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Sarepta Smacked By FDA's Curiously Timed Compassionate Use Revisions

 
• By Donna Young

Sarepta Therapeutics Inc. investors panicked over the FDA's June 2 release of revised expanded access guidances – worried the action was in preparation for the agency to reject the company's Duchenne muscular dystrophy drug eteplirsen, whose verdict was curiously delayed last week.

While the FDA insisted there was absolutely no connection to its June 2 release of its revised expanded access guidances, which include the finalization of a streamlined process for doctors to request "compassionate use" of investigational medicines, and the curiously timed delay last week of the agency's decision on Sarepta Therapeutics Inc.'s experimental Duchenne muscular dystrophy (DMD) treatment eteplirsen, Wall Street was unconvinced.

Indeed, most analysts and investors interpreted the FDA's updates to its expanded access program as having direct implications for Sarepta...

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