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

Brazilian authorities said the death was unlikely to have been caused by Elevidys and was instead more in line with severe ...

The FDA concluded that a recent patient death in Brazil was unrelated to Sarepta’s Elevidys treatment, allowing the company ...

Most investors don’t see the drugmaker’s executive management as credible, following the failure to disclose a patient death, ...

A 51-year-old man died last month after receiving an experimental treatment from Sarepta, the third death this year tied to ...

Despite a new setback for Elevidys in Europe, Roche—which markets Sarepta’s gene therapy outside the U.S.—remains committed ...

After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy ...

Sarepta rebuffed a call from the Food and Drug Administration to halt all shipments of its gene therapy for Duchenne muscular ...

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

Shares of Sarepta Therapeutics declined 17% in early trading on Friday after another patient who had received an experimental ...

Sarepta officials said the temporary halt in shipments was done to maintain a productive working relationship with regulators ...

The favorable market reaction indicates investor relief at management’s swift measures to rectify the company's worsening ...