Neurocrine Biosciences (NBIX) Stock News, May-Jul 2025

Neurocrine Biosciences (NASDAQ: NBIX) has scheduled its second quarter 2025 financial results conference call and webcast for July 30, 2025, at 1:30 p.m. Pacific Time. The company will release its Q2 2025 financial results at 1:00 p.m. PT on the same day.

Neurocrine Biosciences is a neuroscience-focused biopharmaceutical company with FDA-approved treatments for multiple conditions including tardive dyskinesia, Huntington's disease chorea, congenital adrenal hyperplasia, endometriosis, and uterine fibroids. The company maintains a diverse pipeline with several compounds in mid to late-phase clinical development.

Neurocrine Biosciences (Nasdaq: NBIX) has initiated a Phase 1 first-in-human clinical study for NBIP-01435, a long-acting corticotropin-releasing factor type 1 receptor (CRF1) antagonist. The study will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity in healthy adult participants.

NBIP-01435 is administered via subcutaneous injection and is being developed for the treatment of congenital adrenal hyperplasia (CAH), a rare genetic condition affecting adrenal steroid hormone production. This represents the company's first investigational peptide from its biologics pipeline to enter clinical trials.

The development builds on Neurocrine's existing presence in CAH treatment, following the FDA approval of crinecerfont in December 2024, which was the first new CAH treatment in 70 years. NBIP-01435 originated from a research collaboration with Sentia Medical Sciences, Inc., initiated in April 2021, for which Neurocrine holds exclusive development and commercialization rights.

Neurocrine Biosciences (NASDAQ:NBIX) announced new post-hoc data analyses from the KINECT-HD study showing that INGREZZA (valbenazine) significantly reduced both cognitive and motor-related disease burden in Huntington's disease chorea patients compared to placebo.

The 12-week Phase 3 trial demonstrated statistically significant improvements (p<0.05) across multiple measures. Key cognitive improvements included reduced memory loss (-0.9 vs -0.2), better decision-making abilities (-1.0 vs -0.3), and improved word-finding (-0.9 vs -0.3). Motor improvements included enhanced mobility (-0.9 vs -0.2), reduced abnormal movements (-1.5 vs -0.8), and better swallowing (-1.0 vs -0.3).

These findings represent the first clinical study demonstrating measurable changes in cognitive and motor disease burden with a vesicular monoamine transporter 2 inhibitor in Huntington's disease chorea patients.

Neurocrine Biosciences (NBIX) presented new Phase 4 data showing INGREZZA (valbenazine) significantly improved health-related quality of life in older adults with tardive dyskinesia. The post-hoc analyses, involving 29 patients aged 65+ years, demonstrated that continued INGREZZA treatment led to substantial improvements in functional status compared to placebo. The study used two validated assessment tools: the EQ-5D-5L for measuring health status across five dimensions and the Sheehan Disability Scale for functional impairment. These findings expand on previous studies, including KINECT 3 and KINECT 4, which showed long-term safety and efficacy in older adults. The results are particularly significant as older adults face increased risk of developing tardive dyskinesia and its associated physical, functional, and social impacts.

Neurocrine Biosciences (NBIX) has appointed Lewis Choi as Chief Information Officer, effective June 9, 2025. Choi brings 25 years of experience in information technology and artificial intelligence, joining at a crucial time as the company focuses on launching CRENESSITY, growing INGREZZA, and advancing its pipeline. Previously, Choi spent 13 years at Thermo Fisher Scientific, most recently as VP of AI Automation & Data, where he held various leadership positions in digital platforms and solutions. His prior experience includes IT roles at Life Technologies, SysGroup Inc., Serene Corporation, ADP, and Corio, Inc. The appointment aligns with Neurocrine's strategic focus on leveraging technology to enhance business operations and treatment delivery.

Neurocrine Biosciences (NBIX) announced positive results from their Phase 4 KINECT-PRO study of INGREZZA for tardive dyskinesia treatment. The study, involving 59 patients, demonstrated significant improvements in patients' physical, social, and emotional functioning. Key findings showed improvements as early as Week 4 with the lowest dose (40mg) and sustained through Week 24, with 52 patients completing the study. The trial used multiple validated scales including TDIS, SDS, EQ-VAS, and AIMS, showing robust improvements across all TD severity levels. Notable results included a -8.0 mean change in TDIS, -2.3 in SDS-Social Life, and a +13.1 improvement in EQ-VAS by Week 24. The study was particularly significant as it was the first to specifically evaluate patient-reported improvements using multiple clinically validated scales. Safety and tolerability remained consistent with INGREZZA's known profile.

Neurocrine Biosciences (NBIX) presented positive Phase 2 study results for NBI-1117568, their novel oral muscarinic M4 selective orthosteric agonist for schizophrenia treatment. The study demonstrated that the 20 mg daily dose achieved statistically significant improvements in PANSS total score by Week 3 and CGI-S scale by Week 2, maintaining improvements through Week 6. The drug was generally safe and well-tolerated across all doses, with minimal side effects including somnolence (10.7%) and dizziness (9.3%). Notably, the treatment showed no significant weight gain compared to placebo. Based on these promising results, Neurocrine has initiated a Phase 3 registrational program, planning to enroll approximately 280 adults with schizophrenia experiencing acute symptom exacerbation.

Neurocrine Biosciences (NBIX) presented one-year data from its Phase 3 CAHtalyst™ Pediatric study of CRENESSITY™ (crinecerfont) in pediatric patients with classic congenital adrenal hyperplasia. The study, involving 103 pediatric patients aged 4-17, demonstrated sustained reductions in glucocorticoid doses while maintaining hormone control. Key findings include:

- Maintained reduction in glucocorticoid doses over 52 weeks - 32% of patients achieved physiologic glucocorticoid dose range by week 52 - Improvements in body mass index and insulin resistance - Hormone levels (ACTH, 17-OHP, androstenedione) remained below baseline - Generally well-tolerated with common side effects including headache (25%), abdominal pain (13%), and fatigue (7%)

The study consisted of a 28-week double-blind, placebo-controlled period followed by a 24-week open-label period, representing the largest interventional trial in classic CAH to date.

Neurocrine Biosciences (NBIX) presented new analyses from a Phase 4 study of INGREZZA® (valbenazine) for tardive dyskinesia at the 2025 ISPOR Conference. The study involved 127 patients who received up to 80mg of INGREZZA for 8 weeks, followed by randomization to continue INGREZZA (n=59) or receive placebo (n=59) for another 8 weeks. Patients receiving INGREZZA showed significant improvements in health-related quality of life measures, including mobility (-0.27), self-care (-0.28), usual activities (-0.36), and pain/discomfort (-0.34). Those continuing INGREZZA for an additional 8 weeks demonstrated further improvements, particularly in mobility (-0.34) and anxiety/depression (-0.38) compared to placebo. The study also revealed significant functional improvements in work/school (-1.37), social life (-1.65), family/home life (-1.30), and SDS total score (-4.28). Continued treatment showed additional benefits in social life (-0.95) and family/home life (-0.89) versus placebo.