Corcept Therapeutics Resubmits New Drug Application
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2 days ago
0mins
The company states: "Corcept Therapeutics announced it has resubmitted its New Drug Application to the U.S. Food and Drug Administration for relacorilant as a treatment for patients with Cushing's syndrome. As requested by the FDA, the resubmission includes additional analyses of data included in the original NDA submission. Corcept expects the resubmission to receive a six-month review. Corcept's resubmission is based on positive data from its pivotal GRACE trial, the double-blind, placebo-controlled Phase III GRADIENT trial, relacorilant's long-term extension study and earlier-stage development data. Corcept believes that these data show that relacorilant provides meaningful, durable improvements in the signs and symptoms of Cushing's syndrome, without causing some of the serious adverse events associated with currently approved medications - termination of pregnancy, hypokalemia, endometrial hypertrophy, vaginal bleeding, adrenal insufficiency and QT prolongation."
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Analyst Views on CORT
Wall Street analysts forecast CORT stock price to rise
6 Analyst Rating
4 Buy
1 Hold
1 Sell
Moderate Buy
Current: 81.750
Low
50.00
Averages
91.00
High
121.00
Current: 81.750
Low
50.00
Averages
91.00
High
121.00
About CORT
Corcept Therapeutics Incorporated is a commercial-stage company. The Company is engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol. It is also conducting advanced clinical trials in patients with solid tumors, Amyotrophic Lateral Sclerosis (ALS) and liver disease. It operates through the discovery, development and commercialization of the pharmaceutical products segment. It sells Korlym and a generic version of Korlym in the United States using sales representatives to call on physicians caring for patients with hypercortisolism (Cushing’s syndrome). The Company's portfolio of selective cortisol modulators consists of four series totaling approximately 1,000 compounds. It sells and distributes Lifyorli in the United States. It is developing its proprietary, selective cortisol modulator, relacorilant, as a treatment for patients with hypercortisolism.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Corcept Resubmits NDA for Relacorilant to Treat Cushing's Syndrome
- NDA Resubmission: Corcept Therapeutics has resubmitted its New Drug Application for relacorilant to the FDA for treating Cushing's syndrome, including additional analyses as requested, and expects a six-month review period, reflecting the company's confidence in advancing this treatment.
- Clinical Trial Evidence: The resubmission is supported by positive data from the pivotal GRACE trial and the double-blind, placebo-controlled Phase III GRADIENT trial, indicating that relacorilant effectively improves symptoms of Cushing's syndrome without causing serious adverse effects associated with current medications, enhancing its competitive edge in the market.
- Therapeutic Potential: As a selective glucocorticoid receptor antagonist, relacorilant modulates cortisol activity and may provide significant clinical benefits for many patients, particularly in alleviating hypertension, obesity, and diabetes symptoms, showcasing its broad application prospects in the treatment landscape.
- Company Overview: With over 25 years of experience in cortisol modulation, Corcept has developed more than 1,000 proprietary selective cortisol modulators and is leading advanced clinical trials for Cushing's syndrome and other serious disorders, further solidifying its position in the biopharmaceutical industry.
See More
Kuehn Law Investigates Corcept Executives for Fiduciary Breach
- Legal Investigation Launched: Kuehn Law, PLLC is investigating whether Corcept Therapeutics executives breached their fiduciary duties to shareholders, as a federal lawsuit alleges the company failed to disclose adverse information regarding FDA approval, potentially harming shareholder interests.
- FDA Approval Risks: While the company touted the expected success of its new drug relacorilant, the FDA expressed concerns about the adequacy of its clinical development program, resulting in a material risk of rejection for the New Drug Application, which could negatively impact the company's market outlook.
- Shareholder Rights Protection: Kuehn Law urges shareholders who purchased CORT stock before October 31, 2024, to contact the firm promptly to enforce their rights, indicating the company's commitment to legal support and protective measures for investors.
- Call for Market Integrity: Kuehn Law emphasizes the importance of shareholder participation in maintaining the integrity and fairness of financial markets, encouraging investors to engage actively to safeguard their investments and future rights.
See More
Corcept Therapeutics Resubmits NDA for Relacorilant
- NDA Resubmission: Corcept Therapeutics has resubmitted its New Drug Application (NDA) for relacorilant, a candidate for Cushing's syndrome, including new data analyses aimed at addressing the FDA's request for additional data to advance the drug's approval process.
- FDA Feedback: The US FDA issued a Complete Response Letter in December, indicating that it could not determine a favorable benefit-risk assessment for the drug without further data, prompting the company to expedite data collection and analysis to meet regulatory requirements.
- Market Potential: Cushing's syndrome is characterized by high blood pressure related to a hormonal disorder, and relacorilant, as a selective glucocorticoid receptor antagonist, holds significant market potential, with projected sales for Cushing's expected to reach $2 billion by 2026.
- Financial Outlook: Corcept Therapeutics raised its revenue guidance for 2026 to between $950 million and $1.05 billion, reflecting strong market confidence in relacorilant and other products, further solidifying its position in the biopharmaceutical sector.
See More
New Data Reveals Korlym's Potential in Diabetes Treatment
- Clinical Trial Results: At the ADA conference, the CATALYST trial demonstrated that patients treated with Korlym achieved a 1.3% reduction in HbA1c and a 5.1 kg weight loss, indicating significant efficacy in difficult-to-control diabetes, which could reshape treatment strategies.
- High Prevalence Confirmation: The MOMENTUM trial revealed that 27.3% of patients with resistant hypertension had hypercortisolism, underscoring the importance of this condition in cardiometabolic diseases and potentially driving broader screening and treatment efforts.
- Synergistic Effects with GLP-1 Agonists: Among patients receiving GLP-1 receptor agonists, those treated with Korlym experienced a 1.7% reduction in HbA1c and a 6.1 kg weight loss, highlighting its synergistic potential with existing therapies, which may enhance patient outcomes.
- Strategic Implications: These findings not only provide a rationale for screening for hypercortisolism but may also encourage more physicians to consider Korlym as an adjunct therapy for diabetes management, ultimately improving patient quality of life.
See More
New Data Reveals Korlym's Potential in Diabetes Treatment
- Clinical Trial Results: At the ADA conference, the CATALYST trial demonstrated that patients treated with Korlym achieved a 1.3% reduction in HbA1c and a 5.1 kg weight loss, indicating significant efficacy in managing difficult-to-control type 2 diabetes, which may alter treatment strategies.
- High Prevalence Confirmation: The MOMENTUM trial found that 27.3% of patients with resistant hypertension had endogenous hypercortisolism, highlighting the commonality of this condition among diabetes patients and suggesting a need for enhanced screening and treatment.
- Synergistic Effects with GLP-1 Agonists: In the CATALYST trial, patients on GLP-1 receptor agonists showed a 1.7% HbA1c reduction and a 6.1 kg weight loss with Korlym treatment, demonstrating the potential synergistic effect of Korlym with existing therapies, which could enhance patient outcomes.
- Strategic Implications: These findings not only provide a basis for screening hypercortisolism but may also promote the use of Korlym in diabetes treatment, strengthening the company's market position in the endocrinology sector.
See More
Corcept Presents New Survival Data for Lifyorli
- Significant Survival Improvement: Corcept's presentation at ASCO 2026 revealed that patients treated with Lifyorli plus nab-paclitaxel experienced a 35% reduction in death risk (HR: 0.65) with a median survival of 16.0 months, compared to 11.9 months for nab-paclitaxel alone, highlighting the clinical importance of this combination therapy for platinum-resistant ovarian cancer.
- New FDA Approval Standard: Lifyorli received FDA approval in March 2026 as the first selective glucocorticoid receptor antagonist for platinum-resistant ovarian cancer, with no biomarker selection required, marking a new standard in cancer treatment and expected to enhance patient treatment options.
- Broad Applicability: The ROSELLA trial demonstrated significant survival benefits across all prespecified subgroups, including patients with poor prognostic features, indicating Lifyorli's consistent efficacy across diverse patient populations and its potential to reshape treatment paradigms for platinum-resistant ovarian cancer.
- Good Clinical Tolerability: The combination of Lifyorli with nab-paclitaxel was well-tolerated, with adverse events comparable to those in the nab-paclitaxel monotherapy group; although some patients experienced neutropenia, the overall safety profile supports its promotion in clinical practice.
See More
Corcept Resubmits NDA for Relacorilant to Treat Cushing's Syndrome
- NDA Resubmission: Corcept Therapeutics has resubmitted its New Drug Application for relacorilant to the FDA for treating Cushing's syndrome, including additional analyses as requested, and expects a six-month review period, reflecting the company's confidence in advancing this treatment.
- Clinical Trial Evidence: The resubmission is supported by positive data from the pivotal GRACE trial and the double-blind, placebo-controlled Phase III GRADIENT trial, indicating that relacorilant effectively improves symptoms of Cushing's syndrome without causing serious adverse effects associated with current medications, enhancing its competitive edge in the market.
- Therapeutic Potential: As a selective glucocorticoid receptor antagonist, relacorilant modulates cortisol activity and may provide significant clinical benefits for many patients, particularly in alleviating hypertension, obesity, and diabetes symptoms, showcasing its broad application prospects in the treatment landscape.
- Company Overview: With over 25 years of experience in cortisol modulation, Corcept has developed more than 1,000 proprietary selective cortisol modulators and is leading advanced clinical trials for Cushing's syndrome and other serious disorders, further solidifying its position in the biopharmaceutical industry.
See More
Kuehn Law Investigates Corcept Executives for Fiduciary Breach
- Legal Investigation Launched: Kuehn Law, PLLC is investigating whether Corcept Therapeutics executives breached their fiduciary duties to shareholders, as a federal lawsuit alleges the company failed to disclose adverse information regarding FDA approval, potentially harming shareholder interests.
- FDA Approval Risks: While the company touted the expected success of its new drug relacorilant, the FDA expressed concerns about the adequacy of its clinical development program, resulting in a material risk of rejection for the New Drug Application, which could negatively impact the company's market outlook.
- Shareholder Rights Protection: Kuehn Law urges shareholders who purchased CORT stock before October 31, 2024, to contact the firm promptly to enforce their rights, indicating the company's commitment to legal support and protective measures for investors.
- Call for Market Integrity: Kuehn Law emphasizes the importance of shareholder participation in maintaining the integrity and fairness of financial markets, encouraging investors to engage actively to safeguard their investments and future rights.
See More
Corcept Therapeutics Resubmits NDA for Relacorilant
- NDA Resubmission: Corcept Therapeutics has resubmitted its New Drug Application (NDA) for relacorilant, a candidate for Cushing's syndrome, including new data analyses aimed at addressing the FDA's request for additional data to advance the drug's approval process.
- FDA Feedback: The US FDA issued a Complete Response Letter in December, indicating that it could not determine a favorable benefit-risk assessment for the drug without further data, prompting the company to expedite data collection and analysis to meet regulatory requirements.
- Market Potential: Cushing's syndrome is characterized by high blood pressure related to a hormonal disorder, and relacorilant, as a selective glucocorticoid receptor antagonist, holds significant market potential, with projected sales for Cushing's expected to reach $2 billion by 2026.
- Financial Outlook: Corcept Therapeutics raised its revenue guidance for 2026 to between $950 million and $1.05 billion, reflecting strong market confidence in relacorilant and other products, further solidifying its position in the biopharmaceutical sector.
See More
New Data Reveals Korlym's Potential in Diabetes Treatment
- Clinical Trial Results: At the ADA conference, the CATALYST trial demonstrated that patients treated with Korlym achieved a 1.3% reduction in HbA1c and a 5.1 kg weight loss, indicating significant efficacy in difficult-to-control diabetes, which could reshape treatment strategies.
- High Prevalence Confirmation: The MOMENTUM trial revealed that 27.3% of patients with resistant hypertension had hypercortisolism, underscoring the importance of this condition in cardiometabolic diseases and potentially driving broader screening and treatment efforts.
- Synergistic Effects with GLP-1 Agonists: Among patients receiving GLP-1 receptor agonists, those treated with Korlym experienced a 1.7% reduction in HbA1c and a 6.1 kg weight loss, highlighting its synergistic potential with existing therapies, which may enhance patient outcomes.
- Strategic Implications: These findings not only provide a rationale for screening for hypercortisolism but may also encourage more physicians to consider Korlym as an adjunct therapy for diabetes management, ultimately improving patient quality of life.
See More
New Data Reveals Korlym's Potential in Diabetes Treatment
- Clinical Trial Results: At the ADA conference, the CATALYST trial demonstrated that patients treated with Korlym achieved a 1.3% reduction in HbA1c and a 5.1 kg weight loss, indicating significant efficacy in managing difficult-to-control type 2 diabetes, which may alter treatment strategies.
- High Prevalence Confirmation: The MOMENTUM trial found that 27.3% of patients with resistant hypertension had endogenous hypercortisolism, highlighting the commonality of this condition among diabetes patients and suggesting a need for enhanced screening and treatment.
- Synergistic Effects with GLP-1 Agonists: In the CATALYST trial, patients on GLP-1 receptor agonists showed a 1.7% HbA1c reduction and a 6.1 kg weight loss with Korlym treatment, demonstrating the potential synergistic effect of Korlym with existing therapies, which could enhance patient outcomes.
- Strategic Implications: These findings not only provide a basis for screening hypercortisolism but may also promote the use of Korlym in diabetes treatment, strengthening the company's market position in the endocrinology sector.
See More
Corcept Presents New Survival Data for Lifyorli
- Significant Survival Improvement: Corcept's presentation at ASCO 2026 revealed that patients treated with Lifyorli plus nab-paclitaxel experienced a 35% reduction in death risk (HR: 0.65) with a median survival of 16.0 months, compared to 11.9 months for nab-paclitaxel alone, highlighting the clinical importance of this combination therapy for platinum-resistant ovarian cancer.
- New FDA Approval Standard: Lifyorli received FDA approval in March 2026 as the first selective glucocorticoid receptor antagonist for platinum-resistant ovarian cancer, with no biomarker selection required, marking a new standard in cancer treatment and expected to enhance patient treatment options.
- Broad Applicability: The ROSELLA trial demonstrated significant survival benefits across all prespecified subgroups, including patients with poor prognostic features, indicating Lifyorli's consistent efficacy across diverse patient populations and its potential to reshape treatment paradigms for platinum-resistant ovarian cancer.
- Good Clinical Tolerability: The combination of Lifyorli with nab-paclitaxel was well-tolerated, with adverse events comparable to those in the nab-paclitaxel monotherapy group; although some patients experienced neutropenia, the overall safety profile supports its promotion in clinical practice.
See More
