The market woke to investor pleasing news from Neurocrine biosciences, Inc. which plans to resubmit the new drug application for the immediate release (IR) insomnia drug indiplon during the second quarter, with review likely taking about 6 months.
After trading ended monday, Neurocrine disclosed that another safety and efficacy trial will not be done for the compound, a non-benzodiazepine agent that acts on a specific site of the GABA-A receptor that is designed for use as needed by patients, whether to fall asleep quickly or go back to sleep after waking in the night.
After talks with the agency [FDA] the odds of indiplon's approval "are so high that to spend $20 million on an 'insurance' study they didnt ask for would not be prudent." Instead, neurocrine will spend the money on pre-commercial work and phase IIIb/IV activities.
The companies shares NBIX closed tuesday at $13.88, up 93 cents. TODAY- NBIX closed at $14.02.
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