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Biotechnology News 5 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…
Precigen (PGEN) Soars as PAPZIMEOS Launch, Q3 2025 Earnings and Fresh Analyst Upgrades Ignite Investor Interest

Precigen (PGEN) Soars as PAPZIMEOS Launch, Q3 2025 Earnings and Fresh Analyst Upgrades Ignite Investor Interest

On 14 November 2025, Precigen, Inc. (NASDAQ: PGEN) is back in the spotlight. The gene‑therapy specialist’s stock is trading roughly 25–30% higher intraday around $4.90–$5.00, after closing at $3.86 on 13 November, on surging volume of nearly 11 million shares. StockAnalysis The move caps a spectacular 12‑month run in which the stock has delivered well over 300% total return, powered…
Scholar Rock (NASDAQ: SRRK) Soars on FDA Progress, $200M ATM and Q3 2025 Earnings – November 14, 2025 Update

Scholar Rock (NASDAQ: SRRK) Soars on FDA Progress, $200M ATM and Q3 2025 Earnings – November 14, 2025 Update

Scholar Rock Holding Corporation (NASDAQ: SRRK) is back in the spotlight as its stock jumps more than 25% on the day after a pivotal FDA meeting, fresh Q3 2025 financial results, and the launch of a new $200 million at-the-market (ATM) stock offering. SRRK stock jumps over 25% after FDA “constructive” meeting Scholar Rock shares are surging today. As of…
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…
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…
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…
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)…
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…
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…
Iovance Biotherapeutics (IOVA) Q3 2025: Revenue Climbs ~13% to ~$68M; Gross Margin Hits 43%, Guidance Reaffirmed — November 6, 2025

Iovance Biotherapeutics (IOVA) Q3 2025: Revenue Climbs ~13% to ~$68M; Gross Margin Hits 43%, Guidance Reaffirmed — November 6, 2025

Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) reported third‑quarter 2025 results this morning (Nov. 6), highlighting sequential revenue growth, materially higher gross margins, and steady commercial momentum for its tumor‑infiltrating lymphocyte (TIL) therapy Amtagvi. Management also reaffirmed full‑year revenue guidance and flagged pipeline milestones led by encouraging lung‑cancer data for lifileucel. GlobeNewswire What Iovance announced (Nov. 6, 2025) Revenue, margin, and guidance.…
Novavax (NVAX) Raises 2025 Revenue Outlook After Q3 Beat; Sanofi Milestones Drive Guidance — November 6, 2025

Novavax (NVAX) Raises 2025 Revenue Outlook After Q3 Beat; Sanofi Milestones Drive Guidance — November 6, 2025

What happened today Novavax, Inc. (NASDAQ: NVAX) reported Q3 2025 results and raised its full‑year adjusted revenue framework to $1.04–$1.06 billion (from $1.00–$1.05 billion). Management cited momentum from licensing, supply, and milestone revenue—while excluding Sanofi‑led sales and royalties from the outlook. The company also reaffirmed 2025 operating‑expense guidance. Novavax Revenue for the quarter came in at $70 million, above Wall…
From Crash to Breakthrough: Why Lunai Bioworks (LNAI) Is Suddenly on Investors’ Radar

From Crash to Breakthrough: Why Lunai Bioworks (LNAI) Is Suddenly on Investors’ Radar

Company Overview: AI-Powered Biotech at the Intersection of Therapeutics & Biodefense Lunai Bioworks Inc. is a pre-clinical stage biotechnology company pioneering an unusual dual focus: AI-driven drug discovery and biodefense. The company’s mission is to “capture biological signals at scale, decode them with AI, and rapidly validate insights in model systems”, bridging cutting-edge computation with experimental biotech Ainvest Ainvest. In…
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Stock Market Today

  • Morgan Stanley Cuts Lennox International Price Target, Signals Caution
    February 2, 2026, 1:34 PM EST. Morgan Stanley lowered its price target for Lennox International (NYSE:LII) from $475 to $450, assigning an "underweight" rating that suggests a 9% downside. The construction company's stock currently trades near $495 with a mixed analyst consensus: four Buy, nine Hold, and two Sell ratings. Recent earnings missed expectations with $4.45 per share versus the anticipated $4.76, and revenue fell 11.2% year-on-year to $1.20 billion. Lennox's net margin stands at 15.13%, and return on equity is high at 80.23%. The firm projects earnings per share between $23.50 and $25.00 for fiscal 2026. Market sentiment remains cautious amid mixed forecasts and declining quarterly results.
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