Sarepta Slashes Workforce After Patient Deaths on Gene Therapy
The Cambridge, Massachusetts-based biotech company said Wednesday it would eliminate about 500 employees as part of a sweeping restructuring. It's also pausing several drugs in its pipeline. Sarepta said the moves would contribute to an estimated $400 million in annual cost savings.
The company agreed to warn doctors and patients about the risk of liver failure from Elevidys, its gene therapy to treat Duchenne muscular dystrophy, at the request of the US Food and Drug Administration. Black box labels are the most serious safety warnings a drug can have, and indicate severe or potentially deadly complications.
Sarepta said the job cuts will help it maintain access to a $600 million revolving credit line and create cash flow that could help it repay a convertible note due in 2027.
The company also disclosed preliminary second-quarter results showing total net product revenue of $513 million. More than half came from Elevidys.
Last month, Sarepta reported that a second teenage boy died of acute liver failure while being treated with its $3.2 million gene therapy. Both fatalities occurred in patients who weren't able to walk because of the muscle-wasting disease.
At the time, the company suspended its 2025 revenue guidance, and pledged to take a careful look at its costs going forward. Sarepta also paused a clinical trial and halted shipments of the drug for non-ambulatory patients.
Sarepta said it will submit a plan to the FDA for patients who can't walk that includes suppressing their immune systems before administering Elevidys, which may reduce their risk of complications. It will also discuss a path to resuming shipment of the therapy for those patients, typically older boys and young men.
The FDA is investigating the Elevidys deaths. The fatalities pose one of the first big tests for Vinay Prasad, the new head of the regulator's gene therapy division. As an academic at the University of California San Francisco, prior to his current role, he was highly critical of the FDA's expedited approval process and its use for Sarepta's gene therapies in particular.
In social media posts in March, Prasad questioned Sarepta's treatment, saying it 'seems to be killing kids' with Duchenne and 'destroying their livers.'
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