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Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission (EC) should approve relacorilant, combined with the chemotherapy drug nab-paclitaxel, for the treatment of patients with platinum-resistant ovarian cancer.
The CHMP's recommendation is based on positive data from Corcept's Phase 2 and pivotal Phase 3 ROSELLA trials, in which patients receiving relacorilant combined with nab-paclitaxel experienced improved progression-free and overall survival compared to patients who received nab-paclitaxel alone. The safety profile of relacorilant plus nab-paclitaxel in these trials was consistent with the safety profile of nab-paclitaxel monotherapy.
The EC will review the CHMP's opinion and issue a final decision regarding approval in the fourth quarter of 2026.
"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. We look forward to the European Commission's final decision," said Joseph K. Belanoff, M.D., Corcept's Chief Executive Officer. "I want to thank the CHMP for conducting such an efficient and timely review. I also want to thank the healthcare providers and patients who participated in relacorilant's clinical trials. Without them, advancing this fundamentally new approach to treating cancer would not have been possible."
About Relacorilant
Relacorilant achieves its effects by binding to the glucocorticoid receptor but not to the body's other hormone receptors. Relacorilant is the only selective glucocorticoid receptor modulator approved by the U.S. Food and Drug Administration for any indication. It is marketed in the United States for the treatment of patients with platinum-resistant ovarian cancer under the trade name Lifyorli ® . Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use, formulation, manufacturing and other patents.
About the ROSELLA Pivotal Trial
ROSELLA was relacorilant's pivotal Phase 3 trial. It enrolled 381 patients with platinum-resistant ovarian cancer at sites in the United States, Europe, South Korea, Brazil, Argentina, Canada and Australia. Patients were randomized 1:1 to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel alone. The ROSELLA trial is being conducted in collaboration with the GOG Foundation, Inc., the European Network of Gynaecological Oncological Trial groups, the Asia-Pacific Gynecologic Oncology Trials Group, the Latin American Cooperative Oncology Group and the Australia New Zealand Gynaecological Oncology Group.
About Ovarian Cancer
Ovarian cancer is the fifth most common cause of cancer death in women. Patients with disease that progresses less than six months after commencing platinum-based chemotherapy have "platinum-resistant" disease. There are few treatment options for these women. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe.
About Cortisol's Role in Oncology
Cortisol plays a role in tumor growth through several mechanisms. It helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol promotes tumor growth by activating oncogenic signaling in the cells to which it binds. Cortisol also suppresses the body's immune response, which weakens its ability to fight all diseases, including cancer.
About Corcept Therapeutics
For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders and has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced development programs in patients with hypercortisolism, a variety of solid tumors, ALS and liver disease.
Forward-Looking Statements
Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations and are subject to risks and uncertainties that might cause our actual results to differ materially from any future results expressed or implied by such forward-looking statements.
In this press release, forward-looking statements include statements concerning: relacorilant's safety profile and potential as a treatment for patients with platinum-resistant ovarian cancer; the anticipated timing and outcome of the EC's review of the CHMP opinion, including the potential for the EC to approve our marketing application in the fourth quarter of 2026; and Corcept's intent to make the benefits of glucocorticoid receptor antagonism available to patients in the EU.
A further description of risks and uncertainties affecting our forward-looking statements can be found in our SEC filings, which are available at our website and the SEC's website. These risks and uncertainties include, but are not limited to, those related to: our ability to operate our business; our efforts to study and develop Korlym, Lifyorli, relacorilant, miricorilant, dazucorilant, nenocorilant and our other product candidates; those molecules' clinical attributes; regulatory approvals, mandates, oversight and other requirements imposed on our products or our business by laws, regulations or discretion of government authorities; and the scope and protective power of our intellectual property. We disclaim any intention or duty to update forward-looking statements made in this press release.
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