CORT Rises on FDA Nod to Lifyorli in Platinum-Resistant Ovarian Cancer

Core Insights - Corcept Therapeutics (CORT) received FDA approval for its selective glucocorticoid receptor antagonist, Lifyorli (relacorilant), in combination with nab-paclitaxel for treating adult patients with platinum-resistant ovarian cancer [1][2] Group 1: FDA Approval and Clinical Data - Lifyorli is now the first FDA-approved selective glucocorticoid receptor antagonist for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, specifically for patients who have undergone one to three prior systemic treatments, including at least one with bevacizumab [2] - The approval was based on the pivotal phase III ROSELLA study, which met its dual primary endpoints of progression-free survival and overall survival [4] - The study demonstrated a 35% reduction in the risk of death for patients treated with Lifyorli plus nab-paclitaxel compared to nab-paclitaxel alone, with median overall survival of 16 months versus 11.9 months [5] - Additionally, there was a 30% reduction in the risk of disease progression for the combination treatment compared to nab-paclitaxel alone [6] Group 2: Market Impact and Revenue Diversification - Following the announcement, Corcept's shares increased by 19.7%, and the stock has risen 16.3% year-to-date, contrasting with a 4.9% decline in the industry [3] - The approval of Lifyorli is expected to diversify Corcept's revenue base, which has been heavily reliant on Korlym, currently approved for treating Cushing's syndrome [9] - Management believes Lifyorli is positioned to become a new standard-of-care treatment for platinum-resistant ovarian cancer, potentially reducing dependence on Korlym for revenues [9] Group 3: Future Developments - Corcept is also developing relacorilant for Cushing's syndrome, although it recently faced a setback with a complete response letter from the FDA regarding its new drug application for this indication [10][11] - The company is engaging with the FDA to find a path forward for relacorilant and has submitted a marketing authorization application to the European Medicines Agency for relacorilant in platinum-resistant ovarian cancer, with a decision expected in 2026 [13]