Welcome to our dedicated page for Corcept Therapeutics news (Ticker: CORT), a resource for investors and traders seeking the latest updates and insights on Corcept Therapeutics stock.
Corcept Therapeutics Inc. (NASDAQ: CORT) is a commercial-stage pharmaceutical company dedicated to the discovery and development of innovative medications that target the underlying effects of abnormal cortisol levels. Cortisol, a hormone essential for various bodily functions, can become dysregulated and contribute to a range of serious health conditions, including metabolic disorders, oncologic diseases, and neuropsychiatric illnesses. Corcept leverages its deep scientific expertise to address these challenges by developing drugs that modulate the glucocorticoid receptor (GR), a key mediator of cortisol's effects.
Core Business Areas
Corcept's business model is centered on the research, development, and commercialization of GR antagonists. The company’s flagship product, mifepristone, is approved for the treatment of hypercortisolism in certain conditions. Beyond this, Corcept has built an extensive pipeline of over 300 proprietary molecules, each designed to selectively block the GR without affecting the progesterone receptor. This specificity minimizes side effects and enhances therapeutic potential.
Addressing Unmet Medical Needs
Corcept’s innovative compounds are being evaluated in clinical trials for their ability to treat a variety of severe and life-threatening conditions. These include:
- Hypercortisolism: A disorder characterized by excessive cortisol levels, often linked to Cushing's syndrome.
- Oncologic Applications: Advanced ovarian cancer, prostate cancer, and other malignancies where cortisol plays a role in disease progression.
- Neuropsychiatric Disorders: Conditions such as post-traumatic stress disorder (PTSD), mild cognitive impairment, and Alzheimer’s disease.
- Metabolic Diseases: Non-alcoholic steatohepatitis (NASH) and other metabolic syndromes influenced by cortisol dysregulation.
Scientific Approach and Differentiation
What sets Corcept apart in the competitive pharmaceutical landscape is its singular focus on GR antagonism. Unlike traditional therapies that may broadly target hormonal pathways, Corcept’s compounds are designed to selectively block the GR, thereby mitigating the adverse effects of excess cortisol while preserving other hormonal functions. This approach is supported by extensive scientific literature and represents a promising avenue for treating diseases with high unmet medical needs.
Market Position and Growth Potential
Operating in the dynamic pharmaceutical industry, Corcept occupies a niche position as a pioneer in cortisol modulation therapies. Its focus on conditions with limited treatment options provides a strategic advantage, as does its robust pipeline of proprietary molecules. However, the company faces challenges typical of the sector, including regulatory approvals, competition from larger pharmaceutical firms, and the inherent risks of clinical trial outcomes. Despite these hurdles, Corcept’s unique scientific approach and targeted focus position it as a significant player in its field.
Commitment to Innovation
Corcept’s commitment to advancing medical science is evident in its investment in research and development. By exploring the role of cortisol in various diseases and developing compounds that address these mechanisms, the company aims to deliver transformative therapies that improve patient outcomes. Its strategic focus on unmet medical needs underscores its potential to make a lasting impact on the healthcare landscape.
Conclusion
Corcept Therapeutics Inc. exemplifies the intersection of scientific innovation and patient-focused care. Through its pioneering work in cortisol modulation, the company addresses some of the most pressing challenges in modern medicine. With a strong foundation in research, a growing pipeline of proprietary compounds, and a commitment to addressing unmet medical needs, Corcept is well-positioned to contribute significantly to the pharmaceutical industry.
Corcept Therapeutics (NASDAQ: CORT) has launched BELLA, a new Phase 2 trial evaluating the combination of relacorilant with nab-paclitaxel and bevacizumab in patients with platinum-resistant ovarian cancer. The single-arm, open-label trial aims to enroll 90 women across approximately 50 sites in North America, Europe, and Asia-Pacific.
The trial builds on the success of their pivotal Phase 3 ROSELLA trial, where the combination of relacorilant and nab-paclitaxel demonstrated improved progression-free and overall survival without increasing side effects. BELLA will investigate whether adding bevacizumab to this combination could provide an additional treatment option for patients.
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.
FAQ
What is the current stock price of Corcept Therapeutics (CORT)?
What is the market cap of Corcept Therapeutics (CORT)?
What does Corcept Therapeutics specialize in?
What is Corcept’s flagship product?
What makes Corcept’s approach unique?
What diseases are Corcept’s compounds being developed to treat?
How does Corcept generate revenue?
What challenges does Corcept face in its industry?
What is the significance of glucocorticoid receptor antagonism?
What is Corcept’s competitive advantage?
What industries does Corcept Therapeutics operate in?
How does Corcept contribute to addressing unmet medical needs?
