Sarepta Therapeutics stock tumbles on concern about FDA study requirements

Published 24/07/2025, 17:14
© Reuters.

Investing.com -- Sarepta Therapeutics (NASDAQ:SRPT) stock fell 20% Thursday, extending recent declines after reports that the company would need to conduct new studies to return its Duchenne muscular dystrophy treatment to the market.

According to Endpoints News, FDA officials stated that the Center for Biologics Evaluation and Research (CBER) review staff are "unanimous" that Elevidys should never return to market. The report indicates Sarepta would be required to conduct new studies before any potential market reintroduction.

The decline follows Sarepta’s Monday announcement that it would voluntarily and temporarily pause all shipments of Elevidys in the United States. This decision came after the death of a 51-year-old non-ambulant Limb-Girdle Muscular Dystrophy patient.

Elevidys (delandistrogene moxeparvovec) is Sarepta’s gene therapy treatment for Duchenne muscular dystrophy, a rare genetic disorder characterized by progressive muscle degeneration and weakness.

The stock has faced significant pressure as investors assess the potential timeline and costs associated with conducting additional studies, as well as uncertainty around whether the treatment can eventually return to market.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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