Neurocrine Biosciences Presents New Analysis Establishing Benchmark for Clinically Meaningful Change in Overall Health Reported by Patients with Tardive Dyskinesia

• New analysis establishes a 6-point increase on the EQ Visual Analogue Scale as a threshold for clinically meaningful change in overall health ratings in patients with tardive dyskinesia treated with INGREZZA^®(valbenazine) capsules
• The 6-point threshold helps contextualize the meaningful improvement with INGREZZA observed in the KINECT-PRO™ study, including a mean 13.1-point improvement in EQ Visual Analogue Scale scores, and complements established measures of tardive dyskinesia-specific impact and movement severity
• Findings are among three Neurocrine Biosciences analyses to be presented at the Academy of Managed Care Pharmacy Nexus 2026 conference

SAN DIEGO, Oct. 26, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced new research that helps define clinically meaningful improvement in overall health reported by people living with tardive dyskinesia who were treated with INGREZZA^® (valbenazine) capsules. The findings will be presented at the Academy of Managed Care Pharmacy Nexus 2026 conference, taking place Oct. 26-29 in San Diego.

The EQ Visual Analogue Scale (EQ-VAS) captures a patient's own assessment of their overall health on a scale from 0 to 100, where 0 is the worst possible health and 100 is the best possible health. Using this measure, the new analysis identified a 6-point improvement as the benchmark for clinically meaningful change, providing important context for interpreting previously reported findings from the Phase 4 KINECT-PRO™ study. Those results showed a mean 13.1-point improvement from baseline in overall health scores reported by tardive dyskinesia (TD) patients at Week 24 following treatment with INGREZZA.

In KINECT-PRO, patients reported meaningful improvements in the physical, social, and emotional impact of TD measured by the Tardive Dyskinesia Impact Scale (TDIS™). Additionally, the study demonstrated clinically meaningful improvements in involuntary movement severity measured by the clinician-rated Abnormal Involuntary Movement Scale (AIMS). Both measures exceeded minimal clinically important difference (MCID) thresholds as early as Week 8 for TDIS and Week 4 for AIMS, with improvements sustained through Week 24. KINECT-PRO is a first-of-its-kind clinical study designed to evaluate and demonstrate patient-reported improvements in quality of life and functionality with vesicular monoamine transporter 2 inhibitor treatment, specifically INGREZZA, on TD, using multiple clinically validated scales.

"Patient-reported outcomes provide an important perspective on how tardive dyskinesia and its treatment affect patients beyond changes in involuntary movements alone," said Eiry W. Roberts, M.D., Chief Medical Officer, Neurocrine Biosciences. "Establishing what represents a clinically meaningful change in patients' overall health can help clinicians better interpret patient-reported improvements in quality of life and builds on the established body of evidence demonstrating the broader impact of treating tardive dyskinesia with INGREZZA."

Researchers analyzed EQ-VAS data from two Phase 4 studies, KINECT-PRO and TD-4002, using two established approaches to determine the amount of change in EQ-VAS score that could be considered clinically meaningful to an individual patient diagnosed with TD. The primary anchor-based analysis used KINECT-PRO data to evaluate EQ-VAS changes among participants rated "minimally improved" based on patient- and clinician-reported global assessments. A supportive distribution-based analysis used data from both KINECT-PRO and TD-4002 to evaluate EQ-VAS scores.

Based on the anchor- and distribution-based analyses, researchers established a 6-point increase in EQ-VAS score as the minimum clinically meaningful within-patient change threshold. The 6-point threshold was also consistent with previous estimates of meaningful change for the EQ-VAS reported in literature.

Together with established meaningful change thresholds for TDIS and AIMS, the new EQ-VAS threshold helps provide a more complete picture of meaningful improvement across patients' TD-specific impact, health-related quality of life, and movement severity, as shown with INGREZZA in KINECT-PRO.

Additional presentations at the Academy of Managed Care Pharmacy Nexus 2026 conference include:

• Anticholinergic Polypharmacy Among Medicare Beneficiaries ≥65 Years With and Without Tardive Dyskinesia
• Real-World Dosing Trends Over Time and Projections for Valbenazine and Deutetrabenazine XR in the U.S.

About Tardive Dyskinesia
Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrollable, 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 severe and are often persistent and irreversible. TD is estimated to affect at least 800,000 adults in the U.S.

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.

About the TD-4002 Phase 4 Study
TD-4002 was a Phase 4, randomized withdrawal study conducted to assess the persistence of valbenazine effect in adults with moderate to severe tardive dyskinesia (TD). This study included an initial, eight-week, open-label valbenazine treatment period, followed by an eight-week, randomized, double-blind, placebo-controlled withdrawal period and then a four-week, no-drug washout period until the final study visit at Week 20. During the eight-week open-label treatment period, once-daily valbenazine was initiated at 40 mg and escalated to 80 mg after one week (dose reduction was allowed for tolerability). After eight weeks of open-label valbenazine, participants were randomized (1:1) to receive eight weeks of placebo or continue taking the same valbenazine dose. Baseline socio-demographic and clinical characteristics of the participants were broadly similar to those of the KINECT^® 3 and KINECT^® 4 studies.

About the Tardive Dyskinesia Impact Scale
The Tardive Dyskinesia Impact Scale (TDIS™) is a novel, psychometrically validated patient-reported outcome measure in TD. 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 domains 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
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. 

About INGREZZA^® (valbenazine) Capsules and INGREZZA^® SPRINKLE (valbenazine) Capsules
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.

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 biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing, and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine, and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, 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 more than 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, Facebook, and YouTube. (*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 and TDIS 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, the interpretation and potential relevance of the data described in this press release, including statements regarding the meaningful change threshold for patient-reported overall health in patients with tardive dyskinesia and its relevance to interpreting previously reported KINECT-PRO study results, 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 as to whether the data described in this press release, including the meaningful change threshold for patient-reported overall health, will be replicated or validated in additional studies or will be predictive of efficacy or other clinical outcomes in subsequent clinical studies or real-world use of INGREZZA; 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, 2026. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law.

© 2026 Neurocrine Biosciences, Inc. All Rights Reserved. CAP-TD-US-0096 10/2026 

SOURCE Neurocrine Biosciences, Inc.