FDA hands Neurocrine approvable letter

Neurocrine investors won't be sleeping well tonight. The company's stock plummeted 45 percent after the FDA said that it would need additional data on its sleep therapy indiplon before it can be approved. Shares sank to $4.60, well below its 52-week low of $9. Neurocrine's indiplon has been in regulatory limbo since the middle part of last year, when its 15 mg dose ran afoul of the FDA. It resubmitted its application for 5 mg and 10 mg doses six months ago.

"While we are disappointed in the FDA action, we will accept the FDA's offer to discuss the applications via a meeting or telephone conference in order to clarify and determine the next steps required," said Neurocrine President and Chief Executive Gary A. Lyons.

- see this release on the FDA's decision
- check out the AP's report on the fallout

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