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

Neurocrine Biosciences (NBIX) presented a systematic literature review at the 2025 ISPOR Annual Meeting, examining the relationship between glucocorticoid (GC) dosage and adverse clinical outcomes in congenital adrenal hyperplasia (CAH) patients. The study analyzed 105 publications, with 65% focusing on CAH patients.

Key findings revealed that 62% of publications found statistically significant associations between GC dose and clinical outcomes, with 98% of these indicating higher GC doses led to adverse effects, including decreased bone mineral density, increased insulin resistance, and higher body mass index. The most commonly reported outcomes were bone health (43%), cardiometabolic (41%), and height and growth (24%).

Neurocrine Biosciences (NBIX) announced new results from subgroup analyses of the Phase 3 CAHtalyst™ Pediatric study for CRENESSITY™ (crinecerfont). The study, involving 103 patients (69 CRENESSITY, 34 placebo), demonstrated consistent positive results across all patient subgroups. Key findings showed that CRENESSITY significantly reduced androstenedione (A4) levels by -6.9 nmol/L versus +2.5 nmol/L for placebo at Week 4. Additionally, glucocorticoid doses were reduced by -18.0% versus +5.6% for placebo at Week 28, while maintaining or improving A4 levels. The drug was generally well-tolerated, with common side effects including headache, abdominal pain, fatigue, nasal congestion, and nosebleed. These results suggest CRENESSITY could significantly improve treatment outcomes for pediatric patients with classic congenital adrenal hyperplasia (CAH) by reducing reliance on high-dose glucocorticoids while controlling hormone levels.

Neurocrine Biosciences (NASDAQ: NBIX) has announced its participation in two major investor conferences in May 2025. CEO Kyle Gano and VP of Investor Relations Todd Tushla will present at the BofA Securities 2025 Health Care Conference on May 13 at 11:20 AM PT in Las Vegas. Additionally, CFO Matt Abernethy and CCO Eric Benevich will present at the RBCCM Global Healthcare Conference on May 20 at 11:30 AM ET in New York. Both presentations will be available via webcast on the company's website, with replays accessible for approximately one month. 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) has launched "ConnectING with Carnie™," a multimedia awareness campaign featuring Grammy-nominated singer Carnie Wilson. The campaign focuses on tardive dyskinesia (TD), an involuntary movement disorder caused by antipsychotic medications. While Wilson doesn't have TD herself, she will serve as an advocate to reduce stigma and encourage patients to seek treatment.

The initiative aims to empower individuals with TD to discuss their symptoms openly and explore treatment options, including INGREZZA® (valbenazine) capsules. The campaign will feature video interviews and resources on ConnectingWithCarnie.com, sharing stories from TD patients, care partners, and healthcare professionals about their experiences with the condition and its treatment.

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.