Detailed Narrative
Record Commercial Performance
Neurocrine Biosciences achieved its first-ever quarter with net product sales exceeding $800 million, marking a 44% year-over-year growth. This was primarily fueled by INGREZZA, which grew 20% year-over-year to $657 million, and CRENESITY, which generated $153 million and is now annualizing at over $600 million. The company reaffirmed its INGREZZA guidance for FY26 at $2.7 billion to $2.8 billion, reflecting strong underlying demand and operating execution.
Pipeline Expansion and Key Readouts
The company plans to initiate 6 new Phase I and 4 new Phase II programs in 2026 across neurology, psychiatry, endocrinology, and immunology. Significant data catalysts are expected in 2027, including top-line Phase III readouts for osavampator in major depressive disorder and the first Phase III study of direclidine in schizophrenia, as well as top-line data for NBIP-'2118 in obesity. Enrollment for current Phase III neuropsych assets is progressing well, with all osavampator studies expected to read out next year.
INGREZZA Market Opportunity and Persistence
Despite its nine years on the market, INGREZZA continues to see strong demand, with record new patient additions. Management highlighted that approximately 90% of the estimated 800,000 tardive dyskinesia (TD) patients in the U.S. are not yet receiving standard-of-care VMAT2 inhibitor treatment, indicating significant remaining growth potential. Real-world data presented at AMCP 2026 demonstrated greater treatment persistence with INGREZZA compared to deuterated tetrabenazine, reinforcing its differentiated profile and supporting continued commercial execution.
CRENESITY Launch Momentum and Patient Dynamics
The CRENESITY launch carried strong momentum from 2025 into Q1 2026, driven by steady new patient starts, high persistency and compliance rates, and favorable reimbursement dynamics. Over 1,200 healthcare providers have prescribed CRENESITY, with adoption balanced across pediatric and adult populations, though with a modest skew towards pediatrics and females. New 2-year data from the CATALYST study showed sustained reductions in glucocorticoid doses and normal androgen levels for 70% of patients, with over 80% study retention, reinforcing its long-term value proposition.
Strategic Business Development and Capital Allocation
The pending acquisition of Soleno Therapeutics and its product VYKAT XR is on track to close in Q2, which is expected to strengthen Neurocrine's long-term growth profile and commercial portfolio, particularly in serving patients with Prader-Willi Syndrome. This acquisition aligns with the company's capital allocation priorities to drive revenue growth, advance its pipeline, and invest in business development. The recent sale of the diurnal business was noted as a strategic move to focus on core areas.
Addressing Unmet Needs in CAH
The company is initiating a Phase II study for crinecerfont in classic CAH patients under 4 years of age, addressing a significant unmet need given the current labeling is for patients aged 4 and above. This initiative aims to protect growth trajectory and bone age in younger patients. Additionally, the NBIP-'1435 program, an injectable peptide, is being developed as a potential second-line therapy for CAH, offering an alternative route of administration and potentially better durable efficacy.