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Biotech News 4 November 2025 - 18 November 2025

Arvinas (ARVN) Soars 14% as Investors Cheer Pipeline Reset and Jefferies Update

Arvinas (ARVN) Soars 14% as Investors Cheer Pipeline Reset and Jefferies Update

Arvinas (NASDAQ: ARVN) jumped in double digits on November 18, 2025 amid a focused pipeline reset, FDA momentum for vepdegestrant and attention at the Jefferies London Healthcare Conference. ARVN stock pops on November 18, 2025 Arvinas shares are in rally mode this Tuesday. By mid‑afternoon U.S. trading, ARVN is up more than 14% on the day, with intraday prices hovering around the low‑$13 level and turnover far above normal. Quiver Quantitative+1 Pre‑market data set the tone: ChartMill flagged Arvinas as one of the most active names before the bell, with premarket quotes around $13.60, up more than 23% from the
18 November 2025
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Aspire Biopharma (ASBP) Jumps on $100M Equity Line and Q3 Filing – What Matters on November 14, 2025

Aspire Biopharma (ASBP) Jumps on $100M Equity Line and Q3 Filing – What Matters on November 14, 2025

Micro‑cap biotech Aspire Biopharma Holdings, Inc. (NASDAQ: ASBP) is back in the spotlight today after securing a new $100 million equity line of credit and releasing its Q3 2025 10‑Q, sending the stock sharply higher in pre‑market trading. ASBP stock among Friday’s biggest pre‑market movers Aspire Biopharma shares were one of the most active health‑care names in U.S. pre‑market trade on Friday. StockTitan data places Aspire’s current market capitalization at roughly $5.3 million, with a public float of about 27.2 million shares and insider ownership above 30%. Stock Titan Today’s move comes as investors digest two major disclosures: a fresh
14 November 2025
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Invivyd (IVVD) Rockets Over 50% Pre‑Market on November 14, 2025 as Traders Rush Into COVID Antibody Play

Invivyd (IVVD) Rockets Over 50% Pre‑Market on November 14, 2025 as Traders Rush Into COVID Antibody Play

Invivyd, Inc. (NASDAQ: IVVD) is back in the spotlight this Friday, November 14, 2025, with its stock exploding higher in pre‑market trading on the back of building momentum around its COVID‑19 antibody franchise and recent earnings. By early morning, IVVD was one of the most actively watched biotech names on Wall Street. Invivyd stock today: IVVD among top pre‑market gainers Multiple market data sources show Invivyd staging a huge move before the opening bell: In short, Invivyd stock is up roughly 40–60% in Friday’s pre‑market session, depending on the venue and timestamp, after closing at $1.77 on November 13. Notably,
14 November 2025
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Outlook Therapeutics (OTLK) Soars as FDA Accepts ONS‑5010 BLA and Sets December 31, 2025 Review Date

Outlook Therapeutics (OTLK) Soars as FDA Accepts ONS‑5010 BLA and Sets December 31, 2025 Review Date

Outlook Therapeutics (NASDAQ: OTLK) shares jumped today after the U.S. FDA accepted the company’s resubmitted Biologics License Application (BLA) for ONS‑5010/LYTENAVA, its bevacizumab-based eye drug for wet AMD, and set a PDUFA review date of December 31, 2025. Here’s what investors need to know. What Outlook Therapeutics announced today This morning, Outlook Therapeutics, Inc. (NASDAQ: OTLK) announced that the U.S. Food and Drug Administration has accepted the company’s resubmitted Biologics License Application for ONS‑5010 (bevacizumab‑vikg)/LYTENAVA, its investigational ophthalmic formulation of bevacizumab for the treatment of wet age‑related macular degeneration (wet AMD). GlobeNewswire+2Outlook Therapeutics+2 According to the company’s press release and
13 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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Vor Biopharma (VOR) Prices $100M Stock Offering at $10; Shares Slide as Investors Weigh Dilution — Nov. 11, 2025

Vor Biopharma (VOR) Prices $100M Stock Offering at $10; Shares Slide as Investors Weigh Dilution — Nov. 11, 2025

What happened today Vor Biopharma Inc. (NASDAQ: VOR) priced an underwritten public offering of 10 million common shares at $10.00 per share for $100 million in expected gross proceeds. The company granted underwriters a 30‑day option to purchase up to 1.5 million additional shares. Vor expects the transaction to close on or about Wednesday, Nov. 12, 2025, subject to customary conditions. J.P. Morgan, Jefferies, Citigroup, and TD Cowen are joint book‑running managers. The deal is being made under a shelf registration declared effective on March 31, 2025; a final prospectus supplement will be filed with the SEC. GlobeNewswire+1 How the
11 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 to start in 2026 and continued partnering discussions to accelerate development across indications. What InflaRx reported today The numbers investors will care about (Q3 2025 6‑K) Why this matters Market reaction (Nov 10, 2025) Key data points from the press
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 dose (6E13 vg/kg), with a simultaneous publication in Cardiovascular Research. GlobeNewswire Cleveland Clinic, which led the podium talk, summarized the early experience: six adults treated across two dose cohorts were monitored for months to >1 year; the therapy reached heart
8 November 2025
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Biohaven (BHVN) Stock Plunges on FDA Setback – Will Its Biotech Pipeline Fuel a Comeback?

Biohaven (BHVN) Stock Plunges on FDA Setback – Will Its Biotech Pipeline Fuel a Comeback?

FDA Setback: Complete Response Letter Halts Lead Drug Ambitions Biohaven’s recent troubles center on VYGLXIA (troriluzole) – its lead drug candidate for spinocerebellar ataxia (SCA), a degenerative brain disorder that currently has no approved treatment reuters.com. On November 4, 2025, after market close, Biohaven announced that the FDA had issued a Complete Response Letter (CRL) rejecting the company’s New Drug Application. This CRL cited multiple concerns with Biohaven’s data: potential bias, design limitations, lack of pre-specification, and unmeasured confounding factors in the supporting studies stocktwits.com stocktwits.com. In simpler terms, the FDA was uneasy with how Biohaven ran and analyzed its
5 November 2025
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Roche’s $3.5B Bet on 89bio (ETNB) – Stock Soars to New Highs as NASH Breakthrough Looms

Roche’s $3.5B Bet on 89bio (ETNB) – Stock Soars to New Highs as NASH Breakthrough Looms

Recent Developments and News (Nov 2025) 89bio has dominated biotech headlines in late 2025 due to Roche’s takeover move. On October 30, 2025, Roche announced it had successfully completed a tender offer for 89bio at $14.50/share + a $6.00 CVR, and would immediately merge 89bio into its subsidiary roche.com investing.com. By acquiring over 60% of shares in the tender (and securing another ~27% via guaranteed delivery), Roche was able to execute a short-form merger without a shareholder vote investing.com investing.com. All remaining ETNB shares will convert into the same $14.50 + CVR deal, and 89bio’s stock will cease trading on Nasdaq investing.com
5 November 2025
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Prelude Therapeutics (PRLD) Stock’s Wild Ride: 150% Surge, Big Pharma Deal & What’s Next

Prelude Therapeutics (PRLD) Stock’s Wild Ride: 150% Surge, Big Pharma Deal & What’s Next

A Wild Week for PRLD Stock Prelude Therapeutics – a small precision oncology biotech – suddenly became one of the market’s most volatile stocks in early November 2025. On Monday, Nov 3, PRLD shares skyrocketed, at one point gaining over 150%. The stock surged from roughly $1.60 into the $3–4 range, fueled by speculative buzz and unusually heavy trading rttnews.com. More than 29 million shares changed hands in a single day (versus an average of ~250,000), and the price hit a 52-week high of $4.19 rttnews.com. By the session’s end, Prelude closed near $4 – an astronomical one-day move for
4 November 2025
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