Neurocrine Biosciences said on Monday its drug failed to meet the main goal in a late-stage clinical trial in patients with a type of disorder that disrupts the brain's ability to control muscles. ...

® SAN DIEGO, Dec. 22, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that its Phase 3 KINECT-DCP study evaluating the efficacy, safety, and tolerability of valbenazine in pediatric and adult participants who have dyskinetic cerebral palsy (DCP) did not meet primary or key secondary endpoints. The primary objective of the study was to assess improvement in chorea, a type of involuntary movement, in individuals with DCP. "These results are disappointing, as there are no appro ...

Core Points - Neurocrine Biosciences held its 2025 R&D Day, emphasizing the importance of the event for stakeholders [1] - The event featured key executives including the CEO, Chief Medical Officer, and Chief Scientific Officer, highlighting the leadership team's experience [2][3] - Dr. John Krystal, a prominent figure in neurology and psychiatry, participated in the event, indicating the company's commitment to collaboration with leading experts [3]

Core Insights - Neurocrine Biosciences is advancing a diversified pipeline of first- and best-in-class medicines across therapeutic modalities, including two Phase 3 programs targeting major depressive disorder and schizophrenia, with expectations to deliver an approved medicine every two years by the end of the decade [2][4] R&D Strategy - The company has unveiled a transformed R&D engine aimed at delivering at least four new Phase 1 and two Phase 2 programs annually, focusing on genetically or clinically validated mechanisms of action [4] - The R&D strategy is designed to create long-term value and accelerate the delivery of new medicines for patients [3][4] Pipeline Highlights - Osavampator is a potential first-in-class AMPA positive allosteric modulator for major depressive disorder, with topline data from three ongoing Phase 3 studies expected in 2027 [5] - Direclidine is an M4 muscarinic agonist for psychiatric disorders, with topline data from ongoing studies expected in 2027 and 2028 [5] - The pipeline includes next-generation VMAT2 inhibitors and a suite of differentiated assets for better quality weight loss, including a CRF2 agonist expected to enter Phase 1 development in the first half of 2026 [5] Leadership and Vision - The CEO emphasized the company's commitment to developing novel therapies across metabolic diseases, starting with obesity, aiming for superior weight loss while preserving muscle mass [3] - The company has a proven track record in drug development and commercialization, positioning it uniquely to advance its pipeline and create sustained value for stakeholders [3]

Neurocrine Biosciences 2025 R&D Day Summary Company Overview - **Company**: Neurocrine Biosciences (NasdaqGS:NBIX) - **Event**: 2025 R&D Day held on December 16, 2025 - **Key Speakers**: - Kyle Gano, Chief Executive Officer - Sanjay Keswani, Chief Medical Officer - Jude Onyia, Chief Scientific Officer - Dr. John Krystal, expert in neurology and psychiatry Core Industry Insights - **Transition**: Neurocrine is evolving from a single-product biotech to a multi-product diversified biopharmaceutical company with scale [11] - **Employee Base**: The company has grown to 2,000 employees, consolidating all departments under one roof for enhanced collaboration [11][6] - **R&D Focus**: Emphasis on innovative science and pipeline development, particularly in neuropsychiatry [8] Key Products and Pipeline - **Current Products**: - Ingrezza (for tardive dyskinesia) - Krenesti (for CAH) - **Future Products**: - Osirvampetor (for major depressive disorder) - Direclidine (for schizophrenia) - **Pipeline Strategy**: Focus on delivering multiple best-in-class medicines by 2030, leveraging a transformed R&D engine [12][16] R&D Transformation - **R&D Engine**: Fully operational and over-delivering on innovative science, with a focus on high-quality programs across various modalities [12][13] - **CRF Biology**: Leveraging 30 years of expertise in corticotropin-releasing factor (CRF) biology to expand into metabolic disorders, including obesity [14] - **Clinical Trials**: Anticipated phase three trials for Osirvampetor and Direclidine to start reading out in 2027 [16] Market Opportunity - **Mental Health Crisis**: Over one-third of individuals with depression do not respond to current treatments, highlighting a significant unmet need [45] - **Safety and Tolerability**: Osirvampetor aims to provide ketamine-like efficacy without the associated safety issues, such as psychotomimetic effects [40][46] Competitive Advantages - **Institutional Knowledge**: Deep expertise in neurology, psychiatry, endocrinology, and immunology, providing a competitive edge in drug development [19][20] - **Business Development**: Active role in partnerships to enhance R&D capabilities and fill pipeline gaps [31] Future Outlook - **Investment in R&D**: Strong financial profile allows for continued investment in R&D across therapeutic areas [26] - **Execution and Innovation**: Commitment to execution and repeatable innovation as key drivers for future success [36][37] Conclusion Neurocrine Biosciences is positioned for significant growth and innovation in the biopharmaceutical space, particularly in neuropsychiatry, with a robust pipeline and a commitment to addressing unmet medical needs in mental health. The company's strategic focus on leveraging its institutional knowledge and transforming its R&D capabilities is expected to yield multiple new therapies by the end of the decade [11][12][16].

Company Strategy & R&D Transformation - Neurocrine Biosciences is positioned as a diversified neuroscience and endocrinology leader aiming for sustainable growth and value creation[12] - The company aims to deliver a new medicine every two years, driven by a redesigned R&D organization[30, 31, 132] - R&D transformation includes a goal to advance 20 development candidates in 5 years, focusing on clinically or genetically validated targets[94, 99, 101] - The company is diversifying its therapeutic areas beyond neurology and psychiatry to include endocrinology and immunology[23, 94, 100] - New modalities, including peptides, antibodies, and gene therapy, now represent approximately 60% of the portfolio across therapeutic areas[105] Neuropsychiatry Pipeline - The neuropsychiatry pipeline is positioned to deliver multiple first- and best-in-class medicines this decade[12] - Osavampator, an AMPA PAM, is in Phase 3 development for Major Depressive Disorder (MDD), with data expected in 2027[23, 59] - Phase 2 SAVITRI study results showed statistically significant improvements in depression severity with osavampator, with an effect size of 0.53 at day 28 and 0.73 at day 56 for the 1mg dose[52, 55] - Direclidine, an M4 agonist, is in Phase 3 development for schizophrenia, with initial topline data expected in 2027[23, 77] - Phase 2 data for direclidine showed a PANSS total score change from baseline of -18.2 at week 6, with a change vs placebo of -7.5 (p=0.011) and an effect size of 0.61[73] Endocrinology Pipeline - The company is leveraging its Corticotropin Releasing Factor (CRF) biology expertise to expand in endocrinology and metabolic disease[12, 137] - NBIP-'2118, a CRF2 agonist, is being developed for obesity, with a Phase 1 study planned for the first half of 2026[159]

Core Insights - Neurocrine Biosciences, Inc. will hold its 2025 R&D Day on December 16, 2025, at 12:00 p.m. Eastern Time in San Diego [1] - The event will showcase the company's ongoing R&D transformation and its expanding neuroscience pipeline, featuring a discussion with key opinion leader John Krystal, M.D. from Yale University [2] Company Overview - Neurocrine Biosciences is a leading biopharmaceutical company focused on neuroscience, dedicated to developing treatments for neurological, neuroendocrine, and neuropsychiatric disorders [4] - The company has a diverse portfolio that includes FDA-approved treatments for conditions such as tardive dyskinesia, chorea associated with Huntington's disease, and endometriosis, along with a robust pipeline of compounds in mid- to late-phase clinical development [4]

Group 1: Market Performance - Israel's stock market has outperformed the U.S. market since October 7, 2023, with significant gains in U.S.-traded companies such as Teva Pharmaceutical, Elbit Systems, and Tower Semiconductor [5] Group 2: Company Highlights - Neurocrine Biosciences (NBIX) is highlighted as a key stock to watch, currently within a 5% buy zone from a recent entry, with flagship drugs including Crenessity for congenital adrenal hyperplasia and Ingrezza for movement disorders [6][10] - Neurocrine Biosciences has seen its Relative Strength Rating rise to 82, indicating improved market performance [7][10] - Despite a strong quarterly performance, Neurocrine's stock experienced volatility, reflecting market reactions to broader industry trends [10] Group 3: Industry Insights - The top money manager emphasizes the need for investors to return to realistic expectations, noting that while companies like Nvidia and Palantir are currently underperforming, there is significant interest in AI-related investments [8]

PresentationSo it's been quite a year. So I would love to turn it over to Matt for just a few opening remarks on, I guess, a reflection on what's been to say the least, an interesting year, both for Neurocrine and for the biotech space, we're at large.Well, let's kick things off. This is David Amsellem from the Piper Sandler biopharma research team. We're delighted to have Neurocrine here. We have Matt Abernethy, CFO. We have Eric Benevich, Chief Commercial Officer. We have Todd Tushla, director of Investor ...

Summary of Neurocrine Biosciences FY Conference Call Company Overview - **Company**: Neurocrine Biosciences (NasdaqGS:NBIX) - **Date**: December 02, 2025 - **Key Speakers**: Matt Abernethy (CFO), Eric Benevich (Chief Commercial Officer), Todd Tushla (Director of Investor Relations) Core Industry Insights - The biotech industry has faced significant challenges over the past year, but Neurocrine has executed well despite these difficulties [8][10][26] - The company is focused on helping patients with conditions like tardive dyskinesia and congenital adrenal hyperplasia (CAH) [10][14] Key Products and Financial Performance - **Ingrezza**: - Generated approximately $2.5 billion in revenue this year [11] - Only 10% of patients with tardive dyskinesia are currently treated with VMAT2 inhibitors, indicating substantial growth potential [12][62] - **Crinecerfont**: - Approved for CAH, with no approved treatment options for over 70 years [14] - One year post-launch, the company has reached 10% of the CAH patient population [16][94] Strategic Challenges and Responses - The company is navigating the implications of the Inflation Reduction Act (IRA) and believes it can manage the impact on Ingrezza from 2027 to 2029 [22][61] - Neurocrine aims to increase its market cap beyond $20 billion, currently positioned between $10-$20 billion [26][28] Market Position and Competitive Landscape - The company has a strong cash position of $2 billion with no debt, allowing for potential business development opportunities [28] - The competitive landscape includes recent acquisitions in the psych space, but Neurocrine is focused on internal development and leveraging its commercial infrastructure [56][58] Sales and Marketing Strategy - The company is expanding its sales force to include advanced practice providers, which are now the largest group of prescribers for VMAT2 medications [90][92] - The expansion is driven by double-digit growth in the VMAT2 category, with Ingrezza growing faster than the overall category [89] Future Outlook - The company is optimistic about the continued growth of Ingrezza and Crinecerfont, with plans to maintain formulary coverage and negotiate favorable pricing with Medicare [62][67] - Upcoming R&D day is anticipated to provide further insights into the company's pipeline and strategic direction [108][111] Additional Considerations - The company emphasizes patient-centric approaches and aims to increase awareness and treatment rates for tardive dyskinesia and CAH [62][90] - The management team is committed to maximizing the value of existing products while exploring new opportunities in neuro and endocrine spaces [58][44]