Lifyorli (relacorilant) + Nab-paclitaxel

Development notes

ROSELLA Trial. 7/29/24 - Enrollment complete. 3/31/25- Primary endpoint met. Late-breaking oral presentation at ASCO'25. 7/14/25- NDA submitted. 9/10/25- NDA accepted with PDUFA date July 11, 2026. 10/14/25- MAA submitted to EMA. Presented new data at ESMO'25. 11/04/25:- Final ROSELLA OS results expected early 2026; EMA MAA approval expected by end of 2026. 01/22/26:- ROSELLA Ph3 showed 35% OS risk reduction; full results at upcoming medical conference; NDA, MAA reviews ongoing. 02/24/26:- ROSELLA dual endpoints met; full PROC results at SGO April 2026; EMA MAA approval expected by Q4 2026. 03/25/26:- FDA approved Lifyorli plus nab-paclitaxel in platinum-resistant ovarian cancer. Complete ROSELLA results at SGO April 2026. 04/10/26:- Final ROSELLA OS data at SGO 2026. FDA approved March 2026; NCCN lists preferred. 04/21/26:- ROSELLA OS subgroup analyses for prior taxane use to be presented at ASCO on May 29, 2026. 04/30/26:- ROSELLA complete results presented at SGO 2026 and published in The Lancet; EMA MAA approval still expected by Q4 2026. 05/29/26:- ASCO 2026 ROSELLA OS subgroup data: hazard ratio 0.60–0.67; safety comparable. 07/29/26:- Q2 2026 Lifyorli revenue was $47.6M. Over 1,300 patients started treatment.