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Biotechnology News 4 November 2025 - 11 November 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 (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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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 a risk‑mitigation plan for nexiguran ziclumeran (nex‑z; NTLA‑2001), its in vivo CRISPR therapy for transthyretin amyloidosis (ATTR). The FDA’s clinical holds on MAGNITUDE (ATTR‑CM) and MAGNITUDE‑2 (ATTR‑PN) are still in effect pending a formal hold letter. GlobeNewswire+1 Sell‑side reaction was
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. (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. Total product revenue grew to ~$68M in Q3 (Amtagvi ~$58M; Proleukin ~$10M). Gross margin expanded to 43% on improved execution and early cost‑savings. Management reaffirmed $250–$300M in 2025 revenue. GlobeNewswire Earnings snapshot. An AP/Automated Insights brief noted a net loss
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

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. ir.novavax.com Revenue for the quarter came in at $70 million, above Wall Street expectations, while the GAAP net loss widened to $202 million year‑over‑year, reflecting $126 million in non‑cash charges, including $97 million related to a previously announced Maryland facility consolidation. Reuters On a per‑share basis, Novavax posted a GAAP loss of
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

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.com ainvest.com. In practical terms, Lunai is developing both therapeutic platforms (for diseases like cancer and neurodegeneration) and advanced diagnostics/screening tools (including detecting chemical/biological threats), all underpinned by machine learning. Core Technology & Pipeline: Lunai’s flagship approach is a next-generation allogeneic dendritic cell
5 November 2025
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Recursion Pharmaceuticals (RXRX) – AI Drug Discovery Breakthroughs, CEO Shakeup & 2025 Stock Outlook

Recursion Pharmaceuticals (RXRX) – AI Drug Discovery Breakthroughs, CEO Shakeup & 2025 Stock Outlook

Below we dive into a detailed analysis of RXRX – covering the latest developments, the company’s AI-powered business model, financials, key partnerships, expert commentary, technical trends, forecasts, and how Recursion compares to other AI-focused biotech players. Latest Developments and News (Early November 2025) Q3 2025 Earnings & Milestone: Recursion’s third-quarter 2025 report (released Nov 5) was a mixed bag. The company posted quarterly revenue of $5.2 million, a steep drop from $26.1 million in Q3 last year stocktitan.net. This was a significant miss versus Wall Street’s ~$17 million forecast, reflecting the lumpy nature of partnership payments (no big milestone was booked as revenue in
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

Key facts (updated Nov 5, 2025): The story: Biology is moving from thought experiment to flight plan Europe’s HOBI‑WAN pilot (Hydrogen‑Oxidizing Bacteria in Weightlessness As a source of Nutrition) 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 (H₂, O₂, CO₂) 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
5 November 2025
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COMPASS Pathways (CMPS) Psychedelic Breakthrough Stock – Latest News, Analysis & 2025 Outlook

COMPASS Pathways (CMPS) Psychedelic Breakthrough Stock – Latest News, Analysis & 2025 Outlook

Below is a full breakdown of COMPASS Pathways’ recent performance, news, expert commentary, industry positioning, and an analysis of the stock’s fundamentals, technicals, and future scenarios. Stock Performance Overview (Nov 2025) COMPASS Pathways’ stock has experienced considerable volatility in 2025, mirroring the company’s clinical trial news cycle. As of November 4, 2025, CMPS trades in the mid-$5 range (around $5.95–$6.00), roughly flat versus a week prior intellectia.ai. This price is well above its summertime lows, but slightly off the highs reached in October. Recent Trading Range: In mid-October 2025, CMPS rallied to $6.76 per share, marking a new 52-week high
4 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

Company Overview & 2025 Developments Zoetis is the global frontrunner in animal health, offering a diverse portfolio for both companion animals (pets) 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.com proclinical.com. Zoetis continues to leverage this scale and innovation engine in 2025, focusing on pet care growth while managing challenges in livestock. Recent 2025 highlights: The first half of 2025 saw Zoetis deliver solid growth. In
4 November 2025
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Sarepta Therapeutics (SRPT) Surges After FDA Greenlights Duchenne Gene Therapy – Is a Rebound Ahead?

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

SRPT Stock Price & Recent Performance 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-date marketbeat.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 year marketbeat.com. This implosion has vastly underperformed the biotech sector (for context, the biotech index is up ~19% in
4 November 2025
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