Sarepta Therapeutics, a biotech company known for its work in gene therapy treatments for Duchenne muscular dystrophy, has announced layoffs of approximately 493 employees, including 80 in Ohio, as reported by ABC6. The company, with operations that date back to 2018 in Ohio, has recently seen its stock prices plummet by more than 30% on a single Friday and an astonishing 87% over the year.
These layoffs come amid serious scrutiny from the U.S. Food and Drug Administration (FDA) concerning their gene therapy treatment, Elevidys, which is designed to combat Duchenne muscular dystrophy but has been linked to three patient deaths. The treatment represents more than half of the company's total net product revenue, according to an announcement by the company filed with the state. FOX28 noted that the FDA is reportedly considering requesting a halt to all shipments of Elevidys.
In response to the layoffs, Sarepta Therapeutics cited a need for restructuring, including a significant reduction in its workforce and a pipeline reprioritization. As detailed in a report by WBNS, the company stated that anticipated cost savings through the end of 2025 would exceed $100 million, offset by estimated severance and one-time charges of $32 million to $37 million. Employees affected by this layoff do not have bumping rights and are not represented by a union. The precise timeline for completion of these layoffs remains unclear.
Following the FDA's clinical hold on Sarepta's gene therapy trials, the company came under fire for its handling of the Elevidys treatment. According to WBNS, the FDA placed a clinical hold after an investigational efforts tied to Elevidys were believed to be linked to patient fatalities, and the agency also withdrew Sarepta’s platform technology designation. Sarepta refused FDA's request to stop shipments of Elevidys voluntarily. "We look forward to continued discussions and sharing of information with FDA in order to advance our shared purpose of protecting patient safety and informed access to care," the company declared in a statement.
