Lifyorli (relacorilant) plus nab-paclitaxel approved for platinum-resistant ovarian cancer, the first selective glucocorticoid receptor antagonist approved by the FDA.
Approved ~15 weeks early.
The PDUFA target date was July 11, 2026. The FDA approved on March 25, 2026: roughly 108 days ahead of schedule. Early approvals are uncommon and are one reason a PDUFA date should be read as a deadline, not an appointment.
Run-up into the decision (T-120 → T+5)
Daily close. Green marker = the approval date. Run-up from T-120 to the last close before the decision: -59.9%. Pre-decision high $90.32 (Oct 7), low $32.15 (Mar 13). Close on decision day $40.47; next-day move -4.8%. Historical price action, not a forecast.
Key facts
Company
Corcept Therapeutics (CORT)
Drug
Lifyorli (relacorilant) + nab-paclitaxel
Indication
Platinum-resistant ovarian, fallopian tube or primary peritoneal cancer
Pivotal trial
ROSELLA (Phase 3, n=381)
PDUFA target
2026-07-11
Actual decision
2026-03-25: Approved
Context
Relacorilant had previously received a Complete Response Letter for a separate application in hypercortisolism (PDUFA Dec 30, 2025). The ovarian cancer approval is a different indication, supported by the ROSELLA trial. Verify against primary FDA and company filings.
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