(Reuters) – Shares of Sarepta Therapeutics Inc slumped 18% in premarket trade on Friday due to uncertainty over approval of its gene therapy for Duchenne muscular dystrophy after the U.S. health regulator reversed its decision on whether to hold a panel meeting.
Sarepta said late Thursday the U.S. Food and Drug Administration planned to hold a meeting of its independent experts to review the gene therapy, less than a month after saying it would not do so.
“This change adds drama to the equation,” said Baird analyst Brian Skorney. He added the decision to hold a meeting was not concerning in a vacuum but the FDA’s inconsistency may be a signal of more internal debate than previously anticipated.
Sarepta is developing the gene therapy for treatment of Duchenne muscular dystrophy, an inherited disorder of progressive muscular weakness typically seen in boys. Roche holds the right to launch and commercialize the therapy outside the United States.
Massachusetts-based Sarepta had said in February the FDA did not plan a meeting, which sent shares jumping to their biggest one-day percentage gain in over three years.
The FDA is expected to take a decision on the drug by May 29, and typically follows the advice of its independent experts.
Shares of Sarepta, which had a market capitalization of $13 billion, were down 18.2% at $122.50 before the opening bell.
(Reporting by Aditya Samal; Editing by Krishna Chandra Eluri)
