# LIFYORLI (relacorilant) + nab-paclitaxel PDUFA Event: Platinum-resistant ovarian cancer

Canonical URL: https://biopharmsignal.com/pdufa-calendar/CORT/relacorilant-platinum-resistant-ovarian-cancer

Ticker: CORT

Company: Corcept

Event date: 2026-07-11

Event type: FDA Decision

Stage: PDUFA

Result: Approved

Result date: 2026-03-25

Application type: NDA

FDA approved LIFYORLI plus nab-paclitaxel. FDA approved LIFYORLI with nab-paclitaxel for eligible adults with platinum-resistant epithelial ovarian, fallopia...

## Event Timeline

### March 25, 2026 — FDA approved LIFYORLI plus nab-paclitaxel

FDA approved LIFYORLI with nab-paclitaxel for eligible adults with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. The approval came more than three months before the July 11 PDUFA date.

[Corcept — FDA approval of LIFYORLI](https://ir.corcept.com/news-releases/news-release-details/fda-approves-corcepts-selective-glucocorticoid-receptor)

### January 22, 2026 — ROSELLA met the overall survival endpoint

LIFYORLI plus nab-paclitaxel reduced the risk of death by 35% versus nab-paclitaxel alone, with median overall survival of 16.0 versus 11.9 months; both dual primary endpoints were met.

[Corcept — ROSELLA overall survival results](https://ir.corcept.com/news-releases/news-release-details/overall-survival-primary-endpoint-met-corcepts-pivotal-phase-3)

### September 10, 2025 — FDA accepted the NDA

FDA accepted the relacorilant NDA and assigned a July 11, 2026 PDUFA date. The application was supported by the Phase 3 ROSELLA and Phase 2 trials.

[Corcept — NDA acceptance and PDUFA date](https://ir.corcept.com/news-releases/news-release-details/fda-files-corcepts-new-drug-application-relacorilant-treatment-0/)

### July 2025 — Corcept submitted the NDA

Corcept submitted the U.S. NDA for relacorilant plus nab-paclitaxel in platinum-resistant ovarian cancer.

[Corcept — Second-quarter 2025 corporate update](https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-second-quarter-financial-3/)

### March 31, 2025 — ROSELLA met the progression-free survival endpoint

The Phase 3 trial met its blinded independent central review progression-free survival endpoint without increasing the overall side-effect burden.

[Corcept — ROSELLA progression-free survival results](https://ir.corcept.com/news-releases/news-release-details/primary-endpoint-met-corcepts-pivotal-phase-3-rosella-trial/)

### June 29, 2022 — Phase 3 ROSELLA study started

The pivotal trial began evaluating relacorilant plus nab-paclitaxel versus nab-paclitaxel alone in platinum-resistant ovarian, primary peritoneal or fallopian-tube cancer.

[ClinicalTrials.gov — ROSELLA study record (NCT05257408)](https://clinicaltrials.gov/study/NCT05257408)

## Regulatory Designations

- Orphan Drug EMA: [Corcept — EU orphan designation for relacorilant in ovarian cancer](https://ir.corcept.com/news-releases/news-release-details/fda-approves-corcepts-selective-glucocorticoid-receptor)

## Related Pages

- CORT PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/CORT.md

- CORT company profile: https://biopharmsignal.com/company/CORT.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md

## Related News

- 2026-09-23 — Corcept Announces Planned Leadership Transition: https://biopharmsignal.com/news/CORT/corcept-announces-planned-leadership-transition-200a04c5.md

- 2026-09-18 — Corcept Announces CHMP Opinion Recommending EU Marketing Authorization for Lifyorli® (Relacorilant): https://biopharmsignal.com/news/CORT/corcept-announces-chmp-opinion-recommending-eu-marketing-authorization-for-lifyo-ce826197.md

- 2026-07-29 — Corcept Therapeutics Announces Second Quarter Financial Results and Provides Corporate Update: https://biopharmsignal.com/news/CORT/corcept-therapeutics-announces-second-quarter-financial-results-and-provides-cor-8ea3b293.md

- 2026-07-22 — Corcept Therapeutics to Announce Second Quarter Financial Results, Provide Corporate Update and Host Conference Call: https://biopharmsignal.com/news/CORT/corcept-therapeutics-to-announce-second-quarter-financial-results-provide-corpor-1db34366.md

- 2026-06-17 — Corcept Resubmits New Drug Application for Relacorilant as a Treatment for Patients with Cushing’s Syndrome: https://biopharmsignal.com/news/CORT/corcept-resubmits-new-drug-application-for-relacorilant-as-a-treatment-for-patie-aa5e76db.md