regulatory
confidence high
sentiment positive
materiality 0.80
FDA accepts Corcept's NDA for relacorilant in platinum-resistant ovarian cancer; PDUFA July 11, 2026
CORCEPT THERAPEUTICS INC
- FDA accepted Corcept's NDA for relacorilant in platinum-resistant ovarian cancer with a PDUFA date of July 11, 2026.
- NDA based on positive Phase 3 ROSELLA and Phase 2 data showing improved PFS and OS without biomarker selection.
- Relacorilant plus nab-paclitaxel was well-tolerated; adverse events similar to nab-paclitaxel monotherapy.
- CEO Joseph Belanoff: 'FDA acceptance brings us closer to offering a much-needed treatment option for this dire disease.'
- Relacorilant may redefine platinum-resistant ovarian cancer treatment, Corcept states.