Sarepta Therapeutics announced on Monday that it will resume shipping its gene therapy Elevidys to patients with muscular dystrophy who are able to walk, causing the company’s shares to surge 59% in after-hours trading.
The decision follows the U.S. Food and Drug Administration’s recommendation to lift a voluntary pause on Elevidys after an investigation found that the death of an eight-year-old patient in Brazil was not linked to the treatment. Sarepta had faced intense scrutiny after the deaths of two non-ambulatory teenage patients treated with Elevidys, as well as a 51-year-old man who received the company’s experimental gene therapy SRP-9004.
While shipments to ambulatory patients will resume, the FDA said the therapy remains paused for those with Duchenne muscular dystrophy (DMD) who cannot walk, as investigations continue into the deaths of two patients. Sarepta had previously halted dosing for non-ambulatory patients and complied with the FDA’s request to pause all shipments, including those handled by Roche, its partner for sales outside the United States.