CORT Corcept Therapeutics Incorporated

17.09
+0.32  (+2%)
Previous Close 16.77
Open 16.91
52 Week Low 9.7
52 Week High 23.48
Market Cap $1,974,880,341
Shares 115,557,656
Float 88,353,641
Enterprise Value $1,573,027,341
Volume 605,844
Av. Daily Volume 3,482,054
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Upcoming Catalysts

Drug Stage Catalyst Date
Exicorilant plus Enzalutamide
Castration-resistant prostate cancer (CRPC)
Phase 1/2
Phase 1/2
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
Relacorilant plus Abraxane
Ovarian cancer
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
Miricorilant
Nonalcoholic steatohepatitis (NASH)
Phase 2
Phase 2
Phase 2 trial to be initiated 4Q 2020.
Relacorilant (GRACE)
Cushing’s syndrome
Phase 3
Phase 3
Phase 3 commencement of enrolment announced November 19, 2018. NDA planned for 2Q 2022.
Miricorilant (GRATITUDE 2)
Long-standing antipsychotic-induced weight gain (APIWG)
Phase 2
Phase 2
Phase 2 trial to be initiated 3Q 2020.
Relacorilant plus Keytruda
Adrenocortical cancer
Phase 1b
Phase 1b
Phase 1b trial to be initiated 3Q 2020.
Relacorilant (GRADIENT)
Cushing’s syndrome
Phase 3
Phase 3
Phase 3 initiation announced July 28, 2020.
Relacorilant plus nab-paclitaxel (RELIANT)
Pancreatic cancer
Phase 3
Phase 3
Phase 3 initiation announced June 30, 2020.
Miricorilant
Healthy volunteers
Phase 1b
Phase 1b
Phase 1b 900 mg cohort data released May 4, 2020.
Miricorilant
Antipsychotic-induced weight gain (APIWG)
Phase 2
Phase 2
Phase 2 (GRATITUDE) trial enrolling.
Corlux - Korlym
Cushing's Syndrome
Approved
Approved
Approved February 17, 2012.

Latest News

  1. MENLO PARK, Calif., Sept. 10, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced enrollment of its first patient in GRATITUDE II, a randomized, double-blind, placebo-controlled, Phase 2 trial of miricorilant in obese patients with schizophrenia and long-standing antipsychotic-induced weight gain (APIWG).

    GRATITUDE II has a planned enrollment of 150 patients, who will continue to receive their established dose of antipsychotic medication, plus either 600 milligrams of miricorilant, 900 milligrams of miricorilant or placebo, for…

    MENLO PARK, Calif., Sept. 10, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced enrollment of its first patient in GRATITUDE II, a randomized, double-blind, placebo-controlled, Phase 2 trial of miricorilant in obese patients with schizophrenia and long-standing antipsychotic-induced weight gain (APIWG).

    GRATITUDE II has a planned enrollment of 150 patients, who will continue to receive their established dose of antipsychotic medication, plus either 600 milligrams of miricorilant, 900 milligrams of miricorilant or placebo, for 26 weeks. The primary endpoint is reduction in bodyweight. GRATITUDE II will be conducted at 35 centers in the United States.

    GRATITUDE I, Corcept's first Phase 2 trial of miricorilant in APIWG, continues to enroll patients with schizophrenia and recent weight gain. Patients in GRATITUDE I receive, in addition to their established antipsychotic regimen, either 600 milligrams of miricorilant or placebo for 12 weeks. The primary endpoint is change in bodyweight.

    "Substantial, sustained weight gain and associated metabolic co-morbidities shorten the lives of many of the millions of patients who take antipsychotic medications and significantly reduce quality of life for many more," said Andreas Grauer, MD, Corcept's Chief Medical Officer. "Miricorilant has demonstrated promise as a potential treatment for this disorder.1 In our double-blind, placebo-controlled, Phase 1b trial, after just two weeks of treatment, healthy subjects given miricorilant in addition to olanzapine gained significantly less weight than subjects who received olanzapine plus placebo. Patients receiving miricorilant also experienced smaller increases in the enzymes AST and ALT, which suggests miricorilant may help protect the liver. We hope to confirm and extend our Phase 1b results in GRATITUDE II, which is using an improved formulation of miricorilant and a longer treatment duration."

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    CONTACT:

    Christopher S. James, MD

    Director, Investor Relations

    Corcept Therapeutics

    650-684-8725



    www.corcept.com

    1 For data from our studies in animal models of APIWG, see our 2020 American Psychiatry Association (APA) poster at the Research & Pipeline / Publications tab of our website.

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  2. MENLO PARK, Calif., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, today reported its results for the quarter ended June 30, 2020.

    Financial Highlights

    • Revenue of $88.6 million, a 23 percent increase from second quarter 2019
    • GAAP diluted net income of $0.23 per share, compared to $0.17 per share in second quarter 2019
    • Non-GAAP diluted net income of $0.32 per share, compared to $0.25 per share in second quarter 2019
    • Cash and investments of $409.6 million, compared to $349.0 million at March 31, 2020
    • Reaffirmed 2020

    MENLO PARK, Calif., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, today reported its results for the quarter ended June 30, 2020.

    Financial Highlights

    • Revenue of $88.6 million, a 23 percent increase from second quarter 2019
    • GAAP diluted net income of $0.23 per share, compared to $0.17 per share in second quarter 2019
    • Non-GAAP diluted net income of $0.32 per share, compared to $0.25 per share in second quarter 2019
    • Cash and investments of $409.6 million, compared to $349.0 million at March 31, 2020
    • Reaffirmed 2020 revenue guidance of $355 – 375 million

    Revenue was $88.6 million in the second quarter, compared to $72.3 million in the second quarter of 2019.   Second quarter revenue was $4.7 million lower than in the first quarter, primarily because in March 2020 some patients refilled their prescriptions a few days earlier than usual as a safeguard against pandemic-related delays.  These safety stocks were consumed in the second quarter.   This shift in refill timing increased shipments of Korlym tablets in the first quarter and decreased them by a similar amount in the second quarter.

    We reaffirm our 2020 revenue guidance of $355 – 375 million.

    Second quarter GAAP net income was $28.3 million, compared to $20.2 million in the same period last year.  Excluding non-cash expenses related to stock-based compensation and the utilization of deferred tax assets, together with related income tax effects, non-GAAP net income in the second quarter was $39.7 million, compared to $31.0 million in the second quarter of 2019.  A reconciliation of GAAP to non-GAAP net income is included below.

    Second quarter operating expenses were $53.3 million, compared to $47.6 million in the second quarter of 2019, primarily due to increased spending to conduct clinical trials in Cushing's syndrome, antipsychotic-induced weight gain and solid tumors and to formulate and manufacture the company's proprietary, selective cortisol modulators and to increased employee recruiting and compensation expense.

    Cash and investments were $409.6 million at June 30, 2020, an increase of $60.6 million from March 31, 2020.

    "Patients with Cushing's syndrome are at elevated risk of infection with the novel coronavirus," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer.  "Our clinical specialists, medical science liaisons and patient advocates have done an excellent job helping physicians provide the care these patients need, despite the challenges posed by the Covid-19 pandemic.

    "The pandemic's impact on Corcept has been varied," Dr. Belanoff added.  "As our first and second quarter results showed, pandemic-related changes in patient refill choices can shift revenue from one quarter to another.  More fundamentally, while the heightened vulnerability of patients with Cushing's syndrome to Covid-19 has caused patients to stay on therapy, which tends to increase demand for Korlym, it remains difficult for doctors to arrange the tests and on-going monitoring needed to diagnose new patients and optimize their care.  In addition, many patients are reluctant to leave their homes, even to visit their doctor.  And opportunities for our clinical specialists to meet with physicians in person remain limited, although telephone and video conference contact is becoming more common. 

    "We expect that these countervailing forces will continue in coming quarters, but also expect any changes to be manageable and reiterate our 2020 revenue guidance of $355 – 375 million."

    Cushing's Syndrome

    • Phase 3 trial of relacorilant in patients with all etiologies of Cushing's syndrome (GRACE) continues at 60 sites in the United States, Europe and Israel; NDA submission planned

      in second quarter 2022
    • Enrollment underway in Phase 3 trial of relacorilant in patients with Cushing's syndrome of adrenal origin (GRADIENT)

    "Although the Covid-19 pandemic has slowed patient enrollment and clinical site activation, our Cushing's syndrome program continues to make important progress," said Andreas Grauer, MD, Corcept's Chief Medical Officer.  "We opened five additional clinical sites in GRACE, our pivotal trial of relacorilant to treat patients with all etiologies of Cushing's syndrome, bringing the total to 60.  Enrollment activity has increased, particularly in Europe, where pandemic-related restrictions have eased.  We plan to submit relacorilant's NDA, based on the results of GRACE, in the second quarter of 2022.

    "In addition, enrollment has begun in GRADIENT, our double-blind, placebo-controlled, Phase 3 trial with a planned total of 130 patients whose Cushing's syndrome is caused by an adrenal adenoma or adrenal hyperplasia.1 GRADIENT is the first controlled clinical trial of medical treatment in this etiology of the disease.

    Solid Tumors

    • Completed enrollment in controlled, Phase 2 trial of relacorilant plus nab-paclitaxel in patients with metastatic ovarian cancer; results expected in first half 2021
    • Initiated Phase 3 trial of relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer (RELIANT)
    • Selection of optimum dose of exicorilant plus enzalutamide in patients with castration-resistant prostate cancer expected by year-end
    • Phase 1b trial of relacorilant plus PD-1 checkpoint inhibitor pembrolizumab in patients with metastatic or unresectable adrenal cancer expected to start in third quarter 2020

    "Our development of relacorilant as a potential treatment for solid tumors recently achieved two important milestones," said Dr. Grauer.  "We completed enrollment in our controlled, Phase 2 trial of relacorilant combined with nab-paclitaxel to treat patients with metastatic ovarian cancer.  We also initiated RELIANT, our Phase 3 trial of relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer.  Data from our open-label, Phase 1/2 trial in patients with these tumors were very encouraging.2  Replicating those results in these larger, more rigorous trials would be an important medical advance."

    Our controlled, Phase 2 trial of relacorilant plus nab-paclitaxel in patients with metastatic, platinum-resistant ovarian cancer has enrolled its goal of 178 patients, at 28 sites in the United States, Canada and Europe.  Participants were randomly assigned to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel alone.  The trial's primary endpoint is progression free survival, with secondary endpoints including objective response rate and duration of objective response.  Data is expected in the first half of next year.

    RELIANT has a planned enrollment of 80 patients with metastatic pancreatic cancer, with an interim analysis of data from the first 40 patients.  Each patient will receive relacorilant plus nab-paclitaxel.  The primary endpoint is objective response rate, with secondary endpoints including progression-free survival and duration of response.  RELIANT will be conducted at 20 sites in the United States.  We believe sufficiently positive results would support accelerated approval by the FDA.

    "In the third quarter, we plan to initiate an open-label, 20-patient, Phase 1b trial of relacorilant combined with the PD-1 checkpoint inhibitor pembrolizumab in patients with metastatic or unresectable adrenal cancer that produces excess cortisol," said Dr. Grauer.  "These patients respond poorly to pembrolizumab monotherapy and also suffer from Cushing's syndrome.  By modulating the effects of excess cortisol, including cortisol-induced immune suppression, relacorilant may both treat the symptoms of Cushing's syndrome and allow pembrolizumab achieve its full cancer-killing effect."

    Metabolic Diseases

    • Enrollment continues in double-blind, placebo-controlled, Phase 2 trial of miricorilant to reverse recent APIWG (GRATITUDE)
    • Double-blind, placebo-controlled Phase 2 trial (GRATITUDE 2) of miricorilant to reverse long-standing antipsychotic-induced weight gain (APIWG) planned to start in third quarter 2020
    • Double-blind, placebo-controlled Phase 2 trial of miricorilant in patients with non-alcoholic steatohepatitis (NASH) planned to start in fourth quarter 2020

    "Miricorilant has shown great promise as a treatment for APIWG," said Dr. Grauer.  "In our Phase 1b trial, healthy subjects given olanzapine plus miricorilant gained less weight and had lower triglycerides and less sharply elevated liver enzymes than subjects who received olanzapine plus placebo – despite being treated for only two weeks.  We hope to confirm and extend these results in the GRATITUDE trials.

    "Our on-going GRATITUDE trial is testing the ability of miricorilant to reduce recent weight gain caused by antipsychotic medications in 100 patients with schizophrenia," added Dr. Grauer.  "Study participants continue to receive their established dose of antipsychotic medication and either 600 milligrams of miricorilant or placebo for 12 weeks.  Our second trial, GRATITUDE 2 will test the same effect in patients with long-standing APIWG.

    "Completion of formulation work for miricorilant has allowed us to advance by one quarter the start of our second Phase 2 trial in patients with APIWG and our first Phase 2 trial in patients with NASH," said Dr. Grauer.

    Conference Call

    We will hold a conference call on August 4th, 2020, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).  To participate, dial 1-800-353-6461 from the United States or 1-334-323-0501 internationally approximately ten minutes before the start of the call (passcode 6800706).  A replay will be available through August 18, 2020 at 1-888-203-1112 in the United States and 1-719-457-0820 internationally (passcode 6800706).

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. We have discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol. We own extensive United States and foreign intellectual property covering the composition of our selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    GAAP Measures of Net Income

    To supplement our financial results presented on a GAAP basis, we use non-GAAP measures of net income, basic net income per share and diluted net income per share that exclude the following non-cash expenses – (i) stock-based compensation, (ii) our use of deferred tax assets to offset current tax expense and (iii) related income tax effects. We believe these non-GAAP measures help investors evaluate our financial performance and potential future results. Our non-GAAP measures may be different from, and not directly comparable to, those used by other companies. They are not a substitute for comparable GAAP measures and should not be considered in isolation. Investors should read our non-GAAP presentation in conjunction with our financial statements prepared in accordance with GAAP.

    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 statements express or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business and achieve our goals during the Covid-19 pandemic and to generate sufficient revenue to fund our commercial operations and development programs; the availability of competing treatments, including generic versions of Korlym; our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym; and risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates and oversight, and other requirements. 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 those concerning our 2020 revenue guidance; the impact of the Covid-19 pandemic on our operations, financial performance and clinical development programs; the progress, enrollment, timing, design and results of our clinical trials; and the clinical and commercial attributes of relacorilant, exicorilant and miricorilant. 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, except per share data)
     
     June 30,

    2020
     December 31,

    2019 (1)
     
     (Unaudited)   
    Assets    
    Cash and investments$409,558  $315,314 
    Trade receivables, net of allowances22,725   19,928  
    Inventory16,120   17,405  
    Operating lease right-of-use asset3,472   3,446  
    Deferred tax assets, net35,470   45,677  
    Other assets10,478   10,542  
    Total assets$497,823  $412,312 
    Liabilities and Stockholders' Equity    
    Accounts payable$6,304  $7,537 
    Operating lease liabilities3,505   3,461  
    Other liabilities34,316   30,132  
    Stockholders' equity453,698   371,182  
    Total liabilities and stockholders' equity$497,823  $412,312 
         
    (1) Derived from audited financial statements at that date    



    CORCEPT THERAPEUTICS INCORPORATED



    CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

    (In thousands, except per share data)
        
     Three Months Ended June 30, Six Months Ended June 30,
     2020 2019 2020 2019
    Revenues       
    Product revenue, net$88,565   $72,257   $181,812   $137,086  
            
    Operating expenses       
    Cost of sales1,234   1,377   3,112   2,617  
    Research and development26,497   21,656   52,620   41,900  
    Selling, general and administrative25,572   24,591   53,107   48,980  
    Total operating expenses$53,303   $47,624   $108,839   $93,497  
    Income from operations35,262   24,633   72,973   43,589  
    Interest and other income1,010   1,178   2,481   2,275  
    Income before income taxes36,272   25,811   75,454   45,864  
    Income tax expense(7,945)  (5,625)  (17,062)  (7,404) 
    Net income$28,327   $20,186   $58,392   $38,460  
    Other comprehensive income (loss):       
    Net unrealized gain on available-for-sale investments, net of tax impact of $(170), $(73), $(190) and $(124), respectively545   227   606   391  
    Foreign currency translation loss, net of tax(15)     (27)    
    Total comprehensive income$28,857   $20,413   $58,971   $38,851  
            
    Basic net income per share$0.25   $0.18   $0.51   $0.34  
            
    Diluted net income per share$0.23   $0.17   $0.48   $0.31  
            
    Shares used in computing basic net income per common share115,006   114,340   114,790   114,590  
    Shares used in computing diluted net income per common share123,234   121,783   122,756   122,831  
                    



    CORCEPT THERAPEUTICS INCORPORATED



    RECONCILIATION OF GAAP TO NON-GAAP NET INCOME

    (In thousands, except per share data)
        
     Three Months Ended June 30, Six Months Ended June 30,
     2020  2019  2020  2019 
    GAAP net income$28,327  $20,186  $58,392  $38,460 
            
    Non-cash expenses (benefits)       
    Stock-based compensation       
    Cost of sales15  55  38  83 
    Research and development2,794  2,505  5,399  4,484 
    Selling, general and administrative5,680  5,176  10,970  9,865 
    Total stock-based compensation8,489  7,736  16,407  14,432 
    Deferred income taxes4,922  4,908  10,017  5,834 
    Income tax effect of non-GAAP adjustments (1)(2,037) (1,857) (3,938) (3,464)
    Non-GAAP net income, adjusted for non-cash expenses$39,701  $30,973  $80,878  $55,262 
            
    GAAP basic net income per share$0.25  $0.18  $0.51  $0.34 
            
    GAAP diluted net income per share$0.23  $0.17  $0.48  $0.31 
            
    Non-GAAP basic net income

    per share, adjusted for

    non-cash expenses
    $0.35  $0.27  $0.70  $0.48 
            
    Non-GAAP diluted net income

    per share, adjusted for

    non-cash expenses
    $0.32  $0.25  $0.66  $0.45 
            
    Shares used in computing basic

    net income per share
    115,006  114,340  114,790  114,590 
    Shares used in computing diluted net income per share123,234  121,783  122,756  122,831 
            
    (1) Calculated by applying the statutory tax rate to the pre-tax, non-discrete, non-GAAP adjustments.

    ________________________

    1 See our 2020 ENDO poster at the Research & Pipeline / Publications tab of our website.

    2 See our ASCO poster at the Investors / Events tab of our website.

    CONTACT:

    Christopher S. James, MD

    Director, Investor Relations

    Corcept Therapeutics

    650-684-8725



    www.corcept.com 

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  3. MENLO PARK, Calif., July 28, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT) today announced it will report second quarter financial results and provide a corporate update on August 4, 2020. The company will also host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

    Conference Call Information
    To participate, dial 1-800-353-6461 from the United States or 1-334-323-0501 internationally approximately ten minutes before the start of the call. The passcode will be 6800706.

    A replay will be available through August 18, 2020 at 1-888-203-1112 from the United States and 1-719-457-0820 internationally. The passcode will be 6800706.

    About Corcept Therapeutics Incorporated

    Corcept is a commercial-stage…

    MENLO PARK, Calif., July 28, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT) today announced it will report second quarter financial results and provide a corporate update on August 4, 2020. The company will also host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

    Conference Call Information

    To participate, dial 1-800-353-6461 from the United States or 1-334-323-0501 internationally approximately ten minutes before the start of the call. The passcode will be 6800706.

    A replay will be available through August 18, 2020 at 1-888-203-1112 from the United States and 1-719-457-0820 internationally. The passcode will be 6800706.

    About Corcept Therapeutics Incorporated

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds, that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    CONTACT:

    Christopher S. James, MD

    Director, Investor Relations

    Corcept Therapeutics

    650-684-8725



    www.corcept.com

     

    View Full Article Hide Full Article
  4. MENLO PARK, Calif., July 28, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced enrollment of its first patient in GRADIENT, a double-blind, placebo-controlled, Phase 3 trial of relacorilant in patients with Cushing's syndrome caused by adrenal adenomas or hyperplasia.

    "We are excited to begin enrollment in GRADIENT," said Andreas Grauer, MD, Corcept's Chief Medical Officer.  "Patients with Cushing's syndrome of adrenal origin have poor health outcomes, even if the course of their decline is sometimes less rapid than in Cushing's…

    MENLO PARK, Calif., July 28, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced enrollment of its first patient in GRADIENT, a double-blind, placebo-controlled, Phase 3 trial of relacorilant in patients with Cushing's syndrome caused by adrenal adenomas or hyperplasia.

    "We are excited to begin enrollment in GRADIENT," said Andreas Grauer, MD, Corcept's Chief Medical Officer.  "Patients with Cushing's syndrome of adrenal origin have poor health outcomes, even if the course of their decline is sometimes less rapid than in Cushing's syndrome of other etiologies.  GRADIENT is the first systematic study of the benefits of a medical treatment in these patients. We expect it to contribute meaningfully to physicians' ability to provide optimal care."

    GRADIENT is a double-blind, placebo-controlled Phase 3 trial, with a planned enrollment of 130 patients at sites in the United States and Europe.  Half of the patients will receive relacorilant and the other half placebo for six months.  The trial's primary endpoints are improvement in glucose metabolism and hypertension.1

    GRADIENT is Corcept's second Phase 3 trial of relacorilant in patients with hypercortisolism.  The company's pivotal GRACE trial is enrolling 130 patients with all etiologies of Cushing's syndrome at sites in the United States, Canada, Europe and Israel.  Corcept expects the results of GRACE, if positive, to be the basis for relacorilant's new drug application as a treatment for all etiologies of Cushing's syndrome.

    About Relacorilant

    Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor that does not bind to the body's other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders, including Cushing's syndrome and adrenal, ovarian and pancreatic cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents. Relacorilant has received orphan drug designation in the United States for the treatment of Cushing's syndrome and pancreatic cancer.

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds, including relacorilant, that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    1 See our poster at the Research & Pipeline / Publications tab of our website and Clinicaltrials.gov (NCT04308590).

    CONTACT:

    Christopher S. James, MD

    Director, Investor Relations

    Corcept Therapeutics

    650-684-8725



    www.corcept.com



    View Full Article Hide Full Article
  5. MENLO PARK, Calif., July 23, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced the completion of enrollment in its controlled, Phase 2 trial of relacorilant combined with nab-paclitaxel (Abraxane®) in patients with metastatic, platinum-resistant ovarian cancer.

    "We achieved this milestone thanks in part to the hard work and enthusiasm of our clinical investigators," said Andreas Grauer, MD, Corcept's Chief Medical Officer. "Data from our open-label, Phase 1/2 trial were very promising.1 We expect to have results from this larger…

    MENLO PARK, Calif., July 23, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced the completion of enrollment in its controlled, Phase 2 trial of relacorilant combined with nab-paclitaxel (Abraxane®) in patients with metastatic, platinum-resistant ovarian cancer.

    "We achieved this milestone thanks in part to the hard work and enthusiasm of our clinical investigators," said Andreas Grauer, MD, Corcept's Chief Medical Officer. "Data from our open-label, Phase 1/2 trial were very promising.1 We expect to have results from this larger, controlled trial in the first half of next year."

    The trial has enrolled 177 patients at 28 sites in the United States, Canada and Europe. Participants were randomly assigned to receive either relacorilant in combination with nab-paclitaxel or nab-paclitaxel alone. The trial's primary endpoint is progression free survival, with secondary endpoints including objective response rate and duration of objective response.2

    About Relacorilant

    Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor, the receptor for cortisol which is activated when cortisol levels are high. Relacorilant does not bind to the body's other hormone receptors. Corcept is studying relacorilant as a potential treatment for a variety of serious disorders, including Cushing's syndrome and advanced adrenal, ovarian and pancreatic cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents. Relacorilant has received orphan drug designation in the United States for the treatment of Cushing's syndrome and pancreatic cancer.

    About Corcept Therapeutics

    Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol. Corcept's medication Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds, including relacorilant, that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

    Abraxane® is a registered trademark of Abraxis BioScience, LLC.

    1 For more data, see our ASCO poster at the Investors/Past Events tab of our website.

    2 For additional information, see Clinicaltrials.gov (trial identifier: NCT03776812)

    CONTACT:

    Christopher S. James, MD

    Director, Investor Relations

    Corcept Therapeutics

    650-684-8725



    www.corcept.com

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