Neurocrine Biosciences Inc Stock Price, News & Analysis

Neurocrine Biosciences (NBIX) reported strong Q1 2025 financial results, with INGREZZA net product sales reaching $545 million, up 8% year-over-year, and reaffirmed 2025 guidance of $2.5-$2.6 billion. The company's new drug CRENESSITY achieved $14.5 million in first-quarter sales with 413 patient enrollment forms. Key developments include initiating Phase 3 programs for osavampator in major depressive disorder and NBI-'568 in schizophrenia. Q1 2025 total revenues were $572.6 million, with GAAP net income of $7.9 million ($0.08 per share) and non-GAAP net income of $71.5 million ($0.70 per share). The company maintains a strong balance sheet with $1.8 billion in cash and has completed a $300 million share repurchase program while initiating a new $500 million program.

Neurocrine Biosciences (NBIX) released findings from a Harris Poll survey highlighting the significant impact of tardive dyskinesia (TD) on patients' lives. The survey of 150 U.S. patients revealed that 80% wished for earlier screening and 86% desired earlier discussion of treatment options. Key findings showed TD's substantial impact: 43% needed help with daily activities, 41% couldn't perform job functions, and 86% felt judged due to their movements. Despite affecting 800,000+ U.S. adults, an estimated 60% remain undiagnosed. Notably, 75% of patients were unaware that their mental health medications could cause TD before diagnosis, emphasizing the need for better education and routine screening. The survey, conducted December 2024, included patients with varying TD severity, with 75% reporting mild to moderate uncontrolled movements.

Neurocrine Biosciences has launched a Phase 3 registrational program to test NBI-1117568, an oral muscarinic M4 selective orthosteric agonist, for treating adults with schizophrenia. This advancement follows successful Phase 2 results from August 2024.

The Phase 3 trial will be a global, double-blind, placebo-controlled study involving approximately 280 adult patients with schizophrenia experiencing acute symptom exacerbation. The study's primary goal is to measure reduction in the Positive and Negative Syndrome Scale (PANSS), with a secondary focus on the Clinical Global Impression of Severity (CGI-S) scale.

Phase 2 results showed promising outcomes with the 20 mg daily dose, including:

• A significant PANSS score reduction of 7.5 points versus placebo
• An 18.2-point reduction from baseline
• Improvements in secondary endpoints
• Good safety profile with minimal side effects

Neurocrine Biosciences (NBIX) has published a groundbreaking post-hoc analysis in The Journal of Clinical Psychiatry, demonstrating INGREZZA's long-term efficacy and safety in treating tardive dyskinesia (TD) in adults aged 65 and older.

The analysis, pooling data from two 48-week studies (KINECT 3 extension and KINECT 4), included 304 participants, with 55 (18.1%) aged ≥65 years. Key findings show that older adults achieved substantial TD symptom improvements within 8 weeks, sustained through 48 weeks:

• 95% of patients on INGREZZA 80mg showed ≥30% improvement in AIMS scores
• 95% on 80mg demonstrated CGI-TD improvements
• 90% on 80mg reported PGIC improvements

The safety profile remained consistent with no new treatment-emergent adverse events of clinical concern compared to younger adults. Common side effects included urinary tract infection and somnolence, each affecting 6 of 55 older participants.

Neurocrine Biosciences (NBIX) has scheduled its first quarter 2025 financial results conference call and webcast for May 5, 2025, at 1:30 p.m. Pacific Time. The company will release its Q1 2025 financial results via press release at 1:00 p.m. PT on the same day.

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

Neurocrine Biosciences (NBIX) has appointed Dr. Sanjay Keswani as Chief Medical Officer (CMO), effective June 2, 2025. Dr. Keswani, bringing over 20 years of pharmaceutical industry experience, will lead clinical development and medical affairs activities.

Dr. Keswani succeeds Dr. Eiry W. Roberts, who served as CMO for seven years and will transition to a strategic advisory role. His previous positions include CEO of ImmunoBrain, SVP and R&D Head at Hoffman La Roche, and VP at Bristol-Myers Squibb.

During her tenure, Dr. Roberts led key developments including INGREZZA indication expansion and the crinecerfont program resulting in FDA approval of CRENESSITY. She also oversaw successful Phase 2 studies for osavampator and NBI-1117568, both advancing to registrational programs this year.

Neurocrine Biosciences (NBIX) presented new real-world data comparing therapeutic dose attainment between INGREZZA and deutetrabenazine in tardive dyskinesia treatment. The retrospective study (2022-2024) analyzed 3,527 INGREZZA patients, 2,166 deutetrabenazine BID patients, and 326 deutetrabenazine XR patients.

Key findings showed that 100% of INGREZZA patients reached therapeutic doses from day one, while only 47.5% of deutetrabenazine BID and 54.3% of deutetrabenazine XR patients achieved therapeutic doses within six months. Among deutetrabenazine patients who reached therapeutic doses, nearly 10% couldn't maintain them.

The study also revealed that INGREZZA patients experienced fewer dose changes (33.7%) compared to deutetrabenazine patients (BID: 48.1%; XR: 54.0%) after the first month of treatment.

Neurocrine Biosciences (NBIX) has presented new long-term data from the KINECT® 4 study showing significant remission rates in tardive dyskinesia patients treated with INGREZZA® (valbenazine). The 48-week study involved 103 participants and demonstrated that 59.2% achieved remission, with consistent results across different doses and psychiatric conditions.

The study showed remarkable AIMS score improvements, with patients on 40 mg doses seeing scores decrease from 12.4 to 2.1, and those on 80 mg doses improving from 15.1 to 2.5. Specifically, 58.6% of participants on the 40 mg dose and 59.5% on the 80 mg dose achieved remission. The treatment proved effective across different psychiatric diagnoses, with 57.7% of schizophrenia/schizoaffective disorder patients and 62.5% of mood disorder patients reaching remission thresholds.

Neurocrine Biosciences (NBIX) has presented new data from the KINECT®-HD study demonstrating significant improvements in chorea symptoms with INGREZZA® (valbenazine) capsules in Huntington's disease patients. The post-hoc analysis, presented at the 2025 American Association of Neuroscience Nurses Symposium, showed consistent benefits across body regions.

The Phase 3 clinical trial involved 125 patients randomized to receive either INGREZZA (n=64) at doses of 40mg, 60mg, or 80mg, or placebo (n=61) over 12 weeks. The study measured chorea severity using the UHDRS® Total Maximal Chorea score across seven body regions.

Key findings revealed:

• More participants showed meaningful chorea improvements with INGREZZA versus placebo across all affected body regions
• Statistically significant improvements were observed in upper and lower extremities (P<0.05)
• Greatest improvements were seen in arms and legs, which had the highest severity at baseline