Sarepta's shares jump on initiation of FDA filing for DMD therapy eteplirsen

Shares in Sarepta Therapeutics climbed as much as 39 percent after the company announced that it reached an agreement with the FDA on the initiation of a rolling marketing application for eteplirsen for the treatment of Duchenne muscular dystrophy (DMD).

According to Sarepta, it will submit the non-clinical and CMC components of the application by the end of this week, while as previously announced, it expects to submit the final component of the filing by mid-year. Edward Kaye, who took over as Sarepta's CEO earlier this year following delays in the timeline for filing eteplirsen, said the meeting with the FDA was described by the agency as "the best meeting they’ve had with Sarepta."

"It was validation that we could turn it around. Rather than arguing with them on what they needed, we made sure we gave them exactly what they asked for," Kaye said. Last year, Sarepta disclosed that the FDA had asked for further data to be included in the filing. Kaye indicated that the company has received priority review from the agency and eteplirsen could be approved by the beginning of 2016.

For related analysis, see ViewPoints: Sarepta sky-rockets – can it maintain momentum?

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