FDA de­lays Sarep­ta's Duchenne gene ther­a­py de­ci­sion by a month

The FDA de­layed its de­ci­sion whether to grant ac­cel­er­at­ed ap­proval to Sarep­ta Ther­a­peu­tics’ gene ther­a­py for Duchenne mus­cu­lar dy­s­tro­phy, push­ing it back about one month to June 22.

Sarep­ta an­nounced the de­lay in a news re­lease on Wednes­day morn­ing, say­ing the FDA needs “mod­est ad­di­tion­al time to com­plete the re­view, in­clud­ing fi­nal la­bel ne­go­ti­a­tions and post-mar­ket­ing com­mit­ment dis­cus­sions.”

The com­pa­ny’s stock tum­bled about 9% in trad­ing on Wednes­day.

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