Most Studies Meeting the Literature Review Criteria Found That a Higher Glucocorticoid Dose was Statistically Significantly Associated with Adverse Clinical Outcomes Findings Presented at the 2025 International Society for Pharmacoeconomics and Outcomes Research Annual Meeting SAN DIEGO, Calif. — Neurocrine Biosciences, Inc. (Nasdaq: NBIX) presented today a systematic literature review illustrating the...
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SAN DIEGO, Calif. — Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the presentation of new one-year data from the CAHtalyst™ Adult study of CRENESSITY® (crinecerfont) showing that patients achieved lasting, more physiologic glucocorticoid doses, while adrenocorticotropic hormone, 17-hydroxyprogesterone and androstenedione remained at or below baseline levels. These data complement the recently announced CAHtalyst™ Pediatric one-year results and were presented at the Endocrine Society’s Annual Meeting,...
SAN DIEGO, Calif. — Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration has approved INGREZZA® SPRINKLE (valbenazine) capsules, a new oral granules formulation of INGREZZA® (valbenazine) capsules prescribed for the treatment of adults with tardive dyskinesia and chorea associated with Huntington’s disease. INGREZZA SPRINKLE provides...
SAN DIEGO, Calif. — Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced new data from a post-hoc analysis of the Phase 4 KINECT-PRO™ open-label study confirming that robust rates of symptomatic remission of tardive dyskinesia were achieved with once-daily INGREZZA® (valbenazine) capsules. The analysis also showed sustained improvements in patient-reported outcomes among participants who achieved symptomatic remission....
SAN DIEGO, Calif. — Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the presentation of the first head-to-head data comparing vesicular monoamine transporter 2 (VMAT2) target occupancy between INGREZZA® (valbenazine) capsules and AUSTEDO XR (deutetrabenazine) at therapeutic doses. Results from the study confirmed that both compounds engage VMAT2; however, INGREZZA demonstrated significantly higher VMAT2 target occupancy and greater potency. Findings...
SAN DIEGO, Calif. — Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the publication of the first peer-reviewed expert recommendations to guide glucocorticoid dose reduction in patients with classic congenital adrenal hyperplasia treated with CRENESSITY® (crinecerfont). Published in The Journal of Clinical Endocrinology & Metabolism, the recommendations address a critical unmet need as real-world use of CRENESSITY expands in...
SAN DIEGO, Calif. — Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the presentation of new two-year data from the Phase 3 CAHtalyst® Pediatric study demonstrating durable androgen control, sustained decreases in glucocorticoid (GC) doses and meaningful improvements in clinical outcomes associated with excess androgens and long-term GC exposure in children and adolescents with classic congenital...
CHARLESTON, S.C. – Neuroene Therapeutics announced that the FDA has granted orphan drug designation for the company’s proprietary compound: NT102. NT102 was developed as part of a novel patented platform of mitochondrial and neuroprotective chemicals for the treatment of neurological diseases such as pharmacoresistant epilepsies. In preclinical studies funded by...
NEW YORK – Neurogene Inc., a company founded to bring life-changing genetic medicines to patients and families affected by rare neurological diseases, today announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to its adeno-associated virus (AAV) encoding a codon-optimized human CLN5 transgene (hCLN5) for patients...
Oral presentation at ASGCT Annual Meeting to describe algorithm to monitor, detect and treat HLH, which can be adopted for AAV gene therapy NEW YORK, NY – Neurogene Inc. (Nasdaq: NGNE), a clinical-stage company founded to bring life-changing genetic medicines to patients and families affected by rare neurological diseases, today...