Latest news with #Korlym
Business Insider
3 hours ago
- Health
- Business Insider
Corcept says Catalyst trial met primary endpoint
Corcept Therapeutics (CORT) Incorporated presented data from the randomized, double-blind, placebo-controlled treatment phase of its CATALYST trial of Korlym in patients with hypercortisolism and difficult-to-control type 2 diabetes at the American Diabetes Association's 85th Scientific Sessions. CATALYST met its primary endpoint. Patients who received Korlym exhibited a clinically meaningful and statistically significant improvement in hemoglobin A1c, which decreased 1.47 percent from baseline, compared to a 0.15 percent decrease in patients who received placebo. Of the 91 patients in the treatment group, 65received at least 600mg of Korlym and 28 received 900mg. Patients who received 900mg of Korlym had an improvement in HbA1c of 2.01 percent, compared to a 0.16 percent decrease in patients who received placebo. The trial also met its secondary endpoints, as patients who received Korlym exhibited significantly reduced body weight and waist circumference, compared to patients who received placebo. Patients receiving Korlym achieved these improvements despite reducing or discontinuing their glucose-lowering medications. Adverse events in CATALYST were manageable and consistent with Korlym's known safety profile. The most common adverse events were hypokalemia, fatigue and nausea.
Yahoo
7 hours ago
- Health
- Yahoo
Corcept Presents Data from Treatment Phase of CATALYST Trial at American Diabetes Association's 85th Scientific Sessions with Simultaneous Publication in Diabetes Care
Treatment with a cortisol modulator significantly improves glucose control in patients with hypercortisolism and difficult-to-control diabetes, accompanied by reductions in body weight, waist circumference and glucose-lowering medications CATALYST's prevalence phase identified hypercortisolism in 24 percent of patients with difficult-to-control type 2 diabetes REDWOOD CITY, Calif., June 23, 2025--(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 data from the randomized, double-blind, placebo-controlled treatment phase of its CATALYST trial of Korlym® in patients with hypercortisolism (Cushing's syndrome) and difficult-to-control type 2 diabetes at the American Diabetes Association's 85th Scientific Sessions. CATALYST met its primary endpoint. Patients who received Korlym exhibited a clinically meaningful and statistically significant improvement in hemoglobin A1c (HbA1c), which decreased 1.47 percent from baseline, compared to a 0.15 percent decrease in patients who received placebo (p-value: < 0.001). Of the 91 patients in the treatment group, 65 (71%) received at least 600mg of Korlym and 28 (31%) received 900mg. Patients who received 900mg of Korlym had an improvement in HbA1c of 2.01 percent, compared to a 0.16 percent decrease in patients who received placebo (p-value: < 0.001). The trial also met its secondary endpoints, as patients who received Korlym exhibited significantly reduced body weight (5.1 kg; p-value: 0.001) and waist circumference (5.1 cm; p-value: 0.002), compared to patients who received placebo. Patients receiving Korlym achieved these improvements despite reducing or discontinuing their glucose-lowering medications. Adverse events in CATALYST were manageable and consistent with Korlym's known safety profile. The most common adverse events (> 20% of participants receiving Korlym) were hypokalemia, fatigue and nausea. The conference presentations can be found here. Results were published simultaneously in Diabetes Care, in an article titled "Inadequately Controlled Type 2 Diabetes and Hypercortisolism: Improved Glycemia With Mifepristone Treatment." 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 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. "Many people with type 2 diabetes do not respond adequately to conventional glucose-lowering therapies," said John Buse, M.D., Ph.D., director of the University of North Carolina's Diabetes Center. "CATALYST shows that these patients should be screened for hypercortisolism and that treatment with a cortisol-directed therapy can confer significant clinical benefits, including meaningful reductions in HbA1c, body weight and waist circumference. These powerful findings provide important guidance for physicians treating patients with difficult-to-control type 2 diabetes." "We urgently need all physicians, not just endocrinologists, to develop a greater understanding of Cushing's syndrome," said Leslie Edwin, President of the Cushing's Support & Research Foundation. "As a person who has lived with the complex and far-reaching effects of Cushing's syndrome for almost two decades, it is difficult to see that some things have been slow to change. Patients are still spending years on average searching for the cause of deceptively common symptoms, like elevated blood sugar, weight gain, depression and anxiety treated as individual diagnoses instead of parts of a bigger, more burdensome problem that carries tremendous health risk. The CATALYST data will help physicians identify and treat patients more quickly and accurately through earlier screening, and that is such an exciting prospect for all of us in the Cushing's community." "The CATALYST results will help physicians more accurately diagnose and treat people with hypercortisolism, a serious and deadly disease that too often goes undetected," said Bill Guyer, PharmD, Corcept's Chief Development Officer. "One in four patients with difficult-to-control type 2 diabetes have hypercortisolism and treatment with a cortisol modulator can be highly effective in improving many of their signs and symptoms. Corcept is thankful to the patients who participated in CATALYST. We hope these data can help all patients with this disease." About Hypercortisolism (Cushing's Syndrome) Hypercortisolism 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 lethal if not treated effectively. IMPORTANT SAFETY INFORMATION INDICATIONS AND USAGE 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. IMPORTANT LIMITATIONS OF USE Do not use for the treatment of type 2 diabetes mellitus unrelated to endogenous Cushing's syndrome. 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. 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. 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. Hypokalemia: Hypokalemia should be corrected prior to treatment and monitored for during treatment. 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. QT interval prolongation: Avoid use with QT interval-prolonging drugs, or in patients with potassium channel variants resulting in a long QT interval. Use of strong CYP3A inhibitors: Concomitant use increases mifepristone plasma levels. Adjust Korlym dose as described in Dosage and Administration. Use only when necessary and do not exceed a Korlym dose of 900 mg. 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, 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. Adjust Korlym dose as described in Dosage and Administration. 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. 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 and has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with hypercortisolism, 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 hypercortisolism. Corcept is headquartered in Redwood City, California. For more information, visit 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 that are subject to risks and uncertainties that might cause our actual results to differ materially from those expressed or implied by such statements. 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 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. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. In this press release, forward-looking statements include: the impact of CATALYST on the medical field's practices regarding the screening for and treatment of hypercortisolism. We disclaim any intention or duty to update forward-looking statements made in this press release. View source version on Contacts Investor inquiries:ir@ Media inquiries:communications@ Sign in to access your portfolio
Business Wire
9 hours ago
- Health
- Business Wire
Corcept Presents Data from Treatment Phase of CATALYST Trial at American Diabetes Association's 85
REDWOOD CITY, Calif.--(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 data from the randomized, double-blind, placebo-controlled treatment phase of its CATALYST trial of Korlym ® in patients with hypercortisolism (Cushing's syndrome) and difficult-to-control type 2 diabetes at the American Diabetes Association's 85 th Scientific Sessions. CATALYST met its primary endpoint. Patients who received Korlym exhibited a clinically meaningful and statistically significant improvement in hemoglobin A1c (HbA1c), which decreased 1.47 percent from baseline, compared to a 0.15 percent decrease in patients who received placebo (p-value: < 0.001). Of the 91 patients in the treatment group, 65 (71%) received at least 600mg of Korlym and 28 (31%) received 900mg. Patients who received 900mg of Korlym had an improvement in HbA1c of 2.01 percent, compared to a 0.16 percent decrease in patients who received placebo (p-value: < 0.001). The trial also met its secondary endpoints, as patients who received Korlym exhibited significantly reduced body weight (5.1 kg; p-value: 0.001) and waist circumference (5.1 cm; p-value: 0.002), compared to patients who received placebo. Patients receiving Korlym achieved these improvements despite reducing or discontinuing their glucose-lowering medications. Adverse events in CATALYST were manageable and consistent with Korlym's known safety profile. The most common adverse events (> 20% of participants receiving Korlym) were hypokalemia, fatigue and nausea. The conference presentations can be found here. Results were published simultaneously in Diabetes Care, in an article titled ' Inadequately Controlled Type 2 Diabetes and Hypercortisolism: Improved Glycemia With Mifepristone Treatment.' 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 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. 'Many people with type 2 diabetes do not respond adequately to conventional glucose-lowering therapies,' said John Buse, M.D., Ph.D., director of the University of North Carolina's Diabetes Center. 'CATALYST shows that these patients should be screened for hypercortisolism and that treatment with a cortisol-directed therapy can confer significant clinical benefits, including meaningful reductions in HbA1c, body weight and waist circumference. These powerful findings provide important guidance for physicians treating patients with difficult-to-control type 2 diabetes.' 'We urgently need all physicians, not just endocrinologists, to develop a greater understanding of Cushing's syndrome,' said Leslie Edwin, President of the Cushing's Support & Research Foundation. 'As a person who has lived with the complex and far-reaching effects of Cushing's syndrome for almost two decades, it is difficult to see that some things have been slow to change. Patients are still spending years on average searching for the cause of deceptively common symptoms, like elevated blood sugar, weight gain, depression and anxiety treated as individual diagnoses instead of parts of a bigger, more burdensome problem that carries tremendous health risk. The CATALYST data will help physicians identify and treat patients more quickly and accurately through earlier screening, and that is such an exciting prospect for all of us in the Cushing's community.' 'The CATALYST results will help physicians more accurately diagnose and treat people with hypercortisolism, a serious and deadly disease that too often goes undetected,' said Bill Guyer, PharmD, Corcept's Chief Development Officer. 'One in four patients with difficult-to-control type 2 diabetes have hypercortisolism and treatment with a cortisol modulator can be highly effective in improving many of their signs and symptoms. Corcept is thankful to the patients who participated in CATALYST. We hope these data can help all patients with this disease.' About Hypercortisolism (Cushing's Syndrome) Hypercortisolism 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 lethal if not treated effectively. IMPORTANT SAFETY INFORMATION INDICATIONS AND USAGE 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. IMPORTANT LIMITATIONS OF USE Do not use for the treatment of type 2 diabetes mellitus unrelated to endogenous Cushing's syndrome. 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. 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. 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. Hypokalemia: Hypokalemia should be corrected prior to treatment and monitored for during treatment. 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. QT interval prolongation: Avoid use with QT interval-prolonging drugs, or in patients with potassium channel variants resulting in a long QT interval. Use of strong CYP3A inhibitors: Concomitant use increases mifepristone plasma levels. Adjust Korlym dose as described in Dosage and Administration. Use only when necessary and do not exceed a Korlym dose of 900 mg. 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, 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. Adjust Korlym dose as described in Dosage and Administration. 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. 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 and has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with hypercortisolism, 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 hypercortisolism. Corcept is headquartered in Redwood City, California. For more information, visit 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 that are subject to risks and uncertainties that might cause our actual results to differ materially from those expressed or implied by such statements. 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 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. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. In this press release, forward-looking statements include: the impact of CATALYST on the medical field's practices regarding the screening for and treatment of hypercortisolism. We disclaim any intention or duty to update forward-looking statements made in this press release.
Yahoo
03-06-2025
- Business
- Yahoo
CORT's Q1 Earnings In Line With Estimates, Revenues Lag, Shares Fall
Corcept Therapeutics Incorporated CORT reported first-quarter 2025 earnings of 17 cents per share, which were in line with the Zacks Consensus Estimate. The company had reported earnings of 25 cents per share in the year-ago quarter. Revenues in the first quarter increased 7.1% year over year to $157.2 million. The figure, however, missed the Zacks Consensus Estimate of $178 million. The top line solely comprises product sales of the Cushing's syndrome drug, Korlym. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.) Year to date, shares of Corcept have rallied 46.8% against the industry's decline of 0.4%. Image Source: Zacks Investment Research Revenues from Korlym also missed our model estimate of $179.1 million. Per management, Korlym sales in the first quarter were affected by the insufficient capacity of a specialty pharmacy vendor who was unable to fulfill the surge in demand. The lower-than-expected sales disappointed investors. Consequently, shares of CORT were down 7.5% in after-hours trading on May 5 following the earnings result announcement. Research and development expenses rose 3.8% year over year to $60.7 million. Selling, general and administrative expenses increased around 61.1% year over year to $90.7 million. Consequently, operating expenses increased 31.1% year over year to $153.8 million in the first quarter. Cash and investments, as of March 31, 2025, totaled $570.8 million compared with $603.2 million as of Dec. 31, 2024. Corcept reiterated its total revenue guidance for 2025. The company continues to expect total revenues in the range of $900-$950 million in 2025. The Zacks Consensus Estimate for revenues is pegged at $905.7 million. Corcept is developing its lead candidate, relacorilant, for treating patients with Cushing's syndrome. In December 2024, CORT submitted a new drug application (NDA) for relacorilant to the FDA for the same. The NDA was based on positive data from the GRACE study and confirmatory evidence from the phase III GRADIENT, as well as long-term extension studies and a phase II study in hypercortisolism. In March 2025, the FDA accepted the NDA and assigned a Prescription Drug User Fee Act target action date of Dec. 30, 2025. Corcept is also evaluating relacorilant in combination studies for treating different types of cancer indications. The phase III ROSELLA study, which evaluated relacorilant in combination with nab-paclitaxel for treating patients with platinum-resistant ovarian cancer, met its primary endpoint of improved progression-free survival (PFS). Corcept plans to submit a new drug application in the United States in the third quarter of 2025, while a marketing authorization application in Europe is likely to be filed shortly thereafter. Last month, Corcept initiated the phase II BELLA study evaluating relacorilant plus nab-paclitaxel and Roche's RHHBY Avastin (bevacizumab) for treating patients with platinum-resistant ovarian cancer. Per management, the BELLA study will help in understanding whether combining relacorilant with two medicines — nab-paclitaxel and RHHBY's Avastin — offers patients an additional treatment option or not. The company is also evaluating relacorilant plus Xtandi (enzalutamide) in patients with early-stage prostate cancer. The study is being conducted in collaboration with the University of Chicago. In December 2024, Corcept announced data from the phase II DAZALS study, which evaluated its selective cortisol modulator, dazucorilant, for treating patients with amyotrophic lateral sclerosis (ALS), a degenerative neurologic disorder. The study did not meet its primary endpoint, which was the change from baseline in the ALS Functional Rating Scale-Revised (ALSFRS-R) in patients treated with dazucorilant versus those treated with placebo. However, an exploratory analysis of the DAZALS study at the one-year mark showed that patients who were treated with dazucorilant (300 mg) at baseline demonstrated significantly improved overall survival, compared to patients who received a placebo. Patients then did not switch to dazucorilant in the long-term extension study. Corcept is looking to seek input from the FDA and the European regulatory body to discuss the next steps of development for dazucorilant. Corcept Therapeutics Incorporated price-consensus-eps-surprise-chart | Corcept Therapeutics Incorporated Quote Corcept currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are ADMA Biologics Inc. ADMA and Immunocore Holdings PLC IMCR, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. In the past 60 days, estimates for ADMA Biologics' earnings per share have increased from 69 cents to 71 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from 87 cents to 93 cents. Year to date, shares of ADMA have rallied 38.3%. ADMA's earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 32.80%. In the past 60 days, estimates for Immunocore's loss per share have narrowed from $1.63 to $1.50 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $1.83 to $1.68. Year to date, shares of IMCR have gained 3.9%. IMCR's earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 31.91%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Roche Holding AG (RHHBY) : Free Stock Analysis Report Corcept Therapeutics Incorporated (CORT) : Free Stock Analysis Report ADMA Biologics Inc (ADMA) : Free Stock Analysis Report Immunocore Holdings PLC Sponsored ADR (IMCR) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
26-02-2025
- Business
- Yahoo
Corcept Therapeutics Announces Fourth Quarter and Full-Year 2024 Audited Financial Results and Provides Corporate Update
2024 revenue of $675.0 million, a 40 percent increase over 2023 2025 revenue guidance of $900 – $950 million 2024 net income of $141.2 million, a 33 percent increase over 2023 Cash and investments of $603.2 million as of December 31, 2024 REDWOOD CITY, Calif., February 26, 2025--(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 reported its results for the quarter and year ended December 31, 2024. Financial Results "Once again, we had a record number of new Korlym® prescribers and a record number of patients receiving Korlym in the quarter. Physicians are increasingly aware of hypercortisolism's true prevalence and the poor health outcomes for patients who go untreated. Screening is becoming more common and the number of patients receiving appropriate care continues to increase. We are confident that our Cushing's syndrome business will grow for many years," said Joseph K. Belanoff, M.D., Corcept's Chief Executive Officer. Corcept's fourth quarter 2024 revenue was $181.9 million, compared to $135.4 million in the fourth quarter of 2023. Revenue for the full year was $675.0 million, compared to $482.4 million in 2023. Net income was $30.7 million in the fourth quarter, or $0.26 diluted net income per common share, compared to net income of $31.4 million, or $0.28 diluted net income per common share, in the fourth quarter of 2023. Net income was $141.2 million for the full year, or $1.23 diluted net income per common share, compared to net income of $106.1 million, or $0.94 diluted net income per common share, in 2023. Cash and investments were $603.2 million at December 31, 2024 compared to $425.4 million at December 31, 2023. In 2024, Corcept paid $38.0 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 made substantial progress in all of our clinical development programs in 2024," added Dr. Belanoff. "We submitted a New Drug Application (NDA) for our proprietary, selective cortisol modulator, relacorilant, as a treatment for hypercortisolism, based on compelling results from our GRACE, GRADIENT, long-term extension and Phase 2 studies. Our CATALYST study demonstrated that hypercortisolism is much more common than previously assumed in patients with difficult-to-control diabetes and that treatment with a cortisol modulator can significantly improve their glucose control. We expect data from ROSELLA, our pivotal study in women with platinum-resistant ovarian cancer, this quarter." Hypercortisolism (Cushing's Syndrome) Relacorilant for patients with hypercortisolism – NDA submitted in December 2024 GRACE – Pivotal Phase 3 trial of relacorilant in 152 patients with all etiologies of hypercortisolism – primary endpoint achieved in randomized withdrawal phase; open-label phase demonstrated clinically meaningful improvements in a broad range of hypercortisolism signs and symptoms; relacorilant was well-tolerated, consistent with its known safety profile, with no cases of endometrial hypertrophy or drug-induced vaginal bleeding, relacorilant-induced hypokalemia, adrenal insufficiency or QT prolongation GRADIENT – Supportive data for NDA – Patients treated with relacorilant exhibited clinically meaningful improvements in a broad range of hypercortisolism signs and symptoms in randomized, double-blind, placebo-controlled, Phase 3 trial in 137 patients with hypercortisolism caused by adrenal gland pathology; relacorilant was well-tolerated, consistent with its known safety profile, including no cases of endometrial hypertrophy or drug-induced vaginal bleeding, relacorilant-induced hypokalemia, adrenal insufficiency or QT prolongation Phase 3 long-term extension study – Supportive data for NDA – clinically meaningful and durable cardiometabolic improvements exhibited in 116 patients who completed the GRACE, GRADIENT or Phase 2 relacorilant studies, with no new or notable safety signals observed; treatment duration of up to six years CATALYST Part 1 – Of 1,057 patients with difficult-to-control type 2 diabetes, 23.8 percent were found to have hypercortisolism CATALYST Part 2 – Primary endpoint met in randomized, double-blind, placebo-controlled study of 136 patients identified with hypercortisolism in CATALYST Part 1; patients who received Korlym exhibited a clinically meaningful and statistically significant improvement in hemoglobin A1c, with a decrease from baseline of 1.47 percent compared to a decrease of 0.15 percent in patients who received placebo (p-value: < 0.0001); safety profile of Korlym in this study was consistent with the medication's label; no new adverse events were observed MOMENTUM – 1,000-patient trial examining the prevalence of hypercortisolism in patients with resistant hypertension to begin this quarter "The positive results from our pivotal GRACE study, and confirmatory evidence from our GRADIENT, long-term extension and Phase 2 studies, provide powerful support for relacorilant's NDA in hypercortisolism. Patients in these studies experienced clinically significant improvements in a wide array of hypercortisolism's signs and symptoms, without the off-target effects and toxicities that accompany currently available treatments. Relacorilant's strong efficacy and safety profile positions it to become the new standard of care for patients with hypercortisolism," said Bill Guyer, PharmD, Corcept's Chief Development Officer. "CATALYST is a landmark study that will change the way physicians treat some of their sickest patients. Its findings are striking: One-in-four patients whose type 2 diabetes resists treatment with the best available medications have hypercortisolism and hyperglycemia in these patients responds powerfully to treatment with a cortisol modulator," added Dr. Guyer. "We plan to build on these findings. Our MOMENTUM study will establish the prevalence of hypercortisolism in patients with resistant hypertension." Oncology ROSELLA – Results expected this quarter from pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in 381 patients with platinum-resistant ovarian cancer Early-stage prostate cancer – Enrollment continues in randomized, placebo-controlled, Phase 2 trial of relacorilant plus enzalutamide in patients with early-stage prostate cancer, conducted in collaboration with the University of Chicago "If ROSELLA replicates the positive results of our large, controlled, Phase 2 study, it will constitute a major medical advance and serve as the basis for relacorilant's next NDA. We expect progression-free survival results this quarter," said Dr. Guyer. "Relacorilant has the potential to become the standard of care for patients with platinum-resistant ovarian cancer." Amyotrophic Lateral Sclerosis (ALS) DAZALS – In a randomized, double-blind, placebo-controlled Phase 2 study in 249 patients with ALS, dazucorilant did not meet its primary endpoint of improvement in the ALS Functional Rating Scale-Revised (ALSFRS-R); a statistically significant improvement in overall survival at week 24 was observed; an open-label, long-term extension study is ongoing and one-year overall survival results are expected in the second quarter "ALS is a devastating disease, with few good treatment options. In DAZALS, patients who received dazucorilant did not show improvement in the ALS Functional Rating Scale-Revised (ALSFRS-R), which was the study's primary endpoint. An improvement in overall survival was observed at week 24 of the study – no deaths (0 of 83 patients) were observed in the 300 mg dazucorilant arm, compared to 5 deaths (5 of 82 patients) in the placebo group (p-value: 0.02). The open-label, long-term extension study is ongoing and we expect one-year overall survival results in the second quarter," said Dr. Guyer. Metabolic Dysfunction-Associated Steatohepatitis (MASH) MONARCH – Enrollment continues in randomized, double-blind, placebo-controlled, Phase 2b trial of miricorilant in 120 patients with biopsy-confirmed MASH and in 75 patients with presumed MASH "In our Phase 1b study, miricorilant reduced liver fat very rapidly, improved liver health and key metabolic and lipid measures and was well-tolerated. We look forward to building on these promising results in our MONARCH study," said Dr. Guyer. Conference Call We will hold a conference call on February 26, 2025, 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 About Corcept Therapeutics For over 25 years, Corcept's focus on cortisol modulation and its potential to treat patients with a wide variety of serious disorders has led to the discovery of more than 1,000 proprietary selective cortisol modulators. Corcept is conducting advanced clinical trials in patients with hypercortisolism, 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 hypercortisolism. Corcept is headquartered in Redwood City, California. For more information, visit 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 those such statements express or imply. These risks and uncertainties are set forth in our SEC filings, which are available at our website and the SEC's website. In this press release, forward-looking statements include those concerning: trends in medical practice, including trends regarding the identification and treatment of patients with hypercortisolism; our 2025 revenue guidance and factors that may affect our revenue and continued revenue growth, such as increased uptake or price reductions in competing medications, including generic versions of Korlym, and the performance of our third-party pharmacy and other vendors; relacorilant as a treatment for patients with hypercortisolism and solid tumors, dazucorilant as a treatment for patients with ALS, miricorilant as a treatment for patients with MASH; the timing and outcome of relacorilant's NDA in hypercortisolism; the timing and outcome of our CATALYST, MOMENTUM, ROSELLA, DAZALS and MONARCH trials and their impact on patient care and Corcept's commercial prospects; and the accrual and attributes of our clinical data. 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, 2024 December 31, 2023(1) (Unaudited) Assets Cash and investments $ 603,165 $ 425,397 Trade receivables, net of allowances 53,976 41,123 Insurance recovery receivable related to Melucci litigation — 14,000 Inventory 15,995 15,974 Operating lease right-of-use asset 5,324 120 Deferred tax assets, net 130,914 90,605 Other assets 31,179 34,298 Total assets $ 840,553 $ 621,517 Liabilities and Stockholders' Equity Accounts payable $ 15,376 $ 17,396 Accrued settlement related to Melucci litigation — 14,000 Operating lease liabilities 6,936 151 Other liabilities 138,652 83,265 Stockholders' equity 679,589 506,705 Total liabilities and stockholders' equity $ 840,553 $ 621,517 (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, 2024 2023 2024 2023 Revenues Product revenue, net $ 181,890 $ 135,405 $ 675,040 $ 482,375 Operating expenses Cost of sales 2,956 1,876 10,882 6,481 Research and development 70,300 54,707 246,887 184,353 Selling, general and administrative 83,372 47,152 280,320 184,259 Total operating expenses 156,628 103,735 538,089 375,093 Income from operations 25,262 31,670 136,951 107,282 Interest and other income 6,698 5,139 24,542 17,275 Income before income taxes 31,960 36,809 161,493 124,557 Income tax expense (1,214 ) (5,454 ) (20,284 ) (18,417 ) Net income $ 30,746 $ 31,355 $ 141,209 $ 106,140 Net income attributable to common stockholders $ 30,395 $ 31,138 $ 139,733 $ 105,496 Basic net income per common share $ 0.29 $ 0.30 $ 1.35 $ 1.02 Diluted net income per common share $ 0.26 $ 0.28 $ 1.23 $ 0.94 Weighted-average shares outstanding used in computing net income per common share Basic 103,643 102,455 103,232 103,560 Diluted 118,459 110,886 113,480 111,742 View source version on Contacts Investor inquiries:ir@ Media inquiries:communications@ Sign in to access your portfolio
