other material
confidence high
sentiment positive
materiality 0.95
Neurocrine's crinecerfont meets Phase 3 endpoint in CAH adults; FDA submission planned for 2024
NEUROCRINE BIOSCIENCES INC
- Phase 3 CAHtalyst Adult study met primary endpoint: significant % reduction in daily glucocorticoid dose with androgen control (p<0.0001).
- Key secondary endpoint met: significant decrease in androstenedione at Week 4 vs placebo (p<0.0001).
- 63% of crinecerfont patients achieved physiologic glucocorticoid dose vs 18% on placebo (p<0.0001).
- Company to submit regulatory applications to FDA in 2024 and to EMA afterwards.
- Crinecerfont generally well-tolerated; common AEs: fatigue, headache, coronavirus infection.