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Sarepta Therapeutics Announces Update on Regulatory Review of SRP-9001
May 24, 2023 8:00 AM EDTNew regulatory action date is June 22, 2023
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Sarepta Therapeutics, Inc. (NASDAQ: SRPT), the leader in precision genetic medicine for rare diseases, today provided the following update on the Biologics License Application (BLA) for SRP-9001 (delandistrogene moxeparvovec), which is currently under review for the treatment of ambulant individuals with Duchenne muscular dystrophy (DMD) who have a confirmed mutation of the DMD gene.
Following discussions with FDA, the Agency has indicated that, subject to the completion of the BLA review, it is working... More