Relacorilant

The EMA's drug advisory panel backed a dozen new medicines for approval at its September meeting, including Novo's Frehemgo (denecimig) for haemophilia A, Incyte's Povofortay (povorcitinib) in severe hidradenitis suppurativa (HS) and two therapies for ovarian cancer.Among the more closely watched decisions announced Friday, the agency's Committee for Medicinal Products for Human Use (CHMP) recommended Frehemgo for the routine prophylaxis of bleeding episodes in patients with haemophilia A, regardless of inhibitor status. The decision was supported by findings from the FRONTIER programme, in which Frehemgo significantly reduced the annualised bleeding rate compared to prior clotting factor prophylaxis and on-demand treatment. The next-generation factor VIIIa mimetic bispecific antibody, previously known as Mim8, has also shown comparable effectiveness in children.The drug's dosing flexibility – it can be given once-monthly, once every two weeks, or once-weekly via single-use pre-filled pens – could be a possible key differentiator (see — KOL Views Q&A: Novo Nordisk’s denecimig may struggle to displace entrenched Hemlibra in haemophilia A). A similar application for Frehemgo is under review in the US.On Friday, Novo also received a positive CHMP opinion to expand use of Sogroya (somapacitan) to include children living with idiopathic short stature with persistent growth disturbance. The once-weekly, long-acting human growth hormone analogue is already authorised in the EU for the treatment of growth hormone deficiency in adults and in children ages 3 years and older.Povofortay nears first OKMeanwhile, the positive opinion for Povofortay moves Incyte's oral JAK1 inhibitor one step closer to securing its first approval. CHMP's decision covers the treatment of active moderate-to-severe HS in adults who have responded inadequately to, or who are intolerant or contraindicated to an anti-TNF therapy.The submission is supported by findings from the Phase III STOP-HS1 and STOP-HS2 studies, which both met their primary endpoints by demonstrating significant reductions in abscess and nodule count. Longer-term results presented at this year's American Academy of Dermatology (AAD) meeting showed that up to 57% of HS patients taking Povofortay achieved ≥75% reduction in inflammatory lesions after one year in the trials.A filing in this indication is also under review in the US, while Incyte is planning applications in vitiligo based on data released earlier this year. Pair of ovarian cancer drugsIn ovarian cancer, CHMP backed the approval of drugs with two different mechanisms of action: Corcept Therapeutics' selective glucocorticoid receptor modulator Lifyorli (relacorilant) and IMPACT Therapeutics' oral PARP1/2 inhibitor Sepalna (senaparib).Lifyorli's positive opinion is for use in combination with nab-paclitaxel to treat platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. The drug, which was approved earlier this year in the US, is seen as an advancement in ovarian cancer treatment. Deanna Gerber, an assistant professor of obstetrics and gynaecology at Weill Cornell Medicine, previously told FirstWord that Lifyorli is "going to be the next big thing" in the field (see – KOL Views Q&A: Relacorilant set for early uptake in platinum-resistant ovarian cancer).The recommendation was based on clinical data including from the Phase III ROSELLA trial, in which patients given Lifyorli plus nab-paclitaxel achieved improved progression-free and overall survival compared to nab-paclitaxel alone, without an increase in adverse events.The EMA panel also endorsed Sepalna as a maintenance treatment for advanced epithelial ovarian, fallopian tube and primary peritoneal cancer. The decision was supported by findings from the Phase III FLAMES study, in which Sepalna reduced the risk of disease progression of death by 57% compared to placebo when used as first-line maintenance monotherapy in a broad patient population with advanced ovarian cancer.Sepalna is already approved in China in the ovarian cancer maintenance setting, while IMPACT recently out-licensed certain rights to the drug to Pharmanovia, including in the EU.Other new drugs recommended for approval at CHMP's latest meeting include Xcovery's Gevalka (ensartinib) for adults with ALK-positive advanced non–small-cell lung cancer, AstraZeneca's Klygefa (gefurulimab) for generalised myasthenia gravis, Sanofi's rabies vaccine VaxRabeo, and Zealand Pharma's Zeydovio (glepaglutide) for the treatment of short bowel syndrome.

REDWOOD CITY, Calif.--(BUSINESS WIRE)--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 pro relacorilant plus nab-paclitaxel in these trials was consistent with the safety pro 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 pro 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. Contacts Investor inquiries: ir@corcept.com Media inquiries: communications@corcept.com