Doug Ingram, Sarepta CEO

Sarep­ta won't need FDA ad­comm, boost­ing Duchenne gene ther­a­py's odds

On its quest to get the first gene ther­a­py for Duchenne mus­cu­lar dy­s­tro­phy ap­proved by the FDA, Sarep­ta won’t have to face an FDA ad­vi­so­ry com­mit­tee af­ter all.

The biotech dis­closed in its quar­ter­ly up­date Tues­day af­ter­noon that af­ter a mid-cy­cle re­view of SRP-9001 with the FDA, in which it an­swered ques­tions about chem­istry, man­u­fac­tur­ing and con­trols, the agency said it does not plan to hold an ad­comm. A de­ci­sion on the ther­a­py is due by May 29.

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