Neurocrine Biosciences Initiates Phase 2 Clinical Study Evaluating NBI-1065890 in Adults with Tardive Dyskinesia

Rhea-AI Summary

Neurocrine Biosciences (Nasdaq: NBIX) initiated a Phase 2 randomized, double-blind, placebo-controlled study of investigational NBI-1065890 in adults with tardive dyskinesia (TD) on Jan 26, 2026. NBI-1065890 is described as a next-generation, selective VMAT2 inhibitor designed for a potentially differentiated, longer-acting profile.

The study will enroll approximately 100 adults and will assess efficacy, safety, and tolerability versus placebo. The primary efficacy endpoint is change from baseline in the AIMS dyskinesia total score (Items 1–7) at Week 8. Neurocrine notes prior FDA approvals for valbenazine in 2017 (tardive dyskinesia) and 2023 (Huntington’s chorea).

Positive

• Phase 2 study initiated for NBI-1065890 in adults with TD
• Planned enrollment of ~100 adult subjects
• Primary endpoint specified: AIMS total score change at Week 8
• Company has prior FDA approvals for valbenazine in 2017 and 2023

Negative

• Efficacy unproven in Phase 2; clinical benefit remains to be demonstrated
• Small sample size (~100) may limit subgroup analyses and generalizability

News Market Reaction

-1.23%

1 alert

-1.23% News Effect

On the day this news was published, NBIX declined 1.23%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Study phase: Phase 2 Enrollment: Approximately 100 adults Primary endpoint timepoint: Week 8 +3 more

6 metrics

Study phase Phase 2 NBI-1065890 tardive dyskinesia trial

Enrollment Approximately 100 adults Randomized, double-blind, placebo-controlled Phase 2 TD study

Primary endpoint timepoint Week 8 Change from baseline in AIMS dyskinesia total score

AIMS items Items 1–7 Abnormal Involuntary Movement Scale dyskinesia total score definition

VMAT2 history 2017 approval First FDA approval of valbenazine for tardive dyskinesia

HD indication 2023 approval Valbenazine for chorea associated with Huntington's disease

Market Reality Check

Price: $134.66 Vol: Volume 1,158,900 is 1.08x...

normal vol

$134.66 Last Close

Volume Volume 1,158,900 is 1.08x the 20-day average, indicating slightly elevated trading ahead of the news. normal

Technical Shares at $136.18 trade above the 200-day MA $132.91, about 14.98% below the 52-week high and 61.68% above the 52-week low.

Peers on Argus

NBIX was down 0.87% while close peers were mixed: UTHR and RDY modestly negative...

NBIX was down 0.87% while close peers were mixed: UTHR and RDY modestly negative, VTRS and TEVA slightly positive, and TAK up 1.43%. No broad, aligned sector move is evident.

Common Catalyst Limited same-day peer news; one peer (UTHR) also reported clinical trial data, but overall trading patterns appear company-specific rather than sector-wide.

Previous Clinical trial Reports

5 past events · Latest: Dec 22 (Negative)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 22	Phase 3 update	Negative	-0.2%	Phase 3 KINECT-DCP valbenazine trial in DCP failed primary and key endpoints.
Nov 10	Phase 2 results	Negative	-1.8%	Phase 2 NBI-1070770 MDD study did not meet primary endpoint versus placebo.
Sep 22	Phase 2 data	Positive	+1.0%	Positive Phase 2 SAVITRI osavampator MDD data with significant MADRS improvements.
Jul 14	Phase 3 data	Positive	-2.9%	One-year Phase 3 CAHtalyst data showed weight and metabolic improvements in CAH.
Jun 30	Phase 1 initiation	Positive	+1.8%	Initiation of Phase 1 NBIP-01435 CRF1 antagonist study in healthy adults for CAH.

Pattern Detected

Clinical-trial headlines for NBIX have mostly seen price reactions aligned with the apparent news tone, with one notable divergence on positive Phase 3 data.

Recent Company History

Over the past several months, Neurocrine has reported multiple clinical milestones across CNS and endocrine programs. Events include mixed trial outcomes, from Phase 3 and Phase 2 studies that did not meet endpoints to positive Phase 2 data in major depressive disorder and long-term CAH outcomes. The company also initiated new early-stage programs. Historically, clinical-trial news led to next-day moves averaging about 1.53%. Today’s initiation of a Phase 2 TD study for NBI-1065890 extends this pattern of pipeline diversification around VMAT2 and endocrine-related indications.

Historical Comparison

clinical trial

+1.5 %

Average Historical Move

Historical Analysis

Clinical-trial headlines for NBIX have produced an average one-day move of 1.53%. Today’s Phase 2 TD initiation follows a consistent pattern of R&D-driven news flow across psychiatry and endocrinology.

Typical Pattern

Recent clinical updates span Phase 1 through Phase 3, including new trial initiations, mixed efficacy outcomes, and positive long-term data, illustrating a broad, advancing pipeline across CNS and endocrine indications.

Market Pulse Summary

This announcement extends Neurocrine’s VMAT2 leadership with a Phase 2 trial of NBI-1065890 in tardi...

Analysis

This announcement extends Neurocrine’s VMAT2 leadership with a Phase 2 trial of NBI-1065890 in tardive dyskinesia, targeting about 100 adults with an AIMS-based primary endpoint at Week 8. It builds on prior approvals of valbenazine in 2017 and 2023, reinforcing a franchise strategy in movement disorders. Historically, clinical-trial headlines led to average one-day moves of about 1.53%. Investors may watch enrollment progress, efficacy signals, and how this candidate compares to existing TD therapies.

Key Terms

tardive dyskinesia, vesicular monoamine transporter 2, vmat2, randomized, double-blind, placebo-controlled, +2 more

6 terms

tardive dyskinesia medical

"Phase 2 clinical study of investigational compound NBI-1065890 in adults with tardive dyskinesia (TD)."

A chronic movement disorder marked by repetitive, involuntary motions—often of the face, tongue, or limbs—that can develop after long-term use of certain psychiatric or neurological medications. It matters to investors because the condition creates medical need, regulatory scrutiny, potential for expensive treatments or liability, and can shape the commercial value of drugs in development or on the market; think of it as a persistent side effect that can change a drug’s price tag and sales prospects.

vesicular monoamine transporter 2 medical

"NBI-1065890 is a next-generation, selective inhibitor of the vesicular monoamine transporter 2 (VMAT2)."

Vesicular monoamine transporter 2 (VMAT2) is a protein in nerve cells that acts like a loading dock, moving signaling chemicals such as dopamine and serotonin into storage packets so they can be released at the right time. Investors watch VMAT2 because drugs or imaging tests that affect or measure it can be used to treat or diagnose neurological and psychiatric conditions, creating potential markets, clinical milestones, and regulatory events that affect company value.

vmat2 medical

"Building on nearly 20 years of deep scientific expertise and experience in VMAT2 inhibition, Neurocrine designed NBI-1065890..."

VMAT2 is a protein that acts like a tiny pump in certain brain cells, moving chemical messengers such as dopamine into storage packets so they can be released when cells signal. Investors care because drugs or imaging tests that affect or measure VMAT2 can change how neurological and movement disorders are diagnosed and treated; successful therapies or validated diagnostic scans can alter clinical trial outcomes, regulatory decisions and market value in the healthcare sector.

randomized, double-blind, placebo-controlled medical

"This Phase 2, randomized, double-blind, placebo-controlled study will enroll approximately 100 adult subjects..."

A "randomized, double-blind, placebo-controlled" process is a method used to test the effectiveness of a new treatment or intervention. Participants are randomly assigned to different groups, with one receiving the real treatment and the other a fake version, called a placebo. Neither the participants nor the researchers know who is receiving which, which helps ensure unbiased results. For investors, this rigorous approach increases confidence that the findings are accurate and not influenced by guesswork or bias.

abnormal involuntary movement scale medical

"The primary efficacy endpoint is change from baseline in the Abnormal Involuntary Movement Scale (AIMS) dyskinesia total score..."

AIMS is a standardized clinical checklist doctors use to spot and rate involuntary movements—like facial grimacing, tongue or limb twitching—that can be caused by certain medications. For investors, AIMS scores matter because they are a practical safety measurement in drug trials and ongoing monitoring; high or worsening scores can lead to stronger warnings, tougher regulatory review, reduced marketability or costly label changes, much like a vehicle inspection report revealing serious faults.

clinicaltrials.gov regulatory

"For more information about the Phase 2 study (NBI-1065890-TD2033), visit ClinicalTrials.gov."

clinicaltrials.gov is a publicly accessible U.S. government database that lists details, timelines and status updates for medical studies testing drugs, devices or procedures. For investors it acts like a public calendar and scoreboard—showing when trials start, are delayed, or report results—so it helps gauge a company’s development progress, regulatory risk and potential value impact before official earnings or approvals are announced.

AI-generated analysis. Not financial advice.

SAN DIEGO, Jan. 26, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the initiation of its Phase 2 clinical study of investigational compound NBI-1065890 in adults with tardive dyskinesia (TD). NBI-1065890 is a next-generation, selective inhibitor of the vesicular monoamine transporter 2 (VMAT2). Building on nearly 20 years of deep scientific expertise and experience in VMAT2 inhibition, Neurocrine designed NBI-1065890 to potentially deliver a differentiated profile, including the possibility of longer-acting options for the treatment of TD.

"NBI-'890 is an internally discovered molecule with distinct physical and chemical properties that may allow it to benefit a broader range of patients with tardive dyskinesia," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "Advancing this program to a Phase 2 clinical study is key to our strategy to define the future of VMAT2 biology and deliver lasting impact for patients."

This Phase 2, randomized, double-blind, placebo-controlled study will enroll approximately 100 adult subjects with TD and will assess the efficacy, safety, and tolerability of NBI-1065890 compared with placebo. The primary efficacy endpoint is change from baseline in the Abnormal Involuntary Movement Scale (AIMS) dyskinesia total score (sum of Items 1–7) at Week 8.

Neurocrine successfully developed and received U.S. Food and Drug Administration approval in 2017 for valbenazine, a selective VMAT2 inhibitor, for use as the first drug ever developed for the treatment of tardive dyskinesia. In 2023, the company received FDA approval for valbenazine as a treatment for chorea associated with Huntington's disease. 

For more information about the Phase 2 study (NBI-1065890-TD2033), visit ClinicalTrials.gov. 

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 NBI-1065890
NBI-1065890, discovered and developed internally at Neurocrine, is a potent, selective and orally bioavailable inhibitor of vesicular monoamine transporter 2 (VMAT2) in clinical development for the treatment of tardive dyskinesia (TD). Inhibition of VMAT2 is expected to provide therapeutic benefit in TD, other hyperkinetic movement disorders, and potentially other CNS disorders where dopaminergic signaling is dysregulated.

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 and developing 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, 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, Facebook and YouTube. (*in collaboration with AbbVie) 

The NEUROCRINE BIOSCIENCES logo, NEUROCRINE and YOU DESERVE BRAVE SCIENCE are registered 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 efficacy and therapeutic potential of NBI-1065890. 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 that clinical development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that regulatory submissions for our product candidates may not occur or be submitted in a timely manner; our future financial and operating performance; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities for our products and product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates 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; risks associated with U.S. federal or state legislative or regulatory and/or policy efforts which may result in, among other things, an adverse impact on our revenues or potential revenue; risks associated with potential generic entrants for our products; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's annual report on Form 10-K for the year ended September 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.

© 2026 Neurocrine Biosciences, Inc. All Rights Reserved.

 

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SOURCE Neurocrine Biosciences, Inc.

FAQ

What is Neurocrine announcing about NBI-1065890 (NBIX) on January 26, 2026?

Neurocrine announced the initiation of a Phase 2 randomized, double-blind, placebo-controlled study of NBI-1065890 in adults with tardive dyskinesia.

How many patients will the NBIX NBI-1065890 Phase 2 study enroll and what is the timeline?

The study will enroll approximately 100 adult subjects and evaluates the primary endpoint at Week 8.

What is the primary endpoint for Neurocrine’s NBI-1065890 TD Phase 2 study (NBIX)?

The primary efficacy endpoint is change from baseline in the AIMS dyskinesia total score (Items 1–7) at Week 8.

What mechanism of action does NBI-1065890 use in the NBIX trial?

NBI-1065890 is described as a next-generation, selective inhibitor of the vesicular monoamine transporter 2 (VMAT2).

Does Neurocrine have prior FDA experience relevant to NBI-1065890 development (NBIX)?

Yes; Neurocrine previously received FDA approval for valbenazine for tardive dyskinesia in 2017 and for Huntington’s chorea in 2023.