Neurocrine Biosciences (NBIX) Stock News

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.

Neurocrine Biosciences (NBIX) presented promising Phase 3 data for CRENESSITY™ (crinecerfont) in treating classic congenital adrenal hyperplasia (CAH). The drug showed significant efficacy in both pediatric and adult populations. In the pediatric study, 90% of participants on CRENESSITY versus 21% on placebo achieved androstenedione reduction or glucocorticoid reduction thresholds. 30% of pediatric patients reached physiologic glucocorticoid doses while maintaining/improving androstenedione levels, compared to 0% on placebo. In adult males, the drug demonstrated improvements in reproductive hormones, with 65% normalization in luteinizing hormone and 24% normalization in androstenedione-to-testosterone ratio at Month 12. The treatment was generally well-tolerated, though some adverse reactions were reported, including headache, fatigue, and abdominal pain in pediatric patients.

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.