04:00 PM EST, 11/14/2025 (MT Newswires) -- Sarepta Therapeutics ( SRPT ) said Friday that the U.S. Food and Drug Administration has approved updated prescribing information for Elevidys, its gene therapy for Duchenne muscular dystrophy.

The update adds a boxed warning for acute liver injury and liver failure, expands prescriber guidance with new monitoring requirements, and removes the therapy's non-ambulatory indication.

Sarepta said it will begin a study using an enhanced sirolimus-based immunosuppression regimen, with the goal of restarting dosing in non-ambulatory patients pending FDA concurrence.

The updated label also highlights risks including myocarditis, infusion-related reactions, and immune-mediated myositis, and reaffirms that the therapy is contraindicated for patients with certain DMD gene deletions, the company said.

Shares of the company were up 6% in recent trading.

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