Sarepta rises after FDA requests more data

Sarepta Therapeutics Inc. (NASDAQ:SRPT) jumped $3.62 (23%) to $19.67 on Tuesday after disclosing late Monday that FDA requested additional data from PROMOVI, the company's ongoing Phase III confirmatory trial of Duchenne muscular dystrophy (DMD) candidate eteplirsen ( AVI-4658). Sarepta said it would submit data "over the coming weeks" on dystrophin expression at baseline and 48 weeks from 13 PROMOVI patients.

Last month, FDA delayed its decision on eteplirsen's NDA beyond a May 26 PDUFA date. FDA is reviewing eteplirsen to treat DMD amenable to exon 51 skipping. ...