Sarepta Therapeutics Announces Significant Layoffs Amid FDA Scrutiny
Cambridge-based biotechnology firm Sarepta Therapeutics is set to lay off approximately 500 employees, representing more than a third of its workforce, as it navigates regulatory challenges with the U.S. Food and Drug Administration (FDA). The company filed a notice with the Massachusetts state on July 17, detailing the impending cuts to its payroll.
In a strategic restructuring announcement on July 16, CEO Doug Ingram emphasized the need for decisive action in response to evolving market conditions. The measures aim to save around $400 million annually, ensuring that Sarepta continues its mission to develop treatments for rare genetic diseases like Duchenne muscular dystrophy, amid a financially stable future.
The FDA’s scrutiny stems from the investigation of Sarepta’s gene therapy product, Elevidys, after two patient fatalities linked to liver failure. Recently, the FDA has escalated its request for Sarepta to halt shipments of the therapy entirely, a move the company has resisted, citing an absence of new safety concerns among patients who can walk. Sarepta remains committed to collaborating with the FDA to meet the needs of families seeking access to vital therapies for debilitating conditions.
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