FDA briefing notes do not bode well for Sarepta Therapeutics

11 May 2023

Recently-released US FDA briefing documents reveal an ambiguous response to data for a candidate developed by Sarepta Therapeutics (Nasdaq: SRPT).

A scientific panel of the US Food and Drug Administration is set to review the evidence for investigational Duchenne muscular dystrophy (DMD) therapy SRP-9001 (delandistrogene moxeparvovec) on Friday.

The agency’s Cellular, Tissue, and Gene Therapies Advisory Committee will consider the use of a particular surrogate endpoint as a predictor of clinical benefit.

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