FDA extends eteplirsen decision

Sarepta Therapeutics Inc. (NASDAQ:SRPT) gained $4.91 (27%) to $23.35 on Wednesday after it said FDA will delay its decision whether to approve eteplirsen ( AVI-4658) beyond the candidate's Thursday PDUFA date. Eteplirsen is under review to treat Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping.

Last month, members of FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted 7-3, with three abstentions, that clinical results did not provide substantial evidence that eteplirsen is effective for DMD (see BioCentury, May 2). ...