US Market News
3週前
Corcept Resubmits New Drug Application for Relacorilant as a Treatment for Patients with Cushing’s SyndromeJune 17, 2026 4:28 PM
Business WireCorcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company 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, today announced it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) 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.“We are pleased to return relacorilant’s NDA to the review process and look forward to working with the Agency to advance relacorilant toward approval as a treatment for patients with Cushing’s syndrome,” said Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer. “Relacorilant has the potential to benefit many patients and it’s important we make it available as quickly as possible. We appreciate the FDA’s ongoing engagement with our application.”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.About Hypercortisolism (Cushing’s Syndrome)Hypercortisolism, also known as Cushing’s syndrome, is caused by excessive activity of the hormone cortisol. Symptoms vary, but most patients experience one or more of the following manifestations: hypertension, central obesity, elevated blood sugar and difficult-to-control type 2 diabetes, severe fatigue and weak muscles. Irritability, anxiety, depression and cognitive disturbances are common. Hypercortisolism can affect every organ system and can be fatal if not treated effectively. Cardiovascular events are the most common cause of death among patients with hypercortisolism. Recent research shows that endogenous hypercortisolism is more prevalent than previously believed.About RelacorilantRelacorilant, an oral therapy, is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body's other hormone receptors. 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 (EC) for the treatment of hypercortisolism and by the EC for the treatment of ovarian cancer. Under the brand name Lifyorli™, relacorilant was approved in combination with nab-paclitaxel for adults with platinum-resistant ovarian cancer by the FDA in 2026. Corcept has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for relacorilant to treat patients with platinum-resistant ovarian cancer.About Corcept TherapeuticsFor over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders, leading to the discovery of more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with Cushing’s syndrome, solid tumors, ALS and liver disease. In 2012, the company introduced Korlym®, the first medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with endogenous Cushing’s syndrome, and in 2026, the company introduced Lifyorli™, approved in combination with nab-paclitaxel, the first FDA-approved selective glucocorticoid receptor antagonist for adults with platinum-resistant ovarian cancer. Corcept is headquartered in Redwood City, California. For more information, visit Corcept.com.Forward-Looking StatementsStatements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations and are subject to risks and uncertainties that might cause our actual results to differ materially from any future results expressed or implied by such forward-looking statements.In this press release, forward-looking statements include statements concerning: Corcept’s resubmission of its NDA to the FDA for relacorilant as a treatment for patients with Cushing’s syndrome; Corcept’s expectation that this resubmission will receive a six-month review; Corcept’s intent to work with the FDA to advance relacorilant toward approval as a treatment for patients with Cushing’s syndrome; relacorilant’s potential to benefit many patients; and Corcept’s belief regarding the importance of making relacorilant available as quickly as possible.A further description of risks and uncertainties can be found in our SEC filings, which are available at our website and the SEC’s website. These risks and uncertainties include, but are not limited to, those related to: our ability to operate our business; our efforts to study and develop Korlym, relacorilant, miricorilant, dazucorilant, nenocorilant and our other product candidates; those molecules’ clinical attributes; regulatory approvals, mandates, oversight and other requirements imposed on our products or our business by laws, regulations or discretion of government authorities; and the scope and protective power of our intellectual property. We disclaim any intention or duty to update forward-looking statements made in this press release.View source version on businesswire.com: https://www.businesswire.com/news/home/20260617001418/en/Investor inquiries:
ir@corcept.com
Media inquiries:
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www.corcept.com Original: Corcept Resubmits New Drug Application for Relacorilant as a Treatment for Patients with Cushing’s Syndrome
US Market News
4週前
Corcept Presents New Data at ADA: Improved Outcomes in Patients Receiving a GLP-1 with Difficult-to-Control Type 2 Diabetes and Hypercortisolism Treated with Korlym®June 6, 2026 4:45 PM
Business Wire New data from CATALYST and MOMENTUM trials presented at American Diabetes Association’s (ADA) 86th Scientific Sessions In the CATALYST trial, patients with hypercortisolism treated with Korlym exhibited clinically and statistically significant improvements in hemoglobin A1c (HbA1c) and clinically meaningful reductions in body weight, body mass index and waist circumference, with numerically greater benefit in those taking GLP-1 receptor agonists or tirzepatide Late-breaking data from the MOMENTUM trial confirm high prevalence of endogenous hypercortisolism in patients with type 2 diabetes and resistant hypertension Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company 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, today announced the presentation of new data from its CATALYST and MOMENTUM trials at the American Diabetes Association’s 86th Scientific Sessions. The presentations underscore the critical role of hypercortisolism in difficult-to-control type 2 diabetes and resistant hypertension, and the potential of cortisol modulation treatment. The CATALYST trial screened 1,057 patients with difficult-to-control type 2 diabetes (HbA1c of 7.5 – 11.5 percent despite receiving multiple glucose-lowering medications) and found that 24 percent had hypercortisolism (cortisol levels of greater than 1.8 µg/dL in the 1 mg dexamethasone suppression test (DST)). In CATALYST’s treatment phase, 136 of the patients who had been found to have hypercortisolism were randomized 2:1 to receive either Korlym or placebo for 24 weeks. Patients who received Korlym exhibited a clinically meaningful and statistically significant reduction in HbA1c (1.3 percent, p-value: 10 percent) were hypokalemia, fatigue, nausea, vomiting, headache, peripheral edema, diarrhea and dizziness. The data presented at ADA described treatment outcomes in the 71 patients in CATALYST who were taking GLP-1 receptor agonists or the GLP-1/GIP agonist tirzepatide. In this group, patients who received Korlym exhibited numerically greater benefit than the overall study population with reductions in HbA1c (1.7 percent), body weight (6.1 kg), body mass index (2.0 kg/m2) and waist circumference (6.5 cm), compared to patients who received placebo (all nominal p-values less than 0.04). “These new CATALYST data demonstrate the potential of cortisol modulation to improve critical metabolic parameters, even for patients who have poorly controlled type 2 diabetes despite treatment with powerful GLP-1 or GLP-1/GIP receptor agonists, such as semaglutide or tirzepatide. Excess cortisol disrupts the incretin system, impairs beta cell function, and induces insulin and incretin resistance, potentially limiting the effectiveness of these otherwise potent therapies. Screening for hypercortisolism and considering cortisol-directed treatment is a key part of managing type 2 diabetes in patients not responding to standard-of-care treatments,” said Lance Sloan, M.D., President, Texas Institute for Kidney and Endocrine Disorders. At ADA, Corcept also presented late-breaking data from its MOMENTUM trial, which screened 1,086 patients with resistant hypertension (as defined by the American Heart Association’s criteria) and found that 27.3 percent of them had hypercortisolism. The prevalence of hypercortisolism was even higher in patients who had hemoglobin A1c (HbA1c) of 7.5 percent or higher and were taking 3 or more blood pressure medicines: 36.6 percent in CATALYST and 32.6 percent in MOMENTUM. “Data consistently show that hypercortisolism is an underlying driver of treatment resistant cardiometabolic disease, including in patients receiving best-in-class therapies like GLP-1s,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “Data from CATALYST demonstrate that treatment with a cortisol modulator, such as Korlym, can be synergistic with GLP-1s or tirzepatide to help patients better control type 2 diabetes. It is our hope that this new research will lead to increased screening for hypercortisolism and improved treatment.” About CATALYST CATALYST is the largest and most rigorous trial ever conducted to determine the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes and assess the effect of treating patients found to have hypercortisolism with a cortisol modulator. The initial prevalence phase of the trial screened 1,057 patients with difficult-to-control type 2 diabetes (i.e., patients with HbA1c greater than 7.5 percent despite receiving multiple glucose-lowering medications, including best-in-class therapies such as GLP-1 and GLP-1/GIP agonists) at 36 sites in the United States. Based on results from a standard 1-mg dexamethasone suppression test, 24 percent of the patients screened were found to have hypercortisolism and were eligible to enter the trial’s treatment phase, where they were randomized, 2:1, to receive either Korlym or placebo for 24 weeks. One hundred thirty-six patients enrolled in the treatment phase. About MOMENTUM MOMENTUM was the largest trial ever conducted to assess the prevalence of hypercortisolism in patients with resistant hypertension. A total of 1,086 patients were screened at 50 sites in the United States. All patients had resistant hypertension as defined by the American Heart Association’s criteria (systolic blood pressure greater or equal to 130 mmHg despite taking 3 or more blood-pressure lowering medications, including a diuretic, or taking 4 or more blood-pressure lowering medications). Using a simple, standardized 1-mg dexamethasone suppression test (DST), 27 percent of these patients were found to have hypercortisolism. About Hypercortisolism Hypercortisolism, also known as Cushing’s syndrome, is caused by excessive activity of the hormone cortisol. Symptoms vary, but most patients experience one or more of the following manifestations: hypertension, central obesity, elevated blood sugar and difficult-to-control type 2 diabetes, severe fatigue and weak muscles. Irritability, anxiety, depression and cognitive disturbances are common. Hypercortisolism can affect every organ system and can be fatal if not treated effectively. Cardiovascular events are the most common cause of death among patients with hypercortisolism. Recent research shows that endogenous hypercortisolism is more prevalent than previously believed. INDICATION
KORLYM (mifepristone) is a cortisol receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery.
Limitations of use: KORLYM should not be used in the treatment of patients with type 2 diabetes unless it is secondary to Cushing’s syndrome. IMPORTANT SAFETY INFORMATION
BOXED WARNING: TERMINATION OF PREGNANCY
Mifepristone is a potent antagonist of progesterone and cortisol via the progesterone and glucocorticoid (GR-II) receptors, respectively. The antiprogestational effects will result in the termination of pregnancy. Pregnancy must therefore be excluded before the initiation of treatment with Korlym and prevented during treatment and for one month after stopping treatment by the use of a nonhormonal medically acceptable method of contraception unless the patient has had a surgical sterilization, in which case no additional contraception is needed. Pregnancy must also be excluded if treatment is interrupted for more than 14 days in females of reproductive potential. CONTRAINDICATIONS
Pregnancy; patients taking simvastatin or lovastatin and CYP3A substrates with narrow therapeutic ranges; patients receiving systemic corticosteroids for lifesaving purposes; women with a history of unexplained vaginal bleeding or endometrial hyperplasia with atypia or endometrial carcinoma; patients with known hypersensitivity to mifepristone or to any of the product components. WARNINGS AND PRECAUTIONS
Adrenal insufficiency: Patients should be closely monitored for signs and symptoms of adrenal insufficiency. See full Prescribing Information for further management instructions.
Hypokalemia: Hypokalemia should be corrected prior to treatment and monitored for during treatment. Measure serum potassium 1-2 weeks after starting or increasing the Korlym dose, and periodically thereafter. Mifepristone-induced hypokalemia should be treated with potassium supplementation based on severity. If hypokalemia persists despite potassium supplementation, consider adding mineralocorticoid antagonists.
Vaginal bleeding and endometrial changes: Women may experience endometrial thickening or unexpected vaginal bleeding. Use with caution if the patient also has a hemorrhagic disorder or is on anticoagulant therapy. Women who experience vaginal bleeding during treatment should be referred to a gynecologist for further evaluation.
QT interval prolongation: Avoid use with QT interval-prolonging drugs, or in patients with potassium channel variants resulting in a long QT interval.
Exacerbation/Deterioration of Conditions Treated with Corticosteroids: For medical conditions in which chronic corticosteroid therapy is lifesaving, Korlym is contraindicated.
Use of strong CYP3A inhibitors: Concomitant use increases mifepristone plasma levels. Use only when necessary and do not exceed a Korlym dose of 900 mg per day.
The labeling contains warnings and precautions for Pneumocystis jiroveci Infection and potential effects of hypercortisolemia. See full Prescribing Information for further management instructions. ADVERSE REACTIONS
Most common adverse reactions in Cushing’s syndrome (≥20%): nausea, fatigue, headache, decreased blood potassium, arthralgia, vomiting, peripheral edema, hypertension, dizziness, decreased appetite, and endometrial hypertrophy. DRUG INTERACTIONS
Drugs metabolized by CYP3A: Administer drugs that are metabolized by CYP3A at the lowest dose when used with Korlym.
CYP3A inhibitors: Caution should be used when Korlym is used with strong CYP3A inhibitors. Use only when necessary, and do not exceed a Korlym dose of 900 mg.
CYP3A inducers: Do not use Korlym with CYP3A inducers.
Drugs metabolized by CYP2C8/2C9: Use the lowest dose of CYP2C8/2C9 substrates when used with Korlym.
Drugs metabolized by CYP2B6: Use of Korlym should be done with caution with bupropion and efavirenz.
Hormonal contraceptives: Do not use with Korlym. DOSAGE AND ADMINISTRATION
Obtain a negative pregnancy test prior to initiating treatment with Korlym in females of reproductive potential, or if treatment is interrupted for more than 14 days.
Administer once daily orally with a meal. The recommended starting dose is 300 mg once daily. Renal impairment: Do not exceed 600 mg once daily. Mild-to-moderate hepatic impairment: Do not exceed 600 mg once daily. Do not use in severe hepatic impairment. Based on clinical response and tolerability, the dose may be increased in 300-mg increments to a maximum of 1200 mg once daily. Do not exceed 20 mg/kg per day. Concomitant use of Korlym with a strong CYP3A inhibitor resulted in a 38% increase in mean plasma concentration of mifepristone. For patients already being treated with a strong CYP3A inhibitor, start with a Korlym dose of 300 mg per day and titrate to a maximum of 900 mg per day if clinically indicated. When a strong CYP3A inhibitor is administered to patients already receiving Korlym, adjust the dose as follows: for patients receiving a daily dose of 600 mg, reduce dose to 300 mg. For patients receiving a daily dose of 900 mg, reduce dose to 600 mg. For patients receiving a daily dose of 1200 mg, reduce dose to 900 mg. Titrate if clinically indicated and do not exceed a Korlym dose of 900 mg in combination with a strong CYP3A inhibitor. USE IN SPECIFIC POPULATIONS
Lactation: Mifepristone is present in human milk, however, there are no data on the amount of mifepristone in human milk, the effects on the breastfed infant, or the effects on milk production during long term use of mifepristone. About Corcept Therapeutics For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders, leading to the discovery of more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with Cushing’s syndrome, solid tumors, ALS and liver disease. In 2012, the company introduced Korlym®, the first medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with endogenous Cushing’s syndrome, and in 2026, the company introduced Lifyorli™, approved in combination with nab-paclitaxel, the first FDA-approved selective glucocorticoid receptor antagonist for adults with platinum-resistant ovarian cancer. Corcept is headquartered in Redwood City, California. For more information, visit Corcept.com. Forward-Looking Statements Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations and are subject to risks and uncertainties that might cause our actual results to differ materially from any future results expressed or implied by such forward-looking statements. In this press release, forward-looking statements include statements concerning: the potential for cortisol modulation treatment to improve critical metabolic parameters, even for patients with poorly controlled type 2 diabetes despite treatment with powerful GLP-1 or GLP-1/GIP receptor agonists; and our hope that the findings from the CATALYST and MOMENTUM trials will lead to increased screening for hypercortisolism and improved treatment. A further description of risks and uncertainties can be found in our SEC filings, which are available at our website and the SEC’s website. These risks and uncertainties include, but are not limited to, those related to: our ability to operate our business; our efforts to study and develop Korlym, relacorilant, miricorilant, dazucorilant, nenocorilant and our other product candidates; those molecules’ clinical attributes; regulatory approvals, mandates, oversight and other requirements imposed on our products or our business by laws, regulations or discretion of government authorities; and the scope and protective power of our intellectual property. We disclaim any intention or duty to update forward-looking statements made in this press release. View source version on businesswire.com: https://www.businesswire.com/news/home/20260606758364/en/ Investor inquiries:
ir@corcept.com
Media inquiries:
communications@corcept.com
www.corcept.com Original: Corcept Presents New Data at ADA: Improved Outcomes in Patients Receiving a GLP-1 with Difficult-to-Control Type 2 Diabetes and Hypercortisolism Treated with Korlym®
US Market News
1月前
Corcept Presents New Data at ASCO 2026: Lifyorli™ Overall Survival Across All Subgroups of Patients with Platinum-Resistant Ovarian Cancer, Including Those with Recent Taxane ExposureMay 29, 2026 4:33 PM
Business Wire Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company 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, today presented new overall survival data from its pivotal Phase 3 ROSELLA trial of Lifyorli™ (relacorilant) plus nab-paclitaxel (a taxane chemotherapy) in an oral presentation at the ASCO 2026 (American Society of Clinical Oncology) Annual Meeting. In ROSELLA, patients treated with Lifyorli combined with nab-paclitaxel experienced a 35 percent reduction in the risk of death compared to patients treated with nab-paclitaxel alone (hazard ratio (HR): 0.65; p-value: 0.0004), with a median overall survival of 16.0 months, compared to 11.9 months for patients receiving nab-paclitaxel alone. No biomarker testing was required. Patients in all of ROSELLA’s prespecified subgroups experienced meaningful survival benefits. The data presented at ASCO 2026 describe the overall survival benefit in patients whose treatment included a taxane-free interval of 6 months or less (HR: 0.60) and in those who received a taxane in their most recent treatment regimen (HR: 0.67). “Relacorilant stands to become a new standard-of-care treatment for patients with platinum-resistant ovarian cancer, because of the consistent overall survival observed across all patient subgroups, including those with poor prognostic features and regardless of prior taxane exposure, without the need for biomarker selection," said Lucy Gilbert, M.D., Director of Gynecologic Oncology at McGill University Health Centre, Chair of Oncology, McGill University, Montreal. "The results of the ROSELLA study clearly demonstrate that antagonizing the effects of cortisol at the glucocorticoid receptor (GR) can deliver improved survival outcomes in patients with a challenging-to-treat cancer,” said Bill Guyer, PharmD, Corcept's Chief Development Officer. “They support our long-standing belief in the potential of our GR antagonists to treat patients with many tumor types. We are working to advance GR research in many different treatment settings, including platinum-sensitive ovarian, endometrial, cervical, pancreatic and prostate cancers.” Lifyorli, in combination with nab-paclitaxel, was approved by the U.S. Food and Drug Administration (FDA) in March 2026 for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab. Lifyorli is the first FDA-approved selective glucocorticoid receptor antagonist. It is included in the National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a preferred regimen for patients with platinum-resistant ovarian cancer. In ROSELLA, the combination of Lifyorli with nab-paclitaxel was well-tolerated. Adverse events were comparable to those in the nab-paclitaxel monotherapy arm. The prescribing information for Lifyorli includes warnings and precautions for neutropenia and severe infections, adrenal insufficiency, exacerbation of conditions treated with glucocorticoids and embryo-fetal toxicity. The most common adverse reactions experienced by more than 20 percent of patients (including laboratory abnormalities) were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite. ROSELLA enrolled 381 patients with platinum-resistant ovarian cancer at sites in the United States, Europe, South Korea, Brazil, Argentina, Canada and Australia. Patients were randomized 1:1 to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel alone. The ROSELLA trial was conducted in collaboration with The GOG Foundation, Inc. (GOG-F) (GOG-3073), the European Network of Gynaecological Oncological Trial groups (ENGOT) (ENGOT-ov72), the Asia-Pacific Gynecologic Oncology Trials Group (APGOT) (APGOT-Ov10), the Latin American Cooperative Oncology Group (LACOG) (LACOG-0223) and the Australia New Zealand Gynaecological Oncology Group (ANZGOG) (ANZGOG-221/2023). About Ovarian Cancer Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have "platinum-resistant" disease. There are few treatment options for these women. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe. About Cortisol's Role in Oncology Cortisol plays a role in tumor growth through several mechanisms. It helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol promotes tumor growth by activating oncogenic signaling in the cells to which it binds. Cortisol also suppresses the body's immune response, which weakens its ability to fight all diseases, including cancer. Corcept is developing relacorilant in ovarian, endometrial, cervical, pancreatic and prostate cancers. 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 European Commission (EC) for the treatment of ovarian cancer. Corcept has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for relacorilant to treat patients with platinum-resistant ovarian cancer. About Lifyorli™ Lifyorli (relacorilant), approved in combination with nab-paclitaxel, is the first U.S. Food and Drug Administration (FDA)-approved selective glucocorticoid receptor antagonist for adults with platinum-resistant ovarian cancer. Lifyorli is an oral medication taken the day before, the day of and the day after treatment with nab-paclitaxel. There is no biomarker requirement to receive Lifyorli. Lifyorli competitively binds to the glucocorticoid receptor (GR), where it enhances chemotherapy sensitivity by inhibiting cortisol’s suppression of apoptosis – the programmed cell death that chemotherapies such as nab-paclitaxel are meant to cause. Lifyorli does not have any effect at the body’s other steroid receptors. It is included in the National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a preferred regimen for patients with platinum-resistant ovarian cancer. Corcept is committed to timely patient access for Lifyorli. For questions regarding product availability, please contact Lifyorli Support™ at 1-85-LIFYORLI (1-855-439-6754). LIFYORLI Indication & Usage LIFYORLI is indicated in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1-3 prior systemic treatment regimens, at least one of which included bevacizumab. IMPORTANT SAFETY INFORMATION Contraindications: LIFYORLI is contraindicated in patients receiving systemic glucocorticoids for lifesaving purposes (e.g., immunosuppression after organ transplantation) because LIFYORLI antagonizes the effect of glucocorticoids. Warnings and Precautions: Neutropenia and Severe Infections
LIFYORLI in combination with nab-paclitaxel can cause neutropenia, including febrile neutropenia and severe infections. There was one fatal event of septic shock with febrile neutropenia. Thirty-eight percent of patients initiated granulocyte colony-stimulating factor (G-CSF) during the first or second cycle of therapy. Monitor complete blood counts prior to each weekly treatment with LIFYORLI in combination with nab-paclitaxel and as clinically indicated. Based on the severity of neutropenia, delay dose, reduce dose or permanently discontinue LIFYORLI in combination with nab-paclitaxel. Consider short-acting G-CSF administration as applicable. Consider the possibility of concurrent adrenal insufficiency, particularly in the setting of serious infection. Adrenal Insufficiency
LIFYORLI is a reversible glucocorticoid receptor antagonist and can cause adrenal insufficiency. Adrenal insufficiency can occur at any time during treatment with LIFYORLI. The risk of adrenal insufficiency is increased in situations of stress, such as acute illness, infection, or surgery. Consider whether supplemental glucocorticoids are required in the perioperative period in patients who have received LIFYORLI within 30 days of surgery. Monitor patients receiving LIFYORLI for signs and symptoms of adrenal insufficiency. Withhold LIFYORLI and administer glucocorticoid therapy if adrenal insufficiency is suspected. High doses of supplemental glucocorticoids may be needed to overcome the glucocorticoid receptor antagonism produced by LIFYORLI. After resolution of adrenal insufficiency, resume previous dose, reduce dose or permanently discontinue LIFYORLI based on severity. Exacerbation of Conditions Treated with Glucocorticoids
Use of LIFYORLI in patients taking systemic glucocorticoids for other conditions (e.g., autoimmune disorders) may exacerbate these conditions. LIFYORLI is a glucocorticoid receptor antagonist that may make systemic glucocorticoids less effective. Similarly, coadministration of systemic glucocorticoids may make LIFYORLI less effective. Monitor patients for reduced effectiveness of LIFYORLI and glucocorticoids in patients receiving both. Embryo-Fetal Toxicity
LIFYORLI can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Verify pregnancy status of females of reproductive potential prior to initiating LIFYORLI treatment. Advise females of reproductive potential, including male patients with female partners of reproductive potential, to use effective contraception during treatment with LIFYORLI and for 1 week after the last dose. Adverse Reactions: Serious adverse reactions occurred in 35% of patients who received LIFYORLI in combination with nab-paclitaxel. Serious adverse reactions (≥2%) in patients were neutropenia (4%), pneumonia (3.2%), pleural effusion (3.2%), febrile neutropenia (2.1%), and fatigue (2.1%). Fatal adverse reactions (2.1%) in patients were septic shock (0.5%), cardiac arrest (0.5%), ischemic stroke (0.5%), and intestinal perforation (0.5%). Permanent discontinuation of LIFYORLI in combination with nab-paclitaxel due to adverse reactions occurred in 9% of patients. The adverse reaction (>2%) that resulted in permanent discontinuation of LIFYORLI in patients was intestinal obstruction (2.6%). Dosage interruptions of LIFYORLI due to an adverse reaction occurred in 72% of patients. Adverse reactions (≥5%) that required dosage interruptions of LIFYORLI in combination with nab-paclitaxel in patients included neutropenia (44%), anemia (12%), and fatigue (7%). Adverse reactions requiring dose reductions of LIFYORLI included fatigue (1.6%), decreased appetite (1.2%), abdominal pain (0.5%), neutropenia (0.5%), edema (0.5%), and sciatica (0.5%). LIFYORLI should be interrupted or discontinued when nab-paclitaxel is interrupted or discontinued. The most common adverse reactions (>20%) of patients treated with LIFYORLI plus nab-paclitaxel, including laboratory abnormalities, were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite. Drug Interactions: Strong CYP3A Inducers: Avoid coadministration of LIFYORLI plus nab-paclitaxel with strong CYP3A inducers. Both relacorilant and paclitaxel are CYP3A substrates. Coadministration of strong CYP3A inducers can decrease concentrations of relacorilant and paclitaxel, which may reduce their effectiveness. CYP2C8 and Moderate CYP3A Inducers: Monitor for reduced effectiveness of LIFYORLI plus nab-paclitaxel with CYP2C8 inducers and moderate CYP3A inducers. Paclitaxel is a substrate of CYP2C8 and CYP3A, and relacorilant is a CYP3A substrate. Coadministration of CYP2C8 and moderate CYP3A inducers can decrease concentrations of paclitaxel and relacorilant, which may reduce their effectiveness. CYP2C8 Inhibitors: Monitor for increased adverse reactions and modify the dosage for adverse reactions as recommended. Paclitaxel is a substrate of CYP2C8. Coadministration of CYP2C8 inhibitors may increase concentrations of paclitaxel, which may increase the risk of adverse reactions. CYP3A Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP3A substrates. Relacorilant is a strong CYP3A inhibitor. Relacorilant increases exposure of CYP3A substrates which may increase the risk for adverse reactions related to these substrates. Certain CYP2C8 Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP2C8 substrates where minimal concentration changes may lead to reduced effectiveness. Relacorilant is a weak CYP2C8 inducer. Relacorilant decreases exposure of CYP2C8 substrates which may decrease the effectiveness related to these substrates. Use in Specific Populations: Lactation: Advise women not to breastfeed during treatment with LIFYORLI and for 1 week after the last dose. Geriatric Use: A higher incidence of grade 3-4 adverse events and dosage modification occurred in patients aged ≥65 years compared to younger adult patients. Hepatic Impairment: Avoid LIFYORLI in combination with nab-paclitaxel in patients with moderate or severe hepatic impairment (total bilirubin >1.5 to 10x ULN and any AST). Please see the full Prescribing Information for additional Important Safety Information. About Corcept Therapeutics For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders and has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with Cushing’s syndrome, solid tumors, ALS and liver disease. In 2012, the company introduced Korlym®, the first medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with endogenous Cushing’s syndrome, and in 2026, the company introduced Lifyorli™, approved in combination with nab-paclitaxel, the first FDA-approved selective glucocorticoid receptor antagonist for adults with platinum-resistant ovarian cancer. Corcept is headquartered in Redwood City, California. For more information, visit Corcept.com. Forward-Looking Statements Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations and are subject to risks and uncertainties that might cause our actual results to differ materially from any future results expressed or implied by such forward-looking statements. In this press release, forward-looking statements include statements concerning: Lifyorli’s efficacy, safety profile and other clinical attributes; relacorilant as a new standard-of-care treatment for patients with platinum-resistant ovarian cancer; delivering improved survival outcomes in patients with challenging-to-treat cancer by antagonizing the GR; the potential of our GR antagonists to treat patients with many tumor types; our work to advance GR research in many different treatment settings, including platinum-sensitive ovarian, endometrial, cervical, pancreatic and prostate cancers, and our further development of relacorilant in the treatment of these cancers; the incidence of platinum-resistant ovarian cancer patients expected to start a new therapy each year in the United States and Europe; and our commitment to timely patient access for Lifyorli. A further description of risks and uncertainties can be found in our SEC filings, which are available at our website and the SEC’s website. These risks and uncertainties include, but are not limited to, those related to: our ability to operate our business; our efforts to study and develop Korlym, relacorilant, miricorilant, dazucorilant, nenocorilant and our other product candidates; those molecules’ clinical attributes; regulatory approvals, mandates, oversight and other requirements imposed on our products or our business by laws, regulations or discretion of government authorities; and the scope and protective power of our intellectual property. We disclaim any intention or duty to update forward-looking statements made in this press release. View source version on businesswire.com: https://www.businesswire.com/news/home/20260529589368/en/ Investor inquiries:
ir@corcept.com
Media inquiries:
communications@corcept.com
www.corcept.com Original: Corcept Presents New Data at ASCO 2026: Lifyorli™ Overall Survival Across All Subgroups of Patients with Platinum-Resistant Ovarian Cancer, Including Those with Recent Taxane Exposure
US Market News
2月前
Corcept Phase 2 Study of Dazucorilant Demonstrates Two-Year Overall Survival Benefit in Patients with Amyotrophic Lateral SclerosisApril 30, 2026 4:05 PM
Business Wire
87 percent reduction in risk of death compared to patients who received placebo (hazard ratio: 0.13, p-value: < 0.0001)
Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company 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, today announced two-year overall survival data from the Phase 2 DAZALS study of its proprietary, selective cortisol modulator dazucorilant in patients with amyotrophic lateral sclerosis (ALS).
DAZALS is a randomized, double-blind, placebo-controlled Phase 2 study in which 249 patients with ALS were randomized to receive either 150 mg of dazucorilant, 300 mg of dazucorilant or placebo, daily for 24 weeks. Patients who completed the treatment period were eligible to enter the study’s long-term extension phase, in which all patients received 300 mg of dazucorilant. DAZAL’s primary endpoint was the difference in function, as measured by the ALS Functional Rating Scale – Revised (ALSFRS-R), between patients who received dazucorilant and those who received placebo. Overall survival was a secondary endpoint.
Although DAZALS did not meet its primary endpoint, at the end of the 24-week treatment period patients who received 300 mg of dazucorilant daily did exhibit improved overall survival (p-value: 0.02). Exploratory analyses show that this survival benefit has continued. In the two years following the start of treatment, patients who received 300 mg of dazucorilant experienced an 87 percent reduction in the risk of death compared to patients who received placebo and did not switch to 300 mg of dazucorilant in the extension phase (hazard ratio: 0.13; p-value: < 0.0001). This finding is consistent with the 84 percent reduction in risk of death observed after one year of treatment (hazard ratio: 0.16; p-value: 0.0009). Those one-year data were presented at the European Network to Cure ALS (ENCALS) 2025 annual meeting.
A similarly pronounced survival benefit was observed at both the one-year and two-year marks in patients who received 300 mg of dazucorilant for more than 24 weeks, whether in the treatment period or in the long-term extension phase, compared to patients who received either placebo or 150 mg of dazucorilant for more than 24 weeks and did not receive dazucorilant in the extension phase. Between these groups, the reduction in risk of death in patients who received 300 mg of dazucorilant was 64 percent at one year (hazard ratio: 0.36; p-value: 0.02) and 61 percent at two years (hazard ratio: 0.39; p-value: 0.02).
Dazucorilant continues to demonstrate an acceptable safety profile, with mild to moderate, dose-related, transient abdominal pain being the most common adverse effect. Corcept is conducting a dose titration study to refine methods of improving dazucorilant’s gastrointestinal tolerability and inform the program’s path forward.
“Our data demonstrate that dazucorilant markedly reduces mortality in the first years following diagnosis, when people with ALS retain meaningful function and quality of life,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “We are working with regulators to advance this program as expeditiously as possible and expect to initiate a pivotal Phase 3 study later this year.”
About the DAZALS Study
DAZALS is a randomized, double-blind, placebo-controlled Phase 2 trial in which 249 patients with ALS were randomized 1:1:1 to receive either 150 mg of dazucorilant, 300 mg of dazucorilant or placebo daily for 24 weeks. Patients who completed the treatment period were eligible to enroll in the study’s long-term extension phase, in which all patients received 300 mg of dazucorilant. Baseline patient characteristics, including the ENCALS risk score, time from diagnosis, ALSFRS-R total score, and bulbar onset, were consistent across study arms.
The DAZALS primary endpoint was the difference in change from baseline during the study’s 24-week treatment period in ALSFRS-R score between patients who received dazucorilant and those who received placebo. Key secondary endpoints include overall survival and quality of life. DAZALS was conducted at sites in Europe, the United States and Canada.
About Amyotrophic Lateral Sclerosis
ALS, also known as Lou Gehrig’s disease or motor neuron disease, is a fatal degenerative neurologic disorder that affects more than 55,000 people in the United States and Europe. ALS causes muscles to weaken and, as the disease progresses, severely impairs patients’ ability to speak, eat, move and breathe. There is increasing evidence that patients with ALS, particularly those with rapid disease progression, exhibit elevated or abnormal cortisol levels. A patient’s life expectancy after diagnosis is two to five years.
About Dazucorilant
Dazucorilant is a selective cortisol modulator that binds to the glucocorticoid receptor but not to the body’s other hormone receptors. Corcept is studying dazucorilant as a potential treatment for ALS and other neurologic disorders. The compound is proprietary to Corcept and is protected by composition of matter, method of use and other patents. The U.S. Food and Drug Administration has granted dazucorilant Fast Track Designation and orphan drug status for the treatment of ALS in the United States.
About Corcept Therapeutics
For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders and has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with Cushing’s syndrome, solid tumors, ALS and liver disease. In 2012, the company introduced Korlym®, the first medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with endogenous Cushing’s syndrome, and in 2026, the company introduced Lifyorli™, approved in combination with nab-paclitaxel, the first FDA-approved selective glucocorticoid receptor antagonist, for adults with platinum-resistant ovarian cancer. Corcept is headquartered in Redwood City, California. For more information, visit Corcept.com.
Forward-Looking Statements
Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations and are subject to risks and uncertainties that might cause our actual results to differ materially from any future results expressed or implied by such forward-looking statements.
In this press release, forward-looking statements include statements concerning: the potential efficacy, survival benefit and safety profile of dazucorilant as a treatment for patients with ALS; our plan to initiate a pivotal Phase 3 study of dazucorilant for the treatment of ALS later this year, including our use of a dose-titration study to refine methods of improving dazucorilant’s gastrointestinal tolerability and to inform the path forward for the design of the Phase 3 study; our efforts working with regulators to advance dazucorilant as a treatment for ALS as expeditiously as possible; and dazucorilant’s potential as a treatment for other neurologic disorders.
A further description of risks and uncertainties can be found in our SEC filings, which are available at our website and the SEC’s website. These risks and uncertainties include, but are not limited to, those related to: our ability to operate our business; our efforts to study and develop Korlym, relacorilant, miricorilant, dazucorilant, nenocorilant and our other product candidates; those molecules’ clinical attributes; regulatory approvals, mandates, oversight and other requirements imposed on our products or our business by laws, regulations or discretion of government authorities; and the scope and protective power of our intellectual property. We disclaim any intention or duty to update forward-looking statements made in this press release.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260430885863/en/
Investor inquiries:
ir@corcept.com
Media inquiries:
communications@corcept.com
www.corcept.com
Original: Corcept Phase 2 Study of Dazucorilant Demonstrates Two-Year Overall Survival Benefit in Patients with Amyotrophic Lateral Sclerosis
US Market News
2月前
Corcept to Present New Data from Pivotal Phase 3 ROSELLA Trial of Lifyorli™ (Relacorilant) in Patients with Platinum-Resistant Ovarian Cancer at ASCO 2026April 21, 2026 1:09 PM
Business Wire
Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company 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, will present new data from its pivotal Phase 3 ROSELLA trial of Lifyorli™ (relacorilant) plus nab-paclitaxel in platinum-resistant ovarian cancer at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The data will be presented in an oral presentation on Friday, May 29, 2026.
Overall survival subgroup analyses for prior taxane use in the phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel versus nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (GOG-3073, ENGOT-ov72, APGOT-Ov10, LACOG-0223, and ANZGOG-2221/2023)
Oral Abstract Session – Gynecologic Cancer
May 29, 2026, 2:45 PM – 5:45 PM CDT
Abstract Number: 5503
Lifyorli, in combination with nab-paclitaxel, was approved by the U.S. Food and Drug Administration (FDA) in March 2026 for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab. Lifyorli is the first FDA-approved selective glucocorticoid receptor antagonist (SGRA). It is included in the National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a preferred regimen for patients with platinum-resistant ovarian cancer.
The ROSELLA trial was conducted in collaboration with The GOG Foundation, Inc. (GOG-F), the European Network of Gynaecological Oncological Trial groups (ENGOT), the Asia-Pacific Gynecologic Oncology Trials Group (APGOT), the Latin American Cooperative Oncology Group (LACOG) and the Australia New Zealand Gynaecological Oncology Group (ANZGOG).
About Ovarian Cancer
Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have "platinum-resistant" disease. There are few treatment options for these women. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe.
About Cortisol's Role in Oncology
Cortisol plays a role in tumor growth through several mechanisms. It helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol promotes tumor growth by activating oncogenic signaling in the cells to which it binds. Cortisol also suppresses the body's immune response, which weakens its ability to fight all diseases, including cancer.
Corcept is developing relacorilant in ovarian, endometrial, cervical, pancreatic and prostate cancers. 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 European Commission (EC) for the treatment of ovarian cancer. Corcept has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for relacorilant to treat patients with platinum-resistant ovarian cancer.
About Lifyorli™
Lifyorli (relacorilant), approved in combination with nab-paclitaxel, is the first U.S. Food and Drug Administration (FDA)-approved selective glucocorticoid receptor antagonist for adults with platinum-resistant ovarian cancer. Lifyorli is an oral medication taken the day before, the day of and the day after treatment with nab-paclitaxel. There is no biomarker requirement to receive Lifyorli. Lifyorli competitively binds to the glucocorticoid receptor (GR), where it enhances chemotherapy sensitivity by inhibiting cortisol’s suppression of apoptosis – the programmed cell death that chemotherapies such as nab-paclitaxel are meant to cause. Lifyorli does not have any effect at the body’s other steroid receptors.
It is included in the National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a preferred regimen for patients with platinum-resistant ovarian cancer.
Corcept is committed to timely patient access for Lifyorli. For questions regarding product availability, please contact Lifyorli Support™ at 1-85-LIFYORLI (1-855-439-6754).
LIFYORLI Indication & Usage
LIFYORLI is indicated in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1-3 prior systemic treatment regimens, at least one of which included bevacizumab.
IMPORTANT SAFETY INFORMATION
Contraindications:
LIFYORLI is contraindicated in patients receiving systemic glucocorticoids for lifesaving purposes (e.g., immunosuppression after organ transplantation) because LIFYORLI antagonizes the effect of glucocorticoids.
Warnings and Precautions:
Neutropenia and Severe Infections
LIFYORLI in combination with nab-paclitaxel can cause neutropenia, including febrile neutropenia and severe infections. There was one fatal event of septic shock with febrile neutropenia. Thirty-eight percent of patients initiated granulocyte colony-stimulating factor (G-CSF) during the first or second cycle of therapy.
Monitor complete blood counts prior to each weekly treatment with LIFYORLI in combination with nab-paclitaxel and as clinically indicated. Based on the severity of neutropenia, delay dose, reduce dose or permanently discontinue LIFYORLI in combination with nab-paclitaxel. Consider short-acting G-CSF administration as applicable. Consider the possibility of concurrent adrenal insufficiency, particularly in the setting of serious infection.
Adrenal Insufficiency
LIFYORLI is a reversible glucocorticoid receptor antagonist and can cause adrenal insufficiency. Adrenal insufficiency can occur at any time during treatment with LIFYORLI. The risk of adrenal insufficiency is increased in situations of stress, such as acute illness, infection, or surgery. Consider whether supplemental glucocorticoids are required in the perioperative period in patients who have received LIFYORLI within 30 days of surgery. Monitor patients receiving LIFYORLI for signs and symptoms of adrenal insufficiency. Withhold LIFYORLI and administer glucocorticoid therapy if adrenal insufficiency is suspected. High doses of supplemental glucocorticoids may be needed to overcome the glucocorticoid receptor antagonism produced by LIFYORLI. After resolution of adrenal insufficiency, resume previous dose, reduce dose or permanently discontinue LIFYORLI based on severity.
Exacerbation of Conditions Treated with Glucocorticoids
Use of LIFYORLI in patients taking systemic glucocorticoids for other conditions (e.g., autoimmune disorders) may exacerbate these conditions. LIFYORLI is a glucocorticoid receptor antagonist that may make systemic glucocorticoids less effective. Similarly, coadministration of systemic glucocorticoids may make LIFYORLI less effective. Monitor patients for reduced effectiveness of LIFYORLI and glucocorticoids in patients receiving both.
Embryo-Fetal Toxicity
LIFYORLI can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Verify pregnancy status of females of reproductive potential prior to initiating LIFYORLI treatment. Advise females of reproductive potential, including male patients with female partners of reproductive potential, to use effective contraception during treatment with LIFYORLI and for 1 week after the last dose.
Adverse Reactions:
Serious adverse reactions occurred in 35% of patients who received LIFYORLI in combination with nab-paclitaxel. Serious adverse reactions (≥2%) in patients were neutropenia (4%), pneumonia (3.2%), pleural effusion (3.2%), febrile neutropenia (2.1%), and fatigue (2.1%). Fatal adverse reactions (2.1%) in patients were septic shock (0.5%), cardiac arrest (0.5%), ischemic stroke (0.5%), and intestinal perforation (0.5%).
Permanent discontinuation of LIFYORLI in combination with nab-paclitaxel due to adverse reactions occurred in 9% of patients. The adverse reaction (>2%) that resulted in permanent discontinuation of LIFYORLI in patients was intestinal obstruction (2.6%). Dosage interruptions of LIFYORLI due to an adverse reaction occurred in 72% of patients. Adverse reactions (≥5%) that required dosage interruptions of LIFYORLI in combination with nab-paclitaxel in patients included neutropenia (44%), anemia (12%), and fatigue (7%). Adverse reactions requiring dose reductions of LIFYORLI included fatigue (1.6%), decreased appetite (1.2%), abdominal pain (0.5%), neutropenia (0.5%), edema (0.5%), and sciatica (0.5%). LIFYORLI should be interrupted or discontinued when nab-paclitaxel is interrupted or discontinued.
The most common adverse reactions (>20%) of patients treated with LIFYORLI plus nab-paclitaxel, including laboratory abnormalities, were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite.
Drug Interactions:
Strong CYP3A Inducers: Avoid coadministration of LIFYORLI plus nab-paclitaxel with strong CYP3A inducers. Both relacorilant and paclitaxel are CYP3A substrates. Coadministration of strong CYP3A inducers can decrease concentrations of relacorilant and paclitaxel, which may reduce their effectiveness.
CYP2C8 and Moderate CYP3A Inducers: Monitor for reduced effectiveness of LIFYORLI plus nab-paclitaxel with CYP2C8 inducers and moderate CYP3A inducers. Paclitaxel is a substrate of CYP2C8 and CYP3A, and relacorilant is a CYP3A substrate. Coadministration of CYP2C8 and moderate CYP3A inducers can decrease concentrations of paclitaxel and relacorilant, which may reduce their effectiveness.
CYP2C8 Inhibitors: Monitor for increased adverse reactions and modify the dosage for adverse reactions as recommended. Paclitaxel is a substrate of CYP2C8. Coadministration of CYP2C8 inhibitors may increase concentrations of paclitaxel, which may increase the risk of adverse reactions.
CYP3A Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP3A substrates. Relacorilant is a strong CYP3A inhibitor. Relacorilant increases exposure of CYP3A substrates which may increase the risk for adverse reactions related to these substrates.
Certain CYP2C8 Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP2C8 substrates where minimal concentration changes may lead to reduced effectiveness. Relacorilant is a weak CYP2C8 inducer. Relacorilant decreases exposure of CYP2C8 substrates which may decrease the effectiveness related to these substrates.
Use in Specific Populations:
Lactation: Advise women not to breastfeed during treatment with LIFYORLI and for 1 week after the last dose.
Geriatric Use: A higher incidence of grade 3-4 adverse events and dosage modification occurred in patients aged ≥65 years compared to younger adult patients.
Hepatic Impairment: Avoid LIFYORLI in combination with nab-paclitaxel in patients with moderate or severe hepatic impairment (total bilirubin >1.5 to 10x ULN and any AST).
Please see the full Prescribing Information for additional Important Safety Information.
About Corcept Therapeutics
For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders and has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with Cushing’s syndrome, solid tumors, ALS and liver disease. In 2012, the company introduced Korlym®, the first medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with endogenous Cushing’s syndrome, and in 2026, the company introduced Lifyorli™, approved in combination with nab-paclitaxel, the first FDA-approved selective glucocorticoid receptor antagonist for adults with platinum-resistant ovarian cancer. Corcept is headquartered in Redwood City, California. For more information, visit Corcept.com.
Forward-Looking Statements
Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations and are subject to risks and uncertainties that might cause our actual results to differ materially from any future results expressed or implied by such forward-looking statements.
In this press release, forward-looking statements include statements concerning: Lifyorli’s efficacy, safety profile and other clinical attributes; presentation of the data from the Phase 3 ROSELLA trial at the ASCO meeting; the incidence of platinum-resistant ovarian cancer patients expected to start a new therapy each year in the United States and Europe; our further development of relacorilant in ovarian, endometrial, cervical, pancreatic and prostate cancers; and our commitment to timely patient access for Lifyorli.
A further description of risks and uncertainties can be found in our SEC filings, which are available at our website and the SEC’s website. These risks and uncertainties include, but are not limited to, those related to: our ability to operate our business; our efforts to study and develop Korlym, relacorilant, miricorilant, dazucorilant, nenocorilant and our other product candidates; those molecules’ clinical attributes; regulatory approvals, mandates, oversight and other requirements imposed on our products or our business by laws, regulations or discretion of government authorities; and the scope and protective power of our intellectual property. We disclaim any intention or duty to update forward-looking statements made in this press release.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260421589301/en/
Investor inquiries:
ir@corcept.com
Media inquiries:
communications@corcept.com
www.corcept.com
Original: Corcept to Present New Data from Pivotal Phase 3 ROSELLA Trial of Lifyorli™ (Relacorilant) in Patients with Platinum-Resistant Ovarian Cancer at ASCO 2026
US Market News
3月前
Corcept präsentiert vollständige Daten aus der zulassungsrelevanten ROSELLA-Studie im Rahmen einer Late-Breaker-Präsentation auf der SGO-Konferenz, begleitet von einer gleichzeitigen Veröffentlichung in The Lancet: Lifyorli™ (Relacorilant) Plus...April 13, 2026 3:23 PM
Business Wire
Die Daten belegen eine Senkung des Sterberisikos um 35 Prozent
Lifyorli in Kombination mit Nab-Paclitaxel wurde als bevorzugtes Behandlungsschema in die NCCN Guidelines® aufgenommen
Lifyorli wurde im März 2026 von der FDA zugelassen
Corcept präsentiert vollständige Daten aus der zulassungsrelevanten ROSELLA-Studie im Rahmen einer Late-Breaker-Präsentation auf der SGO-Konferenz, begleitet von einer gleichzeitigen Veröffentlichung in The Lancet: Lifyorli™ (Relacorilant) Plus Nab-Paclitaxel Improves Overall Survival in Patients with Platinum-Resistant Ovarian Cancer
Corcept Therapeutics Incorporated (NASDAQ: CORT), ein Unternehmen im kommerziellen Stadium, das sich mit der Erforschung und Entwicklung von Medikamenten zur Behandlung schwerer endokrinologischer, onkologischer, metabolischer und neurologischer Erkrankungen durch Modulation der Wirkungen des Hormons Cortisol befasst, hat heute in einem aktuellen Vortrag auf der Jahrestagung 2026 der Society of Gynecologic Oncology (SGO) zum Thema Frauenkrebs die endgültigen Daten zur Gesamtüberlebensrate aus seiner zulassungsrelevanten Phase-3-Studie ROSELLA zu Lifyorli™ (Relacorilant) in Kombination mit dem Chemotherapeutikum Nab-Paclitaxel bei Patientinnen mit platinresistentem Eierstockkrebs vorgestellt. Die Folien zur SGO-Präsentation finden Sie hier.
Diese Daten wurden zeitgleich in The Lancet: „Overall survival with relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): a phase 3 randomised controlled trial veröffentlicht.”
Lifyorli plus Nab-Paclitaxel wurde nun in die klinischen Praxisleitlinien des National Comprehensive Cancer Network® (NCCN Guidelines®) als bevorzugtes Behandlungsschema für Patientinnen mit platinresistentem Eierstockkrebs aufgenommen. Lifyorli wurde in Kombination mit Nab-Paclitaxel im März 2026 von der US-amerikanischen Arzneimittelbehörde FDA für die Behandlung von Erwachsenen mit platinresistentem epithelialem Eierstock-, Eileiter- oder primärem Peritonealkrebs zugelassen, die zuvor ein bis drei systemische Therapien erhalten haben, von denen mindestens eine Bevacizumab enthielt. Lifyorli ist der erste von der FDA zugelassene selektive Glukokortikoidrezeptor-Antagonist (SGRA).
Die ROSELLA-Studie erreichte ihre beiden primären Endpunkte – das Gesamtüberleben und das progressionsfreie Überleben – unabhängig vom Biomarkerstatus und ohne erhöhte Sicherheitsbedenken. Bei Patientinnen, die zusätzlich zur Chemotherapie mit Nab-Paclitaxel mit Lifyorli behandelt wurden, war das Sterberisiko um 35 Prozent geringer als bei Patientinnen, die nur mit Nab-Paclitaxel behandelt wurden (Hazard Ratio: 0,65; p-Wert: 0,0004). Das mediane Gesamtüberleben war bei Patienten, die Lifyorli erhielten, um 4,1 Monate länger als bei Patienten, die nur Nab-Paclitaxel erhielten (16,0 gegenüber 11,9 Monaten). Bei Patienten, die zusätzlich zu Nab-Paclitaxel Lifyorli erhielten, zeigte sich im Vergleich zu Patienten, die nur mit Nab-Paclitaxel behandelt wurden, eine Verringerung des Risikos für ein Fortschreiten der Erkrankung um 30 Prozent (Hazard Ratio: 0,70; p-Wert: 0,0076), wie durch eine verblindete, unabhängige zentrale Überprüfung festgestellt wurde.
Die Kombination von Lifyorli mit Nab-Paclitaxel wurde gut vertragen. Die unerwünschten Ereignisse in der Kombinationsgruppe waren mit denen in der Nab-Paclitaxel-Monotherapiegruppe vergleichbar. Die Fachinformation zu Lifyorli enthält Warnhinweise und Vorsichtsmaßnahmen bezüglich Neutropenie und schwerer Infektionen, Nebenniereninsuffizienz, Verschlimmerung von mit Glukokortikoiden behandelten Erkrankungen sowie embryo-fötaler Toxizität. Die häufigsten Nebenwirkungen, die bei mehr als 20 Prozent der Patienten auftraten (einschließlich Laborwertabweichungen), waren ein niedriger Hämoglobinspiegel, eine verminderte Neutrophilenzahl, Müdigkeit, Übelkeit, Durchfall, eine verminderte Thrombozytenzahl, Hautausschlag und Appetitlosigkeit.
„Die Ergebnisse der ROSELLA-Studie hinsichtlich Sicherheit und Wirksamkeit sind bemerkenswert“, sagte Dr. med. Alexander B. Olawaiye, Professor und Vice Chair of Diversity and Inclusion am Magee-Women’s Hospital der University of Pittsburgh, Hauptprüfer der ROSELLA-Studie, Referent bei der SGO und Autor der Veröffentlichung in The Lancet. „Sie geben Patienten und Onkologen Hoffnung, da wir nun über eine neue bevorzugte Therapie bei dieser verheerenden und schwer zu behandelnden Krebserkrankung verfügen.“
„Patientinnen mit platinresistentem Eierstockkrebs benötigen mehr wirksame Behandlungsoptionen. Relacorilant bietet eine solche Option. Es verlängert das Gesamtüberleben signifikant, bei nur sehr geringer zusätzlicher Toxizität“, sagte Dr. med. Domenica Lorusso, Ph.D., Director der Abteilung für gynäkologische Onkologie am Humanitas-Krankenhaus San Pio X in Mailand und ordentliche Professorin für Geburtshilfe und Gynäkologie an der Humanitas-Universität in Pieve Emanuele, leitende Autorin der Lancet-Veröffentlichung und Forscherin des European Network of Gynaecological Oncology Trial Groups (ENGOT) in der ROSELLA-Studie. „Diese Therapie hat sich in den Vereinigten Staaten fest als neue Standardbehandlung für Patienten etabliert. Wir rechnen in Kürze mit der behördlichen Zulassung in Europa.“
„Die positiven Ergebnisse der ROSELLA-Studie bestärken uns in unserer Überzeugung, dass selektive Glukokortikoidrezeptor (GR)-Antagonisten wie Relacorilant bei der Behandlung aller Patienten helfen können, deren Tumor den GR exprimiert“, sagte Bill Guyer, PharmD, Chief Development Officer bei Corcept. „Nach der kürzlich erteilten Zulassung durch die FDA konzentrieren wir uns nun darauf, diese Therapie den Patienten zugänglich zu machen und die Forschung zur Cortisolmodulation bei soliden Tumoren, die GR exprimieren, in vielen verschiedenen Behandlungssituationen fortzusetzen. Wir sind den Patienten und Forschern dankbar, die unsere Studien ermöglichen.“
An der ROSELLA-Studie nahmen 381 Patientinnen mit platinresistentem Eierstockkrebs an Studienzentren in den Vereinigten Staaten, Europa, Südkorea, Brasilien, Argentinien, Kanada und Australien teil. Die Patienten wurden im Verhältnis 1:1 randomisiert und erhielten entweder Relacorilant plus Nab-Paclitaxel oder Nab-Paclitaxel allein. Die ROSELLA-Studie wurde in Zusammenarbeit mit der GOG Foundation, Inc. (GOG-F) (GOG-3073), dem European Network of Gynaecological Oncology Trial Groups (ENGOT) (ENGOT-ov72), der Asia-Pacific Gynecologic Oncology Trials Group (APGOT) (APGOT-Ov10), der Latin American Cooperative Oncology Group (LACOG) (LACOG-0223) und der Australia New Zealand Gynaecological Oncology Group (ANZGOG) (ANZGOG-221/2023) durchgeführt.
Informationen zum Ovarialkarzinom
Eierstockkrebs ist die fünfthäufigste krebsbedingte Todesursache bei Frauen. Patienten, bei denen die Erkrankung weniger als sechs Monate nach einer platinhaltigen Therapie wieder auftritt, leiden an einer „platinresistenten“ Erkrankung. Für diese Frauen gibt es nur wenige Behandlungsmöglichkeiten. In den Vereinigten Staaten kommen jedes Jahr etwa 20.000 Frauen mit einer platinresistenten Erkrankung für den Beginn einer neuen Therapie in Frage, in Europa ist die Zahl mindestens ebenso hoch.
Über die Rolle von Cortisol in der Onkologie
Cortisol beeinflusst das Tumorwachstum über verschiedene Mechanismen. Es unterstützt solide Tumore dabei, einer Chemotherapie zu widerstehen, indem es die Apoptose der Zellen hemmt – also genau den Vorgang, den die Chemotherapie eigentlich stimulieren soll, um den Tumor abzutöten. Bei einigen Krebsarten fördert Cortisol das Tumorwachstum, indem es onkogene Signalwege in den Zellen aktiviert, an die es bindet. Cortisol unterdrückt zudem die Immunantwort des Körpers, was dessen Fähigkeit zur Abwehr aller Krankheiten, einschließlich Krebs, schwächt.
Corcept entwickelt Relacorilant zur Behandlung von Eierstock-, Gebärmutter-, Gebärmutterhals-, Bauchspeicheldrüsen- und Prostatakrebs. Relacorilant ist ein geschützte Marke von Corcept und durch Patente auf die Stoffzusammensetzung, das Anwendungsverfahren und weitere Aspekte geschützt. Es wurde von der Europäischen Kommission (EK) als Orphan-Arzneimittel zur Behandlung von Eierstockkrebs ausgewiesen. Corcept hat bei der Europäischen Arzneimittelagentur (EMA) einen Antrag auf Marktzulassung (MAA) für Relacorilant zur Behandlung von Patientinnen mit platinresistentem Eierstockkrebs gestellt.
Über Lifyorli™
Lifyorli (Relacorilant), zugelassen in Kombination mit Nab-Paclitaxel, ist der erste von der US-amerikanischen Arzneimittelbehörde FDA zugelassene selektive Glukokortikoidrezeptor-Antagonist für Erwachsene mit platinresistentem Eierstockkrebs. Lifyorli ist ein orales Medikament, das am Tag vor, am Tag der und am Tag nach der Behandlung mit Nab-Paclitaxel eingenommen wird. Für Lifyorli besteht keine Anforderung hinsichtlich eines Biomarkers. Lifyorli bindet kompetitiv an den Glukokortikoidrezeptor (GR), wo es die Empfindlichkeit gegenüber einer Chemotherapie erhöht, indem es die durch Cortisol verursachte Hemmung der Apoptose – also des programmierten Zelltods, den Chemotherapien wie Nab-Paclitaxel auslösen sollen – unterbindet. Lifyorli hat keine Wirkung auf die anderen Steroidrezeptoren des Körpers.
Corcept setzt sich dafür ein, dass Patienten zeitnah Zugang zu Lifyorli erhalten. Bei Fragen zur Produktverfügbarkeit wenden Sie sich bitte an den Lifyorli Support™ unter der Nummer 1-85-LIFYORLI (1-855-439-6754).
LIFYORLI – Indikation und Anwendung
LIFYORLI ist in Kombination mit Nab-Paclitaxel zur Behandlung von Erwachsenen mit platinresistentem epithelialem Ovarialkarzinom, Eileiterkarzinom oder primärem Peritonealkarzinom indiziert, die zuvor 1 bis 3 systemische Therapien erhalten haben, von denen mindestens eine Bevacizumab enthielt.
WICHTIGE SICHERHEITSINFORMATIONEN
Gegenanzeigen:
LIFYORLI ist bei Patienten kontraindiziert, die systemische Glukokortikoide zu lebensrettenden Zwecken erhalten (z. B. zur Immunsuppression nach einer Organtransplantation), da LIFYORLI die Wirkung von Glukokortikoiden aufhebt.
Warnungen und Vorsichtsmaßnahmen:
Neutropenie und schwere Infektionen
LIFYORLI kann in Kombination mit Nab-Paclitaxel Neutropenie verursachen, einschließlich febriler Neutropenie und schwerer Infektionen. Es gab einen tödlichen Fall von septischem Schock mit febriler Neutropenie. Bei 38 % der Patienten wurde im ersten oder zweiten Therapiezyklus eine Behandlung mit Granulozyten-Kolonie-stimulierendem Faktor (G-CSF) eingeleitet.
Überwachen Sie das vollständige Blutbild vor jeder wöchentlichen Behandlung mit LIFYORLI in Kombination mit Nab-Paclitaxel sowie nach klinischer Indikation. Je nach Schweregrad der Neutropenie ist die Dosis von LIFYORLI in Kombination mit Nab-Paclitaxel zu verschieben, zu reduzieren oder die Behandlung dauerhaft abzubrechen. Erwägen Sie gegebenenfalls die Gabe von kurz wirksamem G-CSF. Berücksichtigen Sie die Möglichkeit einer begleitenden Nebenniereninsuffizienz, insbesondere bei schweren Infektionen.
Nebenniereninsuffizienz
LIFYORLI ist ein reversibler Glukokortikoidrezeptor-Antagonist und kann eine Nebenniereninsuffizienz verursachen. Eine Nebenniereninsuffizienz kann zu jedem Zeitpunkt während der Behandlung mit LIFYORLI auftreten. Das Risiko einer Nebenniereninsuffizienz ist in Stresssituationen wie bei akuten Erkrankungen, Infektionen oder Operationen erhöht. Prüfen Sie, ob bei Patienten, die innerhalb von 30 Tagen vor der Operation LIFYORLI erhalten haben, in der perioperativen Phase eine zusätzliche Glukokortikoidtherapie erforderlich ist. Überwachen Sie Patienten, die LIFYORLI erhalten, auf Anzeichen und Symptome einer Nebenniereninsuffizienz. Setzen Sie LIFYORLI ab und leiten Sie eine Glukokortikoidtherapie ein, wenn der Verdacht auf eine Nebenniereninsuffizienz besteht. Möglicherweise sind hohe Dosen an Glukokortikoid-Ergänzungspräparaten erforderlich, um den durch LIFYORLI hervorgerufenen Glukokortikoidrezeptor-Antagonismus zu überwinden. Nach Behebung der Nebenniereninsuffizienz ist die bisherige Dosis wieder aufzunehmen, die Dosis zu reduzieren oder die Behandlung mit LIFYORLI je nach Schweregrad dauerhaft abzubrechen.
Verschlimmerung von Erkrankungen, die mit Glukokortikoiden behandelt werden
Die Anwendung von LIFYORLI bei Patienten, die aufgrund anderer Erkrankungen (z. B. Autoimmunerkrankungen) systemische Glukokortikoide einnehmen, kann zu einer Verschlimmerung dieser Erkrankungen führen. LIFYORLI ist ein Glukokortikoidrezeptor-Antagonist, der die Wirksamkeit systemisch verabreichter Glukokortikoide beeinträchtigen kann. Ebenso kann die gleichzeitige Gabe von systemischen Glukokortikoiden die Wirksamkeit von LIFYORLI beeinträchtigen. Bei Patienten, die sowohl LIFYORLI als auch Glukokortikoide erhalten, ist auf eine verminderte Wirksamkeit zu achten.
Embryo-Fötale Toxizität
LIFYORLI kann bei Verabreichung an Schwangere den Fötus schädigen. Schwangere sollten über das potenzielle Risiko für den Fötus aufgeklärt werden. Vor Beginn einer Behandlung mit LIFYORLI ist der Schwangerschaftsstatus von Frauen im gebärfähigen Alter zu überprüfen. Frauen im gebärfähigen Alter, einschließlich männlicher Patienten mit Partnerinnen im gebärfähigen Alter, sollten angewiesen werden, während der Behandlung mit LIFYORLI und für eine Woche nach der letzten Dosis eine wirksame Verhütungsmethode anzuwenden.
Unerwünschte Nebenwirkungen:
Bei 35 % der Patienten, die LIFYORLI in Kombination mit Nab-Paclitaxel erhielten, traten schwerwiegende unerwünschte Wirkungen auf. Zu den schwerwiegenden unerwünschten Wirkungen (≥ 2 %) bei den Patienten zählten Neutropenie (4 %), Pneumonie (3,2 %), Pleuraerguss (3,2 %), febrile Neutropenie (2,1 %) und Fatigue (2,1 %). Tödliche Nebenwirkungen (2,1 %) bei Patienten waren septischer Schock (0,5 %), Herzstillstand (0,5 %), ischämischer Schlaganfall (0,5 %) und Darmperforation (0,5 %).
Ein dauerhafter Abbruch der Behandlung mit LIFYORLI in Kombination mit Nab-Paclitaxel aufgrund von Nebenwirkungen trat bei 9 % der Patienten auf. Die Nebenwirkung (>2 %), die bei Patienten zu einem dauerhaften Abbruch der Behandlung mit LIFYORLI führte, war eine Darmobstruktion (2,6 %). Bei 72 % der Patienten kam es aufgrund einer Nebenwirkung zu einer Unterbrechung der Behandlung mit LIFYORLI. Zu den Nebenwirkungen (≥ 5 %), die bei Patienten eine Unterbrechung der Behandlung mit LIFYORLI in Kombination mit Nab-Paclitaxel erforderlich machten, gehörten Neutropenie (44 %), Anämie (12 %) und Müdigkeit (7 %). Zu den Nebenwirkungen, die eine Dosisreduktion von LIFYORLI erforderlich machten, gehörten Müdigkeit (1,6 %), verminderter Appetit (1,2 %), Bauchschmerzen (0,5 %), Neutropenie (0,5 %), Ödeme (0,5 %) und Ischias (0,5 %). Die Behandlung mit LIFYORLI sollte unterbrochen oder abgebrochen werden, wenn die Behandlung mit Nab-Paclitaxel unterbrochen oder abgebrochen wird.
Die häufigsten Nebenwirkungen (>20 %) bei Patienten, die mit LIFYORLI plus Nab-Paclitaxel behandelt wurden, waren – einschließlich Laborwertabweichungen – ein niedriger Hämoglobinspiegel, eine verminderte Neutrophilenzahl, Müdigkeit, Übelkeit, Durchfall, eine verminderte Thrombozytenzahl, Hautausschlag und Appetitlosigkeit.
Wechselwirkungen mit anderen Arzneimitteln:
Starke CYP3A-Induktoren: Die gleichzeitige Verabreichung von LIFYORLI plus Nab-Paclitaxel mit starken CYP3A-Induktoren ist zu vermeiden. Sowohl Relacorilant als auch Paclitaxel sind CYP3A-Substrate. Die gleichzeitige Gabe starker CYP3A-Induktoren kann die Konzentrationen von Relacorilant und Paclitaxel senken, was deren Wirksamkeit beeinträchtigen kann.
CYP2C8 und moderate CYP3A-Induktoren: Es ist darauf zu achten, dass die Wirksamkeit von LIFYORLI plus Nab-Paclitaxel bei der gleichzeitigen Einnahme von CYP2C8-Induktoren und moderaten CYP3A-Induktoren verringert sein kann. Paclitaxel ist ein Substrat von CYP2C8 und CYP3A, und Relacorilant ist ein CYP3A-Substrat. Die gleichzeitige Gabe von CYP2C8- und moderaten CYP3A-Induktoren kann die Konzentrationen von Paclitaxel und Relacorilant senken, was deren Wirksamkeit beeinträchtigen kann.
CYP2C8-Hemmer: Achten Sie auf verstärkte Nebenwirkungen und passen Sie die Dosierung entsprechend den Empfehlungen bei Auftreten von Nebenwirkungen an. Paclitaxel ist ein Substrat von CYP2C8. Die gleichzeitige Gabe von CYP2C8-Hemmern kann zu einem Anstieg der Paclitaxel-Konzentrationen führen, was das Risiko von Nebenwirkungen erhöhen kann.
CYP3A-Substrate: Vermeiden Sie die gleichzeitige Anwendung, sofern in der Fachinformation für CYP3A-Substrate nichts anderes empfohlen wird. Relacorilant ist ein starker CYP3A-Hemmer. Relacorilant erhöht die Exposition von CYP3A-Substraten, was das Risiko für Nebenwirkungen im Zusammenhang mit diesen Substraten erhöhen kann.
Bestimmte CYP2C8-Substrate: Vermeiden Sie die gleichzeitige Anwendung, sofern in der Fachinformation für CYP2C8-Substrate nichts anderes empfohlen wird, da bereits geringfügige Konzentrationsveränderungen zu einer verminderten Wirksamkeit führen können. Relacorilant ist ein schwacher CYP2C8-Induktor. Relacorilant verringert die Exposition von CYP2C8-Substraten, was zu einer verminderten Wirksamkeit in Bezug auf diese Substrate führen kann.
Anwendung bei bestimmten Patientengruppen:
Laktation: Weisen Sie Frauen darauf hin, während der Behandlung mit LIFYORLI und für eine Woche nach der letzten Dosis nicht zu stillen.
Anwendung bei älteren Patienten: Bei Patienten im Alter von ≥ 65 Jahren traten im Vergleich zu jüngeren erwachsenen Patienten häufiger unerwünschte Ereignisse des Schweregrads 3–4 sowie Dosisanpassungen auf.
Leberfunktionsstörung: Bei Patienten mit mittelschwerer oder schwerer Leberfunktionsstörung (Gesamtbilirubin > 1,5- bis 10-facher oberer Normwert und beliebiger AST-Wert) sollte LIFYORLI nicht in Kombination mit Nab-Paclitaxel angewendet werden.
Weitere wichtige Sicherheitshinweise finden Sie in der vollständigen Fachinformation.
Über Corcept Therapeutics
Seit über 25 Jahren konzentriert sich Corcept auf die Cortisolmodulation und deren Potenzial zur Behandlung von Patienten mit einer Vielzahl schwerwiegender Erkrankungen und hat mehr als 1.000 firmeneigene selektive Cortisolmodulatoren und Glukokortikoidrezeptor-Antagonisten entdeckt. Corcept führt fortgeschrittene klinische Studien bei Patienten mit Cushing-Syndrom, soliden Tumoren, ALS und Lebererkrankungen durch. Im Jahr 2012 brachte das Unternehmen Korlym® auf den Markt, das erste von der US-amerikanischen Arzneimittelbehörde FDA zugelassene Medikament zur Behandlung von Patienten mit endogenem Cushing-Syndrom, und im Jahr 2026 führte das Unternehmen Lifyorli™ ein, das in Kombination mit Nab-Paclitaxel zugelassen wurde und der erste von der FDA zugelassene selektive Glukokortikoidrezeptor-Antagonist für Erwachsene mit platinresistentem Eierstockkrebs ist. Corcept hat seinen Hauptsitz in Redwood City, Kalifornien. Weitere Informationen finden Sie unter Corcept.com.
Zukunftsgerichtete Aussagen
Aussagen in dieser Pressemitteilung, die keine historischen Tatsachen darstellen, sind zukunftsgerichtete Aussagen, die auf unseren derzeitigen Plänen und Erwartungen beruhen und Risiken und Ungewissheiten unterliegen, die dazu führen können, dass unsere tatsächlichen Ergebnisse wesentlich von den in solchen zukunftsgerichteten Aussagen ausdrücklich oder implizit genannten künftigen Ergebnissen abweichen.
In dieser Pressemitteilung enthalten die zukunftsgerichteten Aussagen unter anderem Aussagen zu folgenden Themen: Die Wirksamkeit, das Sicherheitsprofil und andere klinische Eigenschaften von Lifyorli sowie dessen Potenzial, eine neue Standardtherapieoption für Patientinnen mit platinresistentem Eierstockkrebs darzustellen; die erwartete behördliche Zulassung von Relacorilant in Europa; unsere Zuversicht, dass selektive GR-Antagonisten wie Relacorilant zur Behandlung aller Patientinnen beitragen können, deren Tumor den GR exprimiert; unser Fokus auf die Bereitstellung einer Therapie mit selektiven GR-Antagonisten für Patienten und die Fortsetzung der Forschung zur Cortisolmodulation bei soliden Tumoren, die den GR exprimieren, in vielen verschiedenen Behandlungssituationen; unsere weitere Entwicklung von Relacorilant bei Eierstock-, Gebärmutter-, Gebärmutterhals-, Bauchspeicheldrüsen- und Prostatakrebs; sowie unser Engagement für einen zeitnahen Zugang der Patienten zu Lifyorli.
Eine ausführlichere Darstellung der Risiken und Ungewissheiten finden Sie in unseren bei der SEC eingereichten Unterlagen, die auf unserer Website und auf der Website der SEC verfügbar sind. Zu diesen Risiken und Ungewissheiten zählen unter anderem solche, die sich auf Folgendes beziehen: unsere Fähigkeit, unser Geschäft zu betreiben; unsere Bemühungen zur Erforschung und Entwicklung von Korlym, Relacorilant, Miricorilant, Dazucorilant, Nenocorilant und unseren anderen Produktkandidaten; die klinischen Eigenschaften dieser Moleküle; behördliche Genehmigungen, Auflagen, Aufsicht und sonstige Anforderungen, die unseren Produkten oder unserem Geschäft durch Gesetze, Vorschriften oder das Ermessen staatlicher Behörden auferlegt werden; sowie den Umfang und den Schutzumfang unseres geistigen Eigentums. Wir lehnen jede Absicht oder Verpflichtung zur Aktualisierung dieser zukunftsgerichteten Aussagen ab.
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Original: Corcept präsentiert vollständige Daten aus der zulassungsrelevanten ROSELLA-Studie im Rahmen einer Late-Breaker-Präsentation auf der SGO-Konferenz, begleitet von einer gleichzeitigen Veröffentlichung in The Lancet: Lifyorli™ (Relacorilant) Plus...
US Market News
3月前
Corcept Presents Complete Data from Pivotal ROSELLA Trial in SGO Late-Breaker with Simultaneous Publication in The Lancet: Lifyorli™ (Relacorilant) Plus Nab-Paclitaxel Improves Overall Survival in Patients with Platinum-Resistant Ovarian CancerApril 10, 2026 4:45 PM
Business Wire
Data demonstrate a 35 percent reduction in risk of death
Lifyorli, in combination with nab-paclitaxel, added to NCCN Guidelines® as a preferred regimen
Lifyorli approved by the FDA in March 2026
Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company 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, today presented final overall survival data from its pivotal Phase 3 ROSELLA trial of Lifyorli™ (relacorilant) combined with the chemotherapeutic agent nab-paclitaxel in patients with platinum-resistant ovarian cancer in a late-breaking oral presentation at the Society of Gynecologic Oncology (SGO) 2026 Annual Meeting on Women’s Cancer. The SGO presentation slides can be found here.
These data were simultaneously published in The Lancet: “Overall survival with relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): a phase 3 randomised controlled trial.”
Lifyorli plus nab-paclitaxel has now been added to the National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a preferred regimen for patients with platinum-resistant ovarian cancer. Lifyorli, in combination with nab-paclitaxel, was approved by the U.S. Food and Drug Administration (FDA) in March 2026 for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab. Lifyorli is the first FDA-approved selective glucocorticoid receptor antagonist (SGRA).
The ROSELLA trial met its dual primary endpoints of overall and progression-free survival, regardless of biomarker status and without an increased safety burden. Patients treated with Lifyorli in addition to nab-paclitaxel chemotherapy experienced a 35 percent reduction in the risk of death compared to patients treated with nab-paclitaxel alone (hazard ratio: 0.65; p-value: 0.0004). Median overall survival was 4.1 months longer for patients who received Lifyorli, compared to patients receiving nab-paclitaxel alone (16.0 v. 11.9 months). Patients who received Lifyorli in addition to nab-paclitaxel also experienced a 30 percent reduction in the risk of disease progression (hazard ratio: 0.70; p-value: 0.0076), as assessed by blinded independent central review compared to patients treated with nab-paclitaxel alone.
The combination of Lifyorli with nab-paclitaxel was well-tolerated. Adverse events in the combination arm were comparable to those in the nab-paclitaxel monotherapy arm. The prescribing information for Lifyorli includes warnings and precautions for neutropenia and severe infections, adrenal insufficiency, exacerbation of conditions treated with glucocorticoids and embryo-fetal toxicity. The most common adverse reactions experienced by more than 20 percent of patients (including laboratory abnormalities) were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite.
“The safety and efficacy findings from ROSELLA are remarkable,” said Alexander B. Olawaiye, M.D., Professor and Vice Chair of Diversity and Inclusion at Magee-Women’s Hospital of the University of Pittsburgh, Principal Investigator in the ROSELLA trial, SGO presenter and Lancet publication author. “They give hope to patients and oncologists now that we have a new preferred regimen in this devastating and difficult-to-treat cancer.”
“Patients with platinum-resistant ovarian cancer need more good treatment options. Relacorilant provides one. It significantly extends overall survival, with very little added toxicity,” said Domenica Lorusso, M.D., Ph.D., Director of the Gynaecological Oncology Unit at Humanitas Hospital San Pio X in Milan, and Full Professor of Obstetrics and Gynaecology at Humanitas University, Pieve Emanuele, Lancet publication senior author and European Network of Gynaecological Oncological Trial groups (ENGOT) investigator in the ROSELLA trial. “This regimen is firmly positioned as a new standard-of-care treatment for patients in the United States. We anticipate regulatory approval in Europe soon.”
“ROSELLA’s positive findings affirm our confidence that selective glucocorticoid receptor (GR) antagonists, such as relacorilant, may help treat any patient whose tumor type expresses the GR,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “With our recent FDA approval, we are now focused on delivering this therapy to patients and continuing cortisol modulation research in solid tumors that express GR across many different treatment settings. We are grateful for the patients and investigators who make our trials possible.”
ROSELLA enrolled 381 patients with platinum-resistant ovarian cancer at sites in the United States, Europe, South Korea, Brazil, Argentina, Canada and Australia. Patients were randomized 1:1 to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel alone. The ROSELLA trial was conducted in collaboration with The GOG Foundation, Inc. (GOG-F) (GOG-3073), the European Network of Gynaecological Oncological Trial groups (ENGOT) (ENGOT-ov72), the Asia-Pacific Gynecologic Oncology Trials Group (APGOT) (APGOT-Ov10), the Latin American Cooperative Oncology Group (LACOG) (LACOG-0223) and the Australia New Zealand Gynaecological Oncology Group (ANZGOG) (ANZGOG-221/2023).
About Ovarian Cancer
Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have "platinum-resistant" disease. There are few treatment options for these women. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe.
About Cortisol's Role in Oncology
Cortisol plays a role in tumor growth through several mechanisms. It helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol promotes tumor growth by activating oncogenic signaling in the cells to which it binds. Cortisol also suppresses the body's immune response, which weakens its ability to fight all diseases, including cancer.
Corcept is developing relacorilant in ovarian, endometrial, cervical, pancreatic and prostate cancers. 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 European Commission (EC) for the treatment of ovarian cancer. Corcept has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for relacorilant to treat patients with platinum-resistant ovarian cancer.
About Lifyorli™
Lifyorli (relacorilant), approved in combination with nab-paclitaxel, is the first U.S. Food and Drug Administration (FDA)-approved selective glucocorticoid receptor antagonist for adults with platinum-resistant ovarian cancer. Lifyorli is an oral medication taken the day before, the day of and the day after treatment with nab-paclitaxel. There is no biomarker requirement for Lifyorli. Lifyorli competitively binds to the glucocorticoid receptor (GR), where it enhances chemotherapy sensitivity by inhibiting cortisol’s suppression of apoptosis – the programmed cell death that chemotherapies such as nab-paclitaxel are meant to cause. Lifyorli does not have any effect at the body’s other steroid receptors.
Corcept is committed to timely patient access for Lifyorli. For questions regarding product availability, please contact Lifyorli Support™ at 1-85-LIFYORLI (1-855-439-6754).
LIFYORLI Indication & Usage
LIFYORLI is indicated in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1-3 prior systemic treatment regimens, at least one of which included bevacizumab.
IMPORTANT SAFETY INFORMATION
Contraindications:
LIFYORLI is contraindicated in patients receiving systemic glucocorticoids for lifesaving purposes (e.g., immunosuppression after organ transplantation) because LIFYORLI antagonizes the effect of glucocorticoids.
Warnings and Precautions:
Neutropenia and Severe Infections
LIFYORLI in combination with nab-paclitaxel can cause neutropenia, including febrile neutropenia and severe infections. There was one fatal event of septic shock with febrile neutropenia. Thirty-eight percent of patients initiated granulocyte colony-stimulating factor (G-CSF) during the first or second cycle of therapy.
Monitor complete blood counts prior to each weekly treatment with LIFYORLI in combination with nab-paclitaxel and as clinically indicated. Based on the severity of neutropenia, delay dose, reduce dose or permanently discontinue LIFYORLI in combination with nab-paclitaxel. Consider short-acting G-CSF administration as applicable. Consider the possibility of concurrent adrenal insufficiency, particularly in the setting of serious infection.
Adrenal Insufficiency
LIFYORLI is a reversible glucocorticoid receptor antagonist and can cause adrenal insufficiency. Adrenal insufficiency can occur at any time during treatment with LIFYORLI. The risk of adrenal insufficiency is increased in situations of stress, such as acute illness, infection, or surgery. Consider whether supplemental glucocorticoids are required in the perioperative period in patients who have received LIFYORLI within 30 days of surgery. Monitor patients receiving LIFYORLI for signs and symptoms of adrenal insufficiency. Withhold LIFYORLI and administer glucocorticoid therapy if adrenal insufficiency is suspected. High doses of supplemental glucocorticoids may be needed to overcome the glucocorticoid receptor antagonism produced by LIFYORLI. After resolution of adrenal insufficiency, resume previous dose, reduce dose or permanently discontinue LIFYORLI based on severity.
Exacerbation of Conditions Treated with Glucocorticoids
Use of LIFYORLI in patients taking systemic glucocorticoids for other conditions (e.g., autoimmune disorders) may exacerbate these conditions. LIFYORLI is a glucocorticoid receptor antagonist that may make systemic glucocorticoids less effective. Similarly, coadministration of systemic glucocorticoids may make LIFYORLI less effective. Monitor patients for reduced effectiveness of LIFYORLI and glucocorticoids in patients receiving both.
Embryo-Fetal Toxicity
LIFYORLI can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Verify pregnancy status of females of reproductive potential prior to initiating LIFYORLI treatment. Advise females of reproductive potential, including male patients with female partners of reproductive potential, to use effective contraception during treatment with LIFYORLI and for 1 week after the last dose.
Adverse Reactions:
Serious adverse reactions occurred in 35% of patients who received LIFYORLI in combination with nab-paclitaxel. Serious adverse reactions (≥2%) in patients were neutropenia (4%), pneumonia (3.2%), pleural effusion (3.2%), febrile neutropenia (2.1%), and fatigue (2.1%). Fatal adverse reactions (2.1%) in patients were septic shock (0.5%), cardiac arrest (0.5%), ischemic stroke (0.5%), and intestinal perforation (0.5%).
Permanent discontinuation of LIFYORLI in combination with nab-paclitaxel due to adverse reactions occurred in 9% of patients. The adverse reaction (>2%) that resulted in permanent discontinuation of LIFYORLI in patients was intestinal obstruction (2.6%). Dosage interruptions of LIFYORLI due to an adverse reaction occurred in 72% of patients. Adverse reactions (≥5%) that required dosage interruptions of LIFYORLI in combination with nab-paclitaxel in patients included neutropenia (44%), anemia (12%), and fatigue (7%). Adverse reactions requiring dose reductions of LIFYORLI included fatigue (1.6%), decreased appetite (1.2%), abdominal pain (0.5%), neutropenia (0.5%), edema (0.5%), and sciatica (0.5%). LIFYORLI should be interrupted or discontinued when nab-paclitaxel is interrupted or discontinued.
The most common adverse reactions (>20%) of patients treated with LIFYORLI plus nab-paclitaxel, including laboratory abnormalities, were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite.
Drug Interactions:
Strong CYP3A Inducers: Avoid coadministration of LIFYORLI plus nab-paclitaxel with strong CYP3A inducers. Both relacorilant and paclitaxel are CYP3A substrates. Coadministration of strong CYP3A inducers can decrease concentrations of relacorilant and paclitaxel, which may reduce their effectiveness.
CYP2C8 and Moderate CYP3A Inducers: Monitor for reduced effectiveness of LIFYORLI plus nab-paclitaxel with CYP2C8 inducers and moderate CYP3A inducers. Paclitaxel is a substrate of CYP2C8 and CYP3A, and relacorilant is a CYP3A substrate. Coadministration of CYP2C8 and moderate CYP3A inducers can decrease concentrations of paclitaxel and relacorilant, which may reduce their effectiveness.
CYP2C8 Inhibitors: Monitor for increased adverse reactions and modify the dosage for adverse reactions as recommended. Paclitaxel is a substrate of CYP2C8. Coadministration of CYP2C8 inhibitors may increase concentrations of paclitaxel, which may increase the risk of adverse reactions.
CYP3A Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP3A substrates. Relacorilant is a strong CYP3A inhibitor. Relacorilant increases exposure of CYP3A substrates which may increase the risk for adverse reactions related to these substrates.
Certain CYP2C8 Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP2C8 substrates where minimal concentration changes may lead to reduced effectiveness. Relacorilant is a weak CYP2C8 inducer. Relacorilant decreases exposure of CYP2C8 substrates which may decrease the effectiveness related to these substrates.
Use in Specific Populations:
Lactation: Advise women not to breastfeed during treatment with LIFYORLI and for 1 week after the last dose.
Geriatric Use: A higher incidence of grade 3-4 adverse events and dosage modification occurred in patients aged ≥65 years compared to younger adult patients.
Hepatic Impairment: Avoid LIFYORLI in combination with nab-paclitaxel in patients with moderate or severe hepatic impairment (total bilirubin >1.5 to 10x ULN and any AST).
Please see the full Prescribing Information for additional Important Safety Information.
About Corcept Therapeutics
For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders and has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with Cushing’s syndrome, solid tumors, ALS and liver disease. In 2012, the company introduced Korlym®, the first medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with endogenous Cushing’s syndrome, and in 2026, the company introduced Lifyorli™, approved in combination with nab-paclitaxel, the first FDA-approved selective glucocorticoid receptor antagonist for adults with platinum-resistant ovarian cancer. Corcept is headquartered in Redwood City, California. For more information, visit Corcept.com.
Forward-Looking Statements
Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations and are subject to risks and uncertainties that might cause our actual results to differ materially from any future results expressed or implied by such forward-looking statements.
In this press release, forward-looking statements include statements concerning: Lifyorli’s efficacy, safety profile and other clinical attributes and its potential to provide a new standard-of-care treatment option for patients with platinum-resistant ovarian cancer; the anticipated regulatory approval of relacorilant in Europe; our confidence that selective GR antagonists, such as relacorilant, may help treat any patient whose tumor type expresses the GR; our focus on delivering selective GR antagonist therapy to patients and continuing cortisol modulation research in solid tumors that express GR across many different treatment settings; our further development of relacorilant in ovarian, endometrial, cervical, pancreatic and prostate cancers; and our commitment to timely patient access for Lifyorli.
A further description of risks and uncertainties can be found in our SEC filings, which are available at our website and the SEC’s website. These risks and uncertainties include, but are not limited to, those related to: our ability to operate our business; our efforts to study and develop Korlym, relacorilant, miricorilant, dazucorilant, nenocorilant and our other product candidates; those molecules’ clinical attributes; regulatory approvals, mandates, oversight and other requirements imposed on our products or our business by laws, regulations or discretion of government authorities; and the scope and protective power of our intellectual property. We disclaim any intention or duty to update forward-looking statements made in this press release.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260410882270/en/
Investor inquiries:
ir@corcept.com
Media inquiries:
communications@corcept.com
www.corcept.com
Original: Corcept Presents Complete Data from Pivotal ROSELLA Trial in SGO Late-Breaker with Simultaneous Publication in The Lancet: Lifyorli™ (Relacorilant) Plus Nab-Paclitaxel Improves Overall Survival in Patients with Platinum-Resistant Ovarian Cancer
US Market News
3月前
Corcept Presents Data from MOMENTUM Trial at American College of Cardiology Annual Scientific SessionMarch 28, 2026 2:45 PM
Business Wire
Hypercortisolism identified in 27.3 percent of patients with resistant hypertension
Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company 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, today presented late-breaking data from its MOMENTUM trial examining the prevalence of endogenous hypercortisolism in patients with resistant hypertension at the 2026 American College of Cardiology Annual Scientific Session (ACC 2026).
MOMENTUM screened 1,086 patients with resistant hypertension (as defined by the American Heart Association’s criteria) and found that 27.3 percent, or 297 patients had hypercortisolism. This finding complements the results of Corcept’s CATALYST trial, which found hypercortisolism in 23.8 percent of the 1,057 patients screened with difficult-to-control type 2 diabetes. The prevalence of hypercortisolism in patients who had hemoglobin A1c (HbA1c) of 7.5 percent or higher and were taking 3 or more blood pressure medicines was 32.6 percent in MOMENTUM and 36.6 percent in CATALYST.
“Resistant hypertension increases the risk of cardiovascular events like heart attacks, strokes, and heart failure, as well as kidney damage,” said Deepak L. Bhatt, M.D., M.P.H., M.B.A., Director of Mount Sinai Fuster Heart Hospital and the Dr. Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai. “MOMENTUM shows that hypercortisolism contributes to resistant hypertension in over a quarter of patients and that screening for hypercortisolism in these challenging-to-treat patients may help physicians provide more personalized care.” Dr. Bhatt presented the data as Featured Clinical Research at ACC 2026, is a lead investigator and steering committee member for MOMENTUM, and a paid consultant to Corcept Therapeutics.
“It is now clear that hypercortisolism is more common than previously assumed in patients whose hypertension and diabetes don’t respond to standard-of-care treatments,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “We are grateful to the investigators and patients who have participated in this research and hope that the findings will provide critical information to support increased screening for hypercortisolism, more accurate diagnoses and improved treatment options.”
About MOMENTUM
MOMENTUM was the largest US-based trial ever conducted to assess the prevalence of hypercortisolism in patients with resistant hypertension. A total of 1,086 patients were screened at 50 sites across the United States. All patients had resistant hypertension as defined by the American Heart Association’s criteria (systolic blood pressure greater or equal to 130 mmHg despite taking 3 or more blood-pressure lowering medications, including a diuretic, or taking 4 or more blood-pressure lowering medications). Using a simple, standardized 1-mg dexamethasone suppression test (DST), 27 percent of these patients were found to have hypercortisolism.
About Hypercortisolism
Hypercortisolism, also known as Cushing’s syndrome, is caused by excessive activity of the hormone cortisol. Symptoms vary, but most patients experience one or more of the following manifestations: hypertension, central obesity, elevated blood sugar and difficult-to-control type 2 diabetes, severe fatigue and weak muscles. Irritability, anxiety, depression and cognitive disturbances are common. Hypercortisolism can affect every organ system and can be fatal if not treated effectively. Cardiovascular events are the most common cause of death. Recent research shows that endogenous hypercortisolism is more prevalent than previously believed.
About Corcept Therapeutics
For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders, leading to the discovery of more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with Cushing’s syndrome, solid tumors, ALS and liver disease. In 2012, the company introduced Korlym®, the first medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with endogenous Cushing’s syndrome, and in 2026, the company introduced Lifyorli™, approved in combination with nab-paclitaxel, the first FDA-approved selective glucocorticoid receptor antagonist for adults with platinum-resistant ovarian cancer. Corcept is headquartered in Redwood City, California. For more information, visit Corcept.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260328971109/en/
Investor inquiries:
ir@corcept.com
Media inquiries:
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www.corcept.com
Original: Corcept Presents Data from MOMENTUM Trial at American College of Cardiology Annual Scientific Session
US Market News
3月前
FDA Approves Corcept’s Selective Glucocorticoid Receptor Antagonist Lifyorli™ (relacorilant) Plus Nab-Paclitaxel for Treatment of Patients with Platinum-Resistant Ovarian CancerMarch 25, 2026 12:43 PM
Business Wire
Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company 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, today announced that the U.S. Food and Drug Administration (FDA) has approved Lifyorli™ (relacorilant) in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab. Lifyorli is the first FDA-approved selective glucocorticoid receptor antagonist (SGRA).
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260325948774/en/Lifyorli logo
Approval was based on the positive outcomes of Lifyorli’s pivotal ROSELLA trial, which enrolled 381 patients with platinum-resistant ovarian cancer who had received one to three prior lines of therapy, at least one of which included bevacizumab. Patients were randomized 1:1 to receive either Lifyorli plus nab-paclitaxel or nab-paclitaxel monotherapy. No biomarker selection was required.
ROSELLA met its dual primary endpoints of progression-free and overall survival. Patients treated with Lifyorli in addition to nab-paclitaxel experienced a 35 percent reduction in the risk of death compared to patients treated with nab-paclitaxel alone (hazard ratio: 0.65; p-value: 0.0004), with a median overall survival (OS) of 16.0 months, compared to 11.9 months for patients receiving nab-paclitaxel alone, a difference of 4.1 months. Patients who received Lifyorli in addition to nab-paclitaxel also experienced a 30 percent reduction in the risk of disease progression (hazard ratio: 0.70; p-value: 0.008), as assessed by blinded independent central review (PFS-BICR), compared to patients treated with nab-paclitaxel alone.
The combination of Lifyorli with nab-paclitaxel was well-tolerated and manageable. The safety of Lifyorli was assessed in a pooled analysis of patients from ROSELLA and Lifyorli’s Phase 2 trial. The prescribing information for Lifyorli includes warnings and precautions for neutropenia and severe infections, adrenal insufficiency, exacerbation of conditions treated with glucocorticoids and embryo-fetal toxicity. The most common adverse reactions experienced by more than 20 percent of patients (including laboratory abnormalities) were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash and decreased appetite.
Data from ROSELLA were first presented at ASCO 2025 (American Society of Clinical Oncology) with simultaneous publication in The Lancet. Complete results from ROSELLA will be presented at the Society of Gynecologic Oncology (SGO) meeting in April.
“Data demonstrate that Lifyorli plus nab-paclitaxel provides a clinically meaningful benefit in overall survival for patients with platinum-resistant ovarian cancer and is well tolerated. Lifyorli is positioned to become a new standard-of-care treatment,” said Rob Coleman, M.D., Texas Oncology and special advisor to the president of the GOG Foundation. "Having a new treatment for this advanced, recurrent disease will provide clinicians with a compelling option to help patients with this extremely difficult-to-treat cancer."
“The FDA’s approval of Lifyorli in combination with nab-paclitaxel is welcome news to all of us in the ovarian cancer community,” said Sarah DeFeo, Chief Program Officer at Ovarian Cancer Research Alliance (OCRA). “We are grateful to everyone who participated in the clinical trials, their families and the physicians who helped advance this urgently needed treatment option for patients with platinum-resistant ovarian cancer.”
“It is a privilege to bring forward a new treatment for patients who historically have had few options,” said Joseph Belanoff, M.D., Corcept’s Chief Executive Officer. “We have worked for years to demonstrate the potential of cortisol modulation in oncology. Today’s approval of Lifyorli is an important first step, but there is much more to explore with this new mode of treatment. We extend our deep appreciation to the patients and healthcare providers who participated in the clinical trials that made this approval possible.”
ROSELLA enrolled patients with platinum-resistant ovarian cancer at sites in the United States, Europe, South Korea, Brazil, Argentina, Canada and Australia, and was conducted in collaboration with The GOG Foundation, Inc. (GOG-F), the European Network of Gynaecological Oncological Trial groups (ENGOT), the Asia-Pacific Gynecologic Oncology Trials Group (APGOT), the Latin American Cooperative Oncology Group (LACOG) and the Australia New Zealand Gynaecological Oncology Group (ANZGOG).
About Ovarian Cancer
Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have "platinum-resistant" disease. There are few treatment options for these women. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe.
About Cortisol's Role in Oncology
Cortisol plays a role in tumor growth through several mechanisms. It helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol promotes tumor growth by activating oncogenic signaling in the cells to which it binds. Cortisol also suppresses the body's immune response, which weakens its ability to fight all diseases, including cancer.
Corcept is developing relacorilant in ovarian, endometrial, cervical, pancreatic and prostate cancers. 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 European Commission (EC) for the treatment of ovarian cancer. Corcept has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for relacorilant to treat patients with platinum-resistant ovarian cancer.
About Lifyorli™
Lifyorli (relacorilant), approved in combination with nab-paclitaxel, is the first U.S. Food and Drug Administration (FDA)-approved selective glucocorticoid receptor antagonist for adults with platinum-resistant ovarian cancer. Lifyorli is an oral medication taken the day before, the day of and the day after treatment with nab-paclitaxel. There is no biomarker requirement for Lifyorli. Lifyorli competitively binds to the glucocorticoid receptor (GR), where it enhances chemotherapy sensitivity by inhibiting cortisol’s suppression of apoptosis – the programmed cell death that chemotherapies such as nab-paclitaxel are meant to cause. Lifyorli does not have any effect at the body’s other steroid receptors.
Corcept is committed to timely patient access for Lifyorli. For questions regarding product availability, please contact Lifyorli Support™ at 1-85-LIFYORLI (1-855-439-6754).
LIFYORLI Indication & Usage
LIFYORLI is indicated in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1-3 prior systemic treatment regimens, at least one of which included bevacizumab.
IMPORTANT SAFETY INFORMATION
Contraindications:
LIFYORLI is contraindicated in patients receiving systemic glucocorticoids for lifesaving purposes (e.g., immunosuppression after organ transplantation) because LIFYORLI antagonizes the effect of glucocorticoids.
Warnings and Precautions:
Neutropenia and Severe Infections
LIFYORLI in combination with nab-paclitaxel can cause neutropenia, including febrile neutropenia and severe infections. There was one fatal event of septic shock with febrile neutropenia. Thirty-eight percent of patients initiated granulocyte colony-stimulating factor (G-CSF) during the first or second cycle of therapy.
Monitor complete blood counts prior to each weekly treatment with LIFYORLI in combination with nab-paclitaxel and as clinically indicated. Based on the severity of neutropenia, delay dose, reduce dose or permanently discontinue LIFYORLI in combination with nab-paclitaxel. Consider short-acting G-CSF administration as applicable. Consider the possibility of concurrent adrenal insufficiency, particularly in the setting of serious infection.
Adrenal Insufficiency
LIFYORLI is a reversible glucocorticoid receptor antagonist and can cause adrenal insufficiency. Adrenal insufficiency can occur at any time during treatment with LIFYORLI. The risk of adrenal insufficiency is increased in situations of stress, such as acute illness, infection, or surgery. Consider whether supplemental glucocorticoids are required in the perioperative period in patients who have received LIFYORLI within 30 days of surgery. Monitor patients receiving LIFYORLI for signs and symptoms of adrenal insufficiency. Withhold LIFYORLI and administer glucocorticoid therapy if adrenal insufficiency is suspected. High doses of supplemental glucocorticoids may be needed to overcome the glucocorticoid receptor antagonism produced by LIFYORLI. After resolution of adrenal insufficiency, resume previous dose, reduce dose or permanently discontinue LIFYORLI based on severity.
Exacerbation of Conditions Treated with Glucocorticoids
Use of LIFYORLI in patients taking systemic glucocorticoids for other conditions (e.g., autoimmune disorders) may exacerbate these conditions. LIFYORLI is a glucocorticoid receptor antagonist that may make systemic glucocorticoids less effective. Similarly, coadministration of systemic glucocorticoids may make LIFYORLI less effective. Monitor patients for reduced effectiveness of LIFYORLI and glucocorticoids in patients receiving both.
Embryo-Fetal Toxicity
LIFYORLI can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Verify pregnancy status of females of reproductive potential prior to initiating LIFYORLI treatment. Advise females of reproductive potential, including male patients with female partners of reproductive potential, to use effective contraception during treatment with LIFYORLI and for 1 week after the last dose.
Adverse Reactions:
Serious adverse reactions occurred in 35% of patients who received LIFYORLI in combination with nab-paclitaxel. Serious adverse reactions (≥2%) in patients were neutropenia (4%), pneumonia (3.2%), pleural effusion (3.2%), febrile neutropenia (2.1%), and fatigue (2.1%). Fatal adverse reactions (2.1%) in patients were septic shock (0.5%), cardiac arrest (0.5%), ischemic stroke (0.5%), and intestinal perforation (0.5%).
Permanent discontinuation of LIFYORLI in combination with nab-paclitaxel due to adverse reactions occurred in 9% of patients. The adverse reaction (>2%) that resulted in permanent discontinuation of LIFYORLI in patients was intestinal obstruction (2.6%). Dosage interruptions of LIFYORLI due to an adverse reaction occurred in 72% of patients. Adverse reactions (≥5%) that required dosage interruptions of LIFYORLI in combination with nab-paclitaxel in patients included neutropenia (44%), anemia (12%), and fatigue (7%). Adverse reactions requiring dose reductions of LIFYORLI included fatigue (1.6%), decreased appetite (1.2%), abdominal pain (0.5%), neutropenia (0.5%), edema (0.5%), and sciatica (0.5%). LIFYORLI should be interrupted or discontinued when nab-paclitaxel is interrupted or discontinued.
The most common adverse reactions (>20%) of patients treated with LIFYORLI plus nab-paclitaxel, including laboratory abnormalities, were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite.
Drug Interactions:
Strong CYP3A Inducers: Avoid coadministration of LIFYORLI plus nab-paclitaxel with strong CYP3A inducers. Both relacorilant and paclitaxel are CYP3A substrates. Coadministration of strong CYP3A inducers can decrease concentrations of relacorilant and paclitaxel, which may reduce their effectiveness.
CYP2C8 and Moderate CYP3A Inducers: Monitor for reduced effectiveness of LIFYORLI plus nab-paclitaxel with CYP2C8 inducers and moderate CYP3A inducers. Paclitaxel is a substrate of CYP2C8 and CYP3A, and relacorilant is a CYP3A substrate. Coadministration of CYP2C8 and moderate CYP3A inducers can decrease concentrations of paclitaxel and relacorilant, which may reduce their effectiveness.
CYP2C8 Inhibitors: Monitor for increased adverse reactions and modify the dosage for adverse reactions as recommended. Paclitaxel is a substrate of CYP2C8. Coadministration of CYP2C8 inhibitors may increase concentrations of paclitaxel, which may increase the risk of adverse reactions.
CYP3A Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP3A substrates. Relacorilant is a strong CYP3A inhibitor. Relacorilant increases exposure of CYP3A substrates which may increase the risk for adverse reactions related to these substrates.
Certain CYP2C8 Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP2C8 substrates where minimal concentration changes may lead to reduced effectiveness. Relacorilant is a weak CYP2C8 inducer. Relacorilant decreases exposure of CYP2C8 substrates which may decrease the effectiveness related to these substrates.
Use in Specific Populations:
Lactation: Advise women not to breastfeed during treatment with LIFYORLI and for 1 week after the last dose.
Geriatric Use: A higher incidence of grade 3-4 adverse events and dosage modification occurred in patients aged ≥65 years compared to younger adult patients.
Hepatic Impairment: Avoid LIFYORLI in combination with nab-paclitaxel in patients with moderate or severe hepatic impairment (total bilirubin >1.5 to 10x ULN and any AST).
Please see the full Prescribing Information for additional Important Safety Information.
About Corcept Therapeutics
For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders and has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with Cushing’s syndrome, solid tumors, ALS and liver disease. In 2012, the company introduced Korlym®, the first medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with endogenous Cushing’s syndrome, and in 2026, the company introduced Lifyorli™, approved in combination with nab-paclitaxel, the first FDA-approved selective glucocorticoid receptor antagonist for adults with platinum-resistant ovarian cancer. Corcept is headquartered in Redwood City, California. For more information, visit Corcept.com.
Forward-Looking Statements
Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations and are subject to risks and uncertainties that might cause our actual results to differ materially from any future results expressed or implied by such forward-looking statements.
In this press release, forward-looking statements include statements concerning: Lifyorli’s efficacy, safety profile and other clinical attributes and its potential to become a new standard-of-care treatment for patients with platinum-resistant ovarian cancer and provide clinicians with a compelling option to help patients with this difficult-to-treat cancer; presentation of the ROSELLA trial’s complete results at the SGO meeting; our ability to demonstrate the potential of cortisol modulation in oncology and to further explore this mode of treatment; our further development of relacorilant in ovarian, endometrial, cervical, pancreatic and prostate cancers; the incidence of platinum-resistant ovarian cancer patients expected to start a new therapy each year in the United States and Europe; and our commitment to timely patient access for Lifyorli.
A further description of risks and uncertainties can be found in our SEC filings, which are available at our website and the SEC’s website. These risks and uncertainties include, but are not limited to, those related to: our ability to operate our business; our efforts to study and develop Korlym, relacorilant, miricorilant, dazucorilant, nenocorilant and our other product candidates; those molecules’ clinical attributes; regulatory approvals, mandates, oversight and other requirements imposed on our products or our business by laws, regulations or discretion of government authorities; and the scope and protective power of our intellectual property. We disclaim any intention or duty to update forward-looking statements made in this press release.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260325948774/en/
Investor inquiries:
ir@corcept.com
Media inquiries:
communications@corcept.com
www.corcept.com
Original: FDA Approves Corcept’s Selective Glucocorticoid Receptor Antagonist Lifyorli™ (relacorilant) Plus Nab-Paclitaxel for Treatment of Patients with Platinum-Resistant Ovarian Cancer
US Market News
4月前
Corcept Therapeutics Announces Fourth Quarter and Full-Year 2025 Audited Financial Results, Provides Corporate UpdateFebruary 24, 2026 4:05 PM
Business Wire
2025 revenue of $761.4 million
Full year 2026 revenue guidance of $900 – $1,000 million
2025 net income of $99.7 million
Cash and investments of $532.4 million at December 31, 2025
Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company 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, today reported its results for the quarter and year ended December 31, 2025.
Financial Results
“In 2025, our Cushing’s syndrome business experienced a surge in demand due to growing recognition among physicians of hypercortisolism’s true prevalence and the necessity of appropriate treatment. We had a record number of new prescriptions written for our medications and a record number of new prescribers in 2025, which translated to a 37 percent increase in the number of tablets sold compared to the prior year. We should have achieved higher growth but were not able to fully meet demand because of capacity constraints at our previous specialty pharmacy vendor. There were also operational disruptions in the fourth quarter as we transitioned our business to our new specialty pharmacy. This transition is now fully complete and February is on track to be a record month for the number of new patients that have started treatment with our medications. We expect that our Cushing’s syndrome business will expand for many years,” said Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer.
Corcept’s fourth quarter 2025 revenue was $202.1 million, compared to $181.9 million in the fourth quarter of 2024. Revenue for the full year was $761.4 million, compared to $675.0 million in 2024.
Net income was $24.3 million in the fourth quarter, or $0.20 diluted net income per common share, compared to net income of $30.7 million, or $0.26 diluted net income per common share, in the fourth quarter of 2024. For the full year, net income was $99.7 million, or $0.82 diluted net income per common share, compared to net income of $141.2 million, or $1.23 diluted net income per common share, in 2024.
Cash and investments were $532.4 million at December 31, 2025, compared to $603.2 million at December 31, 2024. In 2025, Corcept paid $245.9 million to purchase its common stock, pursuant to the company’s stock repurchase program, net exercise of employee stock options and net vesting of restricted stock grants.
Clinical Development
“We are engaged with the FDA to determine the best path forward for our New Drug Application (NDA) for relacorilant in Cushing’s syndrome and are confident that the ultimate outcome will be approval,” said Dr. Belanoff. “Our NDA for relacorilant in platinum-resistant ovarian cancer, which is now bolstered by the final overall survival results from our ROSELLA study, has a Prescription Drug User Fee Act (PDUFA) date of July 11, 2026.
In addition, our ongoing clinical studies will soon produce important data. Results from MOMENTUM, our trial evaluating the prevalence of hypercortisolism in patients with resistant hypertension, will be featured in an oral presentation at the American College of Cardiology (ACC) meeting in March. Results from our BELLA trial in patients with advanced ovarian cancer will be available by the end of this year, as will results from MONARCH, our Phase 2b trial in patients with metabolic dysfunction-associated steatohepatitis (MASH). By the end of next year, we expect results from our studies in platinum-sensitive ovarian, endometrial, cervical and pancreatic cancers.”
“We are also planning to start a Phase 3 trial of dazucorilant in patients with ALS, which will seek to replicate the benefit patients exhibited in our DAZALS trial, by the middle of this year,” added Dr. Belanoff.
Hypercortisolism (Cushing’s Syndrome)
New Drug Application – Engaged with FDA to determine best path forward to approval following Complete Response Letter for relacorilant in patients with Cushing’s syndrome
GRACE – Pivotal Phase 3 trial of relacorilant in 152 patients with Cushing’s syndrome – Results published in The Lancet Diabetes & Endocrinology (Pivonello et al, February 2026)
MOMENTUM – Enrollment completed in 1,000-patient trial examining the prevalence of hypercortisolism in patients with resistant hypertension; results will be presented at ACC meeting in March
“Relacorilant has the potential to become the new standard of care for patients with Cushing’s syndrome. In its Phase 2 and Phase 3 studies, patients treated with relacorilant showed clinically meaningful and statistically significant improvements in hypertension and a wide range of Cushing’s syndrome’s other signs and symptoms. Importantly, these benefits were observed without off-target effects and toxicities such as drug-induced hypokalemia, endometrial hypertrophy, vaginal bleeding, adrenal insufficiency and QT prolongation. These adverse events can have serious health consequences and are associated with currently available treatments. We are working with the FDA to bring relacorilant to patients as soon as possible,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer.
Oncology
Relacorilant in Combination with Chemotherapy
New Drug Application – FDA reviewing NDA for relacorilant plus nab-paclitaxel to treat patients with platinum-resistant ovarian cancer, with a July 11, 2026 PDUFA date
Marketing Authorization Application (MAA) – European Medicines Agency reviewing MAA for relacorilant plus nab-paclitaxel to treat patients with platinum-resistant ovarian cancer – Approval expected by the end of this year
ROSELLA – Both dual primary endpoints (progression-free and overall survival) met, without the need for biomarker selection and without increased safety burden – Complete results will be presented at the Society of Gynecology Oncology (SGO) meeting in April
BELLA Part A – Enrollment completed in Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab in 95 patients with platinum-resistant ovarian cancer – Results expected by the end of this year
BELLA Part B – Enrollment underway in Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab in 90 patients with platinum-sensitive ovarian cancer whose disease progressed while on a PARP inhibitor
BELLA Part C – Enrollment underway in Phase 2 trial of relacorilant plus nab-paclitaxel in 90 patients with endometrial cancer (who have received one or two prior lines of therapy)
STELLA – Phase 2 trial of relacorilant plus nab-paclitaxel in 50 patients with cervical cancer (received one or two prior lines of therapy) to begin in coming weeks, conducted in collaboration with ARCAGY-GINECO, an academic clinical research group specializing in gynecologic cancers
TRIDENT – Enrollment underway in Phase 2 trial of relacorilant plus nab-paclitaxel and gemcitabine as first-line therapy in 50 patients with pancreatic cancer
Relacorilant in Combination with Androgen Deprivation Therapy
Prostate cancer – Enrollment continues in randomized, placebo-controlled Phase 2 trial of relacorilant plus enzalutamide in 90 patients with early-stage prostate cancer, conducted in collaboration with the University of Chicago
Nenocorilant in Combination with Immunotherapy
SYNERGY – Enrollment underway in Phase 1b dose-finding trial of nenocorilant plus nivolumab in 30 patients with a variety of solid tumors
“Results from our pivotal Phase 3 ROSELLA study demonstrate a 35 percent reduction in the risk of death in patients with platinum-resistant ovarian cancer (PROC). These results – without the need for biomarker selection, without increased safety burden and with oral administration – highlight relacorilant’s potential to become the new standard of care in PROC. Our applications are under review with regulatory authorities in both the United States and Europe, and we are working with urgency to bring this medication to patients with this highly challenging form of ovarian cancer,” said Dr. Guyer.
“Our ROSELLA results, as well as other pre-clinical and clinical oncology data, highlight the potential of glucocorticoid receptor antagonism to benefit patients across a wide variety of solid tumor types beyond PROC. We are currently studying relacorilant in other solid tumors, including platinum-sensitive ovarian, endometrial, cervical, pancreatic and prostate cancers, and we will continue to broaden our research to help as many patients as possible,” added Dr. Guyer.
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
MONARCH – Enrollment completed in randomized, double-blind, placebo-controlled, Phase 2b trial of miricorilant in 175 patients with biopsy-confirmed or presumed MASH – Results expected by the end of this year
“In our Phase 1b study, miricorilant was well-tolerated and very rapidly reduced liver fat while improving fibrosis, liver enzymes and other markers of liver health, as well as key metabolic and lipid measures. We look forward to building on these promising findings in our Phase 2b MONARCH study, with results expected by the end of this year,” said Dr. Guyer.
Amyotrophic Lateral Sclerosis (ALS)
DAZALS – Exploratory analyses showed that patients who received dazucorilant 300 mg exhibited an 84 percent reduction in risk of death during the study’s first year compared to patients who received placebo (hazard ratio: 0.16, p-value: 0.0009)
Phase 3 trial – Planned to begin by the middle of this year
“Elevated cortisol activity is linked to ALS. In our Phase 2 DAZALS study, patients who received dazucorilant experienced a profound reduction in early mortality – a period when many patients with ALS retain significant function and quality of life,” said Dr. Guyer. “We are currently conducting a dose titration study, with the goal of improving gastrointestinal tolerability, to inform the direction of our Phase 3 program.”
Conference Call
We will hold a conference call on February 24, 2026, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Participants must register in advance of the conference call by clicking here. Upon registering, each participant will receive a dial-in number and a unique access PIN. Each access PIN will accommodate one caller. A listen-only webcast will be available by clicking here. A replay of the call will be available on the Investors / Events tab of Corcept.com.
About Corcept Therapeutics
For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders, leading to the discovery of more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with Cushing’s syndrome, solid tumors, ALS and liver disease. In February 2012, the company introduced Korlym®, the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with endogenous Cushing’s syndrome. Corcept is headquartered in Redwood City, California. For more information, visit Corcept.com.
Forward-Looking Statements
Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations and are subject to risks and uncertainties that might cause our actual results to differ materially from any future results expressed or implied by such forward-looking statements.
In this press release, forward-looking statements include those concerning: our 2026 revenue guidance; our ability to achieve a record number of new patients that have started treatment with our medications in a month; the expected expansion of our Cushing’s syndrome business for many years; regulatory review of relacorilant, including engagement with the FDA regarding our NDA for relacorilant in Cushing’s syndrome and our confidence that the ultimate outcome will be approval, FDA review of our NDA for relacorilant plus nab-paclitaxel to treat patients with platinum-resistant ovarian cancer, and our expectation to receive approval of relacorilant plus nab-paclitaxel to treat patients with platinum-resistant ovarian cancer from the European Medicines Agency based on its review of our MAA; our ability to bring relacorilant to patients and the timing thereof; statements related to ongoing and planned clinical trials, including statements regarding the potential to produce important data, timing of such trials, expected patient enrollment, and the timing and publication or presentation of results; our ability to broaden our research to help as many patients as possible; relacorilant’s potential, including as a treatment for patients with Cushing’s syndrome, ovarian cancer and other cancers and as the new standard of care for patients with Cushing’s syndrome or platinum-resistant ovarian cancer; the potential of glucocorticoid receptor antagonism to benefit patients with a wide variety of solid tumors; nenocorilant as a treatment for patients with cancer; miricorilant as a treatment for patients with MASH; the expectation that we will have results from our Phase 2b MONARCH study of miricorilant in patients with biopsy-confirmed or presumed MASH by the end of 2026 and our ability to build on the findings from this study; dazucorilant as a treatment for patients with ALS; our intent to replicate our DAZALS findings in a Phase 3 trial and to use a dose titration study to improve gastrointestinal tolerability of dazucorilant in patients with ALS and inform the design of the Phase 3 trial and the timing of this trial.
A further description of risks and uncertainties can be found in our SEC filings, which are available at our website and the SEC’s website. These risks and uncertainties include, but are not limited to, those related to our ability to: operate our business; study and develop Korlym, relacorilant, miricorilant, dazucorilant, nenocorilant and our other product candidates; those molecules’ clinical attributes, regulatory approvals, mandates, oversight and other requirements; and the scope and protective power of our intellectual property. We disclaim any intention or duty to update forward-looking statements made in this press release.
CORCEPT THERAPEUTICS INCORPORATED
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
December 31, 2025(1)
December 31, 2024(1)
Assets
Cash and investments
$
532,422
$
603,165
Trade receivables, net of allowances
59,786
53,976
Inventory
23,962
15,995
Operating lease right-of-use asset
4,583
5,324
Deferred tax assets, net
168,197
130,914
Other assets
47,701
31,179
Total assets
$
836,651
$
840,553
Liabilities and Stockholders’ Equity
Accounts payable
$
40,444
$
15,376
Operating lease liabilities
6,107
6,936
Other liabilities
142,295
138,652
Stockholders’ equity
647,805
679,589
Total liabilities and stockholders’ equity
$
836,651
$
840,553
(1) Derived from audited financial statements at that date
CORCEPT THERAPEUTICS INCORPORATED
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(In thousands, except per share data)
Three Months Ended
Year Ended
December 31,
December 31,
2025
2024
2025
2024
Revenues
Product revenue, net
$
202,125
$
181,890
$
761,407
$
675,040
Operating expenses
Cost of sales
2,545
2,956
12,977
10,882
Research and development
64,856
70,300
254,908
246,887
Selling, general and administrative
130,237
83,372
448,725
280,320
Total operating expenses
197,638
156,628
716,610
538,089
Income from operations
4,487
25,262
44,797
136,951
Interest and other income
5,423
6,698
21,666
24,542
Income before income taxes
9,910
31,960
66,463
161,493
Income tax benefit (expense)
14,378
(1,214
)
33,189
(20,284
)
Net income
$
24,288
$
30,746
$
99,652
$
141,209
Net income attributable to common stockholders
$
23,905
$
30,395
$
98,171
$
139,733
Basic net income per common share
$
0.23
$
0.29
$
0.95
$
1.35
Diluted net income per common share
$
0.20
$
0.26
$
0.82
$
1.23
Weighted-average shares outstanding used in computing net income per common share
Basic
103,695
103,643
103,862
103,232
Diluted
119,855
118,459
119,987
113,480
View source version on businesswire.com: https://www.businesswire.com/news/home/20260224796156/en/
Investor inquiries:
ir@corcept.com
Media inquiries:
communications@corcept.com
www.corcept.com
Original: Corcept Therapeutics Announces Fourth Quarter and Full-Year 2025 Audited Financial Results, Provides Corporate Update
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