other material
confidence high
sentiment positive
materiality 0.85
Corcept's ROSELLA Phase 3 trial meets overall survival endpoint; 35% risk reduction
CORCEPT THERAPEUTICS INC
- Relacorilant + nab-paclitaxel reduced risk of death by 35% vs. nab-paclitaxel alone (HR 0.65, p=0.0004).
- Median OS 16.0 months vs. 11.9 months (4.1-month improvement); both dual primary endpoints met.
- NDA under FDA review with PDUFA date of July 11, 2026; MAA under EMA review.
- Relacorilant well-tolerated without increased safety burden; no biomarker selection required.
- Trial enrolled 381 patients across US, Europe, South Korea, Brazil, Argentina, Canada, Australia.