Neurocrine's crinecerfont Phase 3 pediatric CAH study meets primary, key secondary endpoints

NEUROCRINE BIOSCIENCES INC

Primary endpoint: statistically significant decrease in serum androstenedione at Week 4 vs placebo (p=0.0002).
Key secondary: significant reduction in daily glucocorticoid dose while maintaining androgen control at Week 28 vs placebo (p<0.0001).
About 30% of crinecerfont patients achieved reduction to physiologic GC dose vs 0% placebo.
Drug generally well-tolerated; common AEs: headache, fever, vomiting, URI, nasopharyngitis.
Data to support FDA submission in 2024, with EMA submission to follow.

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