Corcept Therapeutics Stock Price, News & Analysis

Corcept Therapeutics Inc. (NASDAQ: CORT) is a commercial-stage pharmaceutical company focused on cortisol modulation as a way to treat serious medical conditions. According to the company’s public statements, Corcept is engaged in the discovery and development of medications for severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol. Corcept is headquartered in Redwood City, California and its common stock is listed on The Nasdaq Stock Market.

For more than 25 years, Corcept has concentrated on the biology of cortisol and the glucocorticoid receptor (GR), leading to the discovery of more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. The company reports that it is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, amyotrophic lateral sclerosis (ALS) and liver disease. In February 2012, Corcept introduced Korlym, described as the first medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with endogenous hypercortisolism.

Business focus and therapeutic areas

Corcept characterizes itself as a commercial-stage company because it markets Korlym while also investing in a pipeline of investigational therapies. Public disclosures state that its research and development programs target severe endocrinologic conditions such as hypercortisolism, as well as oncology indications, including ovarian and prostate cancer, metabolic disorders such as metabolic dysfunction-associated steatohepatitis (MASH), and neurologic conditions including ALS. The unifying scientific theme across these programs is modulation of cortisol activity via selective glucocorticoid receptor antagonism.

Key products and pipeline candidates

The company reports two main categories of assets: an approved product and multiple clinical-stage compounds.

• Korlym: Corcept states that Korlym was introduced in February 2012 as the first FDA-approved medication for patients with endogenous hypercortisolism. Korlym is used in the company’s CATALYST clinical program in patients with hypercortisolism and difficult-to-control type 2 diabetes.
• Relacorilant: Described as an oral, selective glucocorticoid receptor antagonist that modulates cortisol activity by binding to the GR but not to the body’s other hormone receptors. Corcept reports that relacorilant is being developed in endogenous hypercortisolism and in multiple oncology settings, including platinum-resistant ovarian cancer, earlier-stage ovarian cancer, endometrial cancer, cervical cancer and prostate cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the FDA and the European Commission for the treatment of hypercortisolism and by the European Commission for the treatment of ovarian cancer.
• Miricorilant: In company communications, miricorilant is described as a selective cortisol modulator being studied in the Phase 2b MONARCH trial in patients with metabolic dysfunction-associated steatohepatitis (MASH). A prior Phase 1b study is reported to have shown rapid reductions in liver fat, improvements in liver enzymes and other markers of liver health, as well as metabolic and lipid measures, while being well-tolerated.
• Dazucorilant: Corcept reports that dazucorilant is being developed for ALS. In the DAZALS Phase 2 trial, exploratory analyses cited by the company showed that patients receiving a 300 mg dose had a substantially lower risk of death during the study’s first year compared to placebo, even though the trial did not meet its primary functional endpoint. The company has discussed plans for a Phase 3 trial in ALS.
• Nenocorilant: Company updates describe nenocorilant as a proprietary selective glucocorticoid receptor antagonist being advanced into a Phase 1b dose-finding study in combination with the PD-1 checkpoint inhibitor nivolumab in patients with a variety of solid tumors.

Clinical development programs

Corcept’s public updates outline a broad clinical program centered on cortisol modulation:

• Hypercortisolism (Cushing’s syndrome): The company is conducting advanced clinical trials of relacorilant in patients with hypercortisolism, and has reported that in Phase 2 and Phase 3 studies, patients treated with relacorilant showed clinically meaningful and statistically significant improvements in multiple signs and symptoms of hypercortisolism. Corcept also highlights the CATALYST program, which examined the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes and evaluated Korlym in this population.
• Oncology: Corcept is developing relacorilant in combination with chemotherapy and other agents. Company communications describe the pivotal Phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer, where the combination met its primary endpoint of improved progression-free survival and showed an overall survival benefit versus nab-paclitaxel alone. Additional studies include the Phase 2 BELLA trial in platinum-resistant and platinum-sensitive ovarian cancer and endometrial cancer, as well as trials in cervical and pancreatic cancers and a Phase 2 study of relacorilant plus enzalutamide in early-stage prostate cancer.
• Metabolic disease (MASH): The Phase 2b MONARCH trial of miricorilant in patients with biopsy-confirmed or presumed MASH is described as randomized, double-blind and placebo-controlled, building on earlier Phase 1b findings.
• ALS: The DAZALS trial evaluated dazucorilant in ALS. Corcept reports that exploratory analyses showed a notable reduction in early mortality for patients receiving a specific dose, and the company is working with regulators to define the development path, including a planned Phase 3 trial.

Regulatory milestones and designations

Corcept’s disclosures highlight several regulatory interactions. The company has submitted New Drug Applications (NDAs) to the FDA for relacorilant in hypercortisolism and in platinum-resistant ovarian cancer. The FDA has assigned Prescription Drug User Fee Act (PDUFA) dates for these applications, and the European Medicines Agency is reviewing a Marketing Authorization Application (MAA) for relacorilant in platinum-resistant ovarian cancer. In a later update, Corcept reported receiving a Complete Response Letter from the FDA regarding the NDA for relacorilant in hypertension secondary to hypercortisolism, with the Agency requesting additional evidence of effectiveness despite acknowledging that the pivotal GRACE trial met its primary endpoint and that GRADIENT provided confirmatory evidence.

The company emphasizes that relacorilant has orphan drug designation from the FDA and the European Commission for hypercortisolism and from the European Commission for ovarian cancer. These designations are intended to support development of therapies for rare conditions.

Cortisol biology and therapeutic rationale

In its public materials, Corcept explains the rationale for targeting cortisol and the glucocorticoid receptor. Cortisol is described as influencing tumor growth and treatment resistance by helping solid tumors resist chemotherapy-induced apoptosis, activating oncogenes in some cancers, and suppressing the immune system’s ability to fight disease. By developing selective glucocorticoid receptor antagonists, Corcept aims to modulate cortisol’s effects in a way that may benefit patients with hypercortisolism, various solid tumors, metabolic liver disease and neurologic conditions.

Exchange listing and regulatory reporting

SEC filings state that Corcept Therapeutics Inc.’s common stock, with a par value of $0.001 per share, trades under the symbol CORT on The Nasdaq Stock Market. As a public company, Corcept files periodic and current reports with the U.S. Securities and Exchange Commission, including Forms 10-K, 10-Q and 8-K, which disclose financial results, clinical and regulatory updates, and material corporate events.