Neurocrine Biosciences Showcases R&D Transformation Driving Innovation Across Neuroscience and Endocrinology

Rhea-AI Summary

Neurocrine Biosciences (NASDAQ: NBIX) outlined a transformed R&D strategy at its 2025 R&D Day focused on neuroscience and endocrinology, aiming to deliver multiple first‑ and best‑in‑class medicines this decade. Key clinical milestones include topline Phase 3 data for osavampator and direclidine expected in 2027, additional direclidine and bipolar study readouts in 2028, and a CRF2 obesity program (NBIP-'2118) planned to enter Phase 1 in H1 2026. The company said its R&D engine targets at least four new Phase 1 and two Phase 2 programs per year and expects an approved medicine every two years by the end of the decade.

Positive

• Osavampator Phase 3 topline data expected in 2027
• Direclidine Phase 3 schizophrenia topline data expected in 2027
• NBIP-'2118 CRF2 agonist entering Phase 1 in H1 2026
• R&D engine target: 4 Phase 1 and 2 Phase 2 programs per year

Negative

• Multiple pivotal readouts not expected until 2027–2028
• No financial or commercial timelines provided for potential approvals

News Market Reaction

-4.73%

1 alert

-4.73% News Effect

On the day this news was published, NBIX declined 4.73%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Phase 3 programs: 2 programs Osavampator Phase 3 readout: 2027 Direclidine Phase 3/2 readouts: 2027–2028 +5 more

8 metrics

Phase 3 programs 2 programs Osavampator for MDD and direclidine for schizophrenia

Osavampator Phase 3 readout 2027 Topline data from three ongoing Phase 3 studies expected

Direclidine Phase 3/2 readouts 2027–2028 Topline data in schizophrenia and bipolar mania expected

NBI-'570 Phase 2 readout 2028 Topline data from Phase 2 schizophrenia study expected

New programs per year 4 Phase 1, 2 Phase 2 Target output of transformed R&D engine

Obesity asset timing 1H 2026 NBIP-'2118 CRF2 agonist expected to enter Phase 1

Approval cadence goal 1 medicine every 2 years R&D engine goal by end of decade

Company experience 30+ years Leadership in CRF biology and neuroscience

Market Reality Check

Price: $136.06 Vol: Volume 758,190 is 0.8x th...

normal vol

$136.06 Last Close

Volume Volume 758,190 is 0.8x the 20-day average of 944,655, indicating subdued trading activity. normal

Technical Shares at 154.06 are trading above the 200-day MA of 129.07, reflecting a pre-existing uptrend into this R&D update.

Peers on Argus

Peers showed mixed moves: UTHR +1.73%, RDY +0.5%, TEVA +1.18%, TAK +1.46%, while...

Peers showed mixed moves: UTHR +1.73%, RDY +0.5%, TEVA +1.18%, TAK +1.46%, while VTRS declined 0.6%. With no peers in the momentum scanner and NBIX up 0.82%, trading appeared more company-specific than sector-driven before this R&D news.

Historical Context

5 past events · Latest: Dec 09 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 09	R&D day preview	Positive	+0.4%	Announced upcoming 2025 R&D Day to showcase pipeline and strategy.
Nov 20	VMAT2 review data	Positive	+0.7%	Peer-reviewed review highlighted distinctive clinical and dosing profile of INGREZZA.
Nov 18	Osavampator Phase 2	Positive	-3.4%	Phase 2 SAVITRI showed significant efficacy for 1 mg osavampator in MDD.
Nov 11	Investor conferences	Neutral	-0.3%	Announced participation in Jefferies and Piper Sandler healthcare conferences.
Nov 10	Trial setback	Negative	-1.8%	Phase 2 NBI-1070770 in MDD did not meet primary endpoint versus placebo.

Pattern Detected

Recent NBIX news has mostly seen modest price alignment with fundamentals, with one notable divergence on positive Phase 2 data for osavampator.

Recent Company History

Over the last six weeks, NBIX has reported several clinically and strategically relevant updates. A Nov 10 Phase 2 study of NBI-1070770 in major depressive disorder failed its primary endpoint and the stock fell 1.82%. By contrast, positive Phase 2 SAVITRI results for 1 mg osavampator on Nov 18 saw a 3.43% decline, indicating a divergence from favorable data. A VMAT2 narrative review on Nov 20 and the Dec 16 R&D Day announcement on Dec 9 both drew small positive reactions, suggesting investors may reward platform-strength and portfolio visibility, which this new R&D strategy update further emphasizes.

Market Pulse Summary

This announcement outlines an ambitious R&D transformation, targeting delivery of an approved medici...

Analysis

This announcement outlines an ambitious R&D transformation, targeting delivery of an approved medicine every two years and at least 4 new Phase 1 and 2 Phase 2 programs annually. It expands visibility on late-stage assets like osavampator and direclidine, and introduces a CRF2-based obesity platform. In context of prior mixed trial outcomes, investors may focus on execution milestones, timing of Phase 3 readouts in 2027–2028, and integration with existing commercial franchises such as INGREZZA and CRENESSITY.

Key Terms

AMPA positive allosteric modulator, M4 muscarinic agonist, dual M1 / M4 muscarinic agonist, VMAT2 inhibitors, +4 more

8 terms

AMPA positive allosteric modulator medical

"Osavampator, a potential first in class AMPA positive allosteric modulator for..."

An AMPA positive allosteric modulator is a drug that boosts the activity of AMPA receptors, which help nerve cells communicate in the brain, by attaching to a different spot on the receptor and making its response stronger without directly turning it on. Think of it as turning up the volume on an existing radio signal rather than changing the station. Investors watch these compounds because their safety and effectiveness in trials can drive large gains or losses for companies developing treatments for conditions such as cognitive disorders, depression, or other brain-related illnesses.

M4 muscarinic agonist medical

"Direclidine, an M4 muscarinic agonist for the treatment of psychiatric disorders..."

An m4 muscarinic agonist is a drug that selectively activates the M4 subtype of muscarinic receptors, proteins on nerve cells that respond to the neurotransmitter acetylcholine. Think of it as turning a specific light switch in the brain or nervous system to change how certain circuits work; for investors, these drugs matter because targeting a precise switch can mean more effective therapies with fewer side effects, affecting clinical value, regulatory risk, and market potential.

dual M1 / M4 muscarinic agonist medical

"NBI-'570, a dual M1 / M4 muscarinic agonist with potential as a long acting injectable..."

A dual M1/M4 muscarinic agonist is a drug designed to stimulate two specific types of brain receptors (M1 and M4) that respond to a natural signaling chemical; think of it as flipping two targeted light switches to restore or balance brain communication. For investors, this matters because activating both receptors can address cognitive or psychiatric symptoms more directly than single-target drugs, and clinical trial results or safety findings for such compounds often have major effects on a drug developer’s value.

VMAT2 inhibitors medical

"Next-generation VMAT2 inhibitors NBI-'890 and NBI-'675, engineered for increased half-life..."

VMAT2 inhibitors are a class of medicines that reduce the amount of certain brain chemicals, especially dopamine, that cells release by blocking the transporter that packages them for release. Think of them as turning down a faucet that supplies a signaling chemical; that change can ease involuntary movements and other symptoms in neurological conditions. Investors watch VMAT2 inhibitors because regulatory approvals, safety profiles, patent life and market demand determine a drug’s commercial potential and company valuation.

CRF2 agonist medical

"NBIP-'2118, a CRF2 agonist expected to enter Phase 1 development..."

A CRF2 agonist is a drug or molecule that activates the CRF2 receptor, a protein on certain brain and body cells involved in the body’s stress and hormonal responses. Like turning a specific switch to change a system’s behavior, these compounds can alter stress, appetite or cardiovascular signals; for investors, they matter because successful CRF2 agonists can become treatments for conditions tied to stress or metabolism, driving clinical development milestones, market potential and regulatory risk.

long acting injectable medical

"NBI-'570, a dual M1 / M4 muscarinic agonist with potential as a long acting injectable..."

A long acting injectable is a medicine formulated to be given by injection and then release its active ingredient slowly over weeks or months so patients need fewer doses. Think of it like a slow-release battery that powers treatment steadily instead of daily pills. For investors, these drugs can drive steady revenue, improve patient adherence and lower delivery costs, but they also carry higher development, manufacturing and regulatory risk.

Phase 3 medical

"Topline Phase 3 data from both programs expected in 2027"

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.

Phase 2 medical

"Topline data from the ongoing Phase 3 studies in schizophrenia and the Phase 2 study in bipolar mania..."

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

AI-generated analysis. Not financial advice.

Provided Update on R&D Engine Now On Track to Deliver Multiple First- and Best-in-Class Medicines, Positioning Company for Long-Term Value Creation Across Therapeutic Modalities

Reviewed Positive Data Across Late-Stage Neuropsychiatry Pipeline Including Osavampator and Direclidine; Topline Phase 3 Data from Both Programs Expected in 2027

Announced Expansion of CRF Platform as Foundation of New Class of Medicines for Metabolic Diseases, Including Obesity

SAN DIEGO, Dec. 16, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced a new chapter in its research and development strategy, designed to fuel the Company's next era for growth and deliver long-term value. Neurocrine highlighted this business strategy during its 2025 R&D Day at its headquarters in San Diego, CA.

Building on three decades of leadership in neurology, psychiatry, and endocrinology, Neurocrine is advancing a diversified pipeline of first- and best-in-class medicines across therapeutic modalities including two Phase 3 programs, osavampator for major depressive disorder and direclidine for schizophrenia. The company's clinical portfolio includes a rich pipeline of early- to mid-stage muscarinic agonists and VMAT2 inhibitors for the treatment of neuropsychiatric indications, and CRF-based therapies for metabolic diseases, including obesity. By the end of the decade, Neurocrine expects its R&D engine to deliver an approved medicine every two years.

"We are ushering in a new era for Neurocrine in which we accelerate the delivery of new medicines for patients," said Kyle W. Gano, Ph.D., Chief Executive Officer, Neurocrine Biosciences. "Today, we unveiled the full breadth of our pipeline, featuring multiple first- and best-in-class assets targeting validated biological pathways and powered by an innovative R&D engine. With more than 30 years of leadership in CRF biology, we are now introducing a platform focused on CRF2, with the goal of developing novel therapies across a range of metabolic diseases. Our efforts will begin with obesity, where we believe we can deliver superior weight loss while preserving muscle mass."

"Backed by our proven track record in drug development and commercialization, the strong foundation we built with INGREZZA in neuropsychiatry and CRENESSITY in endocrinology, and an experienced team, we are uniquely positioned to advance our pipeline and create sustained, meaningful value for patients, providers, and shareholders alike," added Dr. Gano.

Highlights from R&D Day:

Updates across mid- to late-stage assets including osavampator and muscarinic agonists, positioning Neurocrine to deliver multiple first- and best-in-class medicines this decade. This includes:

• Osavampator, a potential first in class AMPA positive allosteric modulator for the treatment of major depressive disorder. Topline data from three ongoing Phase 3 studies are expected in 2027.
• Direclidine, an M4 muscarinic agonist for the treatment of psychiatric disorders, including schizophrenia and bipolar mania. Topline data from the ongoing Phase 3 studies in schizophrenia and the Phase 2 study in bipolar mania are expected in 2027 and 2028.
• NBI-'570, a dual M1 / M4 muscarinic agonist with potential as a long acting injectable for the treatment of psychiatric disorders including schizophrenia. Topline data from the recently initiated Phase 2 study in schizophrenia is expected in 2028.

Details of Neurocrine's transformed R&D engine, designed to deliver at least four new Phase 1 and two Phase 2 programs per year by focusing on genetically or clinically validated mechanisms of action were shared during today's event. Highlighted programs include:

• NBI-'569, a dual M1 / M4 agonist for Alzheimer's psychosis, and NBI-'567, an M1 preferring agonist for Alzheimer's cognition and Lewy body dementia.
• Next-generation VMAT2 inhibitors NBI-'890 and NBI-'675, engineered for increased half-life and potency and decreased solubility, and which provide the potential for long-acting injectable administration across multiple central nervous system indications.
• A suite of differentiated assets for better quality weight loss, including NBIP-'2118, a CRF2 agonist expected to enter Phase 1 development in the first half of 2026.

Neurocrine plans to provide update on its emerging early-stage Neurology and Immunology pipeline in 2026.

An archived replay of the webcast and accompanying slides can also be accessed here and on the Neurocrine Biosciences' website under Investors.

About Neurocrine Biosciences
Neurocrine Biosciences is a 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 neuropsychiatric, neurological, and neuroendocrine disorders. The company's diverse portfolio includes U.S. 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)

NEUROCRINE, the NEUROCRINE BIOSCIENCES Logo, YOU DESERVE BRAVE SCIENCE, INGREZZA, and CRENESSITY 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 related to: our business strategy, objectives, and future development plans; the benefits to be derived from our products and product candidates; the value our products and/or our product candidates may bring to patients; the continued success of INGREZZA; successfully launching and commercializing CRENESSITY; our financial and operating performance, including our future revenues, cash position, and profitability; our collaborative partnerships; expected future clinical and regulatory milestones; and the timing of the initiation and/or completion of our clinical, regulatory, and other development activities and those of our collaboration partners. 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, risks and uncertainties associated with the commercialization of INGREZZA and CRENESSITY; risks related to the development of our product candidates; 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 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 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 government and third-party regulatory and/or policy efforts which may, among other things, impose sales and pharmaceutical pricing controls on our products or limit coverage and/or reimbursement for our products; risks associated with competition from other therapies or products, including potential generic entrants for our products; our ability to manage the growth of our organization; and other risks described in our periodic reports filed with the Securities and Exchange Commission, including our 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 as required by law.

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SOURCE Neurocrine Biosciences, Inc.

FAQ

When will Neurocrine (NBIX) report topline data for osavampator?

Topline Phase 3 data for osavampator are expected in 2027.

What is the expected timeline for direclidine clinical readouts for NBIX?

Topline Phase 3 data for direclidine in schizophrenia are expected in 2027, with bipolar mania results in 2028.

When will Neurocrine start Phase 1 for its CRF2 obesity program (NBIP-'2118)?

NBIP-'2118 is expected to enter Phase 1 in the first half of 2026.

What R&D output targets did Neurocrine announce for its pipeline?

The company targets at least four new Phase 1 and two Phase 2 programs per year.

What commercial cadence did Neurocrine forecast for NBIX through the decade?

Neurocrine expects its R&D engine to deliver an approved medicine every two years by the end of the decade.

Which late‑stage NBIX programs are highlighted beyond osavampator and direclidine?

Highlighted programs include long‑acting VMAT2 candidates and muscarinic agonists such as NBI-'570 and dual M1/M4 assets.