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 ...

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

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

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

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

Shares of Sarepta Therapeutics (NASDAQ:SRPT) fell in the premarket on Thursday following news regarding a clinical hold requested by the EU drug regulator, European Medicines Agency (EMA), on ...

In March, Sarepta Therapeutics, Inc. (NASDAQ:SRPT) shared an update on Elevidys (delandistrogene moxeparvovec-rokl), the only approved gene therapy in patients with Duchenne muscular dystrophy.

Gene therapy developer Sarepta Therapeutics (NASDAQ:SRPT) lost ~20% on Tuesday to reach a new 52-week low after the company disclosed the death of a patient treated with Elevidys, its FDA-approved ...

Sarepta Therapeutics, Inc.'s stock is downgraded to Hold due to underperformance, safety concerns with ELEVIDYS, and increased expenses, despite strong long-term fundamentals. Q1 2025 results show ...

Sarepta Therapeutics said Tuesday that a 16-year-old boy died after receiving Elevidys, its gene therapy for Duchenne muscular dystrophy, the first known death linked to the treatment.