences tarcocimab tedromer monoclonal antibody · ophthalmology topline_resultsevent closed Core large impact 60% confidence · backtest +177.96% +1.33% -1.10% 2026-09-01 → 2026-09-30 document 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.
2026-09-28 MIRMMirum Pharmaceuticals brelovitug monoclonal antibody · infectious topline_resultsevent closed Watch large upside 45% confidence · backtest -1.94% -0.48% -2.32% 2026-07-01 → 2026-09-30 document 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.
2026-09-28 RNAZTransCode Therapeutics TTX-MC138 other · oncology interim_analysis Watch — +1.18% -4.68% +2.42% — document 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.
2026-09-28 ACETAdicet Bio prula-cel cell therapy · immunology interim_analysisevent closed Core large downside 50% confidence · backtest -29.60% +7.56% -1.74% 2026-09-28 document 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.
2026-09-25 ACADACADIA Pharmaceuticals remlifanserin small molecule · cns topline_resultsevent closed Watch large impact 55% confidence · backtest -6.76% -0.73% -19.20% 2026-09-01 → 2026-10-31 document 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.
2026-09-24 KYTXKyverna Therapeutics mivocabtagene autoleucel cell therapy · cns topline_resultsevent closed Watch small impact 60% confidence · backtest -1.13% -2.58% +2.46% 2026-07-01 → 2026-09-30 document 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).
2026-09-23 IMVTImmunovant IMVT-1402 monoclonal antibody · dermatology topline_resultsevent closed Watch small impact 68% confidence · backtest -7.37% -1.56% +1.75% 2026-07-01 → 2026-12-31 document 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.
2026-09-23 ORKAOruka Therapeutics ORKA-001 monoclonal antibody · dermatology interim_analysisevent closed Core small impact 62% confidence · backtest -4.89% -4.94% +2.55% 2026-09-01 → 2026-09-30 document "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.
2026-09-23 ARCTArcturus Therapeutics Holdings ARCT-810 other · rare genetic interim_analysisevent closed Watch small impact 50% confidence · backtest -7.51% +6.17% -9.22% 2026-08-06 → 2026-09-30 document 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.
2026-09-23 IONSIonis Pharmaceuticals sefaxersen aso · renal interim_analysisevent closed Watch large impact 80% confidence · backtest -3.98% -0.27% -3.17% 2026-01-01 → 2026-12-31 document 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.
2026-09-23 ACIUAC Immune ACI-7104 vaccine · cns topline_resultsevent closed Watch small impact 50% confidence · backtest +3.66% -6.01% +1.87% 2026-07-01 → 2026-12-31 document 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.
2026-09-22 IONSIonis Pharmaceuticals ulefnersen aso · cns topline_resultsevent closed Watch small impact 80% confidence +1.89% -3.98% -12.71% 2026-01-01 → 2026-12-31 document 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.
2026-09-22 PHARPharming Group leniolisib small molecule · immunology topline_resultsevent closed Core — +4.16% -4.35% -0.09% 2026-10-14 → 2026-10-17 document "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.
2026-09-22 VKTXViking Therapeutics VK2735 peptide · metabolic topline_resultsevent closed Watch small impact 55% confidence · backtest +35.67% +1.96% -4.50% 2026-07-01 → 2026-09-30 document 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.
2026-09-22 ANABAnaptysBio dostarlimab monoclonal antibody · oncology interim_analysis Watch — -1.82% -5.84% +1.50% — document 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.
2026-09-22 CLDXCelldex Therapeutics barzolvolimab monoclonal antibody · dermatology topline_resultsevent closed Watch large impact 55% confidence · backtest -11.56% -7.13% -3.29% 2026-09-01 → 2026-10-31 document 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".
2026-09-21 CUECue Biopharma CUE-221 monoclonal antibody · immunology topline_resultsevent closed Watch large impact 60% confidence · backtest -23.70% +9.30% +28.91% 2026-07-10 → 2026-09-30 document 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.
2026-09-21 ALKSAlkermes ALKS 7290 small molecule · cns topline_results Watch — +1.82% -2.01% -5.61% — document 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.
2026-09-15 ARWRArrowhead Pharmaceuticals ARO-DIMER-PA sirna · cardiovascular topline_resultsevent closed Core — -12.40% -6.91% -6.57% 2026-09-15 document 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.
2026-09-15 BIVIBioVie Bezisterim small molecule · infectious topline_resultsevent closed Watch large impact 60% confidence · backtest -14.63% -1.71% +2.50% 2026-08-01 → 2026-09-22 document 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.
2026-09-15 CNTBConnect Biopharma Holdings rademikibart monoclonal antibody · respiratory topline_resultsevent closed Core large impact 68% confidence · backtest -32.17% +5.98% -6.25% 2026-09-01 → 2026-09-30 document 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.
2026-09-15 CTNMContineum Therapeutics JNJ-5120/PIPE-307 small molecule · cns topline_results Watch — -6.75% -0.43% -11.26% — document 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.
2026-09-15 VERAVera Therapeutics atacicept protein · renal topline_resultsevent closed Watch large impact 68% confidence · backtest -1.12% -5.64% -5.13% 2026-07-01 → 2026-09-30 document 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).
2026-09-14 MDWDMediWound EscharEx protein · other interim_analysis Watch — +5.87% -2.95% -0.76% — document 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.
2026-09-14 CRBPCorbus Pharmaceuticals Holdings CRB-913 small molecule · metabolic topline_resultsevent closed Core large downside 62% confidence · backtest -0.49% -14.36% -29.14% 2026-09-01 → 2026-09-30 document 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.
2026-09-14 DFTXDefinium Therapeutics DT120 ODT small molecule · cns topline_resultsevent closed Core large downside 45% confidence · backtest +3.50% -8.52% +2.34% 2026-09-01 → 2026-09-30 document 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.
2026-09-09 EVMNEvommune EVO756 small molecule · dermatology topline_resultsevent closed Core large impact 60% confidence · backtest -17.13% -2.58% +3.32% 2026-09-01 → 2026-09-30 document 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.
2026-09-09 INBXInhibrx Biosciences INBRX-106 protein · oncology topline_resultsevent closed Watch large downside 55% confidence · backtest -1.29% -1.28% -9.76% 2026-07-01 → 2026-09-30 document 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).
2026-09-09 PYXSPyxis Oncology micvotabart pelidotin (MICVO) adc · oncology interim_analysisevent closed Watch large impact 60% confidence · backtest -13.11% -3.25% +20.06% 2026-09-01 → 2026-11-30 document 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.
2026-09-09 SERSerina Therapeutics SER-252 small molecule · cns interim_analysis Watch — +2.80% -2.72% +3.31% — document 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.
2026-09-09 TYRATyra Biosciences dabogratinib small molecule · oncology topline_resultsevent closed Core large impact 55% confidence · backtest -17.66% +6.95% +6.79% 2026-09-01 → 2026-09-30 document 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.
2026-09-09 BBOTBridgeBio Oncology Therapeutics BBO-8520 small molecule · oncology interim_analysisevent closed Watch large impact 50% confidence · backtest -23.76% -18.28% +0.68% 2026-07-01 → 2026-12-31 document 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.
2026-09-09 IRDOpus Genetics OPGx-BEST1 gene therapy · rare genetic topline_resultsevent closed Core — +32.03% +5.93% +19.89% 2026-09-07 → 2026-09-13 document 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.
2026-09-08 IONSIonis Pharmaceuticals pelacarsen aso · cardiovascular topline_resultsevent closed Watch large impact 60% confidence · backtest -2.38% -1.22% -4.85% 2026-07-01 → 2026-12-31 document "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.
2026-09-08 PHVSPharvaris deucrictibant XR small molecule · immunology topline_resultsevent closed Watch large impact 45% confidence · backtest +7.35% -0.26% -0.20% 2026-07-01 → 2026-09-30 document 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.
2026-09-03 RAREUltragenyx Pharmaceutical apazunersen (GTX-102) aso · cns topline_resultsevent closed Watch large impact 72% confidence · backtest -44.03% +3.03% +0.34% 2026-09-01 → 2026-10-31 document 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.
2026-09-03 ATTOAttovia Therapeutics ATTO-1310 protein · dermatology interim_analysisevent closed Watch large impact 45% confidence · backtest +4.63% +5.58% +18.31% 2026-10-01 → 2026-12-31 document "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.
2026-09-01 PMVPPMV Pharmaceuticals rezatapopt small molecule · oncology interim_analysis Watch — +6.61% -2.33% -7.28% — document 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.
2026-09-01 ALMSAlumis envudeucitinib small molecule · immunology topline_resultsevent closed Watch large impact 60% confidence · backtest -56.58% +9.29% -5.30% 2026-07-01 → 2026-09-30 document 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.
2026-08-31 ZYMEZymeworks zanidatamab bispecific · oncology topline_resultsevent closed Watch large impact 62% confidence · backtest +4.03% +0.88% -1.40% 2026-07-01 → 2026-09-30 document 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").
2026-08-20 ACIUAC Immune ACI-19764 small molecule · cns interim_analysis Watch — +2.33% +9.85% -1.53% — document 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.
2026-08-18 AMLXAmylyx Pharmaceuticals avexitide peptide · metabolic topline_resultsevent closed Core large impact 60% confidence · backtest +63.84% +9.94% -5.47% 2026-08-15 → 2026-09-15 document 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.
2026-08-17 CTORCitius Oncology LYMPHIR (denileukin diftitox-cxdl) protein · oncology topline_results Watch — -18.68% -5.00% +20.85% — document 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.
2026-08-17 CTORCitius Oncology LYMPHIR (denileukin diftitox-cxdl) protein · oncology topline_results Watch — -18.68% -5.00% +20.85% — document 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).
2026-08-17 EYPTEyePoint DURAVYU small molecule · ophthalmology topline_resultsevent closed Core large downside 55% confidence · backtest -66.98% +12.32% +6.19% 2026-08-01 → 2026-08-31 document "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.
2026-08-14 DAREDare Bioscience Ovaprene other · womens health interim_analysis Watch — -32.12% -12.90% +3.01% — document 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.
2026-08-14 MPLTMapLight Therapeutics ML-004 small molecule · cns topline_results Watch — +1.47% -4.30% -12.80% — document 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.
2026-08-13 CGEMCullinan Therapeutics zipalertinib small molecule · oncology topline_resultsevent closed Watch small impact 68% confidence · backtest +0.20% +3.56% +11.30% 2026-08-06 → 2026-12-31 document "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.
2026-08-13 EPRXEupraxia Pharmaceuticals EP-104GI small molecule · gi hepatology interim_analysis Watch — +2.93% +0.75% +0.00% — document 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.
2026-08-13 PRQRProQR Therapeutics AX-0810 aso · gi hepatology interim_analysis Watch — -0.54% +3.78% -5.58% — document 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.
2026-08-13 ADCTADC Therapeutics ZYNLONTA + rituximab adc · hematology topline_results Watch — -14.63% -3.81% +14.95% — document 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.
2026-08-13 ALLOAllogene Therapeutics cema-cel cell therapy · oncology interim_analysis Watch — -4.35% +3.54% +6.15% — document 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.
2026-08-13 AVIRAtea Pharmaceuticals bemnifosbuvir/ruzasvir (BEM/RZR) small molecule · gi hepatology topline_results Watch — +0.20% +0.99% +6.53% — document 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.
2026-08-12 ABSIAbsci ABS-201 monoclonal antibody · dermatology interim_analysis Watch — +0.96% -0.42% +10.97% — document 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).
2026-08-12 DFTXDefinium Therapeutics DT120 ODT small molecule · cns topline_resultsevent closed Core large impact 45% confidence · backtest +4.60% +2.59% -3.33% 2026-08-10 → 2026-08-16 document 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.
2026-08-12 MLYSMineralys Therapeutics lorundrostat small molecule · respiratory topline_results Watch — -1.02% -3.55% +3.13% — document "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.
2026-08-12 NTHINeOnc Technologies Holdings NEO100 small molecule · oncology topline_resultsevent closed Core large downside 50% confidence · backtest -20.46% -7.23% +26.82% 2026-08-12 document 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).
2026-08-12 STROSutro Biopharma STRO-004 adc · oncology interim_analysis Watch — -14.94% +0.05% -2.45% — document 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).
2026-08-11 DMACDiaMedica Therapeutics DM199 protein · womens health interim_analysis Watch — +3.31% -0.44% +1.99% — document 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.
2026-08-11 INTSIntensity Therapeutics INT230-6 small molecule · oncology interim_analysis Watch — -2.10% -0.95% +0.70% — document 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.
2026-08-11 STTKShattuck Labs SL-325 monoclonal antibody · immunology topline_results Watch — +0.56% +4.32% -2.06% — document "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.
2026-08-11 ALMSAlumis envudeucitinib small molecule · dermatology topline_resultsevent closed Watch large impact 45% confidence · backtest -7.85% +0.71% +5.40% 2026-07-01 → 2026-12-31 document 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).
2026-08-11 AURAAura Biosciences bel-sar other · oncology interim_analysis Watch — +4.42% -3.61% +9.38% — document 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.
2026-08-10 JBIOJade Biosciences JADE101 monoclonal antibody · renal interim_analysis Watch — -1.05% +2.85% +11.19% — document 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.
2026-08-10 MAIAMAIA Biotechnology ateganosine small molecule · oncology interim_analysis Watch — -0.70% -2.13% +13.60% — document 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.
2026-08-10 MLTXMoonLake Immunotherapeutics sonelokimab bispecific · immunology topline_results Watch — -5.09% -4.27% -0.98% — document 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).
2026-08-10 ABCLAbCellera Biologics ABCL635 monoclonal antibody · womens health topline_resultsevent closed Core large impact 55% confidence · backtest +34.78% +4.50% +21.37% 2026-08-01 → 2026-08-31 document 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.
2026-08-10 SIONSionna Therapeutics SION-451 small molecule · rare genetic topline_resultsevent closed Watch large impact 55% confidence · backtest -91.18% +13.33% +8.30% 2026-06-01 → 2026-08-31 document 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.
2026-08-10 SIONSionna Therapeutics SION-719 small molecule · rare genetic topline_resultsevent closed Watch large impact 60% confidence · backtest -91.18% +13.33% +8.30% 2026-06-01 → 2026-08-31 document "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.
2026-08-10 SLNSilence Therapeutics Plc American Depository Share divesiran sirna · hematology topline_resultsevent closed Core — +29.12% -4.60% +13.92% 2026-08-01 → 2026-08-31 document 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).
2026-08-10 TENXTenax Therapeutics TNX-103 (oral levosimendan) small molecule · cardiovascular topline_resultsevent closed Core large impact 80% confidence · backtest -89.77% +17.82% -1.90% 2026-08-01 → 2026-08-31 document 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).
2026-08-10 AQSTAquestive Therapeutics Anaphylm (dibutepinephrine) small molecule · immunology topline_results Watch — +8.88% +2.80% +6.63% — document 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.
2026-08-07 OCSOculis Holding OCS-01 small molecule · ophthalmology topline_results Watch — +2.42% +0.63% +10.44% — document 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).
2026-08-07 DNLIDenali Therapeutics DNL151 (BIIB122) small molecule · cns topline_results Watch — +0.40% +0.68% +1.56% — document "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.
2026-08-06 ACRSAclaris Therapeutics ATI-052 bispecific · immunology topline_results Watch — -4.25% -2.96% +24.22% — document "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.
2026-08-06 EWTXEdgewise Therapeutics EDG-7500 small molecule · cardiovascular topline_results Watch — -1.27% -2.03% +13.18% — document 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.
2026-08-06 MNKDMannKind MNKD-201 (nintedanib DPI) small molecule · respiratory topline_results Watch — -5.12% +5.66% +6.49% — document "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.
2026-08-06 NUVBNuvation Bio safusidenib small molecule · oncology topline_results Watch — -4.08% +8.02% -3.34% — document 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.
2026-08-06 PRAXPraxis Precision Medicines elsunersen aso · cns topline_results Watch — +15.95% -2.54% +9.69% — document 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.
2026-08-06 PRAXPraxis Precision Medicines vormatrigine small molecule · cns topline_results Watch — +15.95% -2.54% +9.69% — document 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.
2026-08-06 BIVIBioVie Bezisterim small molecule · cns topline_results Watch — -33.82% -26.00% +61.90% — document 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.
2026-08-06 TNYATenaya Therapeutics TN-201 gene therapy · cardiovascular interim_analysis Watch — -7.52% +0.14% +6.80% — document 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.
2026-08-06 ANNXAnnexon tanruprubart monoclonal antibody · immunology interim_analysis Watch — +4.28% -3.39% +10.49% — document 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.
2026-08-06 AVTXAvalo Therapeutics abdakibart monoclonal antibody · dermatology topline_results Watch — -0.74% -2.03% -0.89% — document 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.
2026-08-05 DNTHDianthus Therapeutics claseprubart monoclonal antibody · immunology interim_analysis Watch — +1.90% -2.29% +8.65% — document 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.
2026-08-05 IMAImageneBio olevaprubart monoclonal antibody · dermatology interim_analysis Watch — +0.70% -2.09% -0.87% — document "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.
2026-08-05 ARWRArrowhead Pharmaceuticals plozasiran sirna · metabolic topline_results Watch — -2.99% -1.24% +4.44% — document 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.
2026-08-04 HRMYHarmony Biosciences Holdings BP-205 small molecule · cns topline_results Watch — +8.93% -1.39% -1.14% — document 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"
2026-08-04 IDYAIDEAYA Biosciences darovasertib small molecule · oncology topline_results Watch — +2.01% -0.19% -3.73% — document 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.
2026-08-04 RYTMRhythm Pharmaceuticals RM-718 peptide · metabolic interim_analysis Watch — +2.92% +4.66% -3.16% — document 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.
2026-07-31 CTNMContineum Therapeutics PIPE-791 small molecule · pain anesthesia topline_results Watch — -1.65% +2.84% +9.60% — document 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.
2026-07-31 KPTIKaryopharm Therapeutics selinexor small molecule · oncology topline_results Watch — -72.61% +2.60% -1.13% — document 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.
2026-07-31 TLSATiziana Life Sciences foralumab monoclonal antibody · cns interim_analysis Watch — +6.19% -5.83% -4.90% — document 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.
2026-07-31 BHCBausch Health Companies rifaximin soluble solid dispersion small molecule · gi hepatology topline_results Watch — +14.26% +1.60% +35.51% — document 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.
2026-07-30 AGIOAgios Pharmaceuticals tebapivat small molecule · hematology topline_results Watch — -6.46% -8.34% -2.88% — document 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.
2026-07-30 AGIOAgios Pharmaceuticals AG-236 sirna · hematology topline_results Watch — -6.46% -8.34% -2.88% — document 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.
2026-07-28 KNSAKiniksa Pharmaceuticals International KPL-387 monoclonal antibody · cardiovascular interim_analysis Watch — +25.03% +1.86% +1.53% — document 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.
2026-07-28 PMNProMIS Neurosciences PMN310 monoclonal antibody · cns interim_analysis Watch — +23.89% -3.17% -22.28% — document 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.
2026-07-28 ALTAltimmune pemvidutide peptide · cns topline_results Watch — +1.01% -2.34% +5.34% — document 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.
2026-07-27 MPLTMapLight Therapeutics ML-007C-MA small molecule · cns topline_results Watch — -72.91% +24.28% -3.46% — document 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.
2026-07-22 CLDXCelldex Therapeutics barzolvolimab monoclonal antibody · dermatology topline_results Watch — -2.50% +1.87% -6.58% — document 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.
2026-07-14 ERASErasca ERAS-0015 small molecule · oncology interim_analysis Watch — +8.94% +9.03% -5.04% — document 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.
2026-07-13 QTTBQ32 Bio bempikibart monoclonal antibody · dermatology topline_results Watch — +90.72% -13.66% -14.36% — document 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.
2026-07-09 IONSIonis Pharmaceuticals eplontersen aso · cardiovascular topline_results Watch — -23.90% -9.37% +6.52% — document "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.
2026-07-08 MCRBSeres Therapeutics SER-155 other · oncology topline_results Watch — -12.29% -5.60% +4.49% — document 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.
2026-07-08 MSLESatellos Bioscience forazapadin small molecule · rare genetic interim_analysisevent closed Watch large impact 55% confidence · backtest +9.38% +5.12% +4.06% 2026-07-01 → 2026-12-31 document 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.
2026-07-07 TTRXTurn Therapeutics GX-03 other · dermatology interim_analysis Watch — +26.27% -5.36% +10.97% — document 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.
2026-07-07 TVRDTvardi Therapeutics TTI-109 small molecule · immunology topline_results Watch — +54.23% +61.29% +34.00% — document 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.
2026-07-01 SXTP60 DEGREES PHARMACEUTICALS, INC tafenoquine small molecule · infectious interim_analysis Watch — -0.57% -2.29% +4.76% — document 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.
2026-06-30 ACIUAC Immune ACI-24 vaccine · cns interim_analysis Watch — -10.53% +0.00% +6.40% — document 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.
2026-06-30 AKBAAkebia Therapeutics vadadustat small molecule · renal interim_analysis Watch — +2.70% +6.14% +1.83% — document 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).
2026-06-29 EVMNEvommune EVO756 small molecule · dermatology topline_results Watch — -40.23% -11.69% +17.88% — document 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.
2026-06-29 LRMRLarimar Therapeutics nomlabofusp protein · rare genetic topline_results Watch — -12.57% -4.69% +0.55% — document 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).
2026-06-29 NGNENeurogene NGN-401 gene therapy · cns interim_analysis Watch — +0.78% -2.57% +1.59% — document "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.