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Sarepta's Expanded FDA Approval For Elevidys Potentially Shaping Future FDA Reviews, Analyst Says

On Thursday, the FDA approved the labeled indication for Sarepta Therapeutics Inc’s (NASDAQ:SRPT) Elevidys (delandistrogene moxeparvovec-rokl) to include individuals with Duchenne muscular dystrophy (DMD) who have a confirmed mutation in the DMD gene and are at least four years old. In June last year, the FDA granted accelerated approval to Sarepta Therapeutics’s one-time gene therapy, Elevidys, for Duchenne muscular dystrophy (DMD) in ambulatory pediatric patients aged 4 through 5 with a confirmed mutation in the DMD gene. William Blair writes that with the label expanded, rapid uptake of Elevidys will be anticipated in the near future, leading to substantial revenue growth for Sarepta in the coming years as they address the ...