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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SRPT
News
- Sarepta Announces Approval to Begin ENDEAVOR Cohort 8 to Evaluate Enhanced Immunosuppression Regimen as Part of ELEVIDYS Gene Therapy for Non-Ambulant Individuals with DuchenneBusiness Wire
- Sarepta Provides Progress Update for SRP-1003, its Investigational siRNA treatment for Myotonic Dystrophy Type 1Business Wire
- INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Sarepta Therapeutics, Inc. - SRPTPR Newswire
- Is Sarepta Therapeutics a Bargain After Its 82% Drop Over the Last Year? [Yahoo! Finance]Yahoo! Finance
- FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths [Yahoo! Finance Canada]Yahoo! Finance Canada
SRPT
Earnings
- 11/3/25 - Beat
SRPT
Sec Filings
- 12/2/25 - Form 4
- 11/19/25 - Form 4
- 11/14/25 - Form SCHEDULE
- SRPT's page on the SEC website