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.

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.

Roche Holding AG’s gene therapy Elevidys failed to get the backing of European regulators, a blow to the Swiss drugmaker and to Sarepta Therapeutics Inc., the embattled US biotech that developed the ...

H.C. Wainwright reiterated a ‘Sell’ rating on Sarepta on Wednesday with a $10 price target. The firm views the FDA as a potential headwind for Sarepta now.

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.

Sarepta Therapeutics has temporarily suspended use of the gene therapy Elevidys in non-ambulatory patients with Duchenne muscular dystrophy (DMD) after a second patient taking the drug died from ...

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 ...

FDA confirms two fatal cases of liver failure in DMD patients treated with Elevidys HC Wainwright reiterates Sell rating on Sarepta, with a $10 price target Tim Melvin’s system has spotted 10X ...