Core Insights - Neurocrine Biosciences has initiated a Phase 2 clinical study for NBI-1065890, a selective VMAT2 inhibitor aimed at treating tardive dyskinesia (TD) [1][2] - The study will involve approximately 100 adult subjects and will evaluate the efficacy, safety, and tolerability of NBI-1065890 compared to a placebo, with the primary endpoint being the change in AIMS dyskinesia total score at Week 8 [2] Company Overview - Neurocrine Biosciences is a biopharmaceutical company focused on developing treatments for neurological, psychiatric, endocrine, and immunological disorders, with a history of successful drug development including valbenazine for TD [3][6] - The company has a robust pipeline with multiple compounds in mid- to late-phase clinical development, reflecting its commitment to addressing under-treated conditions [6] Tardive Dyskinesia (TD) Context - TD is a movement disorder characterized by uncontrolled and repetitive movements, often resulting from the use of certain antipsychotic medications, affecting an estimated 800,000 adults in the U.S. [4][5] - The condition can lead to significant disruption in patients' lives, highlighting the need for effective treatment options [4]

Core Insights - Neurocrine Biosciences Inc. announced data from its Phase 3 KINECT-DCP study evaluating valbenazine for dyskinetic cerebral palsy (DCP) [1] - The trial did not meet its primary or key secondary endpoints, which aimed to assess improvement in chorea among DCP patients [3][4] - Analyst commentary indicates that while the recent trial results are disappointing, they do not significantly impact the company's valuation or investment thesis [5] Study Details - The KINECT-DCP study involved participants aged six to 70 years who were randomized to receive either valbenazine or a placebo for 14 weeks [3] - Following the initial phase, participants had the option to enter an open-label extension phase where all received valbenazine [4] - Adverse events reported were consistent with the established safety profile of valbenazine [4] Market Reaction - Neurocrine Biosciences shares experienced a decline of 1.55%, trading at $145.24 during premarket hours [6] - Analysts expect investor focus to shift towards execution and commercial performance in 2026, with limited near-term clinical catalysts [5]

Core Insights - Neurocrine Biosciences announced that its Phase 3 KINECT-DCP study of valbenazine for dyskinetic cerebral palsy did not meet primary or key secondary endpoints [1][2] Company Overview - Neurocrine Biosciences is a biopharmaceutical company focused on neuroscience, dedicated to developing treatments for neurological, neuroendocrine, and neuropsychiatric disorders [7] - The company has a portfolio that includes FDA-approved treatments for tardive dyskinesia and chorea associated with Huntington's disease, among others [7] Study Details - The KINECT-DCP study was the largest double-blind placebo-controlled trial for dyskinetic cerebral palsy, evaluating 14 weeks of valbenazine treatment against placebo [2][5] - The primary objective was to assess the efficacy of valbenazine in improving chorea in participants aged 6 to 70 years with dyskinetic cerebral palsy [5] Drug Information - Valbenazine is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, previously approved for tardive dyskinesia and more recently for chorea associated with Huntington's disease [6] - The safety profile of valbenazine in the study was consistent with established data [2]

Financial Data and Key Metrics Changes - The company reported $790 million in net product sales for Q3 2025, reflecting a 28% year-over-year growth driven by INGREZZA and CRENESSITY [8][10] - CRENESSITY sales grew from $53 million in Q2 to $98 million in Q3, indicating strong early adoption [8][10] - INGREZZA achieved net sales of $687 million, marking the third consecutive quarter of record new patient additions [8][10] Business Line Data and Key Metrics Changes - INGREZZA's performance has been exceptional, with a prescriber base 30% larger than two years ago, and only about 10% of the estimated 800,000 patients with tardive dyskinesia currently treated with a VMAT2 inhibitor [11][12] - CRENESSITY has seen 540 new patients initiate therapy in Q3, bringing the total to over 1,600 since launch, with 80% of dispensed prescriptions now reimbursed [8][15] Market Data and Key Metrics Changes - The company estimates that only half of the patients living with tardive dyskinesia have received a diagnosis, indicating significant growth potential in the market [11][12] - The pediatric population has shown modestly higher demand for CRENESSITY compared to adults, with strong reimbursement rates observed [15] Company Strategy and Development Direction - The company plans to expand its sales force for both INGREZZA and CRENESSITY to accelerate growth and maximize patient share [9][16] - The capital allocation priorities include driving revenue growth, advancing R&D programs, enabling business development, and returning capital to shareholders [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing momentum for both INGREZZA and CRENESSITY, with expectations for continued growth into 2026 and beyond [6][10] - The company is on track to achieve its R&D productivity goals, with multiple Phase I and II study initiations planned [6][10] Other Important Information - The company is fully cooperating with a Department of Justice investigation related to the sales and marketing of INGREZZA, maintaining a robust compliance program [49][50] - The company has $2.1 billion in cash with no debt, allowing for flexibility in capital allocation [94] Q&A Session Summary Question: Insights on patient dynamics and starts for CRENESSITY - Management noted that the adoption of CRENESSITY has been strong, with 540 new treatment forms in Q3, and they do not see significant seasonality affecting the launch [23][24] Question: Implications of the Inflation Reduction Act (IRA) on pricing - Management is awaiting pricing information for Oscado and is preparing to maximize patient numbers on INGREZZA before the IRA impacts begin [31][33] Question: Reimbursement requirements for CRENESSITY - Reimbursement has been smooth, with no specific steroid tapering required for coverage, focusing instead on the underlying disease [39] Question: Sales force expansion details - The sales force expansion is expected to increase overall coverage by about 30%, primarily targeting psychiatry and neurology [58][60] Question: Persistence and compliance of CRENESSITY - Persistence and compliance for CRENESSITY have been strong, with positive feedback on disease control and androgen reduction from healthcare providers [77][78] Question: Future product launches and sales force readiness - The expanded sales force is positioned to support potential launches of new products in the pipeline, including osavampator and Directlidine [109]