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Clinical Trials News 10 November 2025 - 19 November 2025

Agios Pharmaceuticals (AGIO) Stock Slides on Mixed Phase 3 Sickle Cell Results From RISE UP Trial

Agios Pharmaceuticals (AGIO) Stock Slides on Mixed Phase 3 Sickle Cell Results From RISE UP Trial

Agios Pharmaceuticals, Inc. (NASDAQ: AGIO) is in the spotlight today after unveiling topline results from its pivotal Phase 3 RISE UP trial of mitapivat (Pyrukynd) in sickle cell disease (SCD) — data that are being widely described as “mixed” and have sent the stock sharply lower. GlobeNewswire+2Reuters+2 The study hit one of its two primary endpoints and showed strong effects on markers of hemolysis, but it failed to significantly reduce painful sickle cell crises or fatigue across the full study population — the outcomes many investors were most focused on. GlobeNewswire+2Reuters+2 Key Takeaways From Today’s Agios (AGIO) News What Agios
19 November 2025
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Clearmind Medicine (CMND) Delivers Positive AUD Trial Data Amid New Depression Patent – Nov. 18, 2025

Clearmind Medicine (CMND) Delivers Positive AUD Trial Data Amid New Depression Patent – Nov. 18, 2025

Clearmind Medicine Inc. (NASDAQ: CMND, FSE: CWY0) is back in the spotlight today after releasing positive top-line results from the first cohort of its FDA‑approved Phase I/IIa clinical trial for CMND‑100 in alcohol use disorder (AUD). The update lands just one day after the company highlighted a new Israeli patent filing for a non‑hallucinogenic depression therapy, and as a fresh equity offering is expected to close around today’s date. GlobeNewswire+2GlobeNewswire+2 The cluster of announcements is drawing intense trading interest. As of mid‑afternoon on November 18, CMND shares were changing hands around $0.27, after touching an intraday high near $0.39, on
18 November 2025
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Merck (MRK) Jumps as Oral PCSK9 Data Power Momentum; New Keytruda Diagnostic Cleared — What’s Moving the Stock Today (Nov. 12, 2025)

Merck (MRK) Stock Today, Nov 18, 2025: Shares Jump on Winrevair Phase 2 Win as Cidara Deal Builds Flu Portfolio

November 18, 2025 — Merck & Co. (NYSE: MRK) is trading higher today after the company reported new mid‑stage data for its cardiopulmonary medicine Winrevair (sotatercept‑csrk), fueling optimism about growth beyond Keytruda and adding momentum to last week’s acquisition of Cidara Therapeutics. Merck.com+1 What’s moving the stock Merck announced before the U.S. market open that Winrevair met the primary endpoint in the Phase 2 CADENCE study in adults with combined post‑ and precapillary pulmonary hypertension (CpcPH) due to heart failure with preserved ejection fraction (HFpEF). The trial showed a “statistically significant and clinically meaningful” reduction in pulmonary vascular resistance versus
18 November 2025
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Annovis Bio (ANVS) Soars After New Parkinson’s Biomarker Data Show Buntanetap Halts Cognitive Decline – November 17, 2025

Annovis Bio (ANVS) Soars After New Parkinson’s Biomarker Data Show Buntanetap Halts Cognitive Decline – November 17, 2025

On November 17, 2025, Annovis Bio, Inc. (NYSE: ANVS) released new Phase 3 data in early Parkinson’s disease showing that its lead drug candidate buntanetap halted cognitive decline and improved key Alzheimer’s-related biomarkers in a significant subset of patients. Annovis Bio+1 The update triggered a sharp rally in ANVS stock and put fresh attention on the company’s multi-disease neurodegeneration strategy. What Annovis Bio Announced Today Annovis Bio’s news centers on a deeper analysis of its Phase 3 study in early Parkinson’s disease, registered as NCT05357989. Annovis Bio+1 According to the company, buntanetap: In this subgroup with amyloid co‑pathology, patients were found to
17 November 2025
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Jazz Pharmaceuticals (JAZZ) Soars on Breakthrough Ziihera Phase 3 Results in Gastroesophageal Cancer – Key Updates for 17 November 2025

Jazz Pharmaceuticals (JAZZ) Soars on Breakthrough Ziihera Phase 3 Results in Gastroesophageal Cancer – Key Updates for 17 November 2025

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is in the spotlight today after announcing positive Phase 3 data for its cancer drug Ziihera® (zanidatamab‑hrii) in a large global trial for HER2‑positive gastroesophageal adenocarcinoma (GEA). The news has triggered sharp pre‑market moves in Jazz’s share price and its partners’ stocks, and could reshape the treatment landscape for a difficult‑to‑treat cancer. PR Newswire+1 JAZZ stock today: volatility after a major cancer win As of early afternoon U.S. trading on Monday, November 17, Jazz Pharmaceuticals shares are trading around $141.07, little changed on the day according to real‑time quote data. Earlier, however, markets reacted far
17 November 2025
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Zymeworks (ZYME) Soars on Positive Phase 3 Ziihera Data in Gastric Cancer – What Today’s Breakthrough Means for the Stock and Patients

Zymeworks (ZYME) Soars on Positive Phase 3 Ziihera Data in Gastric Cancer – What Today’s Breakthrough Means for the Stock and Patients

What Zymeworks Announced Today Before the U.S. market open on November 17, 2025, Vancouver‑based Zymeworks Inc. (ZYME) released topline Phase 3 data from its pivotal HERIZON‑GEA‑01 study, evaluating Ziihera (zanidatamab‑hrii) in first‑line treatment of HER2‑positive locally advanced or metastatic gastroesophageal adenocarcinoma, a group that includes cancers of the stomach, gastroesophageal junction, and esophagus. GlobeNewswire+1 The trial compared three regimens: According to Zymeworks and its partners Jazz Pharmaceuticals and BeOne Medicines, HERIZON‑GEA‑01 delivered several key findings: GlobeNewswire+2GlobeNewswire+2 On the back of these data, Jazz plans to: GlobeNewswire+1 For Zymeworks, which originally discovered Ziihera using its Azymetric™ bispecific antibody platform, the company
17 November 2025
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Clearmind Medicine (CMND) Stock Soars as FDA‑Regulated Alcohol Use Disorder Trial Expands to Hadassah – November 13, 2025

Clearmind Medicine (CMND) Stock Soars as FDA‑Regulated Alcohol Use Disorder Trial Expands to Hadassah – November 13, 2025

Vancouver / Jerusalem – November 13, 2025 – Shares of Clearmind Medicine Inc. (NASDAQ: CMND), a clinical‑stage psychedelic and neuroplastogen biotech company, jumped sharply on Thursday after the firm announced final approval to expand its FDA‑regulated Phase 1/2a clinical trial for Alcohol Use Disorder (AUD) to Hadassah Medical Center in Jerusalem. GlobeNewswire+1 At the same time, Clearmind filed a new Form 6‑K detailing a registered direct offering of shares and pre‑funded warrants, adding fresh capital but also raising dilution questions for investors. Stock Titan Below is a full breakdown of today’s key developments and what they mean for CMND stock.
13 November 2025
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Humacyte (HUMA) Q3 2025: Symvess Sales Surge; IND Filed for CABG as Dialysis Data Advance — Nov 12, 2025

Humacyte (HUMA) Q3 2025: Symvess Sales Surge; IND Filed for CABG as Dialysis Data Advance — Nov 12, 2025

Durham, N.C. — November 12, 2025 — Humacyte, Inc. (NASDAQ: HUMA) reported third‑quarter results and a pipeline update this morning, highlighting accelerating Symvess™ sales, new clinical data in dialysis access, and a key regulatory step toward first‑in‑human testing of its coronary bypass graft. GlobeNewswire What Humacyte reported Humacyte posted $753,000 in Q3 revenue—$703,000 from Symvess, the FDA‑approved acellular tissue‑engineered vessel (ATEV) for adult extremity vascular trauma, and ~$100,000 from a collaboration with a large med‑tech partner. Management emphasized a step‑up in VAC approvals and hospital onboarding as the key driver of the sales ramp. GlobeNewswire On profitability, the company recorded
12 November 2025
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Viking Therapeutics (VKTX) Rides Obesity Drug Wave: Stock Steadies as Analysts Eye Big Upside

Viking Therapeutics (VKTX) on Nov. 11, 2025: Stifel Fireside Chat Today, Fresh VK2735 Obesity Data From ObesityWeek, and Phase 3 VANQUISH Progress

Published: November 11, 2025 Viking Therapeutics, Inc. (NASDAQ: VKTX) steps into the spotlight today with a scheduled fireside chat at the Stifel 2025 Healthcare Conference in New York (4:40–5:10 p.m. ET). The appearance comes on the heels of new clinical analyses from ObesityWeek® 2025 and an October corporate update outlining steady Phase 3 progress for its lead obesity candidate, VK2735. Viking Therapeutics InvestorRoom What’s happening today (Nov. 11) Viking’s management will host a fireside chat and hold 1×1 investor meetings at Stifel’s conference, part of a busy November investor-relations calendar that also includes a corporate presentation at the Jefferies 2025
11 November 2025
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Quoin Pharmaceuticals (QNRX) Soars After Hitting 4%/5% Topical Rapamycin Targets; Clinical Batches This Quarter, Human Trials 1H 2026 [Nov. 11, 2025]

Quoin Pharmaceuticals (QNRX) Soars After Hitting 4%/5% Topical Rapamycin Targets; Clinical Batches This Quarter, Human Trials 1H 2026 [Nov. 11, 2025]

What happened today Quoin Pharmaceuticals, Ltd. (NASDAQ: QNRX) announced that it has successfully achieved target loading concentrations for two topical rapamycin delivery technologies—4% in its lotion and 5% in a dermal patch. The company said it will start manufacturing clinical and stability batches this quarter and is planning clinical testing in the first half of 2026. Initial targets include MLM and VM, which currently lack any FDA‑approved treatments. GlobeNewswire Quoin’s topical rapamycin program is identified on its pipeline page as QRX009, a formulation designed to improve skin penetration and local delivery—an area the company says has limited the performance of
11 November 2025
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enGene (ENGN) soars after detailing 62% 6‑month complete response in pivotal bladder‑cancer trial; BLA still targeted for 2H 2026

enGene (ENGN) soars after detailing 62% 6‑month complete response in pivotal bladder‑cancer trial; BLA still targeted for 2H 2026

enGene Holdings Inc. (NASDAQ: ENGN) reported fresh preliminary data this morning from the pivotal cohort of its Phase 2 LEGEND trial of detalimogene voraplasmid (formerly EG‑70) in high‑risk, BCG‑unresponsive non‑muscle invasive bladder cancer (NMIBC) with CIS. The readout shows a 62% complete response (CR) at 6 months (n=37), 56% at 3 months (n=62) and 63% CR at any time (n=62) under the trial’s amended protocol—plus a favorable safety profile (42% treatment‑related adverse events; 1.6% dose interruptions; 0.8% discontinuations). The company completed enrollment of 125 patients in the pivotal cohort, above target, and will refine its analysis with FDA input on
11 November 2025
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Cogent Biosciences (COGT) soars ~115% after PEAK Phase 3 shows 16.5‑month PFS in GIST; NDA targeted for 1H 2026 (Nov. 10, 2025)

Cogent Biosciences (COGT) soars ~115% after PEAK Phase 3 shows 16.5‑month PFS in GIST; NDA targeted for 1H 2026 (Nov. 10, 2025)

Cogent Biosciences (NASDAQ: COGT) announced positive top‑line results from its Phase 3 PEAK trial testing bezuclastinib plus sunitinib in second‑line gastrointestinal stromal tumor (GIST), sending the stock sharply higher in Monday trading. The combination delivered a median progression‑free survival (mPFS) of 16.5 months vs. 9.2 months for sunitinib alone (HR=0.50; 95% CI 0.39–0.65; p<0.0001) and a 46% objective response rate vs. 26% on sunitinib monotherapy (p<0.0001). GlobeNewswire “It is a historic day for Cogent Biosciences and the GIST patient community,” CEO Andrew Robbins said, adding that the bezuclastinib combination “is poised to become the new standard of care” in second‑line
10 November 2025
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