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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
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Scholar Rock (NASDAQ: SRRK) Soars on FDA Progress, $200M ATM and Q3 2025 Earnings – November 14, 2025 Update

Scholar Rock (NASDAQ: SRRK) Soars on FDA Progress, $200M ATM and Q3 2025 Earnings – November 14, 2025 Update

Scholar Rock Holding Corporation (NASDAQ: SRRK) is back in the spotlight as its stock jumps more than 25% on the day after a pivotal FDA meeting, fresh Q3 2025 financial results, and the launch of a new $200 million at-the-market (ATM) stock offering. SRRK stock jumps over 25% after FDA “constructive” meeting Scholar Rock shares are surging today. As of the latest trade, SRRK is changing hands around $37.98, up roughly 26% on the session, after touching an intraday high above $39. Daily trading volume has climbed to about 2.75 million shares, well above normal levels. The move is being
14 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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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 2025, the stock trades in the mid-teens, down from about $120–$130 at the start of the year. In fact, the stock’s 52-week range tells the story: it hit a high of $138.81 and a low of just $10.41 over the past year marketbeat.com. This implosion has vastly underperformed the biotech sector (for context, the biotech index is up ~19% in
4 November 2025
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Biohaven Stock’s Wild Ride: Big Drops, Big Hopes as FDA Verdict Nears

Biohaven Stock’s Wild Ride: Big Drops, Big Hopes as FDA Verdict Nears

In summary, Biohaven’s stock is a tale of high stakes in biotech. Recent price swings underscore the uncertainty, but also the potential reward if Biohaven’s bets pay off. With an FDA verdict looming and multiple shots on goal in its pipeline, investors should brace for more turbulence. The company’s strong institutional backing and “Strong Buy” analyst consensus indicate confidence in the science investing.com directorstalkinterviews.com. Still, caution is warranted – Biohaven will need to deliver clinical and regulatory wins to justify those bullish forecasts. In the coming weeks, news flow (FDA decision, earnings, trial readouts) could rapidly shift the narrative yet
3 November 2025
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UniQure’s Roller-Coaster: Gene Therapy Breakthrough, FDA Setback, and What’s Next for QURE Stock

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 in late September when Phase 1/2 trial data showed a remarkable 75% reduction in disease progression with AMT-130 – news that caused the stock to surge almost 200% that month reuters.com. By late October, QURE was hovering around $68–$70, up roughly 300–500% from spring levels. However, in the past few days the stock’s momentum sharply reversed. On Monday, Nov 3,
3 November 2025
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Salmonella Scare: FDA Upgrades Egg Recall to ‘Highest Risk’ — Are Your Eggs Affected?

Salmonella Scare: FDA Upgrades Egg Recall to ‘Highest Risk’ — Are Your Eggs Affected?

Egg supplies and prices remain the backdrop to this story. 163 million U.S. poultry have died from avian flu since 2022, cutting the egg-laying flock by ~11% vs. 2019 reuters.com. Consumers have seen sticker shock – in some cities eggs cost $8–$10 per dozen reuters.com. This summer’s massive recall (over 6 million eggs from one farm) is partly why the FDA reclassified it at the top risk level newsweek.com foodnetwork.com. How to stay safe: Food-safety experts stress vigilance with eggs. Salmonella is “a leading cause of foodborne illness” in the U.S. foodpoisoningnews.com. The FDA and CDC advise thoroughly cooking eggs
22 October 2025
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Psychedelic Biotech Rally: Atai Life Sciences Stock Soars 18% on FDA Breakthrough and $130M Fundraise

Psychedelic Biotech Rally: Atai Life Sciences Stock Soars 18% on FDA Breakthrough and $130M Fundraise

Stock Surge & Analyst Reaction Atai shares exploded higher on Oct. 17, 2025. Investors bid the stock up ~17.7%, closing at roughly $6.45 ts2.tech (versus ~$5.48 offering price). In after-hours trading it briefly touched ~$6.86 ts2.tech. This rally follows a week of good news: BPL-003’s FDA breakthrough, plus well-received capital raise plans. Volume on Oct. 17 was very high (tens of millions of shares), reflecting heavy trading. Over 2025 the stock has skyrocketed ~348% ts2.tech, making ATAI one of the year’s top biotech performers. Its market cap now hovers around $1.2 billion ts2.tech. Analysts have taken notice. Needham Research just initiated
18 October 2025
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Kezar Life Sciences Stock Soars 40% After FDA Setback Sparks Strategic Shake-Up

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 alignment with the U.S. Food and Drug Administration on the design of a pivotal trial for zetomipzomib in autoimmune hepatitis (AIH) ca.investing.com. The FDA abruptly canceled a Type C meeting that was scheduled for Q4 2025 to discuss Kezar’s proposed Phase 3 trial, and instead requested a new standalone study to characterize zetomipzomib’s pharmacokinetics in patients with severe liver impairment
17 October 2025
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Sarepta Therapeutics (SRPT) Surges After FDA Greenlights Duchenne Gene Therapy – Is a Rebound Ahead?

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 pause, the stock plunged to decade lows (losing ~85% YTD) nasdaq.com biospace.com. (William Blair analysts warned this was a “worst-case scenario” that could “negatively affect patient interest in Elevidys” biospace.com.) On July 17, Sarepta partially paused Elevidys for all patients, and FDA did as well – shares briefly hit the low teens. Then, on July 28 FDA green-lit Elevidys resumption
3 October 2025
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