05:26 AM EDT, 07/29/2025 (MT Newswires) -- Sarepta Therapeutics ( SRPT ) said late Monday that the US Food and Drug Administration has recommended the removal of the company's voluntary pause on shipments of Elevidys, a single-dose gene transfer therapy intended to address the genetic cause of Duchenne muscular dystrophy.

The company had paused shipments of the drug last week to allow the FDA to complete a safety review.

The safety review conducted by the FDA had included the case of an 8-year-old who had died in Brazil. The FDA concluded the death was unrelated to treatment with Elevidys and confirmed Sarepta can resume shipments, the company said.

Sarepta said it will imminently resume shipping of the drug.

Shares of the company rose more than 38% in premarket trading Tuesday.

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