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

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

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

After initially refusing to suspend Elevidys distribution after two deaths, Sarepta has now given in to the FDA’s request, ...

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 ...

Sarepta pauses U.S. Elevidys shipments to complete FDA-requested safety label updates, aiming to resume distribution in the ...

Sarepta (SRPT) plans to continue Elevidys shipments for Duchenne muscular dystrophy, despite FDA request not to do so after ...

CAMBRIDGE, Mass., April 04, 2025--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, shared the following update related to ELEVIDYS ...

Summary Sarepta Therapeutics' stock plummets after its gene therapy drug ELEVIDYS fails to meet its primary endpoint in a confirmatory study. SRPT had previously secured accelerated approval for ...

Sarepta shares fell ~40% in premarket after reporting a second patient death linked to Elevidys. Sarepta halted Elevidys shipments for non-ambulatory patients and paused dosing in the ENVISION trial.

Elevidys generated $375m in sales, falling short of Wall Street’s $427m forecast. The company also reduced its 2025 total product revenue guidance to between $2.3bn and $2.6bn, from a previous ...

The U.S. Food and Drug Administration approved Sarepta's Elevidys, the first gene therapy for DMD, last year and allowed the expanded use of the drug in June.