FDA News News 17 October 2025

Moderna (MRNA) Stock on 8 December 2025: Institutional Tug‑of‑War, FDA Shockwaves and 2026–2030 Forecasts

Published: 8 December 2025 – all data and news current to this date. This article is informational only and not investment advice. Key takeaways Where Moderna stock stands today As of 8 December 2025, Moderna shares trade around $27.70, roughly

8 December 2025

INO Stock: Inovio’s FDA BLA Milestone, New Equity Offerings and 2026 Catalyst – Latest News and Forecasts (December 7, 2025)

Published: December 7, 2025 Inovio Pharmaceuticals (NASDAQ: INO) has quietly turned 2025 into a make‑or‑break year. The small‑cap biotech has completed a Biologics License Application (BLA) for its lead DNA immunotherapy INO‑3107, raised fresh capital through two stock offerings, and

7 December 2025

Biotechnology · FDA News · Financial Forecasts · Investment Strategies · Stock Market

Tempus AI (TEM) Stock: FDA Wins, Q3 Earnings, and Analyst Forecasts – December 6, 2025

Updated: December 6, 2025 Tempus AI Inc. (NASDAQ: TEM) has quickly become one of the most closely watched artificial intelligence stocks in healthcare. After a year marked by multiple FDA clearances, strong revenue growth and high-profile partnerships, Wall Street is

6 December 2025

Artificial Intelligence · Earnings Reports · FDA News · Investment Analysis · NASDAQ:TEM · Stocks

Incannex Healthcare (IXHL) Stock Soars on FDA Fast Track: December 2025 Outlook, Forecast & Key Risks

Incannex Healthcare Inc. (Nasdaq: IXHL) is back on traders’ radar after the U.S. Food and Drug Administration granted Fast Track designation to its lead sleep-apnoea drug candidate, IHL‑42X. The move caps a busy 2025 that also brought strong Phase 2

4 December 2025

FDA News · Healthcare Stocks · Investment Forecasts · NASDAQ:IXHL · Risk Analysis · Stock Market

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

Biotech · Drug Approvals · FDA News · NASDAQ:OTLK · Pharmaceutical Industry · Stock Market

J&J Makes Bold Move: Orthopedics Spin-Off (“DePuy Synthes”) Announced – 2025 Forecast Raised

NJ Stock: What to Know Before the Bell on November 10, 2025 (Fresh FDA Wins, Dividend Date, and Legal Overhang)

Dateline: Monday, November 10, 2025 — pre‑market Johnson & Johnson (NYSE: JNJ) starts the new week with momentum from multiple drug approvals, a firm dividend timetable, and a still‑active litigation backdrop. Here’s a concise, investor‑focused briefing on the key developments

9 November 2025

Dividends · FDA News · Investing · Legal Updates · NYSE:JNJ · NYSE:KMB · NYSE:KVUE · Stock Market

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

Biotechnology · FDA News · Financial Trends · Investment Analysis · NASDAQ:SRPT · 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

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

FDA News News 17 October 2025 - 8 December 2025