Sarepta leaps as FDA sets date for eteplirsen review

US RNA-based drug developer Sarepta Therapeutics (Nasdaq: SRPT) shares were up 14.7% at $15.91 by close of trading on Thursday, after the US Food and Drug Administration announced via a Federal Register notice that the Peripheral and Central Nervous System Drugs Advisory Committee will hold a meeting on April 25, to review the company’s Duchenne muscular dystrophy (DMD) drug candidate eteplirsen.

The company has had a string of delays in the FDA review of the drug, including the cancellation of an advisory panel meeting to review the drug on January 22, due to serious weather conditions in the Washington DC area. On February 8, the FDA postponed the Prescription Drug User Fee Act (PDUFA) date to May 26 (The Pharma Letter February 8), which caused the company’s shares to drop more than 12%. However, the decision to push the meeting forward led many analysts to believe that the drug’s approval seemed like a long shot.

The FDA has previously granted eteplirsen Priority Review status, which is designated for drugs that provide a treatment where no adequate therapy exists. The FDA also granted Rare Pediatric Disease designation to eteplirsen, as well Orphan Drug designation and fast -track status.