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REDWOOD CITY, Calif. - The U.S. Food and Drug Administration has accepted Corcept Therapeutics Incorporated’s (NASDAQ:CORT) New Drug Application for relacorilant as a treatment for patients with platinum-resistant ovarian cancer, according to a company press release. The FDA has assigned a Prescription Drug User Fee Act date of July 11, 2026. The announcement comes as Corcept, now valued at $7.56 billion, has seen its stock surge over 104% in the past year, trading near InvestingPro’s Fair Value estimate.
The application is based on data from Corcept’s Phase 3 ROSELLA and Phase 2 clinical trials. In these studies, patients who received relacorilant in combination with nab-paclitaxel showed improved progression-free and overall survival compared to those who received nab-paclitaxel alone. The company reported that no biomarker selection was needed for the treatment.
"The FDA’s acceptance of our NDA brings us closer to offering a much-needed treatment option to patients with this dire disease," said Joseph Belanoff, Corcept’s Chief Executive Officer. The company’s strong financial position, with a current ratio of 3.06 and minimal debt, supports its development initiatives. InvestingPro analysis reveals 13 additional key insights about Corcept’s financial health and growth prospects.
According to the release, relacorilant is an oral selective glucocorticoid receptor antagonist that modulates cortisol activity. The drug was reportedly well-tolerated in trials, with adverse events in the combination treatment arm similar to those in the nab-paclitaxel monotherapy arm.
Ovarian cancer is the fifth most common cause of cancer death in women. Platinum-resistant disease occurs when a patient’s cancer returns less than six months after receiving platinum-containing therapy. The company states that approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States.
Relacorilant has been designated an orphan drug by the FDA and the European Commission for the treatment of hypercortisolism, and by the European Commission for the treatment of ovarian cancer.
In other recent news, Corcept Therapeutics announced its Q2 2025 earnings, which featured a notable earnings per share (EPS) beat but a slight revenue shortfall. The company reported an EPS of $0.29, surpassing the forecasted $0.19 by 52.63%. On the revenue side, Corcept Therapeutics brought in $194.4 million, which was just shy of the expected $199.4 million, marking a 2.51% discrepancy. These results reflect ongoing supply chain challenges that the company is facing. Despite the impressive EPS results, the revenue miss has drawn attention from investors. The earnings report highlights the complexities of balancing strong earnings with operational challenges. These developments are crucial for investors to consider as they assess Corcept Therapeutics’ financial performance.
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