CORT Files MAA for Relacorilant in Platinum-Resistant Ovarian Cancer

Core Insights - Corcept Therapeutics (CORT) has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for its lead candidate, relacorilant, aimed at treating platinum-resistant ovarian cancer [1] - The MAA is supported by positive results from the pivotal phase III ROSELLA study and phase II studies, which demonstrated improved progression-free and overall survival when relacorilant was combined with nab-paclitaxel compared to nab-paclitaxel alone [2] - The FDA has accepted a new drug application (NDA) for relacorilant, with a final decision expected on July 11, 2026 [2] Company Performance - Year-to-date, Corcept's shares have increased by 43.1%, significantly outperforming the industry average rise of 7.4% [3] - The company's sole marketed drug, Korlym (mifepristone), generated sales of $351.6 million in the first half of 2025, reflecting a year-over-year increase of 13.2% [7] Ongoing Development Activities - Corcept is also developing relacorilant for Cushing's syndrome, having submitted an NDA to the FDA in December 2024, with a target action date of December 30, 2025 [5][6] - The company is conducting the phase II BELLA study to evaluate the combination of relacorilant with nab-paclitaxel and Roche's Avastin for platinum-resistant ovarian cancer [6] Market Position - A potential approval of relacorilant could expand Corcept's market reach and reduce its dependence on Korlym for future growth [5][7] - Corcept currently holds a Zacks Rank of 5 (Strong Sell), while other biotech stocks like Chemomab Therapeutics and ANI Pharmaceuticals have better rankings [8]