FDA Tells Sarepta Therapeutics: Come on Down With Your DMD Drug!

CAMBRIDGE, Mass. (TheStreet) -- Sarepta Therapeutics (SRPT) received the green light from U.S. regulators to finally file a new drug application for eteplirsen, the company's experimental therapy for Duchenne muscular dystrophy (DMD), Sarepta said Tuesday.

Portions of the eteplirsen approval application will be submitted to the U.S. Food and Drug Administration this week, with the filing to be completed by the middle of the year, the company said. 

The announcement came after the close of trading. Sarepta shares were up 31% to $21.40 in after-hours trading after closing the regular session at $16.38.

With Tuesday's announcement, Sarepta puts itself in a position to be included on the agenda of an FDA advisory panel, not yet announced or scheduled, which will likely be asked to review the clinical data on eteplirsen and drisapersen. Drisapersen is the competing DMD drug from Biomarin Pharmaceuticals  (BMRN) already under FDA review. That FDA advisory panel is likely to be scheduled this fall. 

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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