Relacorilant

iStock, valiantsin suprunovich Recent approvals for Corcept Therapeutics and Merck have injected momentum into the space, where GSK, Allarity Therapeutics, OSE Immunotherapies and others are advancing their own candidates. The market for drugs designed to treat the deadliest gynecological malignancy—ovarian cancer—is gaining steam, thanks to two recent approvals and a crop of novel candidates in earlier-stage trials. In February, Merck secured an FDA approval for Keytruda and subcutaneous injection Keytruda Qlex with paclitaxel for patients with platinum-resistant ovarian cancers (PROC). The addition of the blockbuster immunotherapy led to a 24% reduction in the risk of death, according to Phase 3 trial data. The agency then approved Corcept Therapeutics’ glucocorticoid blocker Lifyorli in PROC in March, with recent data showing a 35% reduction in the risk of death in combination with nab-paclitaxel compared to chemotherapy alone. Both approvals were huge wins, particularly for platinum-resistant ovarian cancer, where treatment options are limited, said Premal Thaker, the WashU Medicine director of gynecological oncology clinical research at Siteman Cancer Center . Thaker is the principal investigator on the Phase 3 OVATION-3 trial, which is evaluating a gene therapy from Imunon called IMNN-001 that is designed to boost levels of IL-12 and change the tumor microenvironment, alongside chemotherapy. Phase 2 data reported in March showed a 14.7-month increase in overall survival compared to standard of care chemotherapy. IMNN-001 is one of several candidates bringing new interest to a stubborn disease with a relative 5-year survival rate of 52% and limited treatment options. “A lot of drugs have gone into trials for many, many decades, and we just haven’t had the same success that we’re seeing right now,” Thaker told BioSpace . “It’s smarter drugs and medications.” Here are four candidates, each with a different mechanism of action, that the field is watching. Make way for GSK’s Mo-Rez and the ADCs The biggest frontrunners poised to make a dent in ovarian cancer are antibody-drug conjugates (ADCs), where AbbVie’s folate receptor antagonist Elahere is first-in-class . Another candidate with recent data is GSK’s mocertatug rezetecan, or Mo-Rez, a novel ADC that targets an antigen called B7-H4 and carries a topoisomerase inhibitor payload. In its Phase 1 dose-escalation trial, BEHOLD-1, Mo-Rez had a confirmed objective response rate (cORR) of 62% in patients with PROC and 67% in those with endometrial cancer, according to data presented at the Society for Gynecological Oncology’s annual meeting in April. “We were pretty happy with that,” Eric Richards, senior vice president and head of medicine development leaders for oncology at GSK, told BioSpace . “What we’re seeing is not only a high level of clinical activity but initial signs of pretty good durability.” Richards added that the immune checkpoint protein B7-H4 is overexpressed in the vast majority of ovarian cancer cells, making it an attractive target. GSK is launching five Phase 3 trials evaluating Mo-Rez this year across ovarian and endometrial cancers, including BEHOLD-Ovarian01 in PROC and BEHOLD-Ovarian02 in platinum-sensitive ovarian cancer. Elsewhere, German biotech Tubulis, recently acquired by Gilead, also recently reported positive results from a Phase 1 trial evaluating its ADC, TUB-040, in PROC. And Daiichi Sankyo and Merck are progressing their candidate raludotatug deruxtecan (R-Dxd) in a Phase 2/3 trial. It’s too early to say which candidates look most promising, Thaker said, adding that many of them carry the same topoisomerase payload. Their side effects will likely be a differentiating factor, she said. “It’s a little bit of a scientific conundrum right now—how are we going to sequence these? Because they all look very exciting.” Cancer ASCO: A battle of bispecifics, Eli Lilly’s big win and more Practice-changing data in lung cancer, prostate cancer and more were on display over the weekend at the American Society of Clinical Oncology annual meeting in Chicago. Plus, early readouts on assets that could reshape the cancer landscape. June 1, 2026 · 4 min read · Brianna Abbott Read more Zentalis chases a new target in WEE1 Zentalis Pharmaceuticals, meanwhile, is enrolling a Phase 3 global trial evaluating its novel inhibitor azenosertib in patients with cyclin E1–positive PROC against standard single-agent chemotherapy, according to a May press release . Azenosertib is designed to inhibit the protein kinase WEE1, a master regulator of cell cycle checkpoints. At the 2026 American Society of Clinical Oncology annual meeting, data from the Phase 1b MUIR trial showed that azenosertib plus paclitaxel resulted in an ORR of 39% and a median progression-free survival (PFS) of 7.3 months in an all-comer PROC population. Both the cyclin E1-positive and negative groups had similar responses, the trial found. The FDA granted Fast Track designation to the drug in January 2025 for patients who are positive for the cyclin E1 protein, which is overexpressed in around half of PROC patients. Ovarian cancer tumors positive for cyclin E1 are often especially hard to treat, Thaker noted. “It’s nice that we’re developing a medication that can help overcome that,” Thaker—who is also involved in the research—said. Plus, she added, the azenosertib pill might be easier to take than some of the ADCs, which are delivered via infusions. OSE’s proof-of-concept for cancer vaccines More positive ovarian cancer data at ASCO 2026 came from OSE Immunotherapeutics, which reported Phase 2 results for its off-the-shelf vaccine Tedopi (OSE2101), designed to stimulate a patient’s T cells and target five different tumor-linked antigens. In the TEDOVA trial, some 185 patients with platinum-sensitive recurrent ovarian cancer (PSOC) were randomized to Tedopi, Tedopi plus pembrolizumab or best supportive care as maintenance treatment after chemo. Patients in the trial were also required to be HLA-A2 positive, which shrinks the number of potentially eligible patients, Thaker said. “We have to be mindful when we look at some of these targets, we have to cut the pie a little bit more.” With a median follow-up of 22 months, patients on Tedopi and pembrolizumab experienced a median PFS of 4.1 months, compared to 2.8 months for those getting the best supportive care. The addition of pembrolizumab to Tedopi led to a 28% reduction in the risk of progression or death, compared to Tedopi alone, the trial found, though that result missed the mark for statistical significance. The results are the first proof of concept for a therapeutic vaccine in ovarian cancer and the first positive trial for PSOC in years, Alexandra Leary, deputy head of the department of medical oncology at Gustave Roussy in France and lead investigator on the trial, said in a press release . Allarity’s next generation PARP inhibitor Allarity Therapeutics’ stenoparib is another candidate with FDA Fast Track designation. The drug is a dual-target inhibitor that homes in on PARP 1/2 and tankyrase 1/2, differentiating it from earlier PARP inhibitors such as AstraZeneca and Merck’s Lynparza and GSK’s Zejula. Inhibiting tankyrase can disrupt signaling in the WNT pathway, which has been implicated in multiple cancers, Jeremy R. Graff, president and chief developmental officer at Allarity, told BioSpace . “It really seems to be particularly highly activated in really advanced, chemo- and radio-resistant cancers.” Allarity licensed stenoparib in 2017 from Eisai based on the drug’s Phase 1 data. In Phase 2 data reported in September 2025, the median overall survival had not been reached at 25 months for patients with platinum-resistant and refractory ovarian cancer. The drug appeared to benefit patients regardless of their BRCA status, Graff added. The company is expanding its Phase 2 trial for patients with PROC and has amended its trial protocol to focus on advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer. Like with Zentalis’s azenosertib, the pill will likely be easier to take with milder toxicities than the ADCs, Graff said, which could be particularly helpful for older women. Ovarian cancer hasn’t historically garnered as much attention as cancers with the biggest patient pools, including breast or prostate cancer, Graff said. But the hard-to-treat disease is now capturing more interest. “It’s a huge unmet medical need,” Graff said. “We’d love to, with the era of targeted therapies, go beyond just poisoning people with chemotherapy.” .responsive-container { display: flex; flex-wrap: wrap; border: 1px solid #ededed; font-family: Helvetica, Arial, Sans-Serif; padding: 20px 20px 10px 20px; } .column-left { flex: 1; max-width: 45%; padding: 20px 20px 10px 20px; } .column-right { flex: 2; padding: 20px 20px 10px 20px; } @media (max-width: 768px) { .column-left, .column-right { max-width: 100%; flex: 100%; padding: 10px 0; } } Subscribe to ClinicaSpace! Clinical trial results, research news, the latest in cancer, cell and gene therapy hbspt.forms.create({ region: "na1", portalId: "4413123", formId: "674f4dc0-7371-4190-86cc-e1afd00b08ea", onFormSubmitted: function($form, data) { window.dataLayer = window.dataLayer || []; window.dataLayer.push({ 'event': 'GTMevent', 'event_name': 'newsletter_sign_up' }); } });

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 it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for relacorilant as a treatment for patients with Cushing’s syndrome. As requested by the FDA, the resubmission includes additional analyses of data included in the original NDA submission. Corcept expects the resubmission to receive a six-month review. “We are pleased to return relacorilant’s NDA to the review process and look forward to working with the Agency to advance relacorilant toward approval as a treatment for patients with Cushing’s syndrome,” said Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer. “Relacorilant has the potential to benefit many patients and it’s important we make it available as quickly as possible. We appreciate the FDA’s ongoing engagement with our application.” Corcept’s resubmission is based on positive data from its pivotal GRACE trial, the double-blind, placebo-controlled Phase III GRADIENT trial, relacorilant’s long-term extension study and earlier-stage development data. Corcept believes that these data show that relacorilant provides meaningful, durable improvements in the signs and symptoms of Cushing's syndrome, without causing some of the serious adverse events associated with currently approved medications – termination of pregnancy, hypokalemia, endometrial hypertrophy, vaginal bleeding, adrenal insufficiency and QT prolongation. About Hypercortisolism (Cushing’s Syndrome) Hypercortisolism, also known as Cushing’s syndrome, is caused by excessive activity of the hormone cortisol. Symptoms vary, but most patients experience one or more of the following manifestations: hypertension, central obesity, elevated blood sugar and difficult-to-control type 2 diabetes, severe fatigue and weak muscles. Irritability, anxiety, depression and cognitive disturbances are common. Hypercortisolism can affect every organ system and can be fatal if not treated effectively. Cardiovascular events are the most common cause of death among patients with hypercortisolism. Recent research shows that endogenous hypercortisolism is more prevalent than previously believed. About Relacorilant Relacorilant, an oral therapy, is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body's other hormone receptors. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the FDA and the European Commission (EC) for the treatment of hypercortisolism and by the EC for the treatment of ovarian cancer. Under the brand name Lifyorli™, relacorilant was approved in combination with nab-paclitaxel for adults with platinum-resistant ovarian cancer by the FDA in 2026. Corcept has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for relacorilant to treat patients with platinum-resistant ovarian 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, leading to the discovery of more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with Cushing’s syndrome, solid tumors, ALS and liver disease. In 2012, the company introduced Korlym ® , the first medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with endogenous Cushing’s syndrome, and in 2026, the company introduced Lifyorli™, approved in combination with nab-paclitaxel, the first FDA-approved selective glucocorticoid receptor antagonist for adults with platinum-resistant ovarian cancer. Corcept is headquartered in Redwood City, California. For more information, visit Corcept.com . 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: Corcept’s resubmission of its NDA to the FDA for relacorilant as a treatment for patients with Cushing’s syndrome; Corcept’s expectation that this resubmission will receive a six-month review; Corcept’s intent to work with the FDA to advance relacorilant toward approval as a treatment for patients with Cushing’s syndrome; relacorilant’s potential to benefit many patients; and Corcept’s belief regarding the importance of making relacorilant available as quickly as possible. A further description of risks and uncertainties 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, 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