Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients ...

In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to ...

The company can again ship the Duchenne gene therapy for patients who can still walk, following a one-week pause triggered by ...

As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm ...

Rare disease and gene therapy stocks, battered in recent months by clinical and commercial setbacks, will likely benefit from the sudden departure this past week of Vinayak (Vinay) Prasad, MD, as ...

Shares of Sarepta Therapeutics surged Tuesday morning after the company said it had been informed by the Food and Drug ...

U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a muscular dystrophy patient who received a different, experimental treatment died ...

Sarepta ( SRPT) will begin shipping its top-selling muscular dystrophy therapy, Elevidys, after the U.S. Food and Drug ...

The drug, which was designed to treat Duchenne muscular dystrophy, has been linked to the deaths of two teenage boys.

The agency’s now-reversed decision to halt distribution of a gene therapy for children suffering from muscular dystrophy ...

Company CEO Doug Ingram said the pause was necessary for Sarepta to maintain a "productive and positive working relationship" ...

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...