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Clinical Trials News 3 November 2025 - 17 November 2025

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 The trial compared three regimens: According…
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 At the same time, Clearmind filed a new…
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…
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.…
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…
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)…
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…
10 November 2025
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InflaRx (IFRX) pops on positive INF904 Phase 2a results in HS & CSU; Q3 filing shows €44.4M liquidity and runway into 2027 — Nov 10, 2025

InflaRx (IFRX) pops on positive INF904 Phase 2a results in HS & CSU; Q3 filing shows €44.4M liquidity and runway into 2027 — Nov 10, 2025

InflaRx N.V. (NASDAQ: IFRX) surged into today’s session after unveiling topline Phase 2a data for its oral C5aR inhibitor INF904 in hidradenitis suppurativa (HS) and chronic spontaneous urticaria (CSU), alongside filing its third‑quarter Form 6‑K showing €44.4 million of available funds and a cash runway into 2027. The company also set out next steps: a Phase 2b HS trial targeted…
10 November 2025
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Galecto (GLTO) Soars on Damora Therapeutics Acquisition and $285M Financing: IND in 2026, Proof‑of‑Concept in 2027

Galecto (GLTO) Soars on Damora Therapeutics Acquisition and $285M Financing: IND in 2026, Proof‑of‑Concept in 2027

Galecto, Inc. (NASDAQ: GLTO) said this morning it completed the acquisition of Damora Therapeutics and closed a $284.9 million oversubscribed private placement, a one‑two punch that instantly refocuses the company on mutant calreticulin (mutCALR) therapies for myeloproliferative neoplasms (MPNs) and extends its cash runway into 2029. The announcement sent GLTO screaming higher in pre‑market trading. GlobeNewswire Key takeaways Why this…
10 November 2025
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Tenaya Therapeutics (TNYA) on Nov. 8, 2025: FDA Places Clinical Hold on TN‑201 Trial as AHA 2025 Showcases Encouraging MyPEAK‑1 Data

Tenaya Therapeutics (TNYA) on Nov. 8, 2025: FDA Places Clinical Hold on TN‑201 Trial as AHA 2025 Showcases Encouraging MyPEAK‑1 Data

What happened today (Nov. 8) Tenaya Therapeutics (NASDAQ: TNYA) presented new interim results from its MyPEAK‑1 Phase 1b/2a trial evaluating TN‑201, an AAV9 gene‑replacement therapy designed to deliver a working MYBPC3 gene to cardiomyocytes for MYBPC3‑associated hypertrophic cardiomyopathy (HCM). The late‑breaking presentation in New Orleans highlighted longer‑term follow‑up for the first‑dose cohort (3E13 vg/kg) and initial readouts at the higher…
8 November 2025
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Intellia Therapeutics (NTLA) plunges after patient death in pivotal CRISPR trial; Q3 update, analyst downgrades and what to watch next [Nov. 7, 2025]

Intellia Therapeutics (NTLA) plunges after patient death in pivotal CRISPR trial; Q3 update, analyst downgrades and what to watch next [Nov. 7, 2025]

What happened today Intellia Therapeutics (NASDAQ: NTLA) is under intense pressure after the company said the patient who experienced Grade 4 liver enzyme and bilirubin elevations in its Phase 3 MAGNITUDE study later died. In a Nov. 6 business update, CEO John Leonard said the treating physician cited “complicating comorbidities,” and Intellia is working with investigators and outside experts on…
7 November 2025
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Femasys (FEMY) Skyrockets on Breakthrough Birth Control Trial News – Is This Women’s Health Innovator a Game-Changer?

Femasys (FEMY) Skyrockets on Breakthrough Birth Control Trial News – Is This Women’s Health Innovator a Game-Changer?

Company Overview – Innovating in Women’s Health Femasys Inc. is a Georgia-based medical device and biotherapeutics company specializing in women’s reproductive health solutions. Founded and led by CEO Kathy Lee-Sepsick (a female inventor-entrepreneur), Femasys aims to “transform women’s healthcare” by addressing long-neglected needs with non-surgical, in-office technologies Femasys Gurufocus. The company’s mission is to provide women with minimally invasive, office-based…
3 November 2025
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Stock Market Today

  • Pfizer Q4 Preview: Non-Oncology Segment Sales Outlook and Market Impact
    January 19, 2026, 11:10 AM EST. Pfizer (PFE) is scheduled to report Q4 and full-year 2025 earnings on Feb. 3. While oncology sales account for over 28% of revenues, investor focus also shifts to non-oncology segments including Primary Care and Specialty Care. Key non-oncology products include Eliquis anticoagulant, Prevnar vaccines, COVID-19 vaccine Comirnaty, and newer drugs like RSV vaccine Abrysvo and migraine treatment Nurtec. Eliquis alliance revenues are expected to rise to $2.1 billion despite generic pressures. Prevnar vaccine sales likely declined in the U.S. but increased internationally, estimated at $1.64 billion. COVID-19 medication sales fell due to narrower vaccine recommendations and lower infections. In Specialty Care, Vyndaqel sales remain strong at an estimated $1.66 billion, while Xeljanz and Enbrel may have weakened. Pfizer's stock dropped 2.5% in past year, underperforming the industry, but trades at a forward price/earnings ratio of 8.58, suggesting valuation appeal.
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