02:43 PM EST, 11/14/2025 (MT Newswires) -- Sarepta Therapeutics' ( SRPT ) Elevidys gene therapy will now carry a boxed warning and a restricted indication following reports of fatal acute liver failure in non-ambulatory Duchenne muscular dystrophy patients, the US Food and Drug Administration said Friday.

The FDA revised the label to limit Elevidys to ambulatory patients aged four and older and remove the non-ambulatory indication. Sarepta had already paused distribution for those patients following two fatal cases and another serious liver-injury event.

The updated label adds the boxed warning, new precautions, a limitations-of-use statement, and requires weekly liver tests for at least three months. The FDA also advised against use in patients with certain DMD gene deletions or preexisting liver impairment.

Regulators are requiring a postmarketing study of about 200 patients to further assess liver-injury risk.

Sarepta Therapeutics ( SRPT ) did not immediately respond to MT Newswires' request for comment on the matter.

Shares of Sarepta Therapeutics ( SRPT ) were up 8% in recent Friday trading.

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