Sarepta to begin submitting rolling NDA for eteplirsen

Sarepta Therapeutics Inc. (NASDAQ:SRPT) gained $6.23 (38%) to $22.61 in after-hours trading Tuesday on news it held a pre-NDA meeting with FDA and agreed on a rolling NDA submission for eteplirsen ( AVI-4658) to treat Duchenne muscular dystrophy (DMD). Sarepta said it will begin submitting the rolling NDA this week and plans to complete the submission by mid-2015.

Sarepta's FDA meeting marks a positive development in what has been a bumpy regulatory road that included requests for additional data and the March resignation of Christopher Garabedian as Sarepta's president, CEO and a director. The company has said CMO Edward Kaye would serve as interim CEO through the regulatory submission (see BioCentury Extra, April 1). ...