Shares of Sarepta Therapeutics Inc SRPT plunged 50 percent early Tuesday morning after a federal advisory panel voted that eteplirsen, its drug for the treatment of Duchenne muscular dystrophy (DMD), was not effective.
The U.S. Food and Drug Administration voted 6-7 against the finding of substantial evidence that eteplirsen induces production of dystrophin to a level that is reasonably likely to predict clinical benefit. The committee also voted 3-7 (with three abstentions) against finding substantial evidence based on the clinical results of the single historically controlled study against finding substantial evidence based on the clinical results of the single historically controlled study.
However, the FDA's vote is not a final ruling - this will be determined by May 26.
After being halted on Monday afternoon, the stock opened up around 7:11 a.m. ET Tuesday at $7.87, down 47 percent. It recently traded at $7.56 in the pre-market session.
STAT, a site that covers the health and medicine sector quoted an FDA official who "appeared to leave the door open as the meeting concluded."
"I assure you, we listened very carefully and will take the information we heard here today under serious consideration," Dr. Billy Dunn, who heads the FDA division of neurology products said.
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