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Sarepta Therapeutics (SRPT) stock is in focus after the US Food and Drug Administration (FDA) asked the company to halt ...
The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...
The Food and Drug Administration plans to ask Sarepta Therapeutics Inc. to pause shipments of its Elevidys treatment after ...
Sarepta Therapeutics is refusing to pull its gene therapy Elevidys (delandistrogene moxeparvovec), despite a request from the FDA.
Second patient death from liver failure after Sarepta's Elevidys gene therapy triggers FDA investigation. Stock crashes 41% ...
Shares of Sarepta Therapeutics (NASDAQ: SRPT) plunged 26.85% in Friday pre-market after a clinical trial participant died ...
Elevidys is a gene therapy approved to treat Duchenne muscular dystrophy. Last month, Sarapta halted sales of the therapy for non-ambulatory patients.
Sarepta's cost-saving moves, FDA surprises, and pipeline potential position SRPT as a unique opportunity. Read here for an ...
Shares of drug developer Sarepta Therapeutics surged more than 20% in morning trading, rising after the late-Wednesday news ...
The decision came after a protracted debate about whether drug maker Sarepta Therapeutics had provided enough evidence that its medication, called eteplirsen, had meaningful impact on patients.
The FDA has had concerns about the clinical benefit of SRP-9001 since as far back as December 2018, when the agency questioned the surrogate endpoint and recommended that Sarepta pick one “that ...
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