FDA postpones meeting to discuss Sarepta's eteplirsen

Citing forecasts of inclement weather in Washington, FDA eteplirsen ( AVI-4658) from Sarepta Therapeutics Inc. (NASDAQ:SRPT) to treat Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. The agency said it will announce a new date in the Federal Register.

Sarepta lost $0.18 to $13.26 on Wednesday, and has shed 58% since Jan. 14, the day before FDA released briefing documents that raised questions about eteplirsen's data package. Eteplirsen is a phosphorodiamidate morpholino oligomer (PMO) that induces skipping of exon 51 in dystrophin mRNA. Its PDUFA date is Feb. 26 (see BioCentury Extra, Jan. 15). ...