Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrolled, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients. The condition is associated with taking certain kinds of mental health medicines (antipsychotics) that help control dopamine receptors in the brain. Taking antipsychotics commonly prescribed to treat mental illnesses such as major depressive disorder, bipolar disorder, schizophrenia and schi ...

Neurocrine Biosciences Inc. (NASDAQ:NBIX) on Monday shared data from 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).Cerebral palsy (CP) is a nonprogressive neurodevelopmental disorder that affects movement and posture, starting in early childhood. It occurs in about three per 1,000 children in the United States.People living with dyskinetic cerebral palsy (DCP) often have mixed hyperki ...

® 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 ...

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]