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FDA News News 10 August 2025 - 4 November 2025

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

4 November 2025

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

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

Stock Performance: Skyrockets and Crashes UniQure’s stock has been on a wild ride in 2025. After starting the year in the mid-teens, QURE shares skyrocketed through mid-2025 on hopes for its Huntington’s gene therapy. The rally hit a fever pitch

3 November 2025

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

Spruce Biosciences Skyrockets on FDA Breakthrough – Will SPRB’s Rally Last or Fade?

Spruce Biosciences (SPRB) Skyrockets 1,300% on FDA Breakthrough News – Experts Weigh In

What to Know Before Markets Open on October 20, 2025 FDA Breakthrough News Ignites Rally Spruce Biosciences’ meteoric rise began with a game-changing regulatory win. On October 6, the company announced that the FDA had granted Breakthrough Therapy Designation (BTD)

19 October 2025

Biotech Stocks · Expert Opinions · FDA News · Investment Trends · Market Analysis · NASDAQ:SPRB

Kezar Life Sciences Stock Soars 40% After FDA Setback Sparks Strategic Shake-Up

FDA Setback Triggers Strategic Review Kezar Life Sciences revealed a major regulatory setback for its lead drug and immediately pivoted to consider strategic alternatives. In an October 16 press release, the South San Francisco company announced it failed to reach

17 October 2025

Biotechnology · Company Analysis · FDA News · Investment Strategies · NASDAQ:KZR · Stock Market

Disc Medicine (IRON) Stock Soars on FDA Fast-Track News as Analysts Boost Targets

FDA Voucher Ignites IRON Stock Rally Disc Medicine’s stock price (NASDAQ: IRON) spiked dramatically in mid-October 2025 after news of the FDA voucher, vaulting from the mid-$70s to the low-$90s in a single day gurufocus.com. On Friday (Oct. 17), IRON

17 October 2025

Biotech · FDA News · Investment · Pharma Industry · Stock Market

Sarepta Therapeutics Stock Skyrockets After FDA U-Turn – Gene Therapy Drama Explained

Stock Performance: Wild Swings from Deaths to Resumption SRPT has been a roller-coaster. In early 2025, Sarepta’s shares were largely pummeled by the DMD gene-therapy crisis. After two Duchenne patients (non-ambulatory teens) died in June and FDA urged a full

3 October 2025

Biotechnology · FDA News · Gene Therapy · Healthcare Investing · NASDAQ:SRPT · Stock Market · Stocks

Breakthrough Cures, FDA Shake-Ups & Pharma Mega‑Deals: Global Health News Roundup (Aug 9–10, 2025)

Researchers in China unveiled a hydrogel-based “smart” wound dressing that speeds diabetic ulcer healing, with a single application achieving about 90% wound closure in 12 days by delivering microRNA-loaded vesicles that suppress the vessel-growth inhibitor TSP-1. A Swedish study published

10 August 2025

FDA News · Global Health · Healthcare · Medical Breakthroughs · Pharmaceuticals

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