FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths [Yahoo! Finance]
Sarepta Therapeutics, Inc. (SRPT)
Last sarepta therapeutics, inc. earnings: 2/26 04:05 pm
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Source: Yahoo! Finance
The infused therapy from Sarepta Therapeutics will carry a boxed warning — the most serious type — alerting doctors and patients to the risk of potentially fatal liver failure with the treatment, the FDA said in a release. The one-time therapy, Elevidys, has been under FDA scrutiny since the company reported the first of two deaths of teenage boys in March. Following a second death reported in June, the FDA briefly called for halting all shipments of the drug. But the agency quickly reversed course after facing pushback from patient families and libertarian activists close to President Donald Trump. Elevidys is the first U.S.-approved gene therapy for Duchenne's muscular dystrophy, a fatal muscle-wasting disease that affects boys and young men. In addition to the boxed warning, the FDA is also limiting the drug's approved use to patients who are 4 years old and up and can still walk. Previously the FDA had allowed the drug's use in immobile patients, who generally have more adv
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News
- Sarepta Preliminary Results: Not What The Market Wanted To Hear [Seeking Alpha]Seeking Alpha
- Sarepta Therapeutics: Is Elevidys A Bust? [Seeking Alpha]Seeking Alpha
- Sarepta Therapeutics (NASDAQ:SRPT) had its price target raised by analysts at Royal Bank Of Canada from $16.00 to $18.00. They now have a "sector perform" rating on the stock.MarketBeat
- Sarepta Therapeutics (NASDAQ:SRPT) had its "sell" rating reaffirmed by analysts at HC Wainwright. They now have a $5.00 price target on the stock.MarketBeat
- Sarepta Reports Preliminary* Fourth Quarter and Full-Year 2025 Net Product Revenues [Yahoo! Finance]Yahoo! Finance
SRPT
Earnings
- 11/3/25 - Beat
SRPT
Sec Filings
- 1/12/26 - Form 8-K
- 12/19/25 - Form 4
- 12/19/25 - Form 8-K
- SRPT's page on the SEC website