(Reuters) -Sarepta Therapeutics said on Wednesday it would lay off 36% of its workforce, or about 500 employees, after the recent deaths of two patients who had received its gene therapy Elevidys.
Its shares shot up about 40% in extended trading, as the company also said the restructuring efforts, including layoffs, would reduce annual costs by about $400 million in 2026.
Sarepta has faced heightened regulatory scrutiny after two patients treated with the muscle disorder therapy died from acute liver failure, casting doubts on the treatment’s safety and future demand. Both patients were non-ambulatory, or unable to walk independently.
The U.S. Food and Drug Administration has requested that the prescribing information for Elevidys should include a black box warning, the regulator’s most serious, for acute liver injury and acute liver failure, Sarepta said on Wednesday, adding that it has agreed to the change.
The company had suspended its Elevidys sales forecast for 2025 and halted shipments to non-ambulatory patients last month.
Elevidys, approved by the FDA in 2024 for ambulatory Duchenne muscular dystrophy patients aged four and older, is the only gene therapy available for the disease. It carries a known risk of liver damage and was conditionally approved for non-ambulatory patients despite failing to meet the main goal in a late-stage study.
(Reporting by Christy Santhosh and Mariam Sunny in Bengaluru; Editing by Mohammed Safi Shamsi and Devika Syamnath)
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