Shares of Sarepta Therapeutics Inc SRPT plunged more than 10 percent on Monday and hit a new 52-week low of $10.60 after the company received a notification from the U.S. Food and Drug Administration.
The FDA told Sarepta Therapeutics that it requires additional time to complete its review of the company's New Drug Application (NDA) for etelirsen, for the treatment of Duchenne muscular dystrophy.
Sarepta Therapeutics noted that the Prescription Drug User Fee Act (PDUFA) date for eteplirsen has been extended to May 26, 2016.
Eteplirsen has already been granted Priority Review status which is designated for drugs that provide a treatment where no other adequate therapy exists.
"While our primary goal is to bring treatment to patients with Duchenne as quickly as possible, we appreciate the efforts of the FDA to conduct a complete review of all of the data supporting our NDA and we remain committed to working closely with them throughout the remainder of the regulatory process", said Edward Kaye, Sarepta's interim chief executive officer and chief medical officer.
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