CORT Corcept Therapeutics Incorporated

20.77
+0.48  (+2%)
Previous Close 20.29
Open 21.04
52 Week Low 12.2
52 Week High 31.18
Market Cap $2,422,419,473
Shares 116,630,692
Float 77,636,583
Enterprise Value $1,995,544,740
Volume 748,575
Av. Daily Volume 555,477
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Upcoming Catalysts

Drug Stage Catalyst Date
Relacorilant (GRACE)
Cushing’s syndrome
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Exicorilant plus XTANDI (Enzalutamide)
Castration-resistant prostate cancer (CRPC)
Phase 1/2
Phase 1/2
Selection of optimum dose expected later in 2021.
Miricorilant (GRATITUDE 2)
Long-standing antipsychotic-induced weight gain (APIWG)
Phase 2
Phase 2
Phase 2 enrollment to be completed by end of 2021.
Miricorilant (GRATITUDE)
Antipsychotic-induced weight gain (APIWG)
Phase 2
Phase 2
Phase 2 enrollment to be completed mid-2022.
Relacorilant plus ABRAXANE (nab-paclitaxel)
Ovarian cancer
Phase 3
Phase 3
Phase 3 trial planned for 1Q 2022.
Relacorilant (GRADIENT)
Cushing’s syndrome
Phase 3
Phase 3
Phase 3 initiation announced July 28, 2020.
Relacorilant plus ABRAXANE (nab-paclitaxel) - (RELIANT)
Pancreatic cancer
Phase 3
Phase 3
Phase 3 initial data released June 22, 2021. 2/31 (6%) partial responses. Enrollment to be stopped. Level of benefit does not justify further study.
KORLYM (Corlux)
Cushing's Syndrome
Approved
Approved
Approved February 17, 2012.
Relacorilant plus KEYTRUDA (pembrolizumab)
Adrenocortical cancer
Phase 1b
Phase 1b
Phase 1b enrollment of first patient announced March 15, 2021.
Miricorilant
Nonalcoholic steatohepatitis (NASH)
Phase 2
Phase 2
Phase 2 interim data released May 6, 2021.
Miricorilant
Healthy volunteers
Phase 1b
Phase 1b
Phase 1b 900 mg cohort data released May 4, 2020.

Latest News

  1. MENLO PARK, Calif., July 29, 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 hormone cortisol, today reported its results for the quarter ended June 30, 2021.

    Financial Results

    • Revenue of $91.6 million, compared to $88.6 million in second quarter 2020
    • GAAP diluted net income of $0.21 per share, compared to $0.23 per share in second quarter 2020
    • Non-GAAP diluted net income of $0.30 per share, compared to $0.32 per share in second quarter 2020
    • Cash and investments of $471.6 million, compared to $454.8 million at March 31, 2021
    • Reiterated 2021

    MENLO PARK, Calif., July 29, 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 hormone cortisol, today reported its results for the quarter ended June 30, 2021.

    Financial Results

    • Revenue of $91.6 million, compared to $88.6 million in second quarter 2020
    • GAAP diluted net income of $0.21 per share, compared to $0.23 per share in second quarter 2020
    • Non-GAAP diluted net income of $0.30 per share, compared to $0.32 per share in second quarter 2020
    • Cash and investments of $471.6 million, compared to $454.8 million at March 31, 2021
    • Reiterated 2021 revenue guidance of $355$385 million

    Second quarter 2021 revenue was $91.6 million, compared to $88.6 million in the second quarter of 2020. First quarter 2021 revenue was $79.4 million. Second quarter 2021 GAAP net income was $26.5 million, compared to $28.3 million in the second quarter of 2020. 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 $38.2 million, compared to $39.7 million in the second quarter of 2020. A reconciliation of GAAP to non-GAAP net income is included below.

    Second quarter operating expenses were $59.6 million, compared to $53.3 million in the second quarter of 2020, due to increased employee compensation expenses, commercial spending, spending on clinical trials in Cushing's syndrome and pre-clinical activities.

    Cash and investments were $471.6 million at June 30, 2021, compared to $454.8 million at March 31, 2021. The balance at June 30, 2021 reflects the acquisition of $30.8 million of common stock in the second quarter – 1.4 million shares pursuant to the company's stock repurchase program and 0.1 million shares in connection with the net exercise of stock options. Under the repurchase program's current terms, $127.6 million remains available for the purchase of shares.

    The company reiterated its 2021 revenue guidance of $355 – $385 million.

    "Diminishing COVID-19 public health restrictions and the availability of safe and effective vaccines have allowed our commercial business to resume growing," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer. "Our second quarter results reflect the fact that physicians are seeing their patients more frequently, which allows them to diagnose and optimally treat those who have Cushing's syndrome. Provided COVID-19 restrictions continue to abate – as we believe they will – we expect growth to continue. Korlym is an excellent treatment for hypercortisolism and there are many eligible patients who have yet to receive it. Our planned successor to Korlym, relacorilant, which is currently in its pivotal trial, promises to be an even better medication."

    Clinical Development

    "We are enthusiastic about the potential of cortisol modulation to help treat many diseases, not just Cushing's syndrome," added Dr. Belanoff. "Our programs in solid tumors, non-alcoholic steatohepatitis (NASH) and antipsychotic-induced weight gain (AIWG) continue to make progress. We are especially excited about our advancing platinum-resistant ovarian cancer program. Based on the statistically significant and clinically meaningful results of our 178-patient, controlled Phase 2 trial, we plan to initiate a pivotal trial in the first quarter of next year."

    Solid Tumors

    • Phase 3 pivotal trial in patients with platinum-resistant ovarian cancer to start in the first quarter of 2022
    • Selection of the optimum dose of exicorilant plus enzalutamide in patients with castration-resistant prostate cancer (CRPC) expected later this year
    • Enrollment continues in 20-patient, open-label, Phase 1b trial of relacorilant plus PD-1 checkpoint inhibitor pembrolizumab in patients with adrenal cancer with cortisol excess

    "We look forward to starting a Phase 3 pivotal trial in women with platinum-resistant ovarian cancer," said Andreas Grauer, MD, Corcept's Chief Medical Officer. "Our Phase 2 results illustrated that women who received relacorilant with nab-paclitaxel experienced improved progression free survival (PFS) without experiencing additional side effects, a welcome finding for women with few good treatment options. We will present detailed results of our Phase 2 trial at the European Society for Medical Oncology (ESMO) meeting in September in a proffered paper oral presentation, with overall survival data expected later in the year. And we continue to evaluate relacorilant as a possible treatment for patients with other glucocorticoid receptor-expressing tumors."

    Metabolic Diseases

    • Phase 1b dose-finding trial in patients with presumed NASH to start in the fourth quarter of 2021
    • Enrollment continues in GRATITUDE, a 100-patient 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

    "We plan to begin a Phase 1b, dose-finding trial of miricorilant in patients with presumed NASH in the fourth quarter of this year," said Dr. Grauer. "Patients who received miricorilant in our previous trial experienced exceptionally large and rapid reductions in liver fat accompanied by substantial, but transient, elevations of the liver enzymes ALT and AST. Our hypothesis is that the rapidity and magnitude of miricorilant's fat reducing effect irritated the liver. The objective of our planned study is to identify a dosing regimen that can produce significant reductions in fat without causing liver irritation."

    "Meanwhile, our Phase 2 trials evaluating miricorilant as a treatment for patients with AIWG – GRATITUDE and GRATITUDE II – continue to advance," added Dr. Grauer. "We expect to complete enrollment in GRATITUDE II by year-end and in GRATITUDE by mid-2022."

    Cushing's Syndrome

    • Enrollment continues in Phase 3 GRACE trial of relacorilant as a treatment for patients with all etiologies of Cushing's syndrome; NDA submission expected in the second quarter of 2023
    • Enrollment continues in Phase 3 GRADIENT trial of relacorilant as a treatment for patients with Cushing's syndrome caused by adrenal adenomas

    "We advanced relacorilant to Phase 3 based on its extremely promising Phase 2 efficacy and safety data, which we recently published in Frontiers in Endocrinology (Pivonello 2021)," said Dr. Grauer. "We expect our GRACE trial, which is accruing patients and generating data, to serve as the basis for relacorilant's NDA in Cushing's syndrome. We expect to submit this relacorilant NDA in the second quarter of 2023. The Phase 3 GRADIENT trial will produce valuable data about an etiology of Cushing's syndrome that affects many patients, but has not been subject to rigorous, controlled study."

    Conference Call

    We will hold a conference call on July 29, 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 from the United States or 1-661-407-1581 internationally approximately 15 minutes before the start of the call. The passcode will be 1482035. 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 and can be lethal if not treated effectively. Corcept holds patents covering the composition of relacorilant and the use of cortisol modulators, including Korlym, in the treatment of patients with hypercortisolism.

    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, 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 the clinical attributes of relacorilant and its effects in patients with ovarian cancer, plans to initiate a phase 3 trial in women with platinum-resistant ovarian cancer and continued evaluation of relacorilant as a possible treatment for patients with other glucocorticoid receptor-expressing tumors; the clinical attributes of miricorilant and its effects in patients with NASH and plans to initiate a Phase 1b trial in NASH; 2021 revenue guidance; our expectations regarding growth of our business; our clinical development programs; the progress, enrollment, timing, design and results of our clinical trials, including the timing of enrollment, data and dosing selection; the timing of regulatory submissions; the course of the COVID-19 pandemic and its impact on patients, physicians, medical practice, clinical research activities and our business; 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.



    CORCEPT THERAPEUTICS INCORPORATED

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (In thousands, except per share data)

     June 30, December 31,
     2021 2020
     (Unaudited) (See Note 1)
    Assets   
    Cash and investments$471,639  $476,892 
    Trade receivables, net of allowances27,620  26,198 
    Inventory19,403  21,157 
    Operating lease right-of-use asset1,524  2,509 
    Deferred tax assets, net33,741  31,603 
    Other assets14,553  13,372 
    Total assets$568,480  $571,731 
    Liabilities and Stockholders' Equity   
    Accounts payable$9,216  $10,554 
    Operating lease liabilities1,559  2,551 
    Other liabilities35,030  35,288 
    Stockholders' equity522,675  523,338 
    Total liabilities and stockholders' equity$568,480  $571,731 
        
    (1) Derived from audited financial statements at that date   



    CORCEPT THERAPEUTICS INCORPORATED

    CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

    (Unaudited)

    (In thousands, except per share data)

     Three Months Ended Six Months Ended
     June 30, June 30,
     2021 2020 2021 2020
    Revenues       
    Product revenue, net$91,588  $88,565  $171,025  $181,812 
            
    Operating expenses       
    Cost of sales1,384  1,234  2,652  3,112 
    Research and development28,232  26,497  57,254  52,620 
    Selling, general and administrative30,029  25,572  59,538  53,107 
    Total operating expenses$59,645  $53,303  $119,444  $108,839 
    Income from operations31,943  35,262  51,581  72,973 
    Interest and other income110  1,010  385  2,481 
    Income before income taxes32,053  36,272  51,966  75,454 
    Income tax expense(5,530) (7,945) (1,978) (17,062)
    Net income$26,523  $28,327  $49,988  $58,392 
    Other comprehensive income:       
    Net unrealized (loss) gain on available-for-sale investments, net of tax impact of $16, $(170), 77 and (190), respectively(50) 545  (242) 606 
    Foreign currency translation gain (loss), net of tax16  (15) 42  (27)
    Total comprehensive income$26,489  $28,857  $49,788  $58,971 
            
    Basic net income per share$0.23  $0.25  $0.43  $0.51 
            
    Diluted net income per share$0.21  $0.23  $0.39  $0.48 
            
    Shares used in computing basic net income per common share116,294  115,006  116,555  114,790 
    Shares used in computing diluted net income per common share126,680  123,234  128,204  122,756 



    CORCEPT THERAPEUTICS INCORPORATED

    RECONCILIATION OF GAAP TO NON-GAAP NET INCOME

    (Unaudited)

    (In thousands, except per share data)

     Three Months Ended Six Months Ended
     June 30, June 30,
     2021 2020 2021 2020
    GAAP net income$26,523  $28,327  $49,988  $58,392 
            
    Non-cash expenses (benefits)       
    Stock-based compensation       
    Cost of sales16  15  26  38 
    Research and development3,825  2,794  7,330  5,399 
    Selling, general and administrative7,227  5,680  13,813  10,970 
    Total stock-based compensation11,068  8,489  21,169  16,407 
    Deferred income taxes3,299  4,922  (2,061) 10,017 
    Income tax effect of non-GAAP adjustments (1)(2,656) (2,037) (5,081) (3,938)
    Non-GAAP net income, adjusted for non-cash expenses$38,234  $39,701  $64,015  $80,878 
            
    GAAP basic net income per share$0.23  $0.25  $0.43  $0.51 
            
    GAAP diluted net income per share$0.21  $0.23  $0.39  $0.48 
            
    Non-GAAP basic net income per share, adjusted for non-cash expenses per share$0.33  $0.35  $0.55  $0.70 
            
    Non-GAAP diluted net income per share, adjusted for non-cash expenses per share$0.30  $0.32  $0.50  $0.66 
            
    Shares used in computing basic net income per common share116,294  115,006  116,555  114,790 
    Shares used in computing diluted net income per common share126,680  123,234  128,204  122,756 
            
    (1) Calculated by applying the statutory tax rate to the pre-tax, non-discrete, non-GAAP adjustments.



    CONTACT:


    Corcept Therapeutics

    Investor Relations



    www.corcept.com



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  2. MENLO PARK, Calif., July 22, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT) today announced it will report second quarter financial results and provide a corporate update on July 29, 2021. 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, click the link below and enter your information. The link will become active 15 minutes prior to the scheduled start time.

    Click to Join Meeting

    Alternatively, you may dial 1-833-693-0540 from the United States or 1-661-407-1581 internationally approximately 15 minutes before the start of the call. The passcode will be 1482035.

    A replay will be available through August 12, 2021…

    MENLO PARK, Calif., July 22, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT) today announced it will report second quarter financial results and provide a corporate update on July 29, 2021. 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, click the link below and enter your information. The link will become active 15 minutes prior to the scheduled start time.

    Click to Join Meeting

    Alternatively, you may dial 1-833-693-0540 from the United States or 1-661-407-1581 internationally approximately 15 minutes before the start of the call. The passcode will be 1482035.

    A replay will be available through August 12, 2021 at 1-855-859-2056 from the United States and 1-404-537-3406 internationally. The passcode will be 1482035.

    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:

    Corcept Therapeutics

    Investor Relations



    www.corcept.com



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  3. MENLO PARK, Calif., July 12, 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 Amy Flood has joined the company as Chief Human Resources and Communications Officer.

    "I'm very pleased to welcome Amy to our executive team," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer. "She played a key role in building the talented teams that enabled Gilead Sciences' great success. Her proven communications skills and her ability to attract, engage and retain talented employees will help us meet the challenges…

    MENLO PARK, Calif., July 12, 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 Amy Flood has joined the company as Chief Human Resources and Communications Officer.

    "I'm very pleased to welcome Amy to our executive team," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer. "She played a key role in building the talented teams that enabled Gilead Sciences' great success. Her proven communications skills and her ability to attract, engage and retain talented employees will help us meet the challenges Corcept faces as we expand our commercial business and develop our growing portfolio of selective cortisol modulators."

    Ms. Flood has nearly 25 years of experience in team development and communications in the biotech industry. She previously spent 21 years at Gilead Sciences, most recently as Senior Vice President, Public Affairs, where she led a global team responsible for corporate brand, employee communications, product public relations, advocacy and philanthropy. While at Gilead she also led company-wide efforts to expand professional development opportunities for women, a targeted team mentoring and development initiative, and multiple programs focused on diversity, equity and inclusion. Prior to joining Gilead, Amy worked in healthcare public relations in New York, before relocating to San Francisco in 1998 to help establish her firm's west coast operations. 

    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:

    Investor Relations



    www.corcept.com



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    • Enrollment stopped in RELIANT trial
    • Antitumor activity observed in heavily pretreated patients with metastatic pancreatic cancer, including those previously treated with nab-paclitaxel; addition of relacorilant to nab-paclitaxel therapy was well-tolerated
    • Phase 3 pivotal trial in patients with platinum-resistant ovarian cancer upcoming
    • Treatment of patients with earlier line pancreatic cancer as well as patients with other solid tumors will be evaluated

    MENLO PARK, Calif., June 22, 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 stopped in RELIANT trial
    • Antitumor activity observed in heavily pretreated patients with metastatic pancreatic cancer, including those previously treated with nab-paclitaxel; addition of relacorilant to nab-paclitaxel therapy was well-tolerated
    • Phase 3 pivotal trial in patients with platinum-resistant ovarian cancer upcoming
    • Treatment of patients with earlier line pancreatic cancer as well as patients with other solid tumors will be evaluated

    MENLO PARK, Calif., June 22, 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 preliminary results from its Phase 3 RELIANT trial of relacorilant combined with nab-paclitaxel in patients with metastatic pancreatic cancer.

    "RELIANT evaluated relacorilant plus nab-paclitaxel in pancreatic cancer patients who had relapsed following at least two prior lines of therapy, including treatment with nab-paclitaxel in almost all cases," said Andreas Grauer, MD, Corcept's Chief Medical Officer. "Two of 31 evaluable patients exhibited tumor shrinkage designated as a partial response, a response rate of six percent, while 15 patients achieved stable disease for at least 12 weeks. The combination was well-tolerated. These data are similar to those of our Phase 1 study.

    "Metastatic pancreatic cancer is a dire disease and patients who have relapsed following multiple lines of therapy have no effective treatment options. While our interim analysis suggests that the combination of relacorilant and nab-paclitaxel is active in these patients, the apparent level of benefit does not justify its further study as a treatment for end-stage pancreatic cancer."

    "All of the cancers we are studying are aggressively lethal and we will not pursue an approval unless we believe our candidate therapy offers a substantial benefit," added Joseph K. Belanoff, MD, Corcept's Chief Executive Officer. "Our development program in solid tumors continues to advance. Based on the positive results of our controlled Phase 2 trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer, we are very excited to initiate a pivotal trial for that indication in the first quarter of 2022. Our trials of relacorilant plus pembrolizumab in patients with adrenal cancer and of exicorilant plus enzalutamide in patients with castration-resistant prostate cancer continue to enroll. Based on the promising clinical trial results we have observed across our oncology programs, we are evaluating relacorilant as a potential treatment for patients with earlier stages of pancreatic cancer and with other glucocorticoid receptor-expressing tumors."

    Trial Design and Preliminary Results

    RELIANT is a single-arm, multicenter, open-label, Phase 3 trial of relacorilant combined with nab-paclitaxel in patients with metastatic pancreatic cancer, with a planned enrollment of 80 patients and a planned interim analysis of outcomes in the first 40 patients.   Patients received 100 mg of relacorilant every day and 80 mg/m2 nab-paclitaxel on Days 1, 8 and 15 of each 28-day cycle. RELIANT's primary endpoint is objective response rate.

    At the planned interim analysis, the study had enrolled 43 patients with metastatic pancreatic cancer who had received 2-4 prior lines of therapy (median prior lines of therapy: three), including 40 patients who were previously treated with nab-paclitaxel.   As of the database cutoff date of April 15, 2021, there were 31 efficacy-evaluable patients. Two of these patients (six percent) had a partial response (best response based on RECIST v1.1); and 15 patients (48 percent) had stable disease, with two patients (six percent) with stable disease greater than 18 weeks.   Safety was consistent with known profiles for relacorilant and nab-paclitaxel.   

    About Relacorilant

    Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor that does not bind to other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders, including ovarian, pancreatic and castration-resistant prostate cancer, as well as Cushing's syndrome. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents. It 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 such statements express or imply. These risks and uncertainties concern, but are not limited to, the design and results of our clinical trials; our ability to achieve our goals during the COVID-19 pandemic; the development of relacorilant as a treatment for pancreatic cancer, 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 potential benefits in patients with pancreatic cancer patients and metastatic ovarian cancer, as well as the progress, timing and results of our trials of relacorilant in ovarian cancer, adrenal cancer and of exicorilant in castration-resistant prostate 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.

    CONTACT:

    Corcept Therapeutics

    Investor Relations



    www.corcept.com



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  4. MENLO PARK, Calif., June 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 that it has entered into an agreement with Sun Pharmaceutical Industries Limited and related entities ("Sun") resolving patent litigation related to Korlym®, Corcept's medication for the treatment of patients with Cushing's syndrome. The litigation has been pending in the United States District Court for the District of New Jersey since 2019, shortly after Sun notified Corcept that it had submitted an Abbreviated New Drug Application (ANDA) to the United…

    MENLO PARK, Calif., June 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 that it has entered into an agreement with Sun Pharmaceutical Industries Limited and related entities ("Sun") resolving patent litigation related to Korlym®, Corcept's medication for the treatment of patients with Cushing's syndrome. The litigation has been pending in the United States District Court for the District of New Jersey since 2019, shortly after Sun notified Corcept that it had submitted an Abbreviated New Drug Application (ANDA) to the United States Food and Drug Administration (FDA) seeking approval to market a generic version of Korlym.

    In connection with the settlement, Corcept has granted Sun the right to sell a generic version of Korlym in the United States beginning October 1, 2034 or earlier under circumstances customary for settlement agreements of this type.

    "It is gratifying to put this lawsuit behind us," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer. "Litigation is a costly, time-consuming diversion from our efforts to grow our Korlym business and continue the development of our increasingly mature pipeline of selective cortisol modulators – including relacorilant, our planned successor to Korlym for the treatment of patients with Cushing's syndrome."

    The settlement agreement is subject to entry by the Court of a stipulation and order of dismissal related to the litigation. As required by law, Corcept and Sun will submit the agreement to the United States Federal Trade Commission (FTC) and the United States Department of Justice (DOJ) for review. Similar patent litigation brought by Corcept against two other companies that have filed ANDAs seeking approval to market generic Korlym remains pending.

    About Korlym®

    Korlym modulates the effect of cortisol at the glucocorticoid receptor, one of the two receptors to which cortisol binds, thereby inhibiting the effects of excess cortisol in patients with Cushing's syndrome. Since 2012, Corcept has made Korlym available as a once-daily oral treatment of hyperglycemia secondary to endogenous Cushing's syndrome in adult patients with glucose intolerance or diabetes mellitus type 2 who have failed surgery or are not candidates for surgery. Korlym was the first FDA-approved treatment for that illness.

    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 such statements express or imply. These risks and uncertainties concern, but are not limited to, our patents being determined to be invalid or unenforceable or a third party marketing a generic version of Korlym before the conclusion of applicable patent litigation, and the Court, the FTC or the DOJ requiring changes to the settlement agreement. 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 statements regarding review of the settlement agreement by the Court, the FTC and the DOJ as well as our ability to grow our Korlym business and advance the development of our selective cortisol modulators, including relacorilant as a potential successor to Korlym. We disclaim any intention or duty to update forward-looking statements made in this press release.

    CONTACT:

    Corcept Therapeutics

    Investor Relations



    www.corcept.com



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