PDUFA date for Sarepta's eteplirsen now set for May 26

Shares of US RNA-based drug developer Sarepta Therapeutics (Nasdaq: SRPT) were down 12.2.% at $10.74 in late-morning trading, after the company revealed it is facing yet another delay in a decision from the US Food and Drug Administration as to whether its Duchenne muscular dystrophy (DMD) drug candidate eteplirsen would gain marketing approval.

Sarepta said that the FDA will require additional time to complete its review of the New Drug Application (NDA) for eteplirsen, for the treatment of DMD) amenable to exon 51 skipping. In a notice received from the FDA, the Prescription Drug User Fee Act (PDUFA) date for eteplirsen has been extended to May 26, 2016.

The rescheduled date for the Peripheral and Central Nervous System Advisory Committee meeting has not yet been determined. Sarepta has another Phase III clinical trial underway, but although this will likely satisfy the FDA’s concerns, results from this are not expected before 2018.