FDA Seeks More Data On Sarepta Muscle Disorder Drug, Shares Slump

October 27, 2014 12:07 PM

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FDA Seeks More Data On Sarepta Muscle Disorder Drug, Shares Slump

(Reuters) - Sarepta Therapeutics Inc said the U.S. Food and Drug Administration requested additional data regarding a marketing application for its experimental muscle disorder drug, sending the company's shares down 40 percent in premarket trading.

The regulator had provided a fresh lease of life to Sarepta in April by indicating an alternate path for the accelerated approval of the drug, eteplirsen, after the agency had deemed the drug's approval "premature" late last year.

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