Shares of Sarepta Therapeutics Inc SRPT fell in Monday's premarket after releasing results of its Phase IIb open-label extension study of eteplirsen in patients with Duchenne muscular dystrophy (DMD).
According to the press release, after “more than three years of treatment, results of the 6-minute walk test (6MWT) at 168 weeks showed continued ambulation across all patients evaluable on the test, however all patients showed a decline in distance walked on this measure since the week 144 timepoint. In addition, a continued stability of respiratory muscle function was observed, as assessed by pulmonary function tests.”
The company also “announced last year that the 168 week results are one of several datasets the FDA has requested be included in, or at the time of, the NDA application. Sarepta's plan for a mid-year 2015 NDA submission remains unchanged and will continue to be evaluated based on FDA discussions and as additional data become available.”
After falling 11 percent, the stock regained some losses and traded at $12.76 in the pre-market session, down 8.5 percent.
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