Sarepta Therapeutics Faces Major Crisis Over Gene Therapy Amid FDA Scrutiny
Sarepta Therapeutics is grappling with a significant crisis concerning its Duchenne muscular dystrophy gene therapy, Elevidys. The company has voluntarily paused shipments in the U.S. following mounting safety concerns, including three reported patient deaths linked to the treatment. Despite FDA pressure to withdraw the therapy from the market, Sarepta has initially resisted compliance while announcing a strategic restructuring that includes layoffs of nearly 500 employees. The stock has taken a severe hit, plunging drastically as investors react to the unfolding situation and regulatory investigations. Industry experts highlight the challenges Sarepta faces as it navigates these unprecedented times while maintaining transparency amidst critical scrutiny.
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