Biotech

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

13 November 2025

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

11 November 2025

Biotech · Clinical Trials · Investment Insights · NASDAQ:VKTX · Obesity Research · Pharma News

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

11 November 2025

Biotech · Financial News · Investments · NASDAQ:VOR · Public Offerings · Stock Market

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

10 November 2025

Biotech · Clinical Trials · Drug Development · Financial Reports · NASDAQ:IFRX · Pharma News

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

8 November 2025

Biotech · Clinical Trials · FDA Updates · Gene Therapy · Medical News · NASDAQ:TNYA

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,

5 November 2025

Biotech · FDA · Investing · NASDAQ:BHVN · Pharmaceuticals · Stocks

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

5 November 2025

Biotech · Medical Innovation · NASH · Pharma News · Stock Market

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

4 November 2025

Biotech · Company Analysis · Investing · NASDAQ:INCY · NASDAQ:PRLD · Pharma News · Stock Market

UniQure’s Roller-Coaster: Gene Therapy Breakthrough, FDA Setback, and What’s Next for QURE Stock

UniQure Stock Plunges 50% on FDA Shocker – What’s Next for QURE’s Gene Therapy Ambitions?

4 November 2025

Biotech · FDA News · Gene Therapy · NASDAQ:QURE · Pharma Industry · Stock Market

TG Therapeutics Stock Soars on Briumvi Boom – Key Facts, Analyst Insights & 2025 Outlook

Company Overview: Briumvi-Focused Business Model TG Therapeutics, Inc. is a commercial-stage biopharmaceutical company specializing in treatments for B-cell mediated diseases gurufocus.com. After years as a development-stage biotech, TG entered the commercial arena with Briumvi, its first approved product, and now

3 November 2025

Biotech · Healthcare · Investment · Market Analysis · NASDAQ:TGTX · Stocks

Iovance Biotherapeutics (IOVA): TIL Cancer Breakthrough or Biotech Bust?

Company Overview: Pioneering TIL Therapy in Oncology Iovance Biotherapeutics is focused on developing tumor-infiltrating lymphocyte (TIL) therapies – a novel form of immunotherapy where a patient’s own T cells, harvested from their tumor, are expanded and activated in a lab,

3 November 2025

Biotech · Cancer Research · Immunotherapy · Medical Innovation · NASDAQ:IOVA · Stock Analysis

Rani Therapeutics (RANI) Stock Skyrockets on Biotech Breakthrough: Inside the Surge and What’s Next

RANI Stock Performance: From Penny Stock to Momentum Rocket Rani Therapeutics’ stock price has been on a tear in late 2025, turning heads in the biotech investing community. After languishing under $1 for most of the year, RANI exploded upward

3 November 2025

Biotech · Company News · Investing · NASDAQ:RANI · Pharmaceuticals · Stock Market

Biotech News 3 November 2025 - 13 November 2025