Sarepta shares fall 4% after FDA documents show safety concern about drug [Reuters]
Sarepta Therapeutics, Inc. (SRPT)
Last sarepta therapeutics, inc. earnings: 2/26 04:05 pm
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Source: Reuters
Sarepta shares fall 4% after FDA documents show safety concern about drug (Reuters) - Shares of Sarepta Therapeutics Inc were down around 4% Wednesday after the U.S. Food and Drug Administration revealed documents detailing concerns it had about the safety and efficacy of one of the company’s recently approved Duchenne muscular dystrophy (DMD) drugs. The drug, Vyondys 53, also known as golodirsen, was originally rejected by the FDA last year before the agency reversed that decision in December and approved it. It was the second controversial drug approval for Sarepta. The company saw its first drug, Exondys 51, which also treats DMD, approved in 2016 despite concerns raised by experts about its effectiveness. The newly released documents outlined concerns ranging from kidney toxicity, to infections, to low levels of effectiveness as reasons for the FDA’s original rejection of the drug. The FDA cited some of these concerns at the time of its orginal rejection of Vyondys 53 but the docu
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SRPT
Earnings
- 11/6/24 - Beat
SRPT
Sec Filings
- 11/14/24 - Form SC
- 11/13/24 - Form SC
- 11/6/24 - Form 10-Q
- SRPT's page on the SEC website