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Neurocrine Bio's Ingrezza shows treatment benefit in involuntary movement disorder in late-stage study; shares ahead 2%

  • A Phase 3 clinical trial, Kinect 3, assessing Neurocrine Biosciences' (NASDAQ:NBIX +1.6%) INGREZZA (valbenazine) for the treatment of tardive dyskinesia (TD) met its primary endpoint of a statistically valid change from baseline in a scale called AIMS compared to placebo (p<0.0001). The results were published online by the American Journal of Psychiatry.
  • The company's U.S. marketing application is currently under FDA review with an action date (PDUFA) of April 11.
  • Valbenazine inhibits a protein called Vesicular Monoamine Transporter 2 (VMAT2), which is concentrated in the brain where it plays a key role in the re-packaging and transporting of monoamines (dopamine, norepinephrine, serotonin and histamine) in certain neurons. It modulates dopamine release during nerve communication while exerting minimal impact on other monoamines, thereby minimizing unwanted side effects associated with excessive monoamine depletion. Modulating dopamine levels has shown to deliver positive treatment effects in patients with Tourette, Huntington's chorea, tardive dyskinesia and schizophrenia.
  • Previously: Neurocrine's Ingrezza NDA for involuntary movement disorder accepted under Priority Review by FDA, action date April 11 (Oct. 11, 2016)

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