Neurocrine(US:NBIX)2025-12-16 17:00Company Strategy & R&D Transformation - Neurocrine Biosciences is positioned as a diversified neuroscience and endocrinology leader aiming for sustainable growth and value creation[12] - The company aims to deliver a new medicine every two years, driven by a redesigned R&D organization[30, 31, 132] - R&D transformation includes a goal to advance 20 development candidates in 5 years, focusing on clinically or genetically validated targets[94, 99, 101] - The company is diversifying its therapeutic areas beyond neurology and psychiatry to include endocrinology and immunology[23, 94, 100] - New modalities, including peptides, antibodies, and gene therapy, now represent approximately 60% of the portfolio across therapeutic areas[105] Neuropsychiatry Pipeline - The neuropsychiatry pipeline is positioned to deliver multiple first- and best-in-class medicines this decade[12] - Osavampator, an AMPA PAM, is in Phase 3 development for Major Depressive Disorder (MDD), with data expected in 2027[23, 59] - Phase 2 SAVITRI study results showed statistically significant improvements in depression severity with osavampator, with an effect size of 0.53 at day 28 and 0.73 at day 56 for the 1mg dose[52, 55] - Direclidine, an M4 agonist, is in Phase 3 development for schizophrenia, with initial topline data expected in 2027[23, 77] - Phase 2 data for direclidine showed a PANSS total score change from baseline of -18.2 at week 6, with a change vs placebo of -7.5 (p=0.011) and an effect size of 0.61[73] Endocrinology Pipeline - The company is leveraging its Corticotropin Releasing Factor (CRF) biology expertise to expand in endocrinology and metabolic disease[12, 137] - NBIP-'2118, a CRF2 agonist, is being developed for obesity, with a Phase 1 study planned for the first half of 2026[159]