FDA: Too early for Sarepta to file for approval of Eteplirsen

• The FDA says that Sarepta's (NASDAQ:SRPT) submission of a New Drug Application (NDA) for the company's Eteplirsen drug for the treatment of Duchenne muscular dystrophy (DMD) is premature following the failure of GlaxoSmithKline's and Prosensa's Drisapersen product in a Phase III trial.
• The FDA also indicated that - in Sarepta's words - "new data raise 'considerable doubt' about the dystrophin biomarker and the supportive clinical efficacy assessed on the 6-minute walk test (6MWT) in the Phase IIb clinical study of Eteplirsen."
• Last month, SA author EnhydrisPECorp predicted that the FDA wouldn't grant early approval of Eteplirsen.
• Shares are -29%. (PR) (Q3 results)