Sarepta faces FDA scrutiny over Elevidys as analysts downgrade stock and warn of long-term debt risks amid market uncertainty ...

Shares of Sarepta Therapeutics SRPT are declining in the pre-market hours today after the announcement that it will ...

Sarepta Therapeutics (SRPT) stock is in focus after the US Food and Drug Administration (FDA) asked the company to halt ...

Sarepta Therapeutics Inc. said another patient has died from acute liver failure after receiving one of its gene therapies, ...

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

Children’s Hospital Los Angeles paused Sarepta’s Elevidys gene therapy after FDA flagged safety issues, including deaths in ...

Second patient death from liver failure after Sarepta's Elevidys gene therapy triggers FDA investigation. Stock crashes 41% ...

Sarepta Therapeutics is refusing to pull its gene therapy Elevidys (delandistrogene moxeparvovec), despite a request from the FDA.

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.

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 ...