{"id":869100,"date":"2025-07-14T08:20:02","date_gmt":"2025-07-14T12:20:02","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/corcept-submits-new-drug-application-for-relacorilant-as-a-treatment-for-patients-with-platinum-resistant-ovarian-cancer\/"},"modified":"2025-07-14T08:20:02","modified_gmt":"2025-07-14T12:20:02","slug":"corcept-submits-new-drug-application-for-relacorilant-as-a-treatment-for-patients-with-platinum-resistant-ovarian-cancer","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/corcept-submits-new-drug-application-for-relacorilant-as-a-treatment-for-patients-with-platinum-resistant-ovarian-cancer\/","title":{"rendered":"Corcept Submits New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer"},"content":{"rendered":"

<\/p>\n

Corcept Submits New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer<\/b><\/p>\n

REDWOOD CITY, Calif.–(BUSINESS WIRE<\/a>)–
\nCorcept 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, has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for its proprietary, selective cortisol modulator, relacorilant, to treat patients with platinum-resistant ovarian cancer.<\/p>\n

\nCorcept\u2019s filing is based on positive data from its pivotal Phase 3 ROSELLA and Phase 2 trials. In these trials, patients who received relacorilant plus nab-paclitaxel experienced improved progression-free and overall survival compared to patients who received nab-paclitaxel monotherapy, with no need for biomarker selection. Relacorilant was well-tolerated, consistent with its known safety profile. Importantly, the type, frequency and severity of adverse events in the combination arms were similar to those in the nab-paclitaxel monotherapy arms. Relacorilant did not increase the safety burden of the patients who received it.<\/p>\n

\n\u201cThis submission is an important milestone for Corcept as we now have two New Drug Applications before the FDA: Relacorilant in combination with nab-paclitaxel as a treatment for people with platinum-resistant ovarian cancer and relacorilant as a treatment for patients with hypercortisolism,\u201d said Joseph K. Belanoff, M.D., Corcept\u2019s Chief Executive Officer. \u201cBetter treatment options are needed for the many patients living with these diseases. Our oncology and endocrinology business units are already working to make sure relacorilant is available immediately following regulatory approval.\u201d<\/p>\n

About Relacorilant<\/b><\/p>\n

\nRelacorilant, 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. Corcept is developing relacorilant in ovarian cancer and a variety of other serious disorders, including endogenous hypercortisolism and prostate cancer. 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. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025 for relacorilant as a treatment for patients with hypercortisolism.<\/p>\n

About Cortisol\u2019s Role in Oncology<\/b><\/p>\n

\nCortisol plays a role in tumor growth through several mechanisms. It helps solid tumors resist chemotherapy by inhibiting cellular apoptosis \u2014 the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol promotes tumor growth by activating oncogenes in the cells to which it binds. Cortisol also suppresses the body\u2019s immune response, which weakens its ability to fight all diseases, including cancer.<\/p>\n

About Platinum-Resistant Ovarian Cancer<\/b><\/p>\n

\nOvarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have \u201cplatinum-resistant\u201d disease. There are few treatment options for these women. Median overall survival following recurrence is approximately 12 months with single-agent chemotherapy. 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.<\/p>\n

About Corcept Therapeutics<\/b><\/p>\n

\nFor 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 hypercortisolism, solid tumors, ALS and liver disease. In February 2012, the company introduced Korlym\u00ae, the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with endogenous hypercortisolism. Corcept is headquartered in Redwood City, California. For more information, visit Corcept.com<\/a>.<\/p>\n

Forward-Looking Statements<\/b><\/p>\n

\nStatements 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 those such statements express or imply. These risks and uncertainties are set forth in our SEC filings, which are available at our website and the SEC\u2019s website.<\/p>\n

\nIn this press release, forward-looking statements include statements concerning: relacorilant\u2019s potential to receive regulatory approval from the FDA as a treatment for patients with platinum-resistant ovarian cancer and for patients with hypercortisolism; relacorilant\u2019s ability to provide important benefits to patients living with these diseases; relacorilant\u2019s availability following potential regulatory approval; the scope and protective power of relacorilant\u2019s orphan drug designation and our intellectual property; and the potential of cortisol modulation to treat patients with a wide variety of serious disorders. We disclaim any intention or duty to update forward-looking statements made in this press release.<\/p>\n

\"\"<\/p>\n

View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20250714921466\/en\/<\/a><\/span><\/p>\n

\nInvestor inquiries:
\n
ir@corcept.com
\n<\/a><\/p>\n

Media inquiries:
\n
communications@corcept.com
\n<\/a>
www.corcept.com<\/a><\/p>\n

KEYWORDS:<\/b> United States North America California<\/p>\n

INDUSTRY KEYWORDS:<\/b> Science Biotechnology Research Pharmaceutical Oncology Health FDA Clinical Trials<\/p>\n

MEDIA:<\/b><\/p>\n\n\n\n\n
Logo<\/b><\/font><\/td>\n<\/tr>\n
\"Logo\"<\/td>\n<\/tr>\n
<\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Corcept Submits New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer 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, has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for its proprietary, selective cortisol modulator, relacorilant, to treat patients with platinum-resistant ovarian cancer. Corcept\u2019s filing is based on positive data from its pivotal Phase 3 ROSELLA and Phase 2 trials. In these trials, patients who received relacorilant plus nab-paclitaxel experienced improved progression-free and overall survival compared to patients who received nab-paclitaxel … <\/p>\n

Continue reading “Corcept Submits New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-869100","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nCorcept Submits New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/corcept-submits-new-drug-application-for-relacorilant-as-a-treatment-for-patients-with-platinum-resistant-ovarian-cancer\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Corcept Submits New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Corcept Submits New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer 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, has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for its proprietary, selective cortisol modulator, relacorilant, to treat patients with platinum-resistant ovarian cancer. Corcept\u2019s filing is based on positive data from its pivotal Phase 3 ROSELLA and Phase 2 trials. 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