ARTICLE | Company News

Sarepta jumps on eteplirsen update

April 21, 2014 11:57 PM UTC

Sarepta Therapeutics Inc. (NASDAQ:SRPT) jumped $9.58 (39%) to $33.98 on Monday after the company said it plans to submit an NDA to FDA for eteplirsen ( AVI-4658) to treat Duchenne muscular dystrophy (DMD) by year end. Sarepta had been planning to submit an NDA this half, but in November said approval of eteplirsen could be delayed by at least two years after FDA said it had "considerable doubt" about six-minute walk test (6MWT) data from eteplirsen's Phase IIb program as well as the use of dystrophin as a surrogate endpoint (see BioCentury Extra, Nov. 12, 2013).

On Monday, Sarepta said that based on guidance from FDA, the company now plans to submit an NDA seeking accelerated approval by year end, with potential approval in 2H15. Even with Sarepta's Monday move, the company is still below its price of $36.56 on November 11, before the company fell $23.40 (64%) to $13.16 after announcing the eteplirsen delay. ...