Sarepta receives FDA request to halt ELEVIDYS shipments for some patients

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Go back to Sarepta receives FDA request to halt ELEVIDYS shipments for some patients

Sarepta Therapeutics Provides Statement on ELEVIDYS

July 18, 2025 7:39 PM EDT

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Sarepta Therapeutics, Inc. (NASDAQ: SRPT), the leader in precision genetic medicine for rare diseases, today issued the following statement:

Shortly after 2:30 p.m. ET today, Sarepta received an informal request from the U.S. Food and Drug Administration (FDA) to voluntarily halt shipment of ELEVIDYS (delandistrogene moxeparvovec), our gene therapy for Duchenne muscular dystrophy (Duchenne), in the U.S. We first heard of this potential request earlier in the day at the same time the public and our patient communities did, through media reports.

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