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

Sarepta Therapeutics has rejected a call by the Food and Drug Administration to stop shipments of its muscular dystrophy drug.

Sarepta Therapeutics Inc. shares plunged after European regulators rejected its gene therapy Elevidys, intensifying scrutiny on the drugmaker after it was pressured to halt shipments of its treatment ...

Although Sarepta initially appeared to have avoided the worst possible outcome for Elevidys—a market withdrawal—thanks to the gene therapy’s new black box warning, the FDA is signaling stronger ...

FDA places clinical hold on Sarepta's LGMD gene therapy trials after three deaths and revokes platform tech designation due to safety concerns.

Sarepta said in an email to Reuters, "The FDA communication was triggered by our report to the FDA and our suggested update to the label to include information relating to the recent events." ...

The Food and Drug Administration is conducting an investigation following the deaths of two patients treated with Sarepta's gene therapy for Duchenne muscular dystrophy. Thursday, July 31, 2025 ...

Shares of Sarepta Therapeutics closed down as much as 42% to hit a nine-year low of $18.30 on Monday after a second death of a male teenage patient who had received its gene therapy, Elevidys ...

Pharmalittle: We’re reading about a Sarepta setback with a DMD drug, FDA workload causes a delay, and more Nonprofit led by 23andMe co-founder Anne Wojcicki won a last-minute bidding war to buy ...

Sarepta noted that the FDA had proactively asked if the company has considered using additional immunosuppression, ... A full market withdrawal is not out of the question, though.

FDA evaluating further regulatory actions after deaths Elevidys is the only gene therapy for Duchenne muscular dystrophy Sarepta suggested updating Elevidys' label June 24 (Reuters) - The U.S ...

In June, Sarepta reported a second death in a patient who had received its gene therapy, which raised concerns about the safety and future demand for the treatment. Both boys were non-ambulatory ...