Neurocrine Biosciences, Inc.

Neurocrine Biosciences Presents New Analysis Establishing Benchmark for Clinically Meaningful Change in Overall Health Reported by Patients with Tardive Dyskinesia

Neurocrine Biosciences presented a new analysis establishing a 6-point increase on the EQ Visual Analogue Scale as the threshold for clinically meaningful change in overall health for tardive dyskinesia patients. The findings contextualize Phase 4 KINECT-PRO results, where INGREZZA-treated patients reported a mean 13.1-point improvement in EQ-VAS scores at Week 24 — more than double the newly defined benchmark. The analysis, plus two additional real-world and dosing presentations, will be shared at the Academy of Managed Care Pharmacy Nexus 2026 conference, reinforcing the evidence base supporting INGREZZA's commercial position.

•6d ago

Neurocrine Biosciences Announces Publication in Orphanet Journal of Rare Diseases Advancing Understanding of Hyperphagia in Prader-Willi Syndrome

Neurocrine announced publication of expert perspectives on hyperphagia in Prader-Willi syndrome in Orphanet Journal of Rare Diseases. The manuscript frames hyperphagia as a multidimensional neurobiological condition and concludes VYKAT XR, the first FDA-approved treatment for hyperphagia in PWS, is a significant advancement best used within integrated, multidisciplinary care. No new clinical, regulatory, or financial information was disclosed; the release functions as scientific-communications support for the VYKAT XR commercial franchise.

•10d ago

Neurocrine Biosciences Initiates Phase 2 Clinical Study Evaluating NBI-'567 in Adults with Alzheimer's Disease

Neurocrine Biosciences initiated a Phase 2 study of NBI-'567, an oral M1/M4-preferring muscarinic agonist, as adjunctive treatment for cognitive impairment in mild to moderate Alzheimer's disease. The randomized, double-blind, placebo-controlled trial will enroll approximately 135 adults ages 50-85 on stable acetylcholinesterase inhibitor therapy, with a 12-week treatment period and a primary endpoint of change in a Neuropsychological Test Battery composite score at Week 12. NBI-'567 was licensed from Nxera Pharma and anchors a broader muscarinic portfolio including direclidine in Phase 3 for schizophrenia; the Alzheimer's indication adds early-stage pipeline optionality but is years from any revenue contribution.

•12d ago

Neurocrine Biosciences Presents Real-World Evidence Mapping the Lifelong, Evolving Impact of Classic Congenital Adrenal Hyperplasia

Neurocrine presented real-world evidence at the Endocrine Nurses Society Symposium 2026 mapping how classic congenital adrenal hyperplasia burdens patients across their lifetimes. The CAHtalog registry analysis combined decades of medical records from 10 adults covering more than 300 patient-years, alongside new 2-year CAHtalyst data showing crinecerfont enables sustained glucocorticoid dose reductions with improved clinical and cardiometabolic outcomes. These findings support commercial adoption of CRENESSITY, Neurocrine's already-FDA-approved CAH franchise, but the release is a scientific presentation rather than a regulatory or financial catalyst.

•16d ago

Neurocrine Biosciences Announces Publication of KINECT-PRO™ Findings Demonstrating INGREZZA® (valbenazine) Capsules Improved Patient-Reported Quality of Life and Daily Functioning for People Living with Tardive Dyskinesia

Neurocrine Biosciences announced publication of KINECT-PRO Phase 4 results showing INGREZZA significantly improved patient-reported quality of life and functionality in tardive dyskinesia patients. Approximately 58% of patients met the threshold for symptomatic remission at Week 24, with improvements observed regardless of underlying psychiatric diagnosis or baseline movement severity. The study is the first to demonstrate quality of life benefits for a VMAT2 inhibitor using multiple validated patient-reported outcomes, reinforcing INGREZZA's clinical profile.

•2mo ago

Neurocrine Biosciences Announces Initiation of Phase 1 Clinical Study Evaluating NBIP-'1968, a GLP-1/GIP/Glucagon Receptor Triple Agonist

Neurocrine initiated a Phase 1 first-in-human study evaluating NBIP-'1968, an investigational triple agonist targeting GLP-1, GIP, and glucagon receptors for the treatment of obesity. The study will assess safety and tolerability of single ascending doses in adults across various body mass index categories. NBIP-'1968 is designed for once-weekly administration and is part of a broader obesity portfolio that includes the Phase 1 asset NBIP-'2118.

•2mo ago

Neurocrine Biosciences Reports Second-Quarter 2026 Financial Results

Neurocrine Biosciences reported Q2 2026 revenue of $959 million, up 39% year-over-year, driven by triple-digit growth in Crenessity and solid demand for Ingrezza. Non-GAAP EPS was $2.85, compared to $1.65 in the prior year, with Vykat XR contributing $54 million in sales following the Soleno acquisition. Full-year 2026 guidance for Ingrezza was raised to a range of $2.825 billion to $2.875 billion, reflecting the strong quarterly performance and continued momentum in tardive dyskinesia prescriptions. The company completed the $2.9 billion acquisition of Soleno Therapeutics in May 2026, expanding its portfolio into rare diseases with Vykat XR for Prader-Willi syndrome. Neurocrine ended the quarter with $482 million in cash and equivalents, supported by a new $1.0 billion credit facility.

•3mo ago

Neurocrine Biosciences Announces Key Leadership Hiring, Promotions

Neurocrine Biosciences appointed three Senior Vice Presidents to strengthen its leadership team as the company executes its next phase of growth and expands its commercial portfolio. The new leadership includes Bret Paulson as SVP of Market Access, and the promotions of David Bradfute to SVP and Global Head of IP and Aaron Vosburgh to SVP of Finance and Accounting. CEO Kyle W. Gano stated that these hires are critical to executing on the company's strategy to advance its neuroscience pipeline and deliver value to patients and shareholders.

•3mo ago

Neurocrine Biosciences Initiates Phase 2 Study of Crinecerfont in Pediatric Patients Under 4 Years Old with Classic Congenital Adrenal Hyperplasia

Neurocrine Biosciences initiated a Phase 2 clinical study assessing crinecerfont in children aged 3 months to under 4 years with classic congenital adrenal hyperplasia (CAH). The 24-week, open-label study aims to evaluate safety and tolerability in 20 participants, potentially supporting a supplemental New Drug Application to expand the current indication for CRENESSITY. Separately, the company announced it has achieved target enrollment for a similar Phase 2 study in the European Union for children from birth to under 2 years old.

•4mo ago

Soleno Therapeutics Presents New VYKAT® XR (diazoxide choline) Data at ENDO 2026 Demonstrating Meaningful and Durable Improvements in Hyperphagia and Behavioral Symptoms in Prader-Willi Syndrome Following Randomized Withdrawal Period

Neurocrine Biosciences presented late-breaking Phase 3 data for VYKAT XR at ENDO 2026, demonstrating durable improvements in hyperphagia and behavioral symptoms in Prader-Willi syndrome patients. Patients who resumed treatment after a 16-week placebo withdrawal showed significant recovery of benefit, with HQ-CT scores improving by 6.3 points at two years, while continuous users maintained stable improvements. Comparative analysis against real-world natural history data showed statistically significant superiority for VYKAT XR across all behavioral domains and hyperphagia measures over three years.

•4mo ago

Neurocrine Biosciences Presents First Retrospective Case Series of CRENESSITY® (crinecerfont) in Patients with Classic Congenital Adrenal Hyperplasia Due to 11β‑Hydroxylase Deficiency at ENDO 2026

Neurocrine presented retrospective case series data for CRENESSITY in patients with 11β-hydroxylase deficiency, a rare CAH subtype not included in pivotal trials. The study of 15 patients showed median reductions of 92% in DOC and 95% in 11-deoxycortisol, with 14 of 15 patients able to reduce glucocorticoid doses. These findings provide foundational evidence for CRENESSITY efficacy in this subgroup, supporting potential future label expansions or real-world adoption.

•4mo ago

Neurocrine Biosciences Presents New Two-Year CRENESSITY® (crinecerfont) Data Demonstrating Improved Growth Measures in Pediatric Patients with Classic Congenital Adrenal Hyperplasia at ENDO 2026

Neurocrine presented two-year data from the Phase 3 CAHtalyst Pediatric study showing that CRENESSITY slows bone age progression and improves predicted adult height in children with classic congenital adrenal hyperplasia. Among 24 patients with advanced bone age at baseline, mean bone age SDS decreased by 1.12, and a subset of 9 patients saw reductions greater than two standard deviations, correlating with a 4.7 cm increase in predicted adult height. A caregiver survey of 29 participants reported 100% satisfaction with the treatment and increased optimism regarding long-term quality of life and reduced steroid-related risks.

•4mo ago

Neurocrine Biosciences Presents New Two-Year CRENESSITY® (crinecerfont) Data Demonstrating Improvements in Cardiometabolic Outcomes in Adults with Classic Congenital Adrenal Hyperplasia at ENDO 2026

Neurocrine presented two-year data from the Phase 3 CAHtalyst Adult study at ENDO 2026, showing sustained improvements in cardiometabolic outcomes for patients with classic congenital adrenal hyperplasia. Among overweight or obese participants, 37% achieved clinically meaningful weight loss (>5%), and 43% of those with baseline insulin resistance were no longer insulin resistant after two years of treatment. The data also demonstrated a 38% reduction in glucocorticoid doses and favorable trends in bone mineral density, supporting the drug's long-term safety and efficacy profile for an already approved therapy.

•4mo ago

Neurocrine Biosciences Presents New Clinically Meaningful Response Data on Treatment of Tardive Dyskinesia, Reinforcing the Efficacy of INGREZZA® (valbenazine) Capsules Across a Broad Range of Patients

Neurocrine Biosciences presented new post-hoc data from the KINECT 4 Phase 3 trial, showing that 94% of patients treated with INGREZZA for 48 weeks achieved either symptomatic remission or a clinically meaningful response (≥30% reduction in AIMS score). Among the 41% of patients who did not meet the stringent remission threshold, 86% still achieved a ≥30% reduction in movement severity, reinforcing the drug's efficacy across a broad patient population. A separate retrospective Medicare claims analysis of over 176,000 patients revealed that 90% had at least one hepatic risk factor, highlighting INGREZZA's unique positioning as the only VMAT2 inhibitor with approved dosing for hepatic impairment.

•4mo ago

Neurocrine Biosciences Presents New Data Highlighting Functional and Socio-emotional Improvements with INGREZZA® (valbenazine) Capsules in Individuals with Tardive Dyskinesia and Intellectual and Developmental Disabilities

Neurocrine Biosciences presented new clinician-reported data at the American Academy of Developmental Medicine and Dentistry conference, highlighting functional and socio-emotional improvements in patients with tardive dyskinesia and intellectual disabilities. In a subgroup of 30 individuals, 89% experienced improvement in TD severity within four weeks of starting INGREZZA, and 96% of those with impaired baseline function showed overall functional status improvement. The data supports the drug's efficacy in a complex, underdiagnosed population, reinforcing the commercial narrative for INGREZZA beyond standard clinical trial populations.

•4mo ago

Neurocrine Biosciences to Present New Two‑Year CRENESSITY® (crinecerfont) Data on Key Clinical and Patient‑Reported Outcome Measures at ENDO 2026

Neurocrine Biosciences will present new two-year clinical data for CRENESSITY (crinecerfont) at the ENDO 2026 meeting, highlighting sustained androgen control and glucocorticoid dose reduction in classic CAH patients. The data from the CAHtalyst program covers both adult and pediatric populations, demonstrating long-term benefits in metabolic health, bone health, and quality of life, reinforcing CRENESSITY as the emerging standard of care. Neurocrine will also present late-breaking long-term extension data for VYKAT XR in Prader-Willi syndrome, showing sustained improvements in hyperphagia and behavioral symptoms following a randomized withdrawal period.

•4mo ago

Neurocrine Biosciences Presents Real-World Data Highlighting Functional Impact of Mild Tardive Dyskinesia Severity and Improvement with INGREZZA® (valbenazine) Capsules

Neurocrine Biosciences presented real-world data at the American Psychiatric Association 2026 Annual Meeting showing that INGREZZA significantly improves functional outcomes in patients with mild tardive dyskinesia. In a survey of 90 patients with mild TD, 96% showed clinician-reported improvement in uncontrolled movements, with 86% improving within four weeks of treatment initiation. The data highlights that even mild TD causes significant functional impairment (90% of patients) and that treatment restores independence and ability to work, supporting broader adoption of INGREZZA for mild cases.

•5mo ago

Neurocrine Biosciences Completes Acquisition of Soleno Therapeutics

Neurocrine Biosciences has completed its $2.9 billion acquisition of Soleno Therapeutics, finalizing a cash tender offer at $53.00 per share. The deal adds VYKAT XR, the first and only FDA-approved treatment for hyperphagia in Prader-Willi syndrome, to Neurocrine’s existing portfolio of INGREZZA and CRENESSITY. Approximately 88.9% of Soleno shares were tendered in the offer, with the remaining shares converted to cash, making Soleno a wholly owned subsidiary of Neurocrine.

•5mo ago

Neurocrine Biosciences Announces Publication of Expert Recommendations for Glucocorticoid Dose Reduction after Initiating CRENESSITY® (crinecerfont) for the Treatment of Classic Congenital Adrenal Hyperplasia

Neurocrine Biosciences announced the publication of peer-reviewed expert recommendations guiding glucocorticoid dose reduction in patients with classic congenital adrenal hyperplasia treated with CRENESSITY. Published in The Journal of Clinical Endocrinology & Metabolism, the algorithms provide clinicians with systematic approaches to reduce supraphysiologic glucocorticoid doses in both pediatric and adult populations. The recommendations are derived from the CAHtalyst Phase 3 studies involving 285 patients and aim to mitigate long-term complications associated with steroid excess while maintaining disease control.

•5mo ago

Neurocrine Biosciences Reports First-Quarter 2026 Financial Results

Neurocrine Biosciences reported Q1 2026 total net product sales of $811.0 million, up 44% year-over-year, driven by strong demand for INGREZZA and CRENESSITY. The company reaffirmed its full-year 2026 INGREZZA net sales guidance of $2.7 billion to $2.8 billion and announced a definitive agreement to acquire Soleno Therapeutics for $53.00 per share in cash, representing a total equity value of $2.9 billion. Additionally, Neurocrine initiated a Phase 2 clinical study of NBI-1117570 for adults with schizophrenia and reported a cash position of approximately $2.65 billion as of March 31, 2026.

•5mo ago

Neurocrine Biosciences Announces New Survey Results Showing Significant Burden of Tardive Dyskinesia on Employment

Neurocrine released survey data showing significant employment impacts of tardive dyskinesia (TD), with 1 in 5 working adults quitting jobs due to symptoms and respondents missing 8 hours of work/school weekly prior to treatment. The findings, released during Tardive Dyskinesia Awareness Week, support the use of FDA-approved VMAT2 inhibitors like INGREZZA to reduce this burden. The company emphasizes the need for earlier diagnosis and routine screening, noting that only an estimated 1 in 10 individuals with TD are currently treated with a VMAT2 inhibitor.

•5mo ago

Neurocrine Biosciences Announces Initiation of Phase 1 Clinical Study Evaluating NBIP-'2118, a Corticotropin-Releasing Factor Type 2 Receptor Agonist

Neurocrine Biosciences initiated a Phase 1 first-in-human study for NBIP-'2118, an investigational CRF(2) receptor agonist designed to treat obesity while preserving lean mass. The study will evaluate safety and tolerability in healthy, overweight, and obese adults, with initial data anticipated in 2027. This program is part of a broader obesity strategy that includes the triple agonist NBIP-'1968 and potential long-acting conjugates targeting GLP-1, GIP, and glucagon receptors.

•5mo ago

Neurocrine Biosciences Presents New Two-Year CRENESSITY® (crinecerfont) Data Demonstrating Durable Hormone Control, Reduced Glucocorticoid Exposure and Meaningful Clinical Improvements in Pediatric Patients with Classic Congenital Adrenal Hyperplasia

New two-year data from the Phase 3 CAHtalyst Pediatric study showed durable reductions in androgen levels and glucocorticoid doses for patients taking CRENESSITY. Clinical improvements included 60% of overweight or obese patients achieving meaningful BMI improvement and 61% of those with insulin resistance no longer meeting criteria for the condition. Safety remained consistent with no new signals, and the data builds upon previously reported one-year outcomes presented at the Pediatric Endocrine Society meeting.

•6mo ago

Neurocrine Biosciences Announces Publication Establishing Clinically Meaningful Improvement Threshold for the Tardive Dyskinesia Impact Scale

Neurocrine Biosciences announced the publication of research in The Journal of Clinical Psychiatry that establishes a clinically meaningful improvement threshold for the Tardive Dyskinesia Impact Scale (TDIS) used with INGREZZA. The manuscript defines a minimal clinically important difference of four points for the TDIS total score, based on data from the KINECT clinical program including KINECT-3, KINECT-4, and KINECT-PRO. This validation provides a standardized way to interpret patient-reported outcomes in tardive dyskinesia, reinforcing the drug's impact on physical, social, and emotional functioning beyond clinician-rated movement severity.

•6mo ago

Neurocrine Biosciences Presents New Two-Year CRENESSITY® (crinecerfont) Data Showing Sustained Glucocorticoid Dose Reductions While Maintaining Androgen Control in Adults with Classic Congenital Adrenal Hyperplasia

Neurocrine Biosciences presented two-year data from the Phase 3 CAHtalyst Adult study, showing that treatment with CRENESSITY enabled sustained glucocorticoid dose reductions in adults with classic congenital adrenal hyperplasia. At Month 24, 69% of participants achieved physiologic-range glucocorticoid dosing with a mean 38% reduction from baseline, while maintaining androgen control. Long-term treatment was well tolerated with over 80% study retention and no new safety signals observed, supporting the drug's durability in the standard of care.

•6mo ago