Shares of Corcept Therapeutics (NASDAQ:CORT) surged by 45% on Thursday amid the announcement that its Phase 3 clinical trial evaluating relacorilant in platinum-resistant ovarian cancer achieved the primary endpoint of improved overall survival.
The pivotal ROSELLA trial's findings indicated that patients receiving relacorilant alongside nab-paclitaxel chemotherapy experienced a 35% reduction in mortality risk in comparison to those treated with nab-paclitaxel alone. The median overall survival extended to 16.0 months for patients on the combined regimen, surpassing the 11.9 months observed in the chemotherapy-only group by 4.1 months.
This development complements the company's previous disclosure that the trial also satisfied its other primary endpoint by demonstrating a 30% decrease in risk of disease progression with the combination therapy relative to nab-paclitaxel monotherapy.
Safety profiles reinforced the treatment's viability, with adverse events occurring at rates similar to the nab-paclitaxel-only cohort, indicating that relacorilant introduces survival advantages without exacerbating side effects.
Currently, the U.S. Food and Drug Administration is reviewing relacorilant’s New Drug Application, with an anticipated decision date slated for July 11, 2026. Concurrently, the European Medicines Agency is assessing the Marketing Authorization Application, underscoring the drug’s international regulatory progression.
Alexander B. Olawaiye, Director of gynecological cancer research at Magee-Women’s Hospital of the University of Pittsburgh and Principal Investigator of the ROSELLA study, commented on the significance of these results. He emphasized that combining relacorilant with the trusted chemotherapy agent nab-paclitaxel could establish a new standard of care for patients contending with platinum-resistant ovarian cancer due to the observed survival benefit, favorable side effect profile, and the convenience of oral administration.
Beyond ovarian cancer, Corcept is investigating relacorilant’s efficacy in an array of solid tumors, including platinum-sensitive ovarian, endometrial, cervical, pancreatic, and prostate cancers, seeking to expand its therapeutic applications.