FDA asks Sarepta to stop shipping gene therapy
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Sarepta Therapeutics (NASDAQ:SRPT) shares plummeted on Friday following reports of a third patient death linked to its gene therapy pipeline this year, further clouding investor confidence despite the company’s recent efforts to provide clarity on its restructuring and FDA label plans.
Sarepta's cost-saving moves, FDA surprises, and pipeline potential position SRPT as a unique opportunity. Read here for an investment analysis.
Stocks on Sky High. Sarepta Therapeutics, Inc. (NASDAQ:SRPT) is one of the top-performing companies on Thursday. Sarepta Therapeutics saw its share prices rise by 19.53 percent on Thursday to close at $21.
Sarepta agrees to FDA's black box warning and announces major restructuring, including job cuts and cost-saving measures to meet 2027 goals.
Sarepta Therapeutics announced a layoff of 493 employees, including 80 in Franklin County, amid restructuring efforts and criticism from the FDA.
The FDA concern regarding the impact of the drug on the kidney was properly tackled by Sarepta, as the company recommended monthly monitoring of the patients. The now-public CRL is much more ...
Reviewers at the Food and Drug Administration were leaning toward rejecting a closely watched gene therapy for Duchenne muscular dystrophy made by Sarepta Therapeutics, prompting a top official to ...
Sarepta Therapeutics Inc (NASDAQ:SRPT) shares are soaring in Wednesday’s after-hours session after the company announced a strategic restructuring and cost-cutting measures. What To Know: After the market close on Wednesday,
– Regulatory action date of May 29, 2023 – SRP-9001 would be the first gene therapy for Duchenne, a one-time treatment designed to treat the underlying cause of DMD by delivering a functional ...
The decision came after months of protracted debate about whether drug maker Sarepta Therapeutics had provided enough evidence to demonstrate that its medication, called eteplirsen, had a ...