Corcept Therapeutics Inc Stock Price, News & Analysis

Corcept Therapeutics (NASDAQ: CORT) announced positive results from its pivotal Phase 3 ROSELLA trial of relacorilant combined with nab-paclitaxel in patients with platinum-resistant ovarian cancer. The trial met its primary endpoint, demonstrating a 30% reduction in disease progression risk compared to nab-paclitaxel alone.

Key findings include:

• Median progression-free survival of 6.5 months vs 5.5 months for control group
• Median overall survival of 16.0 months vs 11.5 months for control group
• No new safety concerns identified

The trial enrolled 381 patients across multiple countries without requiring biomarker selection. Based on these results, Corcept plans to submit a New Drug Application (NDA) in Q3 and a Marketing Authorization Application (MAA) in Europe shortly after.

Corcept Therapeutics (NASDAQ: CORT) has launched the MOMENTUM clinical trial to investigate the prevalence of endogenous hypercortisolism (Cushing's syndrome) in patients with resistant hypertension. The study will enroll 1,000 patients across 45 U.S. sites.

The trial follows the successful CATALYST study, which found that one in four patients with difficult-to-control type 2 diabetes has hypercortisolism, with higher prevalence in patients requiring three or more hypertension medications. Patients will be identified as having hypercortisolism if they show dexamethasone suppression test values >1.8 µg/dL and dexamethasone levels >140 ng/dL.

Led by Dr. Deepak L. Bhatt, Director of Mount Sinai Fuster Heart Hospital, the study aims to better understand treatment opportunities for resistant hypertension patients. Results are expected by year-end.

Corcept Therapeutics (NASDAQ: CORT) announced that the FDA has filed its New Drug Application (NDA) for relacorilant, a selective cortisol modulator designed to treat patients with endogenous hypercortisolism (Cushing's syndrome). The FDA has set a PDUFA target action date of December 30, 2025.

The NDA submission is supported by positive results from multiple clinical trials, including the pivotal GRACE trial, Phase 3 GRADIENT trial, long-term extension trial, and a Phase 2 trial. Patients receiving relacorilant showed improvements in various hypercortisolism symptoms. The drug demonstrated favorable safety profiles with no instances of serious adverse events commonly associated with current treatments, such as drug-induced adrenal insufficiency, hypokalemia, or QT prolongation.

Corcept Therapeutics (NASDAQ: CORT) reported strong financial results for Q4 and full-year 2024. The company achieved revenue of $675.0 million in 2024, marking a 40% increase from 2023, with Q4 revenue at $181.9 million. Net income reached $141.2 million for 2024, up 33% year-over-year.

The company's cash position strengthened to $603.2 million as of December 31, 2024. Corcept provided 2025 revenue guidance of $900-950 million. Key developments include the submission of a New Drug Application (NDA) for relacorilant in hypercortisolism treatment, positive results from the GRACE and GRADIENT trials, and promising outcomes from the CATALYST study showing that 23.8% of patients with difficult-to-control type 2 diabetes have hypercortisolism.

Corcept Therapeutics (NASDAQ: CORT) has scheduled the announcement of its fourth quarter and full-year 2024 financial results for February 26, 2025. The company will provide a corporate update and host a conference call on the same day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

Participants must pre-register for the conference call to receive their individual dial-in number and unique access PIN. A listen-only webcast option will also be available, and a replay of the call will be accessible through the Investors / Events section of Corcept.com.

Corcept Therapeutics (NASDAQ: CORT) has submitted a New Drug Application (NDA) to the FDA for relacorilant, its selective cortisol modulator designed to treat endogenous hypercortisolism (Cushing's syndrome). The application is supported by positive results from multiple studies, including the pivotal GRACE trial, Phase 3 GRADIENT, long-term extension studies, and a Phase 2 study.

The drug demonstrated improvements in various hypercortisolism symptoms with an acceptable safety profile. Notably, relacorilant showed no instances of serious adverse events common in current treatments, such as drug-induced adrenal insufficiency, hypokalemia, or QT prolongation. The company believes relacorilant could become the standard of care for medical treatment of hypercortisolism patients.

Corcept Therapeutics (NASDAQ: CORT) presented results from its Phase 3 long-term extension study of relacorilant for treating hypercortisolism at WCIRDC. The study, involving 116 patients with treatment duration up to six years, demonstrated significant cardiometabolic improvements. At month 24, patients showed notable reductions in mean systolic blood pressure (10.0 mm Hg; p=0.012) and mean diastolic blood pressure (7.3 mm Hg; p=0.016).

The drug was well-tolerated, and patients maintained improvements in various cardiometabolic measures, including glycemic control and body weight. Patients who resumed relacorilant after receiving placebo showed both reversal of deterioration and additional improvement. The company plans to submit a new drug application (NDA) this month.

Corcept Therapeutics (NASDAQ: CORT) announced positive results from its CATALYST trial, a Phase 4 study evaluating Korlym® in patients with hypercortisolism (Cushing's syndrome) and difficult-to-control type 2 diabetes. The study met its primary endpoint, with Korlym-treated patients showing a significant 1.47% decrease in hemoglobin A1c compared to a 0.15% decrease in the placebo group (p-value: < 0.0001).

The trial consisted of two parts: a screening phase of 1,057 patients with difficult-to-control diabetes, revealing that 23.8% had hypercortisolism, followed by a treatment phase with 136 randomized patients. The safety profile remained consistent with Korlym's label, with no new side effects identified. Complete results will be presented at an upcoming medical conference.

Corcept Therapeutics (NASDAQ: CORT) has announced results from its DAZALS Phase 2 trial evaluating dazucorilant in ALS patients. The study tested two doses (150mg and 300mg) of the selective cortisol modulator but did not meet its primary endpoint measuring change in ALS Functional Rating Scale-Revised (ALSFRS-R). While patients experienced increased gastrointestinal upset with dazucorilant, notably, no deaths occurred in the 300mg treatment group (0/83) compared to 5 deaths in the placebo group (5/82), showing statistical significance (p=0.02). The drug has received Fast Track Designation from the FDA. An open-label extension study continues, with overall survival assessment planned for March 2025.