Approving Sarepta's DMD Drug Could Force FDA To Get Creative

The Food and Drug Administration is delaying what will probably be the most controversial decision it will make this year. But what does that delay mean?

Sarepta Therapeutics, a start-up firm developing a drug called eteplirsen for Duchenne muscular dystrophy, said yesterday the FDA won’t meet its official deadline for a decision, which was supposed to be today. Sarepta shares popped 20% yesterday because investors see the indecision as better than the rejection they were expecting. The FDA gave no guidance on timing, and can essentially take as long as it needs.

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