Neurocrine Biosciences Presents New Post-Hoc Analysis: Treatment with INGREZZA® (valbenazine) Capsules Achieves Earlier Remission of Tardive Dyskinesia Symptoms While Reducing Patient-Reported Disease Burden
Neurocrine Biosciences (NASDAQ:NBIX) announced new post-hoc analysis data from their Phase 4 KINECT-PRO™ study of INGREZZA® (valbenazine) for tardive dyskinesia (TD) treatment. The study showed that 57.8% of patients (26 of 45) achieved symptomatic remission at Week 24, with success rates of 58.3% at 40mg, 44.4% at 60mg, and 62.5% at 80mg doses.
The analysis demonstrated significant improvements in patient-reported outcomes among those achieving remission, including enhanced quality of life and reduced disease burden. Notably, patients showed substantial improvements across multiple measures: the Tardive Dyskinesia Impact Scale (TDIS™), Sheehan Disability Scale (SDS), and EuroQoL Visual Analog Scale (EQ-VAS). The safety profile remained consistent with previous findings, with no new concerns identified.
[ "High remission rate of 57.8% achieved at Week 24 across different dosages", "Significant improvements in patient-reported outcomes and quality of life metrics", "Earlier achievement of TD symptom remission compared to previous studies", "Consistent safety profile with no new concerns identified" ]Neurocrine Biosciences (NASDAQ:NBIX) ha comunicato nuovi dati di analisi post-hoc dal loro studio di fase 4 KINECT-PRO™ su INGREZZA® (valbenazina) per il trattamento della discinesia tardiva (TD). lo studio ha mostrato che il 57,8% dei pazienti (26 su 45) ha raggiunto una remissione sintomatica alla settimana 24, con tassi di successo del 58,3% a 40 mg, 44,4% a 60 mg e 62,5% a 80 mg. L’analisi ha evidenziato miglioramenti significativi negli esiti riferiti dai pazienti tra coloro che hanno ottenuto la remissione, tra cui una qualità di vita migliorata e una minore incidenza del carico della malattia. In particolare, i pazienti hanno mostrato notevoli miglioramenti su diverse misure: Tardive Dyskinesia Impact Scale (TDIS™), Sheehan Disability Scale (SDS) e EuroQoL Visual Analog Scale (EQ-VAS). Il profilo di sicurezza è rimasto coerente con i dati precedenti, senza nuove preoccupazioni identificate.
Neurocrine Biosciences (NASDAQ:NBIX) anunció nuevos datos de análisis post-hoc de su estudio de fase 4 KINECT-PRO™ de INGREZZA® (valbenazina) para el tratamiento de la discinesia tardía (TD). El estudio mostró que el 57,8% de los pacientes (26 de 45) alcanzó la remisión sintomática en la semana 24, con tasas de éxito de 56,3% a 40 mg, 44,4% a 60 mg y 62,5% a 80 mg. El análisis demostró mejoras significativas en los resultados reportados por los pacientes entre los que lograron la remisión, incluyendo mayor calidad de vida y menor carga de la enfermedad. En particular, los pacientes mostraron mejoras sustanciales en múltiples medidas: Tardive Dyskinesia Impact Scale (TDIS™), Sheehan Disability Scale (SDS) y EuroQoL Visual Analog Scale (EQ-VAS). El perfil de seguridad se mantuvo consistente con hallazgos anteriores, sin nuevas preocupaciones identificadas.
Neurocrine Biosciences (NASDAQ:NBIX)은/는 TD 치료를 위한 INGREZZA®(발벤자민)과 관련된 4상 KINECT-PRO™ 연구의 사후 분석 데이터를 발표했습니다. 연구에 따르면 24주 차에 환자의 57.8%(45명 중 26명)이 증상 완화를 달성했고, 40mg에서 58.3%, 60mg에서 44.4%, 80mg에서 62.5%의 성공률이 보고되었습니다.
분석 결과 완화 달성 환자들 사이에서 삶의 질 향상과 질환 부담 감소를 포함한 환자 보고 지표의 유의미한 개선이 나타났습니다. 특히 TDIS™, SDS, EQ-VAS 등 여러 지표에서 상당한 개선이 관찰되었습니다. 안전성 프로파일은 이전 결과와 일치했고 새로운 문제점은 확인되지 않았습니다.
Neurocrine Biosciences (NASDAQ:NBIX) a publié de nouvelles données d’analyse post-hoc de son essai de phase 4 KINECT-PRO™ évaluant INGREZZA® (valbenazine) pour le traitement de la dyskinésie tardive (TD). L’étude a montré que 52,8% des patients (26 sur 45) avaient atteint une rémission symptomatique à la semaine 24, avec des taux de réussite de 58,3% à 40 mg, 44,4% à 60 mg et 62,5% à 80 mg.
L’analyse a démontré des améliorations significatives des résultats rapportés par les patients parmi ceux qui ont atteint la rémission, notamment une meilleure qualité de vie et une charge réduite liée à la maladie. Notamment, les patients ont montré des améliorations substantielles sur plusieurs mesures : Tardive Dyskinesia Impact Scale (TDIS™), Sheehan Disability Scale (SDS) et EuroQoL Visual Analog Scale (EQ-VAS). Le profil de sécurité est resté cohérent avec les résultats antérieurs, sans nouvelles préoccupations identifiées.
Neurocrine Biosciences (NASDAQ:NBIX) hat neue Post-hoc-Analysetdaten aus ihrer Phase-4-Studie KINECT-PRO™ zu INGREZZA® (Valbenazin) zur Behandlung der tardiven Dyskinesie (TD) bekanntgegeben. Die Studie zeigte, dass 57,8% der Patienten (26 von 45) in Woche 24 eine symptomatische Remission erreichten, mit Erfolgsraten von 58,3% bei 40 mg, 44,4% bei 60 mg und 62,5% bei 80 mg.
Die Analyse belegte signifikante Verbesserungen bei patientenberichteten Outcomes unter den Remissions-Patienten, darunter eine verbesserte Lebensqualität und eine geringere Krankheitsbelastung. Bemerkenswert zeigten sich substanzielle Verbesserungen in mehreren Messgrößen: Tardive Dyskinesia Impact Scale (TDIS™), Sheehan Disability Scale (SDS) und EuroQoL Visual Analog Scale (EQ-VAS). Das Sicherheitsprofil blieb mit früheren Befunden konsistent, es wurden keine neuen Bedenken identifiziert.
Neurocrine Biosciences (NASDAQ:NBIX) أعلنت عن بيانات جديدة لتحليل لاحق من الدرجة الرابعة لدراستها KINECT-PRO™ حول دواء INGREZZA® (فيلبنازين) لعلاج ترهل الحركات المرتبط بالتعاطي للأدوار الدوائية (TD). أظهرت الدراسة أن 57.8% من المرضى (26 من 45) حققوا انخفاضاً أعراضياً خلال الأسبوع 24، مع معدلات نجاح 58.3% عند 40 ملغ، و44.4% عند 60 ملغ، و62.5% عند 80 ملغ.
وأظهرت التحليل تحسنات ملموسة في نتائج يجري الإبلاغ عنها من قبل المرضى بين من حققوا الت remission، بما في ذلك جودة حياة محسنة وانخفاض عبء المرض. وبشكل ملحوظ، أظهر المرضى تحسينات كبيرة عبر عدة مقاييس: مقياس تأثير اضطرابات TD (TDIS™)، مقياس العجز Sheehan (SDS)، ومقياس فهرنهايت اليورو-كول (EQ-VAS). ظل ملف السلامة متسقاً مع النتائج السابقة، ولم تُحدد أية مخاوف جديدة.
Neurocrine Biosciences (NASDAQ:NBIX) 公布了他们的第四阶段研究 KINECT-PRO™ 针对 INGREZZA®（瓦本扎明，valbenazine）治疗迟发性运动障碍（TD）的事后分析新数据。研究显示，在第24周，57.8% 的患者（45例中的26例）达到了症状缓解，且在不同剂量下的成功率为：40 mg 58.3%，60 mg 44.4%，80 mg 62.5%。
分析表明，达到缓解的患者在患者自评结果方面显著改善，包括生活质量提高及疾病负担减轻。具体地，患者在多项指标上均有实质性改善：TDIS™（迟发性运动障碍影响量表）、SDS（Sheehan Disability Scale）以及 EuroQoL Visual Analog Scale（EQ-VAS）。安全性谱与既往结果一致，未发现新的关注点。
- None.
- Small sample size of only 45 patients in the analysis
- Study was open-label, which may introduce potential bias
Insights
Neurocrine's INGREZZA shows faster TD symptom remission (57.8% at 24 weeks) with significant improvements in patient quality of life.
This post-hoc analysis of the KINECT-PRO study reveals substantial advancement in tardive dyskinesia (TD) treatment options. The data demonstrates that 57.8% of patients achieved symptomatic remission by Week 24 across all doses, with the highest rate (62.5%) observed in the 80mg group. This is clinically significant as it shows remission occurring earlier than previously documented.
What's particularly notable is the correlation between symptom remission and meaningful patient-reported outcomes. Patients achieving remission experienced a 10.9-point reduction on the Tardive Dyskinesia Impact Scale, indicating substantial improvement in physical, social, and emotional domains. The 3.2-point decrease in social life/leisure activities impairment and 19.3-point improvement in health-related quality of life represent clinically meaningful changes.
From a clinical perspective, these results are compelling because they address a critical gap in TD management. Previously, efficacy data focused primarily on clinician-assessed movement scores, but this study connects symptom improvement with patient-experienced benefits. The consistent safety profile further strengthens INGREZZA's position as a first-line treatment option.
The remission threshold definition of AIMS score ≤1 in all body regions represents a stringent clinical standard that's difficult to achieve in TD treatment. That nearly 6 in 10 patients met this threshold signals robust efficacy that should translate to real-world clinical practice. The consistent efficacy across dose groups suggests flexibility in dose selection without compromising outcomes.
- The KINECT-PRO™ analysis is the first and only of its kind to report both remission of tardive dyskinesia symptoms and associated improvements in patient-reported outcomes.
- Post-hoc analysis from KINECT-PRO demonstrated substantial symptomatic remission rates at Week 24, even earlier than previous studies have reported.
- Patients who achieved symptomatic remission had robust improvements across multiple patient-reported outcome measures after 24 weeks of INGREZZA treatment.
"These new analyses from KINECT-PRO demonstrated that symptomatic remission from the uncontrollable movements of tardive dyskinesia can be achieved with INGREZZA treatment even sooner than previously available data suggested, regardless of whether these movements were mild or more severe prior to treatment," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "Additionally, the data indicate that patients who achieved remission of tardive dyskinesia symptoms, defined as minimal or no involuntary movements, experienced substantial and meaningful improvements in how tardive dyskinesia affects them physically, socially and emotionally. This reinforces symptomatic remission as an important treatment goal achievable with INGREZZA."
The post-hoc analysis of KINECT-PRO data included patients with mild to severe tardive dyskinesia (TD) severity and awareness with mild to severe associated distress, as measured by the Abnormal Involuntary Movement Scale (AIMS) items 8 and 10 at baseline. Patients received once-daily INGREZZA at an initial dose of 40 mg for four weeks, with the option to adjust the dose to 60 mg or 80 mg through Week 16, followed by a stable dose through Week 24.
At Week 24, 26 of 45 patients (
Among patients meeting the symptomatic remission threshold, changes from baseline were evaluated in three validated patient-reported outcomes (PROs): the Tardive Dyskinesia Impact Scale (TDIS™), the only psychometrically validated PRO that measures the physical, social and emotional impacts of TD, the Sheehan Disability Scale (SDS), which assesses functional impairment and the EuroQoL Visual Analog Scale (EQ-VAS), which measures health-related quality of life (HRQoL).
After 24 weeks of treatment with INGREZZA, these results demonstrated robust and sustained improvements in TD impact, functional impairment and HRQoL.
PRO Outcomes in TD Remitters (n=26)
PRO | Baseline | Mean Change from |
TDIS† | 15.5 | -10.9 |
SDS – Social Life/Leisure Activities† | 5.1 | -3.2 |
SDS – Family Life/Home Responsibilities† | 4.1 | -2.4 |
EQ-VAS (HRQoL)‡ | 61.8 | +19.3 |
*
†A decrease in score indicated improvement.
‡An increase in score indicated improvement.
KINECT-PRO is the first and only study to evaluate and demonstrate patient-reported improvement with vesicular monoamine transporter 2 inhibitor treatment, specifically INGREZZA, on TD using multiple clinically validated scales. This post-hoc analysis demonstrated high rates of symptomatic remission and associated improvements in PROs – including physical and socio-emotional impacts of TD, functional impairment and HRQoL. These findings add to the unique and growing body of evidence supporting the efficacy of INGREZZA in TD severity and impact, as well as its potential to achieve remission of TD symptoms. In the study, safety and tolerability of treatment was consistent with the known profile of INGREZZA, with no new concerns identified.
Additional poster presentations at Psych Congress 2025 include:
- Osavampator (NBI-1065845/TAK-653) Demonstrates Statistically Significant and Clinically Meaningful Improvements in Depression Severity and Is Well Tolerated in Adults with Major Depressive Disorder: Phase 2 SAVITRI™ Results
- Osavampator: A Selective Positive Allosteric Modulator of the AMPA Receptor (AMPA-PAM) in Development for the Treatment of Major Depressive Disorder
- The Functional Impact of Major Depressive Disorder on Patients' Daily Lives: A Qualitative Investigation of Patient and Clinician Perspectives
- Once-Daily Valbenazine Improves the Impacts and Symptoms of Tardive Dyskinesia Regardless of Psychiatric Diagnosis: Results from the Phase 4 KINECT-PRO™ Study
- Valbenazine Improves Physical, Social, and Emotional Impacts on the Tardive Dyskinesia Impact Scale (TDIS): Post Hoc Analyses of KINECT-PRO™ Data
- Estimation of the Minimal Clinically Important Difference and Longitudinal Change in the Tardive Dyskinesia Impact Scale, a Validated, Tardive Dyskinesia-Specific, Patient-Reported Outcome Measure
- Physical, Mental, and Socioemotional Functional Improvement Following Valbenazine Treatment for TD: a Case Series
- Once-Daily Valbenazine for the Treatment of Tardive Dyskinesia in Elderly Adults and Other Special Populations
- Valbenazine Improves Tardive Dyskinesia in Patients Regardless of Ethnicity or Race: Post Hoc Analyses of Long-Term Data from the KINECT® 4 Study
- A Qualitative, Interview-based Study of Patient, Caregiver, and Prescriber Rankings of Functional Outcome Improvements in Schizophrenia
About Tardive Dyskinesia
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
About the KINECT-PRO™ Phase 4 Study
The KINECT-PRO™ Phase 4, open-label study was designed to evaluate patient-reported outcomes on the use of INGREZZA® (valbenazine) capsules in a tardive dyskinesia (TD) patient population reflective of real-world clinical practice. Participants had at least mild TD, were aware of and experiencing at least mild distress from their abnormal, involuntary movements and had a clinical diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder or major depression. The KINECT-PRO study included a four-week screening period, a 24-week treatment period during which participants received 40 mg of INGREZZA once-daily for the first four weeks, followed by flexible dosing of 40 mg, 60 mg or 80 mg once-daily based on individual treatment needs and a two-week safety follow-up period. Baseline socio-demographic and clinical characteristics of the participants were broadly similar to those of the KINECT® 3 and KINECT® 4 studies.
KINECT-PRO is the first and only study to specifically evaluate and demonstrate patient-reported improvement with vesicular monoamine transporter 2 inhibitor treatment on TD using multiple clinically validated scales, including the Tardive Dyskinesia Impact Scale (TDIS™). The TDIS is the only patient-reported outcome instrument designed for and validated in tardive dyskinesia patients that measures the physical, social and emotional impact of the involuntary movements of the condition.
About the Tardive Dyskinesia Impact Scale
The Tardive Dyskinesia Impact Scale (TDIS™) is the only patient-reported outcome instrument designed for and validated in tardive dyskinesia patients that measures the physical, social and emotional impact of the involuntary movements of the condition. It was developed by Neurocrine Biosciences from qualitative studies and Phase 3 trials of INGREZZA for the treatment of TD (KINECT® 3 and KINECT® 4) as a comprehensive measure of impact and burden of TD from a patient's perspective. The TDIS consists of 11 questions evaluating physical and socio-emotional impact. Six scales are assessed: mouth/throat, dexterity, mobility, pain, social and emotional. The TDIS allows people with TD to rate how their symptoms affect daily activities and how their uncontrollable movements make them feel. The questionnaire captures relevant information about the impact of TD to provide a more holistic assessment of the condition. Validation of this scale was published in the Journal of Patient-Reported Outcomes.
About the EQ Visual Analogue Scale and the Sheehan Disability Scale
The EQ Visual Analogue Scale (EQ-VAS) is the second component of the 5-level EQ 5D (EQ-5D-5L). The EQ-VAS is a visual scale ranging from 0 "the worst health you can imagine" to 100 "the best health you can imagine" that assesses a patient's self-rated health, with higher scores indicating better health status.
The Sheehan Disability Scale (SDS) is a five-item, patient-reported outcome measure which includes social, family and occupational life domains. Three items assess impairment in terms of work/school, social life and family life/home responsibilities and are scored independently (0 [not impaired] to 10 [extremely impaired]) or combined for total score (0 to 30). Two items assess number of days lost or underproductive. A decrease in score indicates improvement.
About INGREZZA® (valbenazine) Capsules and INGREZZA® SPRINKLE (valbenazine) Capsules
INGREZZA is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the
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.
Important Information
Approved Uses
INGREZZA® (valbenazine) capsules or INGREZZA® SPRINKLE (valbenazine) capsules are prescription medicines used to treat adults with:
- movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia).
- involuntary movements (chorea) of Huntington's disease. INGREZZA or INGREZZA SPRINKLE do not cure the cause of involuntary movements, and do not treat other symptoms of Huntington's disease, such as problems with thinking or emotions.
It is not known if INGREZZA or INGREZZA SPRINKLE is safe and effective in children.
IMPORTANT SAFETY INFORMATION
INGREZZA or INGREZZA SPRINKLE can cause serious side effects in people with Huntington's disease, including: depression, suicidal thoughts, or suicidal actions. Tell your healthcare provider before you start taking INGREZZA or INGREZZA SPRINKLE if you have Huntington's disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when INGREZZA or INGREZZA SPRINKLE is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of hurting yourself.
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. Allergic reactions, including an allergic reaction that causes sudden swelling called angioedema can happen after taking the first dose or after many doses of INGREZZA or INGREZZA SPRINKLE. Signs and symptoms of allergic reactions and angioedema include: trouble breathing or shortness of breath, swelling of your face, lips, eyelids, tongue, or throat, or other areas of your skin, trouble with swallowing, or rash, including raised, itchy red areas on your skin (hives). Swelling in the throat can be life-threatening and can lead to death. Stop taking INGREZZA or INGREZZA SPRINKLE and go to the nearest emergency room right away if you develop these signs and symptoms of allergic reactions and angioedema.
- Sleepiness and tiredness that could cause slow reaction times (somnolence and sedation). Do not drive a car or operate dangerous machinery until you know how INGREZZA or INGREZZA SPRINKLE affects you. Drinking alcohol and taking other medicines may also cause sleepiness during treatment with INGREZZA or INGREZZA SPRINKLE.
- Heart rhythm problems (QT prolongation). INGREZZA or INGREZZA SPRINKLE may cause a heart rhythm problem known as QT prolongation. You have a higher chance of getting QT prolongation if you also take certain other medicines during treatment with INGREZZA or INGREZZA SPRINKLE. Tell your healthcare provider right away if you develop any signs or symptoms of QT prolongation, including: fast, slow, or irregular heartbeat (heart palpitations), shortness of breath, dizziness or lightheadedness, or fainting or feeling like you are going to faint.
- Neuroleptic Malignant Syndrome (NMS). NMS is a serious condition that can lead to death. Call a healthcare provider right away or go to the nearest emergency room if you develop these symptoms and they do not have another obvious cause: high fever, stiff muscles, problems thinking, irregular pulse or blood pressure, increased sweating, or very fast or uneven heartbeat.
- Parkinson-like symptoms. Symptoms include: body stiffness, drooling, trouble moving or walking, trouble keeping your balance, shaking (tremors), or falls.
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. Make sure you tell all of your healthcare providers that you are taking INGREZZA or INGREZZA SPRINKLE. Taking INGREZZA or INGREZZA SPRINKLE with certain other medicines may cause serious side effects. Especially tell your healthcare provider if you: take digoxin or take or have taken a monoamine oxidase inhibitor (MAOI) medicine. You should not take INGREZZA or INGREZZA SPRINKLE if you are taking, or have stopped taking, a MAOI within the last 14 days.
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.
These are not all of the possible side effects of INGREZZA or INGREZZA SPRINKLE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.
Dosage Forms and Strengths: INGREZZA and INGREZZA SPRINKLE are available in 40 mg, 60 mg, and 80 mg capsules.
Please see full Prescribing Information, including Boxed Warning, and Medication Guide.
About Neurocrine Biosciences, Inc.
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie)
The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, KINECT and INGREZZA are registered trademarks of Neurocrine Biosciences, Inc. KINECT-PRO, TDIS and SAVITRI are trademarks of Neurocrine Biosciences, Inc.
Forward-Looking Statements
In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from INGREZZA and the value INGREZZA may bring to patients. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of INGREZZA; whether INGREZZA receives adequate reimbursement from third-party payors; risks and uncertainties relating to competitive products and technological changes that may limit demand for INGREZZA; risks associated with the Company's dependence on third parties for development and manufacturing activities related to INGREZZA, and the ability of the Company to manage these third parties; risks that additional regulatory submissions for INGREZZA or other product candidates may not occur or be submitted in a timely manner; risks that the FDA or other regulatory authorities may make adverse decisions regarding INGREZZA; risks that post-approval INGREZZA commitments or requirements may be delayed; risks that INGREZZA may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended June 30, 2025. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law.
© 2025 Neurocrine Biosciences, Inc. All Rights Reserved. CAP-VBZ-US-0079 09/2025
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FAQ
What were the key findings of NBIX's KINECT-PRO study for INGREZZA?
How did INGREZZA impact patient-reported outcomes in the KINECT-PRO study?
What dosages of INGREZZA were tested in the KINECT-PRO study?
How does INGREZZA's safety profile compare in the new KINECT-PRO analysis?
What makes the KINECT-PRO study unique for tardive dyskinesia treatment?
