Sarepta Therapeutics Inc (NASDAQ:SRPT) shares were halted in extended trading Monday after the U.S. Food and Drug Administration (FDA) recommended the removal of a voluntary hold for Elevidys.
What Happened: The FDA announced late Monday that it recommended lifting the voluntary hold on Sarepta Therapeutics’ gene therapy for Duchenne Muscular Dystrophy. The company said in a statement that it was notified by the FDA on Monday and plans to resume shipping Elevidys to sites of care for treatment of ambulatory patients with Duchenne “imminently.“
The news comes after the FDA announced on Friday that it was investigating the death of an 8-year-old in Brazil who had received Elevidys. Sarepta said the FDA determined the death was unlikely to be related to treatment with Elevidys, which is the only approved gene therapy for Duchenne.
“Last week, at the suggestion of FDA, Sarepta made the difficult decision to pause shipments of ELEVIDYS to provide the FDA with an opportunity to complete a review of available safety information. We are very pleased that FDA chose to rapidly and comprehensively complete that review and to recommend that we remove our voluntary pause and resume shipment of ELEVIDYS for ambulatory patients,” said Doug Ingram, CEO of Sarepta Therapeutics.
Sarepta said Elevidys treatment for non-ambulatory patients remains on pause pending the outcome of upcoming discussions with the FDA regarding the company’s approach to risk-mitigation.
SRPT Price Action: Sarepta shares closed Monday up 16.18% at $13.86. The stock was briefly halted after-hours. Shares were up 50.57% at $20.87 at the time of publication, according to Benzinga Pro.
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