Core Insights - Corcept Therapeutics (CORT) is making significant progress with its sole-marketed drug, Korlym (mifepristone), which is approved for treating Cushing's syndrome or endogenous hypercortisolism. The company's revenue is currently derived entirely from Korlym sales [1] Sales Performance - In the first nine months of 2025, Korlym generated sales of $559.3 million, reflecting a year-over-year increase of approximately 13.4%. The sales momentum is expected to continue, with a projected compound annual growth rate (CAGR) of around 26.4% over the next three years [2][10] - Despite earlier sales disruptions due to insufficient capacity from a specialty pharmacy vendor, sales have improved, and further enhancements are anticipated with new pharmacy vendors in 2026. For the full year of 2025, Corcept expects total revenues to be between $800 million and $850 million [3][10] Pipeline Development - Corcept is developing relacorilant, its lead pipeline candidate, for treating Cushing's syndrome and certain cancer indications. A new drug application (NDA) for relacorilant was submitted to the FDA in December 2024, with a target action date of December 30, 2025 [4][5] - Approval of relacorilant for Cushing's syndrome is expected to diversify Corcept's revenue streams and reduce reliance on Korlym. Management anticipates that all current Korlym patients will transition to relacorilant upon its approval [6] - The FDA accepted an NDA for relacorilant in combination with nab-paclitaxel for treating platinum-resistant ovarian cancer, with a decision expected on July 11, 2026. Additionally, a marketing authorization application (MAA) has been submitted to the European Medicines Agency for the same indication, with potential approval by the end of 2026 [7] - Corcept is also conducting studies evaluating relacorilant in combination with nab-paclitaxel and Avastin for platinum-resistant ovarian cancer, as well as with Xtandi for early-stage prostate cancer [8][9] Financial Performance and Valuation - Year-to-date, Corcept's shares have increased by 57.6%, outperforming the industry, which rose by 9.4%. The stock has also surpassed the performance of the sector and the S&P 500 [11] - From a valuation perspective, Corcept is trading at a premium, with a price-to-sales (P/S) ratio of 12.80, significantly higher than the industry average of 2.38 and above its five-year mean of 7.66 [12] - The Zacks Consensus Estimate for 2025 earnings per share (EPS) has decreased from $1.15 to $0.89 over the past 60 days, with 2026 EPS estimates also declining from $1.71 to $1.25 [13]

Core Insights - Corcept Therapeutics (CORT) has received FDA acceptance for its new drug application (NDA) for relacorilant, aimed at treating platinum-resistant ovarian cancer, with a decision expected by July 11, 2026 [1][8] Group 1: NDA Submission and Study Results - The NDA submission was based on positive results from the pivotal phase III ROSELLA study and phase II studies, which assessed relacorilant in combination with nab-paclitaxel [2][8] - The ROSELLA study met its primary endpoint of improved progression-free survival, indicating the potential for relacorilant plus nab-paclitaxel to become a new standard of care for this patient population [3][8] Group 2: Financial Performance and Market Position - Year-to-date, Corcept's shares have increased by 42.1%, outperforming the industry average rise of 12.9% [4] - The company’s sole marketed drug, Korlym (mifepristone), generated sales of $351.6 million in the first half of 2025, reflecting a year-over-year increase of 13.2% [10] Group 3: Future Prospects and Additional Studies - Corcept is also pursuing an NDA for relacorilant to treat hypercortisolism (Cushing's syndrome), with a target action date set for December 30, 2025 [5][8] - The company is conducting the phase II BELLA study to evaluate the combination of relacorilant with nab-paclitaxel and Roche's Avastin for platinum-resistant ovarian cancer [9] - A successful approval for relacorilant could broaden Corcept's patient base and reduce reliance on Korlym for future growth [11]

Core Insights - Corcept Therapeutics (CORT) has submitted a new drug application (NDA) to the FDA for its lead candidate, relacorilant, in combination with nab-paclitaxel for treating platinum-resistant ovarian cancer [1][7] - The NDA submission is based on positive data from the pivotal phase III ROSELLA study, which met its primary endpoint of improved progression-free survival [3][2] - The company aims to diversify its product offerings beyond its sole marketed drug, Korlym, to reduce reliance on it for growth [9][7] NDA Submissions and Studies - In December 2024, CORT submitted an NDA for relacorilant to treat hypercortisolism (Cushing's syndrome), which was accepted by the FDA in March 2025 with a target action date of December 30, 2025 [5][2] - The NDA for platinum-resistant ovarian cancer is supported by data from the ROSELLA study and other phase II studies [2][3] - CORT is also conducting additional studies, including the BELLA study, which evaluates relacorilant in combination with nab-paclitaxel and Roche's Avastin for the same indication [10] Financial Performance - Year to date, CORT shares have increased by 44.4%, significantly outperforming the industry average rise of 4.1% [4] - Korlym generated sales of $157.2 million in Q1 2025, reflecting a year-over-year increase of 7.1% due to strong demand [8] Pipeline and Future Prospects - CORT is exploring relacorilant in combination with Xtandi for early-stage prostate cancer and evaluating its selective cortisol modulator dazucorilant for amyotrophic lateral sclerosis (ALS) [11] - Another candidate, miricorilant, is being studied for metabolic dysfunction-associated steatohepatitis [12] - A potential approval for relacorilant could expand CORT's patient base and reduce dependence on Korlym for long-term growth [9]