KINECT

Neurocrine Biosciences Presents New INGREZZA® (valbenazine) Capsules Data Demonstrating Early and Sustained Improvements in Chorea Associated With Huntington's Disease

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Monday, August 28, 2023
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SAN DIEGO, Aug. 28, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced new data on now FDA-approved INGREZZA® (valbenazine) capsules for the treatment of adults with chorea associated with Huntington's disease (HD), including exploratory results from the Phase 3 KINECT®-HD study, which showed consistently greater improvements in HD chorea with INGREZZA versus placebo from Week 2 to Week 12. These data will be presented at the MDS International Congress of Parkinson's Disease and Movement Disorders®August 27-31 in Copenhagen, Denmark.

Key Points: 
  • These data will be presented at the MDS International Congress of Parkinson's Disease and Movement Disorders®August 27-31 in Copenhagen, Denmark.
  • "The exploratory analysis from our KINECT-HD study further exemplifies the value of INGREZZA as a now approved medication for HD chorea with improvements seen with treatment as early as two weeks," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences.
  • "This exploratory analysis has increased our insight regarding the early and sustained improvements in chorea severity."
  • Additional HD chorea presentations at the MDS International Congress of Parkinson's Disease and Movement Disorders include:

Neurocrine Biosciences Announces Publication of Full KINECT™-HD Phase 3 Study Results of Valbenazine for the Treatment of Chorea Associated with Huntington's Disease in The Lancet Neurology

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Friday, May 19, 2023
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SAN DIEGO, May 19, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today announced that the complete study results from its Phase 3 KINECT™-HD study investigating valbenazine for the treatment of chorea associated with Huntington's disease (HD) has been published in The Lancet Neurology online edition and will appear in the June 2023 print issue. The study met pre-defined primary and secondary endpoints of improvement in chorea severity and global impression of change, demonstrating a reduction in chorea symptoms associated with HD and improvement of overall chorea severity as noticed by clinicians and patients, with improvement seen as early as Week 2 of the initial dose in the 12-week study.

Key Points: 
  • "The KINECT-HD study data demonstrated statistically significant improvement in chorea associated with HD as compared with placebo.
  • The safety profile for participants with chorea associated with HD was consistent with the known safety profile of valbenazine.
  • The KINECT-HD study marked the first-ever implementation of the Huntington's Disease Health Index (HD-HI) in a Phase 3 trial.
  • The filing included data from the KINECT-HD Phase 3 study and the ongoing KINECT-HD2 open-label study of valbenazine in adults with chorea associated with HD.

Neurocrine Biosciences Receives Orphan Drug Designation for Valbenazine as a Treatment for Chorea Associated with Huntington Disease

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Friday, May 13, 2022
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SAN DIEGO, May 12, 2022 /PRNewswire/ -- Neurocrine Biosciences, Inc.(Nasdaq: NBIX) today announced that it has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for valbenazine as a treatment for Huntington disease (HD).

Key Points: 
  • SAN DIEGO, May 12, 2022 /PRNewswire/ -- Neurocrine Biosciences, Inc.(Nasdaq: NBIX) today announced that it has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for valbenazine as a treatment for Huntington disease (HD).
  • The treatment of chorea associated with HD is within the scope of this Orphan Drug Designation.
  • Enrollment is ongoing in the KINECT-HD2 open-label study to evaluate the long-term safety and tolerability of valbenazine for the treatment of chorea in Huntington Disease.
  • KINECT-HD2 is an open-label study to evaluate the long-term safety and tolerability of valbenazine in patients with chorea associated withHuntingtondisease (HD).

Neurocrine Biosciences Presents Phase 3 Data for KINECT-HD Study Evaluating Valbenazine for Chorea Associated with Huntington Disease at AAN 2022

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Friday, April 1, 2022
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SAN DIEGO, April 1, 2022  /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced results from the Phase 3 KINECT-HD study, which demonstrated once-daily administration of valbenazine was associated with significant improvement in chorea associated with Huntington disease (HD) compared with placebo. These data (abstract #1199) will be shared as an oral presentation Tuesday, April 5th during the Emerging Science Session at the American Academy of Neurology (AAN) 2022 "Great Neuro Reunion" annual meeting in Seattle, Washington.

Key Points: 
  • The full data results from the Phase 3 KINECT-HD study will be submitted to a peer-reviewed journal later this year.
  • The safety and tolerability of valbenazine in chorea associated with Huntington disease continues to be evaluated in KINECT-HD2, an open-label long-term safety and tolerability study.
  • Neurocrine Biosciences and the Huntington Study Group thank the patients and investigators involved in the KINECT-HD and KINECT-HD2 clinical trials.
  • KINECT-HD2 is an open-label study to evaluate the long-term safety and tolerability of valbenazine in patients with chorea associated withHuntingtondisease (HD).

Neurocrine Biosciences Presents New INGREZZA® (valbenazine) Data at Psych Congress 2021

Retrieved on: 
Monday, November 1, 2021
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SAN DIEGO, Nov. 1, 2021 /PRNewswire/ -- Neurocrine Biosciences, Inc.(Nasdaq: NBIX) today announced that it presented new data from its movement disorder program for tardive dyskinesia (TD) at the 2021 Psych Congress scientific meeting being held October 29November 1, 2021.

Key Points: 
  • SAN DIEGO, Nov. 1, 2021 /PRNewswire/ -- Neurocrine Biosciences, Inc.(Nasdaq: NBIX) today announced that it presented new data from its movement disorder program for tardive dyskinesia (TD) at the 2021 Psych Congress scientific meeting being held October 29November 1, 2021.
  • Characterization of the in vitro activity and pharmacokinetic profile of INGREZZA compared to deutetrabenazine confirms a single, specific, potent INGREZZA metabolite with strong VMAT2 affinity and supports once-daily dosing for INGREZZA.
  • "Presentation of these new data analyses at this year's Psych Congress will continue to help psychiatric healthcare providers further understand the role of INGREZZA in helping people living with tardive dyskinesia," said Eiry W. Roberts, M.D., Chief Medical Officer atNeurocrine Biosciences.
  • Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof.