Neurocrine Biosciences Presents Real-World Data Highlighting Functional Impact of Mild Tardive Dyskinesia Severity and Improvement with INGREZZA® (valbenazine) Capsules
Rhea-AI Summary
Neurocrine Biosciences (Nasdaq: NBIX) reported real-world clinician survey data on mild tardive dyskinesia (TD) and INGREZZA capsules at the APA 2026 meeting. In a subgroup of 90 patients with mild TD, 90% had functional impairment. After starting INGREZZA, 96% showed improved uncontrolled movements, with 86% improving within four weeks. Clinicians also reported high rates of better functional status, independence, daily activities and work or school participation.
AI-generated analysis. Not financial advice.
Positive
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Negative
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News Market Reaction – NBIX
On the day this news was published, NBIX declined 2.18%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
NBIX slipped 0.4% with modest volume while key peers UTHR, RDY, VTRS, TEVA and TAK also traded lower (moves from -0.48% to -3.99%), indicating broader pressure across specialty/generic drug makers rather than a stock-specific move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| May 06 | Clinical guidance update | Positive | +8.9% | Expert algorithms for glucocorticoid dose reduction after CRENESSITY initiation. |
| May 05 | Earnings and M&A | Positive | +8.9% | Strong Q1 2026 results and agreement to acquire Soleno Therapeutics for cash. |
| May 05 | Conference appearance | Neutral | +0.7% | Announcement of presentation at Bank of America Health Care Conference 2026. |
| May 04 | TD burden survey | Positive | +1.7% | Survey showing significant employment burden from TD and low treatment rates. |
| May 04 | Phase 1 trial start | Positive | +1.7% | Initiation of first‑in‑human Phase 1 study for obesity candidate NBIP-'2118. |
Recent NBIX news, especially earnings and clinical updates, has generally coincided with positive share reactions, indicating the stock has tended to trade higher on constructive fundamental or pipeline developments.
Over the last few weeks, NBIX has reported strong Q1 2026 financials, with INGREZZA and CRENESSITY driving revenue growth and an agreement to acquire Soleno for $2.9B. It also initiated a Phase 1 obesity study and highlighted TD burden on employment. These events, which previously saw positive price reactions up to +8.86%, frame today’s real‑world INGREZZA data as another TD‑focused validation rather than a new financial catalyst.
Market Pulse Summary
This announcement adds real‑world evidence that mild tardive dyskinesia meaningfully impairs functioning and that INGREZZA treatment was associated with improvements in movements, independence, and work or school engagement, with response rates up to 96%. In recent months, NBIX also reported strong financial results and advanced pipeline and M&A initiatives, including a $2.9B acquisition. Investors may watch for how such data integrate into long‑term TD treatment uptake and future clinical readouts.
Key Terms
tardive dyskinesia medical
INGREZZA medical
valbenazine medical
Abnormal Involuntary Movement Scale medical
Phase 4 medical
vesicular monoamine transporter 2 inhibitor medical
AI-generated analysis. Not financial advice.
- Clinician survey showed
90% of patients with mild tardive dyskinesia experienced emotional, social or physical impairment
- Following initiation of INGREZZA,
96% of patients with mild tardive dyskinesia showed clinician-reported improvement in uncontrolled movements; of those patients,86% improved within 4 weeks
- Reductions in involuntary movements with INGREZZA treatment were associated with improvements in overall functional status, independence, activities of daily living and ability to work
"A growing body of evidence shows that even tardive dyskinesia identified as mild in severity can meaningfully disrupt patients' daily functioning, impacting their physical, social and emotional well-being," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "These real-world results complement previously published patient-reported data highlighting both the functional impact of mild involuntary movements and the potential benefits of INGREZZA treatment. INGREZZA has been shown to improve tardive dyskinesia and associated functional outcomes that can help patients reclaim their independence and resume everyday activities."
The analysis was based on a previously conducted clinician survey of patient chart data and clinician recall evaluating TD symptoms, functional impairment and improvement following treatment with INGREZZA. The survey included adult patients with TD who initiated INGREZZA between January 1, 2024 and June 30, 2024, completed at least two months of treatment and had at least one follow-up visit. In total, 128 clinicians caring for 315 patients with TD on INGREZZA reported data.
This analysis focused on a subgroup of patients (n=90) with mild movement severity as rated by clinicians using global severity categories aligned with the Abnormal Involuntary Movement Scale. Prior to treatment, clinicians reported that mild TD movements impacted functional status in
Following the initiation of INGREZZA, nearly all patients (
- For patients with impacted functional status (n=81), almost all (
96% ) had improvement in overall functional status. - Across all functional items, clinicians reported improvement in more than
90% of impacted patients, including those with impacted speech (n=55), dexterity (n=54), social status (n=77), emotional status (n=79) and activities of daily living, such as eating (n=50) and self-care (n=44). - Among all patients,
83% (n=75/90) achieved improvement in independence with treatment. - Among patients who were employed or attending school,
70% (n=21/30) experienced improved willingness or ability to work or attend school after initiating treatment.
Findings from this survey and subpopulation analysis support the American Psychiatric Association clinical guidelines, which state that treatment with a vesicular monoamine transporter 2 inhibitor can be considered for patients with mild TD based on associated impairment or patient preference. This research adds to the growing body of evidence demonstrating the benefits of INGREZZA in patients with TD, including those with mild movements. In clinical studies, including the Phase 4 KINECT-PRO™ study, INGREZZA has been shown to improve TD severity and patients have reported reductions in the physical, social and emotional burden of the condition. Together, these real-world and clinical data highlight the potential of INGREZZA to improve movements and associated functional outcomes in patients with TD, including those with mild involuntary movements prior to treatment.
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 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.
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 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 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 patients with 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, INGREZZA and KINECT 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 expectations as to how such data may relate to the therapeutic effects and clinical efficacy of 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 as to whether the data described in this press release will be replicated 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 March 31, 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-VBZ-US-0101 05/2026
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SOURCE Neurocrine Biosciences, Inc.