Stock of Sarepta Therapeutics Inc. (NASDAQ:SRPT) surged 41.05% in Tuesday pre-market following the U.S. Food and Drug Administration’s (FDA) recommendation to lift the voluntary hold on Elevidys, Sarepta’s gene therapy for Duchenne Muscular Dystrophy.
What Happened: The FDA advised the removal of the voluntary hold on Elevidys, which had been implemented after the demise of an 8-year-old patient in Brazil. The FDA determined that the death was unlikely to be related to treatment with Elevidys, the only approved gene therapy for Duchenne.
Sarepta’s CEO, Doug Ingram, expressed his contentment with the FDA’s prompt and comprehensive review, leading to the recommendation to recommence the distribution of Elevidys for ambulatory patients. However, the therapy for non-ambulatory patients continues to be on hold, as talks regarding the company’s risk-mitigation strategy are still underway with the FDA.
Following this development, Sarepta’s shares closed Monday with a 16.18% increase at $13.86.
SEE ALSO: Cathie Wood Goes On A $20M Bitmine Immersion Bargain Hunt As Ark Trims Robinhood And Palantir Stakes
Why It Matters: This news comes as a significant development for Sarepta, especially considering the recent challenges the company has faced. The FDA had previously requested a voluntary suspension of Elevidys distribution following the death of an 8-year-old boy who had received the therapy. This incident occurred on June 7, 2025, raising safety concerns about the therapy.
Furthermore, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had issued a negative opinion on the conditional marketing authorization (CMA) for Elevidys for ambulatory individuals aged three to seven years with Duchenne muscular dystrophy (DMD).
The FDA’s recommendation to lift the hold on Elevidys for certain patients is a positive step forward for Sarepta, potentially paving the way for the resumption of the therapy’s distribution and providing a boost to the company’s stock.
In another development, Arrowhead Pharmaceuticals (NASDAQ:ARWR) has publicly stated that Sarepta owes it $100 million which it must repay within 60 days.
READ MORE:
Image via Shutterstock
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
