ARTICLE | Company News

Sarepta plummets on eteplirsen NDA delay

October 28, 2014 3:01 AM UTC

Sarepta Therapeutics Inc. (NASDAQ:SRPT) fell $7.65 (32%) to $15.91 on Monday after saying it would delay its NDA submission for eteplirsen ( AVI-4658) to treat Duchenne muscular dystrophy (DMD) to mid-2015. In July, the company said it planned to submit the NDA by year end.

Sarepta said FDA last week requested additional data following a pre-NDA meeting in September. The agency will require results from an independent assessment of dystrophin images and 168-week efficacy data from Study 4658-US-202, an open-label extension of Phase IIb Study 4658-US-201. ...