Corcept's Lifyorli wins CHMP backing as EU decision looms
Corcept Therapeutics won a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for relacorilant (Lifyorli) plus nab-paclitaxel in platinum-resistant ovarian cancer, leaving only the European Commission's formal decision, expected in the fourth quarter of 2026, before the combination can launch across the EU.
"The CHMP's positive opinion takes us a big step closer to making the benefits of glucocorticoid receptor antagonism available to patients in the EU," Joseph K. Belanoff, Corcept's chief executive officer, said. "I want to thank the CHMP for conducting such an efficient and timely review."
The opinion rests on the Phase 3 ROSELLA trial, which enrolled 381 patients across the United States, Europe, South Korea, Brazil, Argentina, Canada and Australia. Relacorilant plus nab-paclitaxel produced median progression-free survival of 6.54 months versus 5.52 months for nab-paclitaxel alone, a hazard ratio of 0.70, meaning a 30% reduction in the risk of progression or death. Final analysis of the trial's other dual primary endpoint showed median overall survival of 16.0 months versus 11.9 months, a hazard ratio of 0.65. The safety profile matched nab-paclitaxel monotherapy, with anemia, nausea, diarrhea, neutropenia and fatigue the most common adverse reactions.
The CHMP opinion covers adults with platinum-resistant high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic treatment regimens. Every patient in ROSELLA had prior bevacizumab, and roughly six in 10 had received a PARP inhibitor, a heavily pretreated population that has exhausted platinum-based chemotherapy.
Relacorilant is a selective, reversible glucocorticoid receptor antagonist. It binds the glucocorticoid receptor without engaging the body's other hormone receptors, blocking cortisol signaling that otherwise inhibits chemotherapy-induced apoptosis — the tumor-killing effect chemotherapy is designed to trigger. Corcept says it is the only selective glucocorticoid receptor modulator approved by the FDA for any indication.
The FDA cleared the same combination in March 2026 for platinum-resistant ovarian cancer, and Lifyorli generated $47.6 million in the second quarter of 2026, its first quarter of commercial availability. Corcept resubmitted a new drug application for relacorilant in hypercortisolism, or Cushing's syndrome, in June 2026; the FDA accepted it and set a target action date of Dec. 17, 2026.
The European Commission typically finalizes marketing authorization about 67 days after a CHMP recommendation, which places a decision in the fourth quarter of 2026. Corcept estimates roughly 20,000 women with platinum-resistant disease begin a new therapy each year in the United States, with at least an equal number in Europe — a market the company currently serves only in the U.S.
Corcept is also testing relacorilant with other anticancer therapies in platinum-sensitive ovarian, prostate, endometrial, cervical and pancreatic cancers. The Phase 2 BELLA study, part A, is evaluating relacorilant plus nab-paclitaxel and Roche's Avastin (bevacizumab) in platinum-resistant ovarian cancer, testing whether the three-drug regimen adds benefit over the approved two-drug combination.
Shares of Corcept have climbed 216.9% year to date, against a 2.9% decline for the broader industry, a re-rating that already prices in substantial regulatory success. The EC decision is the next binary event for holders; the Dec. 17, 2026 FDA action date on the Cushing's syndrome application is the second. Both sit inside the same quarter, concentrating the company's near-term risk into a narrow window.
This article is for informational purposes only and does not constitute investment advice.
