Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED
Relacorilant + nab-paclitaxel was approved by the FDA on March 25, 2026 for platinum-resistant ovarian cancer, the 9th novel drug approval of 2026 on the FDA's Novel Drug Approvals list.
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
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.
FDA record of the action: the FDA approved on March 25, 2026, per NDA 220641 ORIG-1 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
Specialist biotech funds holding CORT, 13F for the quarter ended June 30, 2026
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Question
Was Lifyorli (relacorilant) plus A approved by the FDA?
Yes. The FDA approved the application for Lifyorli (relacorilant) plus A on March 25, 2026, per the FDA's own record. The primary source is linked on this page.
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