Neurocrine Biosciences Inc. reports biopharmaceutical developments across neurological, psychiatric, endocrine and immunological disorders. Recurring updates include commercial and clinical information for INGREZZA for tardive dyskinesia and chorea associated with Huntington's disease, CRENESSITY for classic congenital adrenal hyperplasia, and approved therapies for endometriosis and uterine fibroids.
Company news also covers CAHtalyst clinical data, peer-reviewed publications on glucocorticoid dosing and the Tardive Dyskinesia Impact Scale, pipeline programs such as NBIP-'2118, financial results, healthcare conference participation, and governance or capital-structure matters tied to Neurocrine's public-company reporting.
Neurocrine Biosciences (Nasdaq: NBIX) presented three-year open-label KINECT-HD2 data showing once-daily INGREZZA (valbenazine) produced early and sustained reductions in Huntington's disease chorea with an established long-term safety profile.
Key results: 154 adults treated up to 156 weeks; mean UHDRS Total Maximal Chorea improvement by Week 2 was -3.4±0.3 (n=146); PGI-C responders rose from 34.5% at Week 2 to 77.8% at Week 156. TEAEs were consistent with known safety: 97.4% reported ≥1 TEAE; most common were falls (42.9%), somnolence (25.3%), fatigue (21.4%); discontinuations due to TEAEs were 15.6%.
Neurocrine Biosciences (NASDAQ:NBIX) announced new post-hoc analysis data from their Phase 4 KINECT-PRO™ study of INGREZZA® (valbenazine) for tardive dyskinesia (TD) treatment. The study showed that 57.8% of patients (26 of 45) achieved symptomatic remission at Week 24, with success rates of 58.3% at 40mg, 44.4% at 60mg, and 62.5% at 80mg doses.
The analysis demonstrated significant improvements in patient-reported outcomes among those achieving remission, including enhanced quality of life and reduced disease burden. Notably, patients showed substantial improvements across multiple measures: the Tardive Dyskinesia Impact Scale (TDIS™), Sheehan Disability Scale (SDS), and EuroQoL Visual Analog Scale (EQ-VAS). The safety profile remained consistent with previous findings, with no new concerns identified.
[ "High remission rate of 57.8% achieved at Week 24 across different dosages", "Significant improvements in patient-reported outcomes and quality of life metrics", "Earlier achievement of TD symptom remission compared to previous studies", "Consistent safety profile with no new concerns identified" ]Neurocrine Biosciences (Nasdaq: NBIX) announced positive results from its Phase 2 SAVITRI™ study of osavampator (NBI-1065845) for major depressive disorder (MDD). The study demonstrated statistically significant improvements in depression severity at both Day 28 and Day 56 with 1 mg daily oral dosing.
The trial, involving 183 adults, tested two doses (1 mg and 3 mg) against placebo. The 1 mg dose achieved the primary endpoint with significant MADRS score reduction and showed superior results in treatment response and remission rates. Osavampator, a first-in-class selective AMPA-PAM, was well-tolerated with no serious adverse events, with headache and nasopharyngitis being the most common side effects.
Neurocrine Biosciences (Nasdaq: NBIX) will present new data from its Phase 2 SAVITRI study of osavampator at Psych Congress 2025. The study investigates osavampator as an adjunctive treatment for adults with major depressive disorder (MDD) who have inadequate response to oral antidepressants.
Following positive top-line results, the company initiated a Phase 3 registrational program in January 2025, comprising five active enrolling studies. The company will present multiple posters, with two selected as finalists for Psych Congress Poster Awards, focusing on osavampator's clinical improvements in depression severity and its mechanism as a selective AMPA-PAM.
Neurocrine Biosciences (Nasdaq: NBIX), a leading neuroscience-focused biopharmaceutical company, has announced its participation in four major investor conferences this September. The company's leadership team, including CEO Kyle Gano, CFO Matt Abernethy, and other executives, will present at the Cantor Global Healthcare Conference, Morgan Stanley Global Healthcare Conference, Baird Global Healthcare Conference, and TD Cowen Novel Mechanisms Summit.
The presentations will be accessible via live webcasts on Neurocrine's website, with replays available for approximately one month. The company specializes in developing treatments for neurological, neuroendocrine, and neuropsychiatric disorders, with FDA-approved treatments for conditions including tardive dyskinesia, Huntington's disease chorea, and endometriosis.
Neurocrine Biosciences (Nasdaq: NBIX) announced its participation in the Canaccord Genuity 45th Annual Growth Conference on August 13, 2025, at 8:00 a.m. ET. CEO Kyle Gano and VP of Investor Relations Todd Tushla will represent the company at the event.
The presentation will be accessible via live webcast on the company's investor relations website, with a replay available for approximately one month after the event. Neurocrine Biosciences is a neuroscience-focused biopharmaceutical company with FDA-approved treatments for various neurological conditions, including tardive dyskinesia, Huntington's disease chorea, and endometriosis.
Neurocrine Biosciences (NASDAQ:NBIX) reported strong Q2 2025 financial results with total net product sales of $682 million, representing 17% year-over-year growth. INGREZZA achieved Q2 net product sales of $624 million, while CRENESSITY contributed $53 million with 664 new patient enrollment start forms.
The company narrowed its 2025 INGREZZA net product sales guidance to $2.5-$2.55 billion from $2.5-$2.6 billion. Q2 GAAP net income was $107.5 million ($1.06 per share), compared to $65 million ($0.63 per share) in Q2 2024. The company maintains a strong balance sheet with $1.8 billion in cash and marketable securities.
Key developments include initiating Phase 3 trials for NBI-'568 in schizophrenia and advancing the pipeline in neuropsychiatry. The company has repurchased $168 million of common stock under its $500 million share repurchase program.
Neurocrine Biosciences (NASDAQ:NBIX) and PicnicHealth have revealed key findings from their CAHtalog® Registry study focused on congenital adrenal hyperplasia (CAH). The research, conducted in collaboration with the CARES Foundation, identified that CAH patients require continuous, lifelong adjustments to glucocorticoid dosing to maintain condition control.
The study leverages PicnicHealth's AI-powered technology to curate medical records and enable remote participation, overcoming traditional challenges in rare disease research. The technology allows for data collection from multiple care locations while providing patients with an intuitive app featuring an AI assistant for medical record navigation.
Additional findings regarding treatment patterns and condition progression were presented at ENDO 2025, demonstrating the registry's value in advancing understanding of this rare genetic condition affecting adrenal gland function.
Neurocrine Biosciences (NASDAQ: NBIX) presented new analysis from the CAHtalog® registry revealing significant challenges in managing classic congenital adrenal hyperplasia (CAH). The study found that approximately 95% of patients experienced either high glucocorticoid exposure or elevated androstenedione levels during treatment.
The analysis, presented at ENDO 2025, examined data from 98 patients (37 adults, 42 children/adolescents, 19 cross-age contributors) over a median period of 8.6 years. Among patients eligible for health state transition analysis, 88.9% experienced at least one health state change, with 58.7% undergoing three or more changes, highlighting the unpredictable nature of disease control.
The findings emphasize the limitations of current glucocorticoid therapy and demonstrate the need for alternative treatment approaches for managing CAH effectively.
Neurocrine Biosciences (NASDAQ: NBIX) presented one-year data from Phase 3 CAHtalyst™ studies demonstrating CRENESSITY® (crinecerfont) improved weight-related outcomes in classic congenital adrenal hyperplasia patients. The studies, involving 103 pediatric and 182 adult patients, showed significant improvements in body mass index (BMI) and insulin resistance.
Key findings include: 27% of adults achieved >5% weight reduction by Month 12 in the continuous CRENESSITY group, while 27% of pediatric patients achieved ≥0.2 reduction in BMI SDS. Substantial improvements in insulin resistance (HOMA-IR) were observed in both adult and pediatric patients through one year of treatment.
The treatment demonstrated a favorable safety profile, with mostly mild to moderate side effects that were generally temporary and did not lead to discontinuation.