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Neurocrine Biosciences R&D Day 2025 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.R&D Day 2025 summary16 Dec, 2025
Pipeline overview and program updates
Diversified pipeline spans neurology, psychiatry, endocrinology, immunology, and metabolic diseases, with 35+ active programs and multiple compounds in mid- to late-stage studies entering 2026.
Osavampator (AMPA PAM) and direclidine (M4 agonist) anchor the late-stage neuropsychiatry portfolio, both in Phase 3 for major depressive disorder and schizophrenia, with topline data expected in 2027.
Early- to mid-stage assets include muscarinic agonists (NBI-'570, NBI-'569, NBI-'567) and next-gen VMAT2 inhibitors (NBI-'890, NBI-'675) for neuropsychiatric and dementia indications.
Endocrinology pipeline leverages 30+ years of CRF biology, with CRENESSITY approved for congenital adrenal hyperplasia and NBIP-'2118 (CRF2 agonist) entering Phase 1 for obesity in 1H 2026.
Robust early clinical pipeline with 24 new development candidates since 2022 and multiple gene therapy programs on track for FIH studies in 2026 and 2027.
Clinical trial data and development milestones
Osavampator and direclidine demonstrated significant efficacy and safety in Phase 2, with three Phase 3 studies enrolling and topline data expected in 2027.
NBI-'570, a dual M1/M4 muscarinic agonist, is in Phase 2 for schizophrenia with topline data expected in 2028.
NBIP-'2118 (CRF2 agonist) preclinical data show robust fat loss with muscle preservation, supporting Phase 1 initiation in 1H 2026.
Next-gen VMAT2 inhibitors are advancing, with Phase II in tardive dyskinesia planned.
Multiple gene therapy programs are on track for first-in-human studies in 2026 and 2027.
R&D strategy and innovation priorities
R&D transformation aims to deliver one new medicine every two years, with a steady output of at least four Phase 1 and two Phase 2 programs annually.
Focus on high-confidence, genetically and clinically validated targets, with 75% of the portfolio skewed to these.
Multimodality innovation includes small molecules, peptides, antibodies, gene therapy, and conjugates, now representing ~60% of the early pipeline.
Expansion of the CRF platform, especially CRF2, as a foundation for new metabolic disease therapies.
Early-stage investment prioritized in neurology and new modalities.
CRF2 agonist differentiation in obesity market
How to ensure R&D engine delivers on targets?
Impact of long-acting VMAT2s on market share?
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Next Neurocrine Biosciences earnings date
Q4 20259 Feb, 2026
Next Neurocrine Biosciences earnings date
Q4 20259 Feb, 2026
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Neurocrine Biosciences, Inc. is a biopharmaceutical company specializing in the discovery, development, and commercialization of therapies for neurological, endocrine, and psychiatric disorders. The company focuses on treatments for conditions such as movement disorders, adrenal diseases, and mental health challenges. Neurocrine Biosciences, Inc. is headquartered in San Diego, California, and its shares are listed on the NASDAQ.
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