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REDWOOD CITY, Calif. - Corcept Therapeutics Incorporated (NASDAQ:CORT), a pharmaceutical company with a market capitalization of $7.6 billion and impressive revenue growth of 31% over the last twelve months, has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for relacorilant, its selective cortisol modulator, to treat patients with platinum-resistant ovarian cancer.
The application is based on data from the company’s Phase 3 ROSELLA and Phase 2 trials. According to the company, 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 relacorilant was well-tolerated and did not increase the safety burden for patients.
"This submission is an important milestone for Corcept as we now have two New Drug Applications before the FDA," said Joseph K. Belanoff, Corcept’s Chief Executive Officer, in a press release statement. According to InvestingPro data, the company maintains strong financial health with a current ratio of 3.07, indicating robust liquidity to support its drug development pipeline. InvestingPro analysts have set price targets ranging from $131 to $145 for the stock.
Relacorilant is an oral therapy that modulates cortisol activity by binding to the glucocorticoid receptor. The drug has received orphan drug designation from the FDA and the European Commission for the treatment of hypercortisolism, and from the European Commission for ovarian cancer treatment.
The FDA has already assigned a Prescription Drug User Fee Act target action date of December 30, 2025, for relacorilant as a treatment for patients with hypercortisolism.
Ovarian cancer is the fifth most common cause of cancer death in women. Platinum-resistant ovarian cancer occurs when the disease returns less than six months after platinum-containing therapy. According to the company, approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States. With a gross profit margin exceeding 98% and strong momentum reflected in its 128% return over the past year, Corcept appears well-positioned to capitalize on this market opportunity. For deeper insights into Corcept’s financial health and growth prospects, investors can access comprehensive analysis through InvestingPro’s detailed research reports.
In other recent news, Corcept Therapeutics announced positive results from its CATALYST trial, where its drug Korlym demonstrated a significant improvement in blood glucose control for patients with hypercortisolism and type 2 diabetes. The trial showed a 1.47% reduction in hemoglobin A1c levels in the treatment group compared to a 0.15% decrease in the placebo group, highlighting the potential benefits for diabetes management. Additionally, H.C. Wainwright reaffirmed its Buy rating and $145 price target for Corcept following the presentation of the Phase 3 ROSELLA study results, which showed a 30% reduction in the risk of disease progression in ovarian cancer patients receiving combination therapy. Truist Securities also maintained a Buy rating with a $135 price target, citing opportunities in treating hypercortisolism with co-morbid diabetes. Piper Sandler reiterated an Overweight rating and a $131 price target, emphasizing the potential role of relacorilant in treating platinum-resistant ovarian cancer. Furthermore, Corcept disclosed the outcomes of its 2025 annual meeting, where shareholders approved the election of directors, the ratification of the accounting firm, and executive compensation. These developments underscore the ongoing strategic initiatives and research progress at Corcept Therapeutics.
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