Neurocrine Biosciences Inc Stock Price, News & Analysis

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.

Neurocrine Biosciences (NASDAQ: NBIX) presented one-year data from the CAHtalyst™ Adult study of CRENESSITY® (crinecerfont) at ENDO 2025. The Phase 3 trial, involving 182 adult patients aged 18-58, demonstrated sustained efficacy in treating classic congenital adrenal hyperplasia (CAH).

Key findings include 25-30% reduction in glucocorticoid doses while maintaining or improving androstenedione levels. The study showed improvements in insulin resistance and hirsutism in female participants. CRENESSITY demonstrated a favorable safety profile, with headache and fatigue as the most common side effects, mostly mild to moderate and temporary.

The data complements previously reported pediatric results and reinforces CRENESSITY's role in CAH management by effectively controlling ACTH and adrenal steroid imbalances while enabling lower, more physiologic steroid dosing.

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.