
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.“