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FDA News 25 August 2025 - 17 November 2025

Applied Therapeutics (APLT) Stock Explodes on Heavy Volume as FDA Scrutiny and Cash Concerns Collide – November 17, 2025

Applied Therapeutics (APLT) Stock Explodes on Heavy Volume as FDA Scrutiny and Cash Concerns Collide – November 17, 2025

Applied Therapeutics Inc. (NASDAQ: APLT) is back on traders’ radar today, with its penny stock surging on enormous volume despite intense regulatory uncertainty and a stretched balance sheet. On November 17, 2025, APLT is trading like a biotech rollercoaster: pre‑market gains, intraday spikes of 30–70%, and tens of millions of shares changing hands as investors reassess the company’s prospects after last week’s Q3 update and fresh analyst commentary. Benzinga+2Benzinga+2 Below is a detailed look at everything that matters about Applied Therapeutics today, plus the context behind the move. Key Takeaways 1. What Happened to APLT Today? Pre‑market and intraday action
17 November 2025
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
FDA Shockers, Breakthrough Trials & Outbreak Alerts – Biotech & Health News Roundup (Aug 24–25, 2025)

FDA Shockers, Breakthrough Trials & Outbreak Alerts – Biotech & Health News Roundup (Aug 24–25, 2025)

Regulatory Announcements: Approvals & Rejections Clinical Trial Breakthroughs & Research Highlights Industry Deals, Mergers & Investments Public Health Policy & Governance Updates Emerging Diseases & Vaccine News This comprehensive roundup highlights the fast-moving developments in biotech, pharma, and health over the past 48 hours. From life-saving drugs and high-stakes deals to public health challenges, the landscape is evolving daily. As always, readers are advised to consult original sources and official health guidance for more details. Sources: Key information has been drawn from Reuters, AP News, FDA/CDC releases, and expert commentary to ensure accuracy and timeliness reuters.com reuters.com reuters.com thewellnews.com reuters.com
25 August 2025
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