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What Lies Ahead For Sarepta Therapeutics, Inc.?

By Brian Orelli, PhD – Mar 14, 2014 at 8:30AM

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The FDA can't make up its mind about how much data Sarepta's Duchenne muscular dystrophy drug, eteplirsen, needs for approval, and it's sending shares on a roller coaster.

Sarepta Therapeutics (SRPT 1.41%) has been one roller coaster of a stock over the last year while waiting for the Food and Drug Administration to make up its mind about whether its Duchenne muscular dystrophy drug, eteplirsen, deserves an accelerated approval.

In November, Sarepta fell sharply after the biotech told investors that the FDA wasn't sure Sarepta had enough data to justify an accelerated approval. It appears the phase 3 failure of Prosensa (NASDAQ: RNA) and GlaxoSmithKline's (GSK -2.38%) Duchenne muscular dystrophy drug, drisapersen, influenced the FDA's decision.

In the video below, Fool contributor Brian Orelli and health-care bureau chief Max Macaluso discuss Sarepta's current predicament and give some advice on how investors should think about the long-term prospects of the company.

Brian Orelli has no position in any stocks mentioned. Max Macaluso owns shares of Sarepta Therapeutics. The Motley Fool has no position in any of the stocks mentioned. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

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