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Neurocrine Biosciences: A New Era in Research and Development

Neurocrine Biosciences, Inc., listed on Nasdaq as NBIX, is unveiling a transformative approach to its research and development (R&D) strategy, aiming to stimulate significant growth in its therapeutic offerings. On December 16, 2025, during its R&D Day hosted at its San Diego headquarters, the company showcased its ambitious plans to accelerate the development of first- and best-in-class medicines in neuropsychiatry and endocrinology, areas where it has established a robust legacy over the past thirty years.

Looking Ahead: Transformative Goals

As part of this new chapter, Neurocrine is propelling itself into a future defined by innovation and diversification in its medicinal pipeline. The company anticipates introducing an approved medication every two years by the end of the current decade. Current highlights include two promising Phase 3 programs: Osavampator, targeting major depressive disorder, and Direclidine, intended for schizophrenia treatment.

CEO Kyle W. Gano, Ph.D., emphasized the significance of these advancements: "We are ushering in a new era for Neurocrine in which we accelerate the delivery of new medicines for patients. Our new R&D engine is poised to explore and exploit validated biological pathways, driving the creation of novel therapies across various therapeutic modalities."

Expanding Horizons: Current Pipeline

Neurocrine's clinical portfolio is notably rich, featuring early- to mid-stage drugs that include muscarinic agonists and VMAT2 inhibitors designed for neuropsychiatric disorders. They're also actively developing CRF-based therapies aimed at addressing metabolic conditions like obesity, marking a bold step into previously uncharted therapeutic territories.

1. Osavampator: A groundbreaking AMPA positive allosteric modulator, Osavampator is being evaluated across multiple Phase 3 studies, with initial results expected in 2027.
2. Direclidine: An innovative M4 muscarinic agonist currently under exploration in schizophrenia and bipolar mania, expected to yield top-line data from studies set for 2027 and 2028, respectively.
3. NBI-570: This is a dual M1/M4 muscarinic agonist, anticipated to serve as a long-acting injectable treatment for psychiatric disorders, with results from the Phase 2 studies due in 2028.

The Foundation of Growth

Neurocrine's refreshed focus will increase its output to deliver at least four new Phase 1 and two Phase 2 programs annually by concentrating on validated mechanisms of action. Key programs in development include:

• - NBI-569: A dual M1/M4 agonist aimed at treating Alzheimer’s psychosis.
• - NBI-567: An M1-preferring agonist targeting cognitive deficits associated with Alzheimer’s and Lewy body dementia.
• - Next-gen VMAT2 inhibitors (NBI-890 and NBI-675), engineered to improve potency and administrative ease, proposing long-acting options for several CNS disorders.
• - NBIP-2118: A CRF2 agonist focusing on achieving better-quality weight loss without muscle mass loss, entering Phase 1 development in early 2026.

Conclusion: Commitment to Patients and Innovation

As part of its strategic vision, Neurocrine vows to keep the momentum going into 2026, where updates on their emerging early-stage neurology and immunology pipeline are anticipated. This push for innovative treatment reflects Neurocrine’s commitment to alleviating suffering through groundbreaking science, reaffirming its position as a pioneer in neurology and endocrine therapies.

For additional insights into Neurocrine's offerings, including archived events or R&D specifics, please visit Neurocrine's investor relations website. Their promise to deliver 'brave science' underlines a dedication not only to advancing medical research but also to addressing complex diseases that significantly impact patient lives.