Announcement • Jun 09

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Neurocrine Biosciences Presents New Clinically Meaningful Response Data on Treatment of Tardive Dyskinesia Reinforcing the Efficacy of INGREZZA Capsules Across A Broad Range of Patients

Neurocrine Biosciences, Inc. announced new post-hoc data from the KINECT 4 clinical trial demonstrating that adults with tardive dyskinesia (TD) treated with INGREZZA (valbenazine) capsules experienced clinically meaningful and robust improvements in involuntary movement severity, including those who did not meet the stringent symptomatic remission threshold. These results, together with findings from a large retrospective Medicare claims analysis evaluating hepatic risk factors among patients newly diagnosed with TD, were presented at the 2026 Psych Congress Elevate in Las Vegas. Previously presented data from the 48-week KINECT 4 study showed that 59% (61/103) of patients treated with once-daily INGREZZA achieved the stringent threshold for TD symptomatic remission, defined as an Abnormal Involuntary Movement Scale (AIMS) item score of 0 ("none") or 1 ("minimal movements") in each of the seven body regions. Symptomatic remission was achieved across TD movement severity subgroups, including 63% (38/60) of patients with moderate TD and 54% (23/43) of patients with severe TD. A new post-hoc analysis further demonstrated that clinically meaningful improvements were observed even among patients who did not meet the more stringent symptomatic remission threshold. Among the 41% of patients (42/103) who did not meet the symptomatic remission threshold at Week 48, 86% (36/42) achieved =30% total AIMS score reduction (characterized by the authors as clinically meaningful), and 67% (28/42) achieved =50% reduction. INGREZZA is the only vesicular monoamine transporter 2 (VMAT2) inhibitor to demonstrate clinical remission in clinical trials. A separate claims analysis indicates high prevalence of hepatic risk factors among patients with tardive dyskinesia; INGREZZA is the only VMAT2 inhibitor with approved dosing in hepatic impairment. KINECT 4 is a Phase 3, open-label study in which 163 participants with moderate to severe TD and underlying schizophrenia, schizoaffective disorder or mood disorder (including bipolar disorder or major depressive disorder) received 48 weeks of open-label treatment with once-daily INGREZZA (40 mg or 80 mg capsules) followed by a four-week washout. Dosing was initiated at 40 mg/day in all participants, with escalation to 80 mg/day at Week 4 based on effectiveness and tolerability. Dose reduction to 40 mg was allowed in participants who could not tolerate the 80 mg dose. Patients were discontinued if the new dose was not tolerated. Participants experienced TD improvements during long-term treatment as demonstrated by mean change from baseline to Week 48 in AIMS total score (sum of items 1-7, evaluated by site raters) with INGREZZA 40 mg/day (-10.2) or 80 mg/day (-11.0). Consistent with previous studies, INGREZZA was generally well tolerated. After Week 4, treatment-emergent adverse events that occurred in =5% of all participants (combined dose groups) were urinary tract infection (8.5%) and headache (5.2%). Changes from baseline in psychiatric stability, vital signs, electrocardiogram parameters and laboratory test values were generally small and not clinically significant. Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrolled, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients. The condition is associated with taking certain kinds of mental health medicines (antipsychotics) that help control dopamine receptors in the brain. Taking antipsychotics commonly prescribed to treat mental illnesses such as major depressive disorder, bipolar disorder, schizophrenia and schizoaffective disorder and other prescription medicines (metoclopramide and prochlorperazine) used to treat gastrointestinal disorders are associated with TD. In patients with TD, these treatments are thought to result in irregular dopamine signaling in a region of the brain that controls movement. The symptoms of TD can be mild to severe and are often persistent and irreversible. TD is estimated to affect at least 800,000 adults in the U.S. INGREZZA is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of adults with tardive dyskinesia and the treatment of chorea associated with Huntington's disease (HD). Only INGREZZA offers a therapeutic dose from day one with no required titration. INGREZZA, developed by Neurocrine Biosciences, selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic or muscarinic receptors. While the specific way INGREZZA works to treat TD and HD chorea is not fully understood, INGREZZA is unique in that it selectively and specifically targets VMAT2 to inhibit the release of dopamine, a chemical in the brain that helps control movement. INGREZZA is believed to reduce extra dopamine signaling, which may lead to fewer uncontrollable movements. INGREZZA is studied across the widest range of patients. It is always one capsule, once daily and can be taken together with most stable mental health regimens such as antipsychotics or antidepressants. Only INGREZZA offers the benefit of a sprinkle formulation, INGREZZA SPRINKLE, for those who experience dysphagia, have difficulty swallowing or prefer not to swallow a pill. INGREZZA and INGREZZA SPRINKLE dosages approved for use are 40 mg, 60 mg and 80 mg capsules. INGREZZA or INGREZZA SPRINKLE can cause serious side effects in people with Huntington's disease, including: depression, suicidal thoughts, or suicidal actions. Do not take INGREZZA or INGREZZA SPRINKLE if you are allergic to valbenazine, or any of the ingredients in INGREZZA or INGREZZA SPRINKLE. INGREZZA or INGREZZA SPRINKLE can cause serious side effects, including: allergic reactions, sleepiness and tiredness that could cause slow reaction times (somnolence and sedation), heart rhythm problems (QT prolongation), neuroleptic malignant syndrome (NMS), and Parkinson-like symptoms. Before taking INGREZZA or INGREZZA SPRINKLE, tell your healthcare provider about all of your medical conditions including if you have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with tardive dyskinesia are sleepiness and tiredness. The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with chorea associated with Huntington's disease include sleepiness and tiredness, raised itchy red areas on your skin (hives), rash, and trouble getting to sleep or staying asleep. INGREZZA and INGREZZA SPRINKLE are available in 40 mg, 60 mg, and 80 mg capsules.

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