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
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.
Discover the latest trends and insights—explore the Business Insight Journal for up-to-date strategies and industry breakthroughs!
