Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy fell short of its main Phase 3 goal, but the firm contends the full body of evidence supports expanding the therapy’s label to ...

Tracking the FDA advisory panel on Sarepta’s gene therapy for Duchenne muscular dystrophy. By Adam Feuerstein and Jason Mast May 12, 2023. Reprints. Kristoffer Tripplaar/Sipa via AP.

Sarepta Therapeutics said on Monday it will resume shipping of its gene therapy Elevidys to patients with a rare muscular ...

Sarepta Therapeutics is laying off 500 staffers, or 36% of its workforce, as part of a strategic restructuring aiming to save $400 million annually. | Sarepta Therapeutics has laid off 500 staffers, ...

Sarepta Therapeutics failed to win the European drug regulator's backing for its muscle disorder gene therapy on Friday, as ...

Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the company over a mounting string of controversies—to the FDA, Endpoints News and ...

A timeline of key developments surrounding Sarepta Therapeutics' Duchenne muscular dystrophy drug Elevidys, and the potential ...

Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping ...

While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency ...

The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety ...

Sarepta stock plunged again Thursday on a report the FDA will require additional clinical testing to validate the safety ...

New clinical data indicate that Sarepta’s gene therapy led to improvement on a variety of measures of the muscle-wasting disorder. A regulatory submission is almost certain, but the question is ...