Why Sarepta Therapeutics Stock Surged Nearly 48% In After-Hours Trading Today

Sarepta Therapeutics shares jumped after hours on Monday after the U.S. Food and Drug Administration (FDA) allowed the company to resume shipping Elevidys, its gene therapy for Duchenne muscular dystrophy, to children who are still able to walk.

The stock closed up 16.2% on Monday and soared another 47.6% in after-hours trading.

The FDA’s decision follows a review of a recent death reported in Brazil involving an 8-year-old boy who received the treatment. 

Sarepta had voluntarily paused shipments last week at the FDA’s request to allow time for a thorough safety review. The FDA has now concluded that the child’s death was not related to Elevidys, clearing the way for Sarepta to restart shipments “imminently,” the company said.

The boy was not part of a clinical trial, and Brazilian health authorities said the likely cause of death was a viral infection worsened by immune suppression, which is common in Duchenne treatment. Sarepta reported the case to the FDA on June 18.

“We are very pleased that [the] FDA chose to rapidly and comprehensively complete that review,” said Sarepta CEO Doug Ingram. “We look forward to working collaboratively with the FDA to complete the safety label update for ELEVIDYS and to discussing the approach to risk mitigation for non-ambulatory patients.”

Elevidys is the first and only gene therapy approved in the U.S. for Duchenne muscular dystrophy, a rare and progressive condition that affects mostly boys and leads to loss of muscle function. 

The treatment remains available in the U.S. for boys aged four and older who can still walk. Its use in children who have lost mobility was approved under the FDA’s accelerated pathway and is under further review.

Elevidys is also running into hurdles overseas. Last week, European regulators declined to recommend the therapy for approval, but Roche, Sarepta’s partner outside the U.S., said it will keep working with EU officials to resolve the issues.

On Stocktwits, retail sentiment for Sarepta was ‘extremely bullish’ amid a 1,510% surge in 24-hour message volume.

Sarepta’s stock has declined 88.8% so far in 2025.

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