May 28 (Reuters) - Neurocrine Biosciences (NBIX.O), opens new tab CEO Kevin Gorman will retire on Oct. 11 after three decades with the company that he founded and will be succeeded by insider Kyle Gano.
Neurocrine Biosciences` Huntington`s disease drug gets FDA approval
SAN DIEGO, Nov. 2, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced interim results from the ongoing open-label KINECT®-HD2 study about INGREZZA® (valbenazine) capsules when used for the long-term treatment of adults with chorea associated with Huntington's disease (HD). Interim data suggest one-capsule, once-daily INGREZZA improved chorea at the first evaluation at Week 2 with sustained efficacy through Week 50. These data will be presented at the 30th Annual Meeting of the Huntington Study Group on November 2–4 in Phoenix.
SAN DIEGO, Sept. 14, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for INGREZZA® (valbenazine) oral granules, a new sprinkle formulation of INGREZZA® (valbenazine) capsules for oral administration. The agency set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2024.
SAN DIEGO, Aug. 29, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today presented findings from a data analysis of KINECT®-4 demonstrating a comparable pattern of improvement over time of clinician-rated tardive dyskinesia (TD) severity and awareness/distress as measured by the Abnormal Involuntary Movement Scale (AIMS) and patient-reported TD impact as measured by the Trajectories of Tardive Dyskinesia Impact Scale (TDIS). The data (Poster #657) was presented at the MDS International Congress of Parkinson's Disease and Movement Disorders® in Copenhagen, Denmark.
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.
SAN DIEGO, Aug. 18, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration (FDA) has approved INGREZZA® (valbenazine) capsules for the treatment of adults with chorea associated with Huntington's disease (HD).1 INGREZZA is the only selective vesicular monoamine transporter 2 (VMAT2) inhibitor that offers an effective starting dosage that can be adjusted by a patient's healthcare provider based on response and tolerability, with no complex titration.1 Only INGREZZA offers simple dosing that is always one capsule, once daily.1
SAN DIEGO, June 2, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today presented findings from a meta-analysis of three long-term studies evaluating INGREZZA® (valbenazine) capsules that demonstrated substantial and sustained improvements in tardive dyskinesia (TD) in adults with or without concomitant antipsychotic therapy. The data (Poster #4) were presented at 2023 Psych Congress Elevate in Las Vegas.
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.
Lupin gets tentative USFDA approval to market generic valbenazine capsules