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Sarepta Therapeutics shares soar after gene therapy approval
Shares up 37.7% premarket (Il Sole 24 Ore Radiocor) - New York, 21 Jun - Shares in US biotech company Sarepta Therapeutics jumped more than 37% in premarket trading after the US Food and Drug Administration approved its gene therapy for Duchenne muscular dystrophy in patients aged 4 and above.
In a statement, Sarepta said it had received FDA approval of "an expansion to the labeled indication for ELEVIDYS (delandistrogene moxeparvovec-rokl) to include individuals with Duchenne muscular dystrophy with a confirmed mutation in the DMD gene who are at least 4 years of age." The FDA granted traditional approval for ambulatory patients and accelerated approval for non-ambulatory patients, it said.
At 1224 GMT Sarepta shares were up 37.7%.
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(RADIOCOR) 21-06-24 14:29:59 (0401) 5 NNNN