CORT Corcept Therapeutics Incorporated

22.68
-0.23  -1%
Previous Close 22.91
Open 22.76
52 Week Low 11.57
52 Week High 31.18
Market Cap $2,660,643,894
Shares 117,312,341
Float 90,108,326
Enterprise Value $2,249,480,732
Volume 557,551
Av. Daily Volume 603,498
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
Relacorilant plus Abraxane
Ovarian cancer
Phase 2
Phase 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 nab-paclitaxel (RELIANT)
Pancreatic cancer
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.

Drug Pipeline

Drug Stage Notes
Relacorilant plus Keytruda
Adrenocortical cancer
Phase 1b
Phase 1b
Phase 1b enrollment of first patient announced March 15, 2021.
Miricorilant (GRATITUDE)
Antipsychotic-induced weight gain (APIWG)
Phase 2
Phase 2
Phase 2 trial enrolling.
Miricorilant
Nonalcoholic steatohepatitis (NASH)
Phase 2
Phase 2
Phase 2 trial enrolling.
Exicorilant plus Enzalutamide
Castration-resistant prostate cancer (CRPC)
Phase 1/2
Phase 1/2
Selection of optimum dose expected 3Q 2021.
Relacorilant (GRACE)
Cushing’s syndrome
Phase 3
Phase 3
Phase 3 commencement of enrolment announced November 19, 2018. NDA planned for 2Q 2023.
Miricorilant (GRATITUDE 2)
Long-standing antipsychotic-induced weight gain (APIWG)
Phase 2
Phase 2
Phase 2 trial initiated 3Q 2020.
Relacorilant (GRADIENT)
Cushing’s syndrome
Phase 3
Phase 3
Phase 3 initiation announced July 28, 2020.
Miricorilant
Healthy volunteers
Phase 1b
Phase 1b
Phase 1b 900 mg cohort data released May 4, 2020.
Corlux - Korlym
Cushing's Syndrome
Approved
Approved
Approved February 17, 2012.

Latest News

  1. MENLO PARK, Calif., March 15, 2021 (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 the first patient in the Phase 1b trial of relacorilant in combination with the PD-1 checkpoint inhibitor pembrolizumab (Merck's medication, Keytruda®) in patients with adrenal cancer with cortisol excess.

    "Cortisol activity blunts the cancer-killing attributes of immunotherapeutic agents such as checkpoint inhibitors," said Andreas Grauer, MD, Corcept's Chief Medical Officer, "which may be why pembrolizumab is rarely effective as…

    MENLO PARK, Calif., March 15, 2021 (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 the first patient in the Phase 1b trial of relacorilant in combination with the PD-1 checkpoint inhibitor pembrolizumab (Merck's medication, Keytruda®) in patients with adrenal cancer with cortisol excess.

    "Cortisol activity blunts the cancer-killing attributes of immunotherapeutic agents such as checkpoint inhibitors," said Andreas Grauer, MD, Corcept's Chief Medical Officer, "which may be why pembrolizumab is rarely effective as monotherapy in patients with adrenal cancer with cortisol excess. Our trial will examine whether adding relacorilant to pembrolizumab therapy will reduce cortisol-activated immune suppression sufficiently to help pembrolizumab achieve its intended tumor-killing effect, while relacorilant treats the Cushing's syndrome caused by excess cortisol activity."

    The open-label, Phase 1b trial has a planned enrollment of 20 patients with metastatic or unresectable adrenal cancer with cortisol excess at five sites in the United States.

    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.

    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, the progress, enrollment, timing, design and results of our clinical trials; our ability to operate our business and achieve our goals and conduct our clinical trials during the COVID-19 pandemic; the availability of competing treatments; risks related to the development of relacorilant as a product candidate for adrenal cancer with cortisol excess, including its clinical attributes, regulatory approvals, mandates and oversight, and other requirements; and the scope and protective power of our intellectual property. In this press release, forward-looking statements include those concerning the clinical attributes of relacorilant and its effects in patients with adrenal cancer. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. We disclaim any intention or duty to update forward-looking statements made in this press release.

    Keytruda® is a registered trademark of Merck & Co, Inc.

    CONTACT:

    Christopher S. James, MD

    Director, Investor Relations

    Corcept Therapeutics

    650-684-8725



    www.corcept.com



    Primary Logo

    View Full Article Hide Full Article
  2. MENLO PARK, Calif., March 01, 2021 (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 hormone cortisol, today announced that Atabak Mokari has joined the company as Chief Financial Officer. Charles Robb, who has been Corcept's CFO since September 2011, has assumed the role of Chief Business Officer.

    "Atabak's talent and broad experience make him a welcome addition to our executive team," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer. "Further, his arrival will allow Charlie to focus on the significant administrative and operational tasks…

    MENLO PARK, Calif., March 01, 2021 (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 hormone cortisol, today announced that Atabak Mokari has joined the company as Chief Financial Officer. Charles Robb, who has been Corcept's CFO since September 2011, has assumed the role of Chief Business Officer.

    "Atabak's talent and broad experience make him a welcome addition to our executive team," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer. "Further, his arrival will allow Charlie to focus on the significant administrative and operational tasks we will face in 2021 and beyond."

    Atabak Mokari has nearly 20 years leadership experience in life sciences and healthcare finance. From 2018 to 2020, he was Chief Financial Officer and Vice President of Corporate Development at Bellicum Pharmaceuticals, Inc. He served in the same capacity from 2016 to 2018 at medical device manufacturer IRIDEX. Mr. Mokari was a director at Wells Fargo Securities LLC's healthcare investment banking group from 2013 to 2016, at UBS's healthcare investment banking group from 2009 to 2013 and at Credit Suisse's healthcare investment banking group from 2005 to 2009. Prior to that, he was a member of the business development team at Forest Laboratories, a pharmaceutical company, and an analyst at the private equity firm Olympus Partners and the investment banking firm Bowles Hollowell Conner & Co. Mr. Mokari earned an MBA from The Tuck School of Business at Dartmouth and a B.S. in Chemistry and Biology from Duke University.

    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



    Primary Logo

    View Full Article Hide Full Article
    • 2020 revenue of $353.9 million, compared to $306.5 million in 2019
    • Fourth quarter revenue of $85.7 million, compared to $87.9 million in 2019
    • 2020 GAAP net income of $106.0 million, compared to $94.2 million in 2019
    • Fourth quarter GAAP net income of $26.0 million, compared to $29.4 million in fourth quarter 2019
    • Cash and investments of $476.9 million at year-end, compared to $315.3 million at year-end 2019
    • Acquisition of 458,769 shares pursuant to the company's stock repurchase program
    • Reiterated 2021 revenue guidance of $375 – 405 million

    MENLO PARK, Calif., Feb. 23, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic…

    • 2020 revenue of $353.9 million, compared to $306.5 million in 2019
    • Fourth quarter revenue of $85.7 million, compared to $87.9 million in 2019
    • 2020 GAAP net income of $106.0 million, compared to $94.2 million in 2019
    • Fourth quarter GAAP net income of $26.0 million, compared to $29.4 million in fourth quarter 2019
    • Cash and investments of $476.9 million at year-end, compared to $315.3 million at year-end 2019
    • Acquisition of 458,769 shares pursuant to the company's stock repurchase program
    • Reiterated 2021 revenue guidance of $375 – 405 million

    MENLO PARK, Calif., Feb. 23, 2021 (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 hormone cortisol, today reported its results for the quarter- and year-ended December 31, 2020.

    Corcept's 2020 revenue was $353.9 million, compared to $306.5 million in 2019. Fourth quarter revenue was $85.7 million, compared to $87.9 million in the fourth quarter of 2019. The company reiterated its 2021 revenue guidance of $375 – 405 million.

    GAAP net income was $106.0 million for the year and $26.0 million in the fourth quarter of 2020, compared to $94.2 million for the year and $29.4 million in the fourth quarter of 2019. 

    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 was $34.7 million in the fourth quarter, compared to $40.3 million in the fourth quarter of 2019. For the full-year, non-GAAP net income was $145.6 million, compared to $133.3 million in 2019. A reconciliation of GAAP to non-GAAP net income is included below.

    Cash and investments increased by $32.7 million in the fourth quarter, to $476.9 million at December 31, 2020. At December 31, 2019, the balance of cash and investments was 315.3 million.

    The company spent $9.7 million in the fourth quarter repurchasing 458,769 shares of common stock pursuant to its stock repurchase program. Under the currently authorized terms of that program, $190.3 million remains available for the repurchase of shares.

    "Corcept's financial and clinical accomplishments in 2020 lay the foundation for significant progress this year," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer. "As the COVID-19 pandemic is brought under control, the easing of public health restrictions and greater willingness of patients to visit their doctors will allow more physicians to diagnose and optimally treat patients with Cushing's syndrome. We expect revenue next year of $375 – 405 million.

    "Improving conditions should also permit more rapid progress in our clinical development programs, many of which have been significantly slowed by the pandemic," he added. We are currently evaluating our proprietary, selective cortisol modulators as potential treatments for patients with metastatic ovarian and pancreatic cancer, castration-resistant prostate cancer, adrenal cancer, Cushing's syndrome, antipsychotic-induced weight gain and non-alcoholic steatohepatitis. We will have topline data from our ovarian and pancreatic cancer trials in the second quarter. In the fourth quarter, we plan to initiate a Phase 2 trial in patients with amyotrophic lateral sclerosis (ALS)."

    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.

    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, the completion of our financial closing procedures and any adjustments that may result from the completion of the annual independent audit of our consolidated financial statements; our ability to operate our business and achieve our goals and conduct our clinical trials 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; risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates and 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 those concerning our 2021 revenue guidance and our stock repurchase program; the progress, enrollment, timing, design and results of our clinical trials; the course of the COVID-19 pandemic and its impact on patients, physicians, medical practice and clinical research activities; and the clinical and commercial attributes of Korlym, relacorilant, exicorilant and miricorilant and other proprietary, selective cortisol modulators. 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)

     December 31, 2020 (1) December 31, 2019 (1)
        
    Assets   
    Cash and investments$476,892  $315,314 
    Trade receivables, net of allowances26,198  19,928 
    Inventory21,157  17,405 
    Operating lease right-of-use asset2,509  3,446 
    Deferred tax assets, net31,603  45,677 
    Other assets13,372  10,542 
    Total assets$571,731  $412,312 
    Liabilities and Stockholders' Equity   
    Accounts payable$10,554  $7,537 
    Operating lease liabilities2,551  3,461 
    Other liabilities35,288  30,132 
    Stockholders' equity523,338  371,182 
    Total liabilities and stockholders' equity$571,731  $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 Year Ended
     December 31, December 31,
     2020 2019 2020 2019
    Revenues       
    Product revenue, net$85,735  $87,895  $353,874  $306,486 
            
    Operating expenses       
    Cost of sales1,254  1,436  5,582  5,504 
    Research and development28,275  24,312  114,764  89,017 
    Selling, general and administrative25,696  27,131  105,326  100,359 
    Total operating expenses$55,225  $52,879  $225,672  $194,880 
    Income from operations30,510  35,016  128,202  111,606 
    Interest and other income297  1,444  3,400  5,070 
    Income before income taxes30,807  36,460  131,602  116,676 
    Income tax expense(4,813) (7,079) (25,591) (22,495)
    Net income$25,994  $29,381  $106,011  $94,181 
    Other comprehensive income (loss):       
    Net unrealized gain on available-for-sale investments, net of tax impact of $96, $20, $15 and $(104), respectively(309) (62) (50) 327 
    Foreign currency translation loss, net of tax147  9  204  4 
    Total comprehensive income$25,832  $29,328  $106,165  $94,512 
            
    Basic net income per share$0.22  $0.26  $0.92  $0.82 
            
    Diluted net income per share$0.20  $0.24  $0.85  $0.77 
            
    Shares used in computing basic net income per common share116,320  114,347  115,412  114,349 
    Shares used in computing diluted net income per common share127,423  122,688  124,194  122,566 
                

    CORCEPT THERAPEUTICS INCORPORATED

    RECONCILIATION OF GAAP TO NON-GAAP NET INCOME

    (In thousands, except per share data)

     Three Months Ended Year Ended
     December 31, December 31,
     2020 2019 2020 2019
    GAAP net income$25,994  $29,381  $106,011  $94,181 
            
    Non-cash expenses (benefits)       
    Stock-based compensation       
    Cost of sales15  39  66  144 
    Research and development2,865  2,707  11,222  9,541 
    Selling, general and administrative5,550  4,864  22,251  19,628 
    Total stock-based compensation8,430  7,610  33,539  29,313 
    Deferred income taxes2,311  5,146  14,089  16,877 
    Income tax effect of non-GAAP adjustments (1)(2,023) (1,826) (8,049) (7,035)
    Non-GAAP net income, adjusted for non-cash expenses$34,712  $40,311  $145,590  $133,336 
            
    GAAP basic net income per share$0.22  $0.26  $0.92  $0.82 
            
    GAAP diluted net income per share$0.20  $0.24  $0.85  $0.77 
            
    Non-GAAP basic net income per share, adjusted for non-cash expenses per share$0.30  $0.35  $1.26  $1.17 
            
    Non-GAAP diluted net income per share, adjusted for non-cash expenses per share$0.27  $0.33  $1.17  $1.09 
            
    Shares used in computing basic net income per common share116,320  114,347  115,412  114,349 
    Shares used in computing diluted net income per common share127,423  122,688  124,194  122,566 
            
    (1) Calculated by applying the statutory tax rate to the pre-tax, non-discrete, non-GAAP adjustments.
     

    CONTACT:

    Christopher S. James, MD

    Director, Investor Relations

    Corcept Therapeutics

    650-684-8725



    www.corcept.com



    Primary Logo

    View Full Article Hide Full Article
  3. Financial Highlights, 2021 Revenue Guidance and Legal Update

    • Preliminary 2020 revenue $353.9 million, compared to $306.5 million in 2019
    • Preliminary fourth quarter revenue $85.7 million, compared to $87.9 million in fourth quarter 2019
    • 2021 revenue guidance $375 - 405 million
    • Preliminary 2020 fully diluted GAAP net income $0.85 per share, compared to $0.77 per share in 2019
    • Preliminary fourth quarter fully diluted GAAP net income $0.20 per share, compared to $0.24 per share in fourth quarter 2019
    • Preliminary cash and investments at December 31, 2020 of $476.9 million, an increase
      of $161.6 million from December 31, 2019
    • Patent Trial and Appeals Board affirms validity of all claims in Corcept's U.S. Patent No.10,195,214 (patent term: 2037)

    MENLO PARK…

    Financial Highlights, 2021 Revenue Guidance and Legal Update

    • Preliminary 2020 revenue $353.9 million, compared to $306.5 million in 2019
    • Preliminary fourth quarter revenue $85.7 million, compared to $87.9 million in fourth quarter 2019
    • 2021 revenue guidance $375 - 405 million
    • Preliminary 2020 fully diluted GAAP net income $0.85 per share, compared to $0.77 per share in 2019
    • Preliminary fourth quarter fully diluted GAAP net income $0.20 per share, compared to $0.24 per share in fourth quarter 2019
    • Preliminary cash and investments at December 31, 2020 of $476.9 million, an increase

      of $161.6 million from December 31, 2019
    • Patent Trial and Appeals Board affirms validity of all claims in Corcept's U.S. Patent No.10,195,214 (patent term: 2037)

    MENLO PARK, Calif. , Feb. 08, 2021 (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 neuropsychiatric disorders by modulating the effects of the stress hormone cortisol, today reported preliminary fourth quarter revenue of $85.7 million, compared to $87.9 million in the fourth quarter of 2019. Preliminary 2020 revenue was $353.9 million compared to $306.5 million in 2019. The company expects 2021 revenue of $375 – 405 million.

    Cash and investments increased by $32.7 million in the fourth quarter to $476.9 million. At December 31, 2019 cash and investments totaled $315.3 million. The company spent $9.7 million in the fourth quarter repurchasing 458,769 shares of common stock pursuant to its stock repurchase program.  Under the currently authorized terms of that program, $190.3 million remains available for the repurchase of shares.

    These results are prior to completion of the company's annual independent audit and are subject to adjustment.

    "Corcept's performance during the COVID-19 pandemic demonstrates the durability of our business," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer. "Confronted with unprecedented obstacles, we generated significantly more revenue, more income and more cash than we did in 2019. Having won an important legal victory in our dispute with Teva Pharmaceuticals, we look with confidence to the future. As the pandemic is contained, we expect our commercial growth to resume and have provided 2021 revenue guidance of $375 – 405 million.

    "The pandemic's impact on our clinical activities has been variable. Trials in acutely life-threatening indications, such as advanced ovarian and pancreatic cancer, recruited briskly. Studies of illnesses with a slower course of disease, such as Cushing's syndrome, castration-resistant prostate cancer ("CRPC"), anti-psychotic-induced weight gain ("AIWG") and non-alcoholic steatohepatitus ("NASH") have proceeded more slowly.

    "Despite these challenges, our development team made important advances. They maintained our existing trials, although the pandemic significantly slowed enrollment in many of them. They also started new trials that greatly broadened the scope of our clinical program. In 2020, we initiated trials in Cushing's syndrome of adrenal origin, metastatic pancreatic cancer, advanced adrenocortical cancer, AIWG and NASH. We also laid the groundwork for further expansion by advancing promising compounds from our portfolio of selective cortisol modulators towards the clinic."

    Cushing's Syndrome

    • Phase 3 GRACE trial of relacorilant as a treatment for patients with any etiology of

      Cushing's syndrome continues at sites in the United States, Canada, Europe and Israel;

      pandemic conditions delay expected timing of NDA submission
    • Enrollment continues in Phase 3 GRADIENT trial of relacorilant as a treatment for patients with Cushing's syndrome of adrenal origin, with sites planned in the United States, Europe and Israel

    "While our Phase 3 GRACE and GRADIENT trials in patients with Cushing's syndrome continue to accrue patients and generate valuable data, pandemic-related public health measures, which in many places became even more restrictive in the fourth quarter, continue to slow the pace of enrollment," said Andreas Grauer, MD, Corcept's Chief Medical Officer. "As vaccination campaigns falter – especially in Europe, where many of our most productive clinical sites are located – the retarding effects of the pandemic remain in place. Ultimately, relacorilant's NDA submission date will depend on the duration and severity of pandemic-related restrictions, which cannot be known with certainty. The delay may be as long as one year, to the second quarter of 2023.  

    "These delays are especially frustrating because relacorilant's Phase 2 data were extremely promising. Our team of clinical investigators are enthusiastic. We are confident enrollments will accelerate once conditions improve."

    Solid Tumors

    • Preliminary results in 178-patient, controlled, Phase 2 trial of relacorilant plus nab-paclitaxel

      in patients with metastatic ovarian cancer expected in first half 2021
    • Preliminary results in first 40 patients enrolled in open-label Phase 3 RELIANT trial

      of relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer expected

      in first half 2021
    • Selection of optimum dose of exicorilant plus enzalutamide in patients with castration-resistant prostate cancer ("CRPC") expected by third quarter 2021
    • Patient selection underway in 20-patient, open-label, Phase 1b trial of relacorilant plus PD-1 checkpoint inhibitor pembrolizumab in patients with adrenal cancer with cortisol excess

    "Our trials in patients with metastatic ovarian and pancreatic cancer are on track to generate preliminary data in the first half of 2021, as planned," said Dr. Grauer. "These trials are evaluating whether relacorilant can enhance the efficacy of nab-paclitaxel by reducing cortisol's suppression of apoptosis in patients with advanced disease, many of whom have experienced progression on prior rounds of taxane-based therapies. It would be wonderful to be able to offer a therapy that benefits them.

    "The dose-finding trial of our selective cortisol modulator exicorilant with enzalutamide as a treatment for CRPC continues to enroll patients," said Dr. Grauer, "although the pandemic has slowed its pace, pushing selection of an optimum dose to the second or third quarter of this year, depending on how quickly pandemic conditions improve. Our hypothesis, which is well-supported by pre-clinical data, is that combining an androgen receptor antagonist like enzalutamide with a cortisol modulator will block an important tumor escape route.

    "Last year, we initiated a Phase 1b trial in patients with adrenal cancer with cortisol excess," said Dr. Grauer. "This study will evaluate whether adding relacorilant to pembrolizumab therapy will reduce cortisol-activated immune suppression sufficiently to help pembrolizumab achieve its intended tumor-killing effect, while relacorilant treats the Cushing's syndrome caused by excess cortisol activity."

    Metabolic Diseases

    • Enrollment underway in double-blind, placebo-controlled Phase 2 trial of miricorilant

      in patients with NASH
    • Enrollment continues in GRATITUDE, a double-blind, placebo-controlled, Phase 2 trial

      of miricorilant to reverse recent AIWG
    • Enrollment continues in GRATITUDE II, a 150-patient, double-blind, placebo-controlled

      Phase 2 trial of miricorilant to reverse long-standing AIWG

    "In the fourth quarter, we initiated a double-blind, placebo-controlled Phase 2 trial of miricorilant as a potential treatment for NASH, a serious liver disorder that affects millions of people," said Dr. Grauer. "We plan to enroll 120 patients, who will receive either 900 mg miricorilant, 600 mg miricorilant or placebo for twelve weeks. The primary endpoint will be reduction in liver fat content, as measured by MRI. Our pre-clinical data suggest miricorilant may be a potent treatment for NASH. We hope to demonstrate similarly encouraging results in patients.

    "Our Phase 2 trials in AIWG – GRATITUDE and GRATITUDE II – continue to enroll patients, although the pandemic has slowed the pace," added Dr. Grauer. "AIWG reduces the quality of life and shortens the life expectancy of millions of patients. Results from the Phase 1b trial we completed last year suggest that miricorilant may benefit them. In that study, healthy volunteers given miricorilant plus olanzapine gained less weight and had lower triglycerides and less sharply elevated liver enzymes than those who received olanzapine plus placebo after only two weeks of dosing. These results build on those we achieved in similar trials using mifepristone (see Gross et al, Advances in Therapy (2009); Gross et al, Obesity (2010). Miricorilant, like mifepristone, modulates cortisol activity. Unlike mifepristone, miricorilant does not affect progesterone activity."

    Conference Call

    We will hold a conference call on February 8, 2021, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To participate, click this link (listen-only mode) or dial 1-833-693-0540 (United States) or 1-661-407-1581 (international) approximately ten minutes before the start of the call. The conference ID number is 9289307.   A replay will be available on the Investors / Past Events tab of our website.

    Hypercortisolism

    Hypercortisolism, often referred to as Cushing's syndrome, is caused by excessive activity of the hormone cortisol. Endogenous Cushing's syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing's syndrome, with about 3,000 new patients diagnosed each year. Symptoms vary, but most patients experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Hypercortisolism can affect every organ system in the body and can be lethal if not treated effectively.

    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.

    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, the completion of our financial closing procedures and any adjustments that may result from the completion of the annual independent audit of our consolidated financial statements; our ability to operate our business and achieve our goals and conduct our clinical trials 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; risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates and 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 those concerning our preliminary fourth quarter and full year 2020 financial results; 2021 revenue guidance; our clinical development programs; the progress, enrollment, timing, design and results of our clinical trials; the course of the COVID-19 pandemic and its impact on patients, physicians, medical practice and clinical research activities; and the clinical and commercial attributes of Korlym, relacorilant, exicorilant and miricorilant. We disclaim any intention or duty to update forward-looking statements made in this press release.

    CONTACT:

    Christopher S. James, MD

    Director, Investor Relations

    Corcept Therapeutics

    650-684-8725

     

    www.corcept.com 



    Primary Logo

    View Full Article Hide Full Article
  4. MENLO PARK, Calif., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT) today announced it will report its preliminary 2020 fourth quarter and full-year financial results and provide a corporate update on February 8, 2021. The company will 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 1-833-693-0540 (United States) or 1-661-407-1581 (internationally) approximately 15 minutes before the start of the call. The conference ID number is 9289307.

    For access to the call in "listen-only" mode, click this link and provide the requested information. The link will be active 15 minutes prior to the call's scheduled start time.

    About

    MENLO PARK, Calif., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT) today announced it will report its preliminary 2020 fourth quarter and full-year financial results and provide a corporate update on February 8, 2021. The company will 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 1-833-693-0540 (United States) or 1-661-407-1581 (internationally) approximately 15 minutes before the start of the call. The conference ID number is 9289307.

    For access to the call in "listen-only" mode, click this link and provide the requested information. The link will be active 15 minutes prior to the call's scheduled start time.

    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 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



    Primary Logo

    View Full Article Hide Full Article
View All Corcept Therapeutics Incorporated News