FDA moves eteplirsen PDUFA date

FDA extended to May 26 from Feb. 26 the PDUFA date for eteplirsen ( AVI-4658) from Sarepta Therapeutics Inc. (NASDAQ:SRPT) to treat Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. Sarepta fell $1.48 (12%) to $10.74 on Monday.

Sarepta said it submitted four-year clinical effectiveness data to FDA in January that the agency considers to be a major amendment to the NDA. The company added six-minute walk test (6MWT) and loss of ambulation data compared to historical controls. ...