Monte Rosa Therapeutics Inc. (NASDAQ:GLUE) shared interim data from an ongoing Phase 1/2 clinical study evaluating MRT-2359 in combination with enzalutamide in heavily pretreated patients with metastatic castration-resistant prostate cancer (mCRPC).The Phase 1/2 study evaluated 0.5 mg and 0.75 mg of MRT-2359 administered orally on a 21-days-on, 7-day-off drug schedule in combination with Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc.’s (OTC:ALPMF) (OTC:ALPMY) Xtandi (enzalutamide).The study population, as ...

Key Takeaways CORT's revenues are driven by Korlym, which posted $559.3M in nine-month sales in 2025, up 13.4% y/y.The company expects full-year 2025 revenues of $800M-$850M and sustained Korlym growth.Corcept filed NDAs for relacorilant in Cushing's and ovarian cancer, with FDA decisions due in 2025 and 2026.Corcept Therapeutics (CORT) has been making meaningful progress with its sole-marketed drug, Korlym (mifepristone), which is approved for treating Cushing's syndrome or endogenous hypercortisolism. Cur ...

Core Insights - Corcept Therapeutics (CORT) reported Q3 2025 earnings of $0.16 per share, missing the Zacks Consensus Estimate of $0.18, and down from $0.41 in the same quarter last year [1][8] - Revenues for Q3 increased approximately 14% year over year to $207.6 million, but fell short of the Zacks Consensus Estimate of $219 million, with the revenue solely coming from product sales of Korlym [1][8] - The company lowered its total revenue guidance for 2025 to a range of $800-$850 million, down from the previous estimate of $850-$900 million, which contributed to a 4.6% drop in shares during after-hours trading [2][9] Financial Performance - Revenues from Korlym missed the model estimate of $222.6 million [5] - Research and development expenses rose 16% year over year to $68.8 million [5] - Selling, general and administrative expenses increased approximately 68.2% year over year to $124 million, leading to total operating expenses rising 30.8% year over year to $197.4 million in Q3 [5] Cash Position - As of September 30, 2025, cash and investments totaled $524.2 million, an increase from $515 million as of June 30, 2025 [6] Pipeline Developments - Corcept is developing relacorilant for Cushing's syndrome and certain cancer indications, with a new drug application submitted to the FDA in December 2024 [10] - The FDA accepted a new NDA for relacorilant in combination with nab-paclitaxel for treating platinum-resistant ovarian cancer, with a decision expected on July 11, 2026 [11] - Corcept is also conducting a phase II study evaluating relacorilant plus nab-paclitaxel for cervical cancer and plans to start another phase II study for pancreatic cancer soon [13][14] Market Performance - Year to date, shares of Corcept have increased by 41.1%, significantly outperforming the industry average rise of 6.7% [4]

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) reported Q2 2025 earnings of $0.29 per share, exceeding the Zacks Consensus Estimate of $0.23, but down from $0.32 in the same quarter last year [1][7] - Revenues for the second quarter increased by 18.7% year over year to $194.4 million, although this figure fell short of the Zacks Consensus Estimate of $204 million [1][4] - The revenue was solely derived from product sales of the Cushing's syndrome drug, Korlym [1] Financial Performance - Revenue from Korlym missed the model estimate of $211.7 million [4] - Research and development expenses rose by 3.1% year over year to $60.5 million [4] - Selling, general, and administrative expenses surged by approximately 55.1% year over year to $103.8 million [4] - Total operating expenses increased by 30.8% year over year to $167.8 million in Q2 [4] - Cash and investments as of June 30, 2025, totaled $515 million, down from $570.8 million as of March 31, 2025 [5] Guidance and Market Reaction - Corcept lowered its total revenue guidance for 2025 to a range of $850-$900 million from the previous $900-$950 million [6][8] - This revision may have negatively impacted investor sentiment, leading to a 4.7% decline in stock price during pre-market trading on August 1 [8] Pipeline Developments - Corcept submitted a new drug application (NDA) to the FDA for its lead pipeline candidate, relacorilant, in combination with nab-paclitaxel for treating platinum-resistant ovarian cancer [9] - The NDA submission was based on data from the pivotal phase III ROSELLA study, which met its primary endpoint of improved progression-free survival [10] - The company is also evaluating relacorilant in combination with nab-paclitaxel and Avastin in the phase II BELLA study for the same indication [11][12] - Additional studies are ongoing for relacorilant in early-stage prostate cancer and for other pipeline candidates targeting various conditions [13] Market Performance - Year-to-date, Corcept's shares have increased by 33.3%, significantly outperforming the industry average rise of 4.5% [2]

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]