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Sarepta Falls as FDA Calls Drug Application Premature

Sarepta Therapeutics Inc. plummeted the most in 16 years after U.S. regulators questioned trial results for the drugmaker’s experimental treatment for Duchenne muscular dystrophy and indicated more data may be needed.

Sarepta, which has no products on the market, fell 64 percent to $13.16 at the close in New York in its biggest one-day drop since the shares began trading in June 1997. The stock had gained 42 percent this year through yesterday.

The Food and Drug Administration called an application to sell eteplirsen “premature,” Cambridge, Massachusetts-based Sarepta said in a statement today, citing a meeting with the agency last week. The FDA said new data and the failure of a similar medicine in a clinical trial raise “considerable doubt” about the design of Sarepta’s research, according to the company.

“We are very disappointed with the FDA’s decision,” Chris Garabedian, Sarepta’s chief executive officer, said in the statement. “We strongly believe in the potential of eteplirsen to address a serious unmet medical need in DMD and we are committed to its development.”

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