regulatory
confidence high
sentiment positive
materiality 0.80
Corcept submits NDA for relacorilant as treatment for platinum-resistant ovarian cancer
CORCEPT THERAPEUTICS INC
- NDA submitted to FDA for relacorilant plus nab-paclitaxel, based on Phase 3 ROSELLA and Phase 2 trials.
- Improved progression-free and overall survival vs nab-paclitaxel monotherapy; no biomarker selection needed.
- Relacorilant well-tolerated; adverse events similar to monotherapy, no increased safety burden.
- CEO notes this is Corcept's second NDA before FDA; relacorilant also under review for hypercortisolism.
- Company preparing launch once approved; oncology and endocrinology units in place.