Neurocrine Biosciences Provides Update on Phase 3 Study of Valbenazine in Dyskinetic Cerebral Palsy

Rhea-AI Summary

Neurocrine Biosciences (Nasdaq: NBIX) announced that its Phase 3 KINECT-DCP study of valbenazine in pediatric and adult participants with dyskinetic cerebral palsy did not meet primary or key secondary endpoints (Dec. 22, 2025).

The 14-week, double-blind, placebo-controlled study—described as the largest trial ever completed in DCP—assessed improvement in chorea. Adverse events were reported as generally consistent with valbenazine's established safety profile. The company thanked patients, families, investigators, and site staff and said it will present full study results at an upcoming scientific meeting.

Positive

• Completed largest double-blind placebo-controlled DCP trial
• Adverse events generally consistent with established valbenazine safety profile

Negative

• Phase 3 KINECT-DCP did not meet primary endpoints
• Phase 3 KINECT-DCP did not meet key secondary endpoints

Key Figures

Treatment duration 14 weeks Valbenazine vs placebo in Phase 3 KINECT-DCP study

Market Reality Check

$147.53 Last Close

Volume Volume 1,935,216 is 1.83x the 20-day average of 1,057,940 shares. high

Technical Price 145 is trading above the 200-day MA at 129.69, near the upper 52-week range.

Peers on Argus

NBIX showed a pre-news gain of 2.23% with elevated volume, while key peers like UTHR, RDY, TEVA, VTRS, and TAK were also modestly positive (0.25–2.31%). No peers appeared in the momentum scanner and there were no same-day peer headlines, pointing to a more stock-specific setup ahead of this trial update.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 16	R&D day update	Positive	-4.7%	Outlined transformed R&D strategy and multiple future clinical milestones.
Dec 09	Event announcement	Neutral	+0.4%	Announced logistics and agenda for upcoming 2025 R&D Day.
Nov 20	Publication highlight	Positive	+0.7%	Published narrative review underscoring INGREZZA’s distinctive VMAT2 profile.
Nov 18	Phase 2 results	Positive	-3.4%	Reported positive SAVITRI Phase 2 osavampator data in MDD patients.
Nov 11	Investor conferences	Neutral	-0.3%	Management presentations at major healthcare investor conferences.

Pattern Detected

Recent history shows several instances where positive R&D or clinical updates were followed by negative share reactions, indicating occasional divergence between news tone and price moves.

Recent Company History

Over the last few months, Neurocrine reported multiple R&D and clinical updates, including positive Phase 2 data for osavampator and NBI-1117568 and a detailed R&D Day on Dec 16, 2025 outlining ambitions for multiple first- and best-in-class medicines. It also highlighted INGREZZA’s differentiated profile in a narrative review and continued active investor outreach via conferences. Against this backdrop of a broad, advancing pipeline, today’s failed Phase 3 DCP study represents a setback for one specific valbenazine indication rather than the entire portfolio.

Market Pulse Summary

This announcement reported that the KINECT-DCP Phase 3 study of valbenazine in dyskinetic cerebral palsy did not meet its primary or key secondary endpoints, despite being described as the largest double-blind, placebo-controlled DCP trial to date. Safety findings were generally consistent with valbenazine’s established profile. In context of NBIX’s recent stream of clinical updates across multiple programs, investors may focus on how this indication-specific setback affects the overall development balance and future trial readouts.

Key Terms

phase 3 medical

"its Phase 3 KINECT®-DCP study evaluating the efficacy, safety"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

double-blind medical

"the largest double-blind placebo-controlled clinical trial ever completed"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

placebo-controlled medical

"the largest double-blind placebo-controlled clinical trial ever completed"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

clinical trial medical

"whose commitment, dedication, and participation made this clinical trial possible."

A clinical trial is a carefully controlled study in which a new medicine, medical device, or treatment is tested on people to see if it is safe and effective. For investors it matters because trial results determine whether a product can win regulatory approval and reach patients, much like a road test decides if a new car can be sold; positive or negative results can sharply change a company’s prospects and stock value.

adverse events medical

"Adverse events were generally consistent with the established safety profile"

Adverse events are any harmful or unwanted medical occurrences experienced by people using a drug, device, or undergoing a treatment, whether or not the problem is caused by the product. Think of them as complaints or breakdowns noticed during a trial or after a product is on the market; regulators record and investigate them. Investors care because clusters or serious adverse events can delay approvals, trigger costly studies or recalls, change labeling, and quickly alter a company’s revenue and risk profile.

chorea medical

"assess improvement in chorea, a type of involuntary movement, in individuals"

Chorea is a neurological condition that causes sudden, irregular, involuntary movements—like fragments of a dance you can’t control—that can affect the face, limbs, or trunk. It matters to investors because chorea can drive demand for treatments, influence clinical trial design and regulatory decisions, and signal safety or liability risks for companies developing therapies or diagnostics, all of which affect potential market size and financial outlooks.

AI-generated analysis. Not financial advice.

SAN DIEGO, Dec. 22, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that its Phase 3 KINECT^®-DCP study evaluating the efficacy, safety, and tolerability of valbenazine in pediatric and adult participants who have dyskinetic cerebral palsy (DCP) did not meet primary or key secondary endpoints. The primary objective of the study was to assess improvement in chorea, a type of involuntary movement, in individuals with DCP.

"These results are disappointing, as there are no approved treatments for people living with dyskinetic cerebral palsy," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "We are deeply grateful to the patients and their families, as well as the investigators and site staff, whose commitment, dedication, and participation made this clinical trial possible."

The study – the largest double-blind placebo-controlled clinical trial ever completed in DCP – evaluated the efficacy of 14 weeks of treatment with valbenazine compared with placebo in pediatric and adult participants who have dyskinesia due to cerebral palsy with choreiform movements. Adverse events were generally consistent with the established safety profile for valbenazine.

Neurocrine will report the full study results at an upcoming scientific meeting.

About Dyskinetic Cerebral Palsy
Cerebral palsy (CP) is a nonprogressive neurodevelopmental disorder that affects movement and posture, starting in early childhood. It occurs in about three per 1,000 children in the United States. People living with dyskinetic cerebral palsy (DCP) often have mixed hyperkinetic movements, including dystonia (sustained or intermittent involuntary muscle contractions) and choreoathetosis (random or writhing involuntary movements), leading to severe motor impairment. DCP accounts for approximately 15% of CP cases. Currently, no therapies are approved to treat dystonia or choreoathetosis in CP.

About the Phase 3 KINECT^®-DCP Study
The Phase 3, randomized, double-blind, placebo-controlled study was designed to evaluate the efficacy, safety and tolerability of valbenazine for the treatment of dyskinesia due to cerebral palsy in pediatric and adult participants who experience choreiform movements. Participants aged six to 70 years were randomized to receive either valbenazine or placebo for 14 weeks during the double-blind treatment period. Following this, participants had the option to enter an open-label extension phase, during which all received valbenazine. The primary objective for this study is to evaluate the efficacy of valbenazine versus placebo on improving chorea in pediatric and adult subjects who have DCP with choreiform movements.

About Valbenazine
Valbenazine is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor. Neurocrine Biosciences received U.S. Food and Drug Administration approval in 2017 for valbenazine 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. Neurocrine is developing two next generation VMAT2 inhibitors, led by NBI-1065890 entering Phase 2 development for tardive dyskinesia in 2026.

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

The NEUROCRINE BIOSCIENCES logo, NEUROCRINE, YOU DESERVE BRAVE SCIENCE and KINECT 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 clinical results from, and our future development plans with respect to, valbenazine for the treatment of dyskinesia due to cerebral palsy (CP), as well as the therapeutic potential and clinical benefits or safety profile of valbenazine for the treatment of dyskinesia due to CP. 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: top-line data that we report may change following a more comprehensive review of the data related to the clinical study and such data may not accurately reflect the complete results of the clinical study; 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, including valbenazine for the treatment of dyskinesia due to CP, 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 quarterly report on Form 10-Q for the quarter 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.

 © 2025 Neurocrine Biosciences, Inc. All Rights Reserved. 12/2025

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SOURCE Neurocrine Biosciences, Inc.

FAQ

What did Neurocrine announce about the KINECT-DCP study on Dec 22, 2025 (NBIX)?

The company announced the Phase 3 KINECT-DCP study of valbenazine did not meet primary or key secondary endpoints.

Which endpoint did the Phase 3 KINECT-DCP study primarily assess for NBIX?

The primary objective was assessment of improvement in chorea, a type of involuntary movement, in DCP participants.

How long was treatment in the KINECT-DCP valbenazine trial (NBIX)?

The study evaluated 14 weeks of treatment with valbenazine versus placebo.

Were safety findings for valbenazine in the KINECT-DCP study concerning (NBIX)?

Adverse events were reported as generally consistent with the established valbenazine safety profile.

Will Neurocrine present full KINECT-DCP results publicly (NBIX)?

Yes, the company stated it will report the full study results at an upcoming scientific meeting.

Does the KINECT-DCP outcome change availability of approved treatments for dyskinetic cerebral palsy?

The announcement notes no approved treatments for people living with dyskinetic cerebral palsy and reports the trial did not meet its endpoints.