Neurocrine Biosciences: CAHtalyst Pediatric Study Meets Primary Endpoint - Quick Facts

(RTTNews) - Neurocrine Biosciences, Inc. (NBIX) reported positive top-line data from the Phase 3 CAHtalyst Pediatric Study evaluating the efficacy, safety, and tolerability of crinecerfont in children and adolescents with classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency. The company said the Phase 3 Pediatric study met its primary endpoint, showing that treatment with crinecerfont resulted in a statistically significant decrease in serum androstenedione from baseline at Week 4 versus placebo following a glucocorticoid stable period.

Neurocrine Biosciences said the data from the CAHtalyst Pediatric and Adult studies, including data from the open-label treatment periods, will support regulatory submissions to the FDA in 2024 and later to the European Medicines Agency.

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