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Biotechnology 3 November 2025 - 17 November 2025

Iovance shares surge 43% as Amtagvi revenue highlights manufacturing turning point
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

Before the U.S. market open on November 17, 2025, Vancouver‑based Zymeworks Inc. released topline Phase 3 data from its pivotal HERIZON‑GEA‑01 study, evaluating Ziihera 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
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., 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 to Hadassah Medical Center in Jerusalem. GlobeNewswire+1
13 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]

Quoin Pharmaceuticals, Ltd. 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
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. reported fresh preliminary data this morning from the pivotal cohort of its Phase 2 LEGEND trial of detalimogene voraplasmid in high‑risk, BCG‑unresponsive non‑muscle invasive bladder cancer with CIS. The readout shows a 62% complete response at 6 months, 56% at 3 months and 63% CR at any time under the trial’s amended protocol—plus a favorable safety profile. The company completed enrollment of 125 patients in the pivotal cohort, above target, and will refine its analysis with FDA input on the statistical analysis plan. Business Wire
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 announced positive top‑line results from its Phase 3 PEAK trial testing bezuclastinib plus sunitinib in second‑line gastrointestinal stromal tumor, sending the stock sharply higher in Monday trading. The combination delivered a median progression‑free survival of 16.5 months vs. 9.2 months for sunitinib alone and a 46% objective response rate vs. 26% on sunitinib monotherapy. GlobeNewswire
10 November 2025
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Viking Therapeutics (VKTX) Today — Nov 9, 2025: New Institutional Buying, Fresh Technical Levels, and Key Catalysts Ahead

Viking Therapeutics (VKTX) Today — Nov 9, 2025: New Institutional Buying, Fresh Technical Levels, and Key Catalysts Ahead

Ethos Financial Group’s new position adds to a year when institutions already control roughly three‑quarters of the float. MarketBeat’s automated brief also captures the latest insider activity, and a blended “Moderate Buy” Street view. While 13F adds don’t guarantee direction, they often increase visibility ahead of catalysts. MarketBeat
9 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

Tenaya Therapeutics 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. The late‑breaking presentation in New Orleans highlighted longer‑term follow‑up for the first‑dose cohort and initial readouts at the higher dose, with a simultaneous publication in Cardiovascular Research. GlobeNewswire
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]

Intellia Therapeutics 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 a risk‑mitigation plan for nexiguran ziclumeran, its in vivo CRISPR therapy for transthyretin amyloidosis. The FDA’s clinical holds on MAGNITUDE and MAGNITUDE‑2 are still in effect pending a formal hold letter. GlobeNewswire+1
7 November 2025
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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. reported third‑quarter 2025 results this morning, highlighting sequential revenue growth, materially higher gross margins, and steady commercial momentum for its tumor‑infiltrating lymphocyte therapy Amtagvi. Management also reaffirmed full‑year revenue guidance and flagged pipeline milestones led by encouraging lung‑cancer data for lifileucel. GlobeNewswire
6 November 2025
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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

Novavax, Inc. reported Q3 2025 results and raised its full‑year adjusted revenue framework to $1.04–$1.06 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. ir.novavax.com
6 November 2025
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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

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 biotechainvest.comainvest.com. In practical terms, Lunai is developing both therapeutic platforms and advanced diagnostics/screening tools, all underpinned by machine learning.
5 November 2025
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‘Yeast Survives Mars’ & ESA’s ‘Protein Out of Thin Air’: How Biology Is Rewriting the Mars Menu — and What It Means for Investors

‘Yeast Survives Mars’ & ESA’s ‘Protein Out of Thin Air’: How Biology Is Rewriting the Mars Menu — and What It Means for Investors

Europe’s HOBI‑WAN pilot is ESA’s clearest sign yet that microbial food production will be part of living off‑Earth. The agency says the demonstrator feeds a bacterial culture with stored gases to produce Solein, a protein‑rich powder that needs “neither farmland nor sunlight.” The ISS testbed will ride in a standard locker and includes safety‑critical gas‑injection cartridges because hydrogen/oxygen handling in microgravity must be fail‑safe. The first eight months build and validate a ground “science model,” then ESA aims to manufacture, test and launch a flight unit. European Space Agency
5 November 2025
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Zoetis 2025: Animal Health Giant’s Latest Breakthroughs, Stock Outlook & Key Investor Insights

Zoetis 2025: Animal Health Giant’s Latest Breakthroughs, Stock Outlook & Key Investor Insights

Zoetis is the global frontrunner in animal health, offering a diverse portfolio for both companion animals and farm animals. The company’s products range from vaccines and parasiticides to dermatology treatments and high-tech diagnostics. This breadth has helped Zoetis capture the #1 industry position – in 2023 its $8.5B in sales exceeded the next-largest competitor by over 50%proclinical.comproclinical.com. Zoetis continues to leverage this scale and innovation engine in 2025, focusing on pet care growth while managing challenges in livestock.
4 November 2025
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Sarepta (SRPT) Stock Collapses 80% on FDA Bombshell – Is a Big Rebound Coming?

Sarepta (SRPT) Stock Collapses 80% on FDA Bombshell – Is a Big Rebound Coming?

Sarepta’s stock has experienced a dramatic collapse in 2025, wiping out years of gains. After starting the year near all-time highs, SRPT shares have plunged by over 80% year-to-datemarketbeat.com. As of early November 2025, the stock trades in the mid-teens, down from about $120–$130 at the start of the year. In fact, the stock’s 52-week range tells the story: it hit a high of $138.81 and a low of just $10.41 over the past yearmarketbeat.com. This implosion has vastly underperformed the biotech sector and the broader market.
4 November 2025
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Phio Pharmaceuticals (PHIO) Stock Skyrockets on Breakthrough Skin Cancer Trial Results – In-Depth Analysis & 2025 Outlook

Phio Pharmaceuticals (PHIO) Stock Skyrockets on Breakthrough Skin Cancer Trial Results – In-Depth Analysis & 2025 Outlook

Phio Pharmaceuticals Corp. is a clinical-stage biopharmaceutical company specializing in RNA interference therapies for cancer. The company was co-founded by Nobel laureate Dr. Craig Mello, a discoverer of RNAi, leveraging that legacy to develop its proprietary INTASYL™ gene-silencing technologyphiopharma.com. Originally known as RXi Pharmaceuticals, Phio rebranded and refocused on immuno-oncology. Its mission is to use small interfering RNA to “silence” genes that allow tumors to evade the immune system, thereby empowering the body’s own defenses to fight cancerragingbull.com.
3 November 2025
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