EXEL Exelixis Inc.

21.32
-0.9  -4%
Previous Close 22.22
Open 22.41
52 Week Low 13.67
52 Week High 27.8
Market Cap $6,614,401,249
Shares 310,243,961
Float 274,499,377
Enterprise Value $5,753,365,813
Volume 2,778,873
Av. Daily Volume 2,520,380
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Upcoming Catalysts

Drug Stage Catalyst Date
CABOMETYX (cabozantinib) with Opdivo and Yervoy - CheckMate 9ER
First-line renal cell carcinoma
PDUFA priority review
PDUFA priority review
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Cabozantinib
Medullary Thyroid Cancer
Phase 3
Phase 3
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CABOMETYX (cabozantinib) + atezolizumab (TECENTRIQ) - (COSMIC-312)
Hepatocellular Carcinoma
Phase 3
Phase 3
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Cabozantinib and Nivolumab and Ipilimumab (COSMIC-313)
Renal Cell Carcinoma
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Cabozantinib - COSMIC-311
Thyroid Carcinoma
Phase 3
Phase 3
Phase 3 trial met co-primary endpoint of improvement in progression-free survival.
XL092
Solid Tumors
Phase 1
Phase 1
Phase 1 trial initiation announced October 26, 2020.
Cabozantinib and Atezolizumab (CONTACT-03)
Renal Cell Carcinoma
Phase 3
Phase 3
Phase 3 trial is enrolling.
IMspire150 - cobimetinib, atezolizumab and vemurafenib
BRAF V600 mutation-positive metastatic or unresectable locally advanced melanoma
Approved
Approved
FDA approval announced July 30, 2020.
Cabozantinib and Atezolizumab - CONTACT-02
Castration-Resistant Prostate Cancer
Phase 3
Phase 3
Phase 3 initiation announced June 30, 2020.
Cabozantinib + atezolizumab (TECENTRIQ) CONTACT-01
Solid tumors
Phase 3
Phase 3
Phase 3 trial initiation announced June 11, 2020.
Cabozantinib
Medullary thyroid cancer
Approved
Approved
Approved November 29, 2012.
Cabozantinib (CELESTIAL)
Advanced hepatocellular cancer (HCC)
Approved
Approved
FDA Approval announced January 14, 2019.
IMspire170 - cobimetinib and atezolizumab
First-line BRAF wild-type metastatic or unresectable locally advanced melanoma
Phase 3
Phase 3
Phase 3 data did not meet primary endpoint - June 20, 2019.
IMblaze370 - cobimetinib and atezolizumab
Third-line advanced or metastatic colorectal cancer
Phase 3
Phase 3
Phase 3 data released May 10, 2018. Primary endpoint not met.
Cabozantinib
Cancer - Castration-Resistant Prostate Cancer
Phase 3
Phase 3
Phase 3 COMET-2 trial did not meet endpoint December 1 2014
CABOMETYX (cabozantinib)
Metastatic renal cell cancer (RCC)
Approved
Approved
Approved April 25 2016.
Vemurafenib
BRAF V600 Mutation-Positive Advanced Melanoma - Cancer
Approved
Approved
Approved November 10, 2015.
Cabozantinib - CABOSUN
First-Line RCC - cancer
Approved
Approved
Late breaker at ESMO September 10, 2017 showed PFS 8.6 months versus 5.3 months for sunitinib. HR 0.48. PDUFA date under priority review for sNDA February 15, 2018. Approval announced December 19, 2017.

Latest News

  1. Cabozantinib Franchise Preliminary Net Product Revenue of $200 million for the Fourth Quarter 2020, and $741 million for the Full Year 2020 –

    Full Year 2021 Net Product Revenue Guidance of $950 million to $1,050 million –

    – Corporate priorities for 2021 include potentially filing supplemental New Drug Applications for cabozantinib in three additional indications –

    – Presentation and webcast at 2021 J.P. Morgan Healthcare Conference on Monday, January 11th at 5:20 PM EST / 2:20 PM PST –

    Exelixis, Inc. (NASDAQ:EXEL) today announced its preliminary unaudited financial results for the fourth quarter and full year 2020, provided financial guidance for full year 2021, and delivered an update on its business. This 2021 financial guidance takes…

    Cabozantinib Franchise Preliminary Net Product Revenue of $200 million for the Fourth Quarter 2020, and $741 million for the Full Year 2020 –

    Full Year 2021 Net Product Revenue Guidance of $950 million to $1,050 million –

    – Corporate priorities for 2021 include potentially filing supplemental New Drug Applications for cabozantinib in three additional indications –

    – Presentation and webcast at 2021 J.P. Morgan Healthcare Conference on Monday, January 11th at 5:20 PM EST / 2:20 PM PST –

    Exelixis, Inc. (NASDAQ:EXEL) today announced its preliminary unaudited financial results for the fourth quarter and full year 2020, provided financial guidance for full year 2021, and delivered an update on its business. This 2021 financial guidance takes into consideration the anticipated U.S. Food and Drug Administration (FDA) approval and commercial launch of CABOMETYX® (cabozantinib) in combination with OPDIVO® (nivolumab) as a first-line treatment for patients with advanced renal cell carcinoma (RCC), which has a Prescription Drug Use Fee Act (PDUFA) target action date of February 20, 2021.

    Preliminary Fourth Quarter and Full Year 2020 Financial Results & 2021 Financial Guidance

    Exelixis is providing the following preliminary unaudited 2020 financial results and financial guidance for 2021:

     

    Fourth Quarter 2020

    Full Year 2020

    Full Year 2021 Guidance

    Total revenues

    $270 million

    $988 million

    $1,150 million - $1,250 million

    Net product revenues

    $200 million

    $741 million

    $950 million - $1,050 million

    Cost of goods sold

    4.5%

    4.9%

    ~ 5-6% of net product revenues

    Research and development expenses

    $155 million(1)

    $549 million(2)

    $600 million - $650 million(3)

    Selling, general and administrative expenses

    $83 million(4)

    $295 million(5)

    $375 million - $425 million(6)

    Effective tax rate

    n/a(7)

    n/a(7)

    20% - 22%

    Cash and investments at year-end(8)

    ~ $1.5 billion

    $1.6 billion - $1.7 billion

    (1)

    Includes $7.1 million of non-cash stock-based compensation expense.

    (2)

    Includes $37.2 million of non-cash stock-based compensation expense.

    (3)

    Includes $45.0 million of non-cash stock-based compensation expense.

    (4)

    Includes $12.2 million of non-cash stock-based compensation expense.

    (5)

    Includes $67.9 million of non-cash stock-based compensation expense.

    (6)

    Includes $60.0 million of non-cash stock-based compensation expense.

    (7)

    Preliminary results not yet available.

    (8)

    This cash and investments guidance does not include any potential new business development activity.

    The preliminary 2020 financial information presented in this press release has not been audited and is subject to change. The complete Exelixis Fourth Quarter and Full Year 2020 Financial Results are planned for release after market on Wednesday, February 10, 2021.

    "2020 was a year of focused execution for Exelixis as we strengthened our foundation to potentially accelerate top-line revenue growth in 2021 and beyond. Throughout the year, the team advanced all of the components of our business and navigated the challenging COVID-19 pandemic environment to report data from late-stage trials, start new pivotal studies, ready next-generation Exelixis compounds for the clinic, and bring new assets and technologies into our pipeline," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. "We start 2021 with significant momentum as we prepare for the anticipated FDA approval of CABOMETYX in combination with OPDIVO based on the CheckMate -9ER trial. With the preliminary 2020 financial results announced today along with our 2021 guidance, we believe we are well positioned to deliver significant revenue growth throughout the new year and beyond as we capitalize on CABOMETYX's future potential indications."

    Dr. Morrissey continued: "In 2021 and beyond, we intend to pursue additional cabozantinib regulatory approvals and clinical development activities that unlock new treatment regimens, benefit a substantially greater number of patients and create the potential for a multi-billion-dollar franchise. CABOMETYX revenue directly supports our emerging pipeline of compounds with the potential to generate significant clinical and commercial value, including XL092, our improved next-generation oral, multi-targeted tyrosine kinase inhibitor that builds on our experience with cabozantinib. We expect to advance XL092 into pivotal trials in 2021 and believe it may ultimately become a source of long-term revenue for Exelixis. Additional programs are advancing alongside XL092, including XL102, our small molecule CDK7 inhibitor; XB002, our first antibody-drug conjugate; and multiple other programs. Overall, between our commercial, clinical, and pipeline activities, we are well on our way to becoming a multi-product oncology company that delivers on our mission to help cancer patients recover stronger and live longer."

    Ahead of the company's presentation at the J.P. Morgan Healthcare Conference tomorrow, Exelixis is also announcing its corporate priorities and anticipated key milestones for 2021, including potential supplemental New Drug Applications (sNDAs) for CABOMETYX, expanded clinical development activities for XL092, and multiple Investigational New Drug applications (INDs) for preclinical assets.

    CABOMETYX and OPDIVO Combination for First-line Advanced RCC Represents Large and Growing Commercial Opportunity

    • In August 2020, Exelixis announced the submission of an sNDA to the FDA for CABOMETYX in combination with Bristol Myers Squibb's (BMS) OPDIVO for patients with advanced RCC. In October 2020, Exelixis and BMS announced that the FDA had accepted each company's regulatory application, granted Priority Review, and assigned a PDUFA goal date, or target action date, of February 20, 2021. Exelixis is ready to commercially launch this combination regimen in the United States, where an estimated 15,000 patients with advanced RCC are eligible for first-line treatment every year and with immune checkpoint inhibitor (ICI) combination therapy consisting of approximately 80% of that market. Based on the efficacy, safety and longer duration of therapy as observed in the CheckMate -9ER trial, Exelixis estimates that a doubling of CABOMETYX revenues in RCC alone may be achievable, with a potential $1.5 billion annualized run rate exiting 2022.

    Potential sNDA Submissions for Cabozantinib in 2021

    • Relapsed radioiodine-refractory differentiated thyroid cancer (DTC): Exelixis expects to file an sNDA for the approval of cabozantinib monotherapy in patients with radioactive iodine-refractory DTC previously treated with a vascular endothelial growth factor receptor-targeted therapy. The sNDA will be based on the positive results from the phase 3 pivotal COSMIC-311 trial, which met its co-primary endpoint of progression-free survival (PFS) in December 2020.
    • Advanced hepatocellular carcinoma (HCC): Exelixis expects to report top-line data from COSMIC-312, a global phase 3 pivotal trial evaluating cabozantinib in combination with atezolizumab (TECENTRIQ®), F. Hoffmann-La Roche Ltd.'s (Roche) anti-PD-L1 ICI, versus sorafenib in previously untreated advanced HCC, for the co-primary endpoints of PFS and overall survival (OS) in the first half of 2021. If the data are supportive, the company anticipates filing an sNDA in 2021, and its partner Ipsen Pharma SAS would also seek to file marketing applications with regulatory agencies in its respective territories based on the results. Exelixis completed enrollment in August 2020 for this global phase 3 pivotal trial. Separately, patient enrollment remains open in China in order to enroll a sufficient number of patients to potentially enable local registration.
    • Metastatic castration-resistant prostate cancer (CRPC): Should the data continue to be supportive, Exelixis anticipates filing an sNDA in 2021 seeking accelerated approval of cabozantinib in combination with atezolizumab, for the treatment of metastatic CRPC. A confirmatory phase 3 pivotal trial of this regimen in this patient population (CONTACT-02) was initiated in June 2020 under the clinical trial collaboration between Exelixis and Roche.

    Additional Cabozantinib Clinical Updates

    • COSMIC-313: Exelixis expanded the enrollment target to 840 patients to provide additional power to assess the secondary endpoint of OS for COSMIC-313, the phase 3 pivotal trial evaluating the triplet combination of cabozantinib, nivolumab and ipilimumab (YERVOY®) versus the combination of nivolumab and ipilimumab in patients with previously untreated advanced intermediate- or poor-risk RCC and expects to complete the expanded enrollment in early 2021. Top-line results of the event-driven analyses from the study are expected in 2022. If the data are supportive, the company would seek to file an sNDA with the FDA.
    • CONTACT trials: In 2020, as part of a clinical trial collaboration between Exelixis and Roche, three phase 3 global pivotal trials were initiated evaluating the combination of cabozantinib and atezolizumab: CONTACT-01 in patients with metastatic non-small cell lung cancer who have been previously treated with an ICI and platinum-containing chemotherapy; CONTACT-02 in patients with metastatic CRPC who have been previously treated with one novel hormonal therapy; and CONTACT-03, in patients with inoperable, locally advanced or metastatic RCC who progressed during or following treatment with an ICI.

    Anticipated Progress for XL092 and Other Compounds Beginning Clinical Development in 2021

    • XL092: Exelixis is currently enrolling patients into the dose escalation cohorts of the phase 1b clinical trial of XL092 in combination with atezolizumab, and expects to initiate enrollment in the clear cell and non-clear cell RCC, hormone-receptor positive breast cancer and metastatic CRPC expansion cohorts shortly. The company also plans to initiate additional expansion cohorts in other tumor types, as well as potential additional studies, evaluating XL092 in combination with other oncology therapies, including ICIs. As data from these cohorts mature and are supportive, XL092 could enter pivotal trials over the course of 2021.
    • XL102: Following the FDA's acceptance of its IND, Exelixis expects to initiate a phase 1 trial of XL102 (formerly known as AUR102), alone or in combination therapy for the treatment of inoperable, locally advanced or metastatic solid tumors. Exelixis in-licensed XL102 from Aurigene Discovery Technologies Limited in December 2020.
    • XB002: Exelixis anticipates beginning a phase 1 trial of XB002 (formerly known as ICON-2), in patients with inoperable, locally advanced or metastatic solid tumors. Exelixis in-licensed XB002 from Iconic Therapeutics, Inc. in December 2020 and plans to file an IND once the drug product release assays are finalized.
    • Additional INDs planned: Subject to preclinical data, Exelixis has the potential to file up to two additional INDs.

    Presentation and Webcast

    Exelixis President and Chief Executive Officer Michael M. Morrissey, Ph.D., will provide a corporate overview and discuss the company's preliminary fourth quarter and full year 2020 financial results, 2021 financial guidance, and key priorities and milestones for 2021 during the company's presentation at the J.P. Morgan Healthcare Conference beginning at 5:20 p.m. EST / 2:20 p.m. PST on Monday, January 11, 2021.

    To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company's website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcast. A replay will also be available at the same location for 90 days.

    About Exelixis

    Founded in 1994, Exelixis, Inc. (NASDAQ:EXEL) is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Following early work in model system genetics, we established a broad drug discovery and development platform that has served as the foundation for our continued efforts to bring new cancer therapies to patients in need. Our discovery efforts have resulted in four commercially available products, CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib), COTELLIC® (cobimetinib) and MINNEBRO® (esaxerenone), and we have entered into partnerships with leading pharmaceutical companies to bring these important medicines to patients worldwide. Supported by revenues from our marketed products and collaborations, we are committed to prudently reinvesting in our business to maximize the potential of our pipeline. We are supplementing our existing therapeutic assets with targeted business development activities and internal drug discovery – all to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer. Exelixis is a member of the Standard & Poor's (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies. In November 2020, the company was named to Fortune's 100 Fastest-Growing Companies list for the first time, ranking 17th overall and the third-highest biopharmaceutical company. For more information about Exelixis, please visit www.exelixis.com, follow @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.

    Forward-Looking Statements and Preliminary Financial Results

    This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis' anticipation of the FDA's approval and commercial launch of CABOMETYX for patients with advanced RCC as a first-line treatment in combination with Opdivo; Exelixis' 2021 financial guidance; the therapeutic and commercial potential of CABOMETYX and Exelixis' belief that it is well-positioned to deliver significant revenue growth throughout 2021 and beyond; Exelixis' intention to pursue additional regulatory approvals and clinical development activities that create the potential for a multi-billion dollar franchise; Exelixis' clinical development plans for XL092 and belief that it may ultimately become a source of long-term revenue; Exelixis' belief that it is well on its way to becoming a multi-product oncology company; Exelixis' corporate priorities and anticipated key milestones for 2021, including the potential filing of sNDAs for CABOMETYX in three additional indications, expanded clinical development activities for XL092, and multiple INDs for preclinical assets; Exelixis' estimate for CABOMETYX revenues in RCC exiting 2022; Exelixis' expectations for, and the related anticipated timelines for, completing enrollment in, conducting analyses of and obtaining top-line results from its ongoing potential label-enabling clinical studies evaluating cabozantinib, and if supported by the data, pursuing potential regulatory approvals; Exelixis' clinical development plans for XL102 and XB002; Exelixis' plans to reinvest in its business to maximize the potential of the company's pipeline, including through targeted business development activities and internal drug discovery; and other statements that are not historical facts. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis' current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: the continuing COVID-19 pandemic and its impact on Exelixis' clinical trial, drug discovery and commercial activities; the degree of market acceptance of CABOMETYX and other Exelixis products in the indications for which they are approved and in the territories where they are approved, and Exelixis' and its partners' ability to obtain or maintain coverage and reimbursement for these products; the effectiveness of CABOMETYX and other Exelixis products in comparison to competing products; the level of costs associated with Exelixis' commercialization, research and development, in-licensing or acquisition of product candidates, and other activities; Exelixis' ability to maintain and scale adequate sales, marketing, market access and product distribution capabilities for its products or to enter into and maintain agreements with third parties to do so; the availability of data at the referenced times; the potential failure of cabozantinib and other Exelixis product candidates, both alone and in combination with other therapies, to demonstrate safety and/or efficacy in clinical testing; uncertainties inherent in the drug discovery and product development process, including evolving regulatory requirements, slower than anticipated patient enrollment or inability to identify a sufficient number of clinical trial sites; Exelixis' dependence on its relationships with its collaboration partners, including their pursuit of regulatory approvals for partnered compounds in new indications, their adherence to their obligations under relevant collaboration agreements and the level of their investment in the resources necessary to complete clinical trials or successfully commercialize partnered compounds in the territories where they are approved; complexities and the unpredictability of the regulatory review and approval processes in the U.S. and elsewhere, including the risk that regulatory authorities may not approve Exelixis' products as treatments for the indications in which approval has been sought, if at all, as well as the related risk that regulatory authorities may not approve the labeling claims that are necessary or desirable for the successful commercialization of CABOMETYX in any additional indications or of any newly-approved product; Exelixis' continuing compliance with applicable legal and regulatory requirements; unexpected concerns that may arise as a result of the occurrence of adverse safety events or additional data analyses of clinical trials evaluating cabozantinib and other Exelixis products; Exelixis' dependence on third-party vendors for the development, manufacture and supply of its products and product candidates; Exelixis' ability to protect its intellectual property rights; market competition, including the potential for competitors to obtain approval for generic versions of Exelixis' marketed products; changes in economic and business conditions; and other factors discussed under the caption "Risk Factors" in Exelixis' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 5, 2020, and in Exelixis' future filings with the SEC, including, without limitation, Exelixis' Annual Report on Form 10-K expected to be filed with the SEC on February 10, 2021. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law.

    In addition, this press release includes Exelixis' preliminary financial results for the quarter and fiscal year ended January 1, 2021. Exelixis is currently in the process of finalizing its full financial results for the quarter and fiscal year ended January 1, 2021, and the preliminary financial results presented in this press release are based only upon preliminary information available to Exelixis as of January 10, 2021. Exelixis' preliminary financial results should not be viewed as a substitute for full audited financial statements prepared in accordance with U.S. GAAP, and undue reliance should not be placed on Exelixis' preliminary financial results. Exelixis' independent registered public accounting firm has not audited or reviewed the preliminary financial results included in this press release or expressed any opinion or other form of assurance on such preliminary financial results. In addition, items or events may be identified or occur after the date of this press release due to the completion of operational and financial closing procedures, final audit adjustments and other developments may arise that would require Exelixis to make material adjustments to the preliminary financial results included in this press release. Therefore, the preliminary financial results included in this press release may differ, perhaps materially, from the financial results that will be reflected in Exelixis' audited consolidated financial statements for the fiscal year ended January 1, 2021.

    Exelixis, the Exelixis logo, CABOMETYX, COMETRIQ and COTELLIC are registered U.S. trademarks.

    MINNEBRO is a Japanese trademark.

    OPDIVO® and YERVOY® are registered trademarks of Bristol-Myers Squibb Company.

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  2. Presentation to be webcast on www.exelixis.com

    Exelixis, Inc. (NASDAQ:EXEL) today announced that Michael M. Morrissey, Ph.D., the company's President and Chief Executive Officer, will provide a corporate overview at the virtual 39th Annual J.P. Morgan Healthcare Conference on Monday, January 11, 2021 at 5:20 p.m. EST / 2:20 p.m. PST.

    To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company's website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcast. A replay will also be available at the same location for 14 days.

    About Exelixis

    Presentation to be webcast on www.exelixis.com

    Exelixis, Inc. (NASDAQ:EXEL) today announced that Michael M. Morrissey, Ph.D., the company's President and Chief Executive Officer, will provide a corporate overview at the virtual 39th Annual J.P. Morgan Healthcare Conference on Monday, January 11, 2021 at 5:20 p.m. EST / 2:20 p.m. PST.

    To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company's website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcast. A replay will also be available at the same location for 14 days.

    About Exelixis

    Founded in 1994, Exelixis, Inc. (NASDAQ:EXEL) is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Following early work in model system genetics, we established a broad drug discovery and development platform that has served as the foundation for our continued efforts to bring new cancer therapies to patients in need. Our discovery efforts have resulted in four commercially available products, CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib), COTELLIC® (cobimetinib) and MINNEBRO® (esaxerenone), and we have entered into partnerships with leading pharmaceutical companies to bring these important medicines to patients worldwide. Supported by revenues from our marketed products and collaborations, we are committed to prudently reinvesting in our business to maximize the potential of our pipeline. We are supplementing our existing therapeutic assets with targeted business development activities and internal drug discovery - all to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer. Exelixis is a member of the Standard & Poor's (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies. In November 2020, the company was named to Fortune's 100 Fastest-Growing Companies list for the first time, ranking 17th overall and the third-highest biopharmaceutical company. For more information about Exelixis, please visit www.exelixis.com, follow @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.

    Exelixis, the Exelixis logo, CABOMETYX, COMETRIQ and COTELLIC are registered U.S. trademarks. MINNEBRO is a registered Japanese trademark.

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  3. Cabozantinib reduced the risk of disease progression or death by 78%;

    Exelixis will discuss the trial results and regulatory filing plans with the U.S. Food and Drug Administration (FDA) –

    Exelixis, Inc. (NASDAQ:EXEL) today announced that COSMIC-311, the phase 3 pivotal trial evaluating cabozantinib (CABOMETYX®) versus placebo in patients with radioiodine-refractory differentiated thyroid cancer who have progressed after up to two prior vascular endothelial growth factor receptor (VEGFR)-targeted therapies, met the co-primary endpoint of demonstrating significant improvement in progression-free survival. Cabozantinib reduced the risk of disease progression or death by 78% with a hazard…

    Cabozantinib reduced the risk of disease progression or death by 78%; hazard ratio = 0.22, (p<0.0001) compared to placebo –

    Exelixis will discuss the trial results and regulatory filing plans with the U.S. Food and Drug Administration (FDA) –

    Exelixis, Inc. (NASDAQ:EXEL) today announced that COSMIC-311, the phase 3 pivotal trial evaluating cabozantinib (CABOMETYX®) versus placebo in patients with radioiodine-refractory differentiated thyroid cancer who have progressed after up to two prior vascular endothelial growth factor receptor (VEGFR)-targeted therapies, met the co-primary endpoint of demonstrating significant improvement in progression-free survival. Cabozantinib reduced the risk of disease progression or death by 78% with a hazard ratio of 0.22 (96% CI 0.13 – 0.36; p<0.0001) at this planned interim analysis. The safety profile was consistent with that previously observed for cabozantinib.

    "Considering the poor prognosis and lack of progress in the treatment of differentiated thyroid cancer following anti-VEGFR therapy, a significant improvement in progression-free survival is a long-awaited clinical advance," said Marcia S. Brose, M.D., Ph.D., Full Professor of Otorhinolaryngology: Head and Neck Surgery and Director of the Center for Rare Cancers and Personalized Therapy at the Abramson Cancer Center of the University of Pennsylvania, and principal investigator of the trial. "These encouraging results from COSMIC-311 suggest cabozantinib has the potential to become an important new option for these patients. We look forward to sharing the detailed data from the trial at an upcoming medical meeting."

    Given these results, the independent data monitoring committee for the study recommended to stop enrollment and unblind sites and patients. Exelixis intends to discuss the study results, proposed changes to the study conduct, as well as plans for a regulatory filing with the U.S. FDA in the near term.

    "We are very pleased that at this early interim analysis of COSMIC-311, cabozantinib has demonstrated a clinically meaningful and statistically significant improvement in progression-free survival for patients with differentiated thyroid cancer who are in need of additional treatment options after prior therapy," said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. "We are thankful to the patients, physicians and site staff who are participating in this trial during the COVID-19 pandemic. We intend to discuss the findings with regulatory authorities and look forward to sharing the detailed final COSMIC-311 results when they become available."

    COSMIC-311 is a multicenter, randomized, double-blind, placebo-controlled phase 3 pivotal trial that aimed to enroll approximately 300 patients at 150 sites globally. Patients were randomized in a 2:1 ratio to receive either cabozantinib 60 mg or placebo once daily. Detailed results will be submitted for presentation at a future medical conference. More information about this trial is available at ClinicalTrials.gov.

    About Differentiated Thyroid Cancer

    Approximately 53,000 new cases of thyroid cancer will be diagnosed in the U.S. in 2020.1 Nearly three out of four of these cases will be in women, and the disease is more commonly diagnosed at a younger age compared to most other adult cancers.1 While cancerous thyroid tumors include differentiated, medullary and anaplastic forms, differentiated thyroid tumors make up about 90 percent of cases.1 These include papillary, follicular and Hürthle cell cancer.1 Differentiated thyroid cancer is typically treated with surgery followed by ablation of the remaining thyroid tissue with radioiodine, but approximately 5% to 15% of cases are resistant to radioiodine treatment. 2,3 For these patients, life expectancy is only three to six years from the time metastatic lesions are detected.4,5,6

    About CABOMETYX® (cabozantinib)

    In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced RCC and for the treatment of patients with HCC who have been previously treated with sorafenib. CABOMETYX tablets have also received regulatory approvals in the European Union and additional countries and regions worldwide. In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan. In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan. Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the United States.

    CABOMETYX is not indicated for radioiodine-refractory differentiated thyroid cancer.

    Important Safety Information

    Warnings and Precautions

    Hemorrhage: Severe and fatal hemorrhages occurred with CABOMETYX. The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC and HCC studies. Discontinue CABOMETYX for Grade 3 or 4 hemorrhage. Do not administer CABOMETYX to patients who have a recent history of hemorrhage, including hemoptysis, hematemesis, or melena.

    Perforations and Fistulas: Gastrointestinal (GI) perforations, including fatal cases, occurred in 1% of CABOMETYX patients. Fistulas, including fatal cases, occurred in 1% of CABOMETYX patients. Monitor patients for signs and symptoms of perforations and fistulas, including abscess and sepsis. Discontinue CABOMETYX in patients who experience a Grade 4 fistula or a GI perforation.

    Thrombotic Events: CABOMETYX increased the risk of thrombotic events. Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients. Fatal thrombotic events occurred in CABOMETYX patients. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or serious arterial or venous thromboembolic event requiring medical intervention.

    Hypertension and Hypertensive Crisis: CABOMETYX can cause hypertension, including hypertensive crisis. Hypertension occurred in 36% (17% Grade 3 and <1% Grade 4) of CABOMETYX patients. Do not initiate CABOMETYX in patients with uncontrolled hypertension. Monitor blood pressure regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled with medical management; when controlled, resume at a reduced dose. Discontinue CABOMETYX for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.

    Diarrhea: Diarrhea occurred in 63% of CABOMETYX patients. Grade 3 diarrhea occurred in 11% of CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1 and resume at a reduced dose for intolerable Grade 2 diarrhea, Grade 3 diarrhea that cannot be managed with standard antidiarrheal treatments, or Grade 4 diarrhea.

    Palmar-Plantar Erythrodysesthesia (PPE): PPE occurred in 44% of CABOMETYX patients. Grade 3 PPE occurred in 13% of CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1 and resume at a reduced dose for intolerable Grade 2 PPE or Grade 3 PPE.

    Proteinuria: Proteinuria occurred in 7% of CABOMETYX patients. Monitor urine protein regularly during CABOMETYX treatment. Discontinue CABOMETYX in patients who develop nephrotic syndrome.

    Osteonecrosis of the Jaw (ONJ): ONJ occurred in <1% of CABOMETYX patients. ONJ can manifest as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration or erosion, persistent jaw pain, or slow healing of the mouth or jaw after dental surgery. Perform an oral examination prior to CABOMETYX initiation and periodically during treatment. Advise patients regarding good oral hygiene practices. Withhold CABOMETYX for at least 3 weeks prior to scheduled dental surgery or invasive dental procedures, if possible. Withhold CABOMETYX for development of ONJ until complete resolution.

    Impaired Wound Healing: Wound complications occurred with CABOMETYX. Withhold CABOMETYX for at least 3 weeks prior to elective surgery. Do not administer CABOMETYX for at least 2 weeks after major surgery and until adequate wound healing is observed. The safety of resumption of CABOMETYX after resolution of wound healing complications has not been established.

    Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS, a syndrome of subcortical vasogenic edema diagnosed by characteristic findings on MRI, can occur with CABOMETYX. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.

    Embryo-Fetal Toxicity: CABOMETYX can cause fetal harm. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to initiating CABOMETYX and advise them to use effective contraception during treatment and for 4 months after the last dose.

    Adverse Reactions

    The most commonly reported (≥25%) adverse reactions are: diarrhea, fatigue, decreased appetite, PPE, nausea, hypertension, and vomiting.

    Drug Interactions

    Strong CYP3A4 Inhibitors: If coadministration with strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage. Avoid grapefruit or grapefruit juice.

    Strong CYP3A4 Inducers: If coadministration with strong CYP3A4 inducers cannot be avoided, increase the CABOMETYX dosage. Avoid St. John's wort.

    USE IN SPECIFIC POPULATIONS

    Lactation: Advise women not to breastfeed during CABOMETYX treatment and for 4 months after the final dose.

    Hepatic Impairment: In patients with moderate hepatic impairment, reduce the CABOMETYX dosage. CABOMETYX is not recommended for use in patients with severe hepatic impairment.

    Please see accompanying full Prescribing Information: https://cabometyx.com/downloads/CABOMETYXUSPI.pdf.

    About Exelixis

    Founded in 1994, Exelixis, Inc. (NASDAQ:EXEL) is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Following early work in model system genetics, we established a broad drug discovery and development platform that has served as the foundation for our continued efforts to bring new cancer therapies to patients in need. Our discovery efforts have resulted in four commercially available products, CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib), COTELLIC® (cobimetinib) and MINNEBRO® (esaxerenone), and we have entered into partnerships with leading pharmaceutical companies to bring these important medicines to patients worldwide. Supported by revenues from our marketed products and collaborations, we are committed to prudently reinvesting in our business to maximize the potential of our pipeline. We are supplementing our existing therapeutic assets with targeted business development activities and internal drug discovery — all to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer. Exelixis is a member of the Standard & Poor's (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies. In November 2020, the company was named to Fortune's 100 Fastest-Growing Companies list for the first time, ranking 17th overall and the third-highest biopharmaceutical company. For more information about Exelixis, please visit www.exelixis.com, follow @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.

    Forward-Looking Statements

    This press release contains forward-looking statements, including, without limitation, statements related to: the potential for cabozantinib to become an important new option for patients with differentiated thyroid cancer following anti-VEGFR therapy; Exelixis' plans to discuss the study results, proposed changes to the study conduct, as well as plans for a regulatory filing with the U.S. FDA in the near term; Exelixis' plans to present detailed final COSMIC-311 results, when they become available, at a future medical conference; and Exelixis' plans to reinvest in its business to maximize the potential of the company's pipeline, including through targeted business development activities and internal drug discovery. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements are based upon Exelixis' current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the availability of data at the referenced times; complexities and the unpredictability of the regulatory review and approval processes in the U.S. and elsewhere; Exelixis' continuing compliance with applicable legal and regulatory requirements; the potential failure of cabozantinib to demonstrate continued safety and efficacy in clinical testing; uncertainties inherent in the product development process; the continuing COVID-19 pandemic and its impact on Exelixis' research and development operations; the costs of conducting clinical trials; Exelixis' dependence on third-party vendors for the development, manufacture and supply of cabozantinib; Exelixis' ability to protect its intellectual property rights; market competition, including the potential for competitors to obtain approval for generic versions of CABOMETYX; changes in economic and business conditions; and other factors affecting Exelixis and its development programs discussed under the caption "Risk Factors" in Exelixis' quarterly report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 5, 2020, and in Exelixis' future filings with the SEC. The forward-looking statements made in this press release speak only as of the date of this press release. Exelixis expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Exelixis' expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based, except as required by law.

    Exelixis, the Exelixis logo, CABOMETYX, COMETRIQ and COTELLIC are registered U.S. trademarks. MINNEBRO is a Japanese trademark.


    1 American Cancer Society. About Thyroid Cancer. Available at: https://www.cancer.org/cancer/thyroid-cancer/about.html. Accessed December 2020.

    2 Cooper DS, et al. 2009. Revised American Thyroid Association management guidelines for patients with thyroid nodules and differentiated thyroid cancer: The American Thyroid Association (ATA) Guidelines Taskforce on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 19:1167–1214.

    3 Worden F. 2014. Treatment strategies for radioactive iodine-refractory differentiated thyroid cancer. Ther Adv Med Oncol. 6:267–279.

    4 Xing M, Haugen BR, Schlumberger M. 2013. Progress in molecular-based management of differentiated thyroid cancer. Lancet. 381:1058–1069.

    5 Pacini F, et al. 2012. Radioactive iodine-refractory differentiated thyroid cancer: unmet needs and future directions. Expert Rev Endocrinol Metab. 7:541–554.

    6 Durante C, et al. 2006. Long-term outcome of 444 patients with distant metastases from papillary and follicular thyroid carcinoma: benefits and limits of radioiodine therapy. J Clin Endocrinol Metab. 91:2892–2899.

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  4. REDWOOD CITY, Calif. and WUHAN, China, Dec. 16, 2020 (GLOBE NEWSWIRE) -- XWPharma Ltd. today announced that Michael M. Morrissey, Ph.D. has been appointed to the company's Board of Directors. Dr. Morrissey brings extensive experience as a scientist, leader of highly productive Research and Development organizations, and chief executive officer of a fully-integrated, widely respected biopharma company.

    "We are very excited to welcome Mike to our Board," said Leonard Blum, XWPharma President and CEO. "As a seasoned R&D and company leader, his perspective will be invaluable as we prioritize the multiple high potential opportunities our research unit has identified and navigate the evolving landscape of creating first of their kind therapeutics…

    REDWOOD CITY, Calif. and WUHAN, China, Dec. 16, 2020 (GLOBE NEWSWIRE) -- XWPharma Ltd. today announced that Michael M. Morrissey, Ph.D. has been appointed to the company's Board of Directors. Dr. Morrissey brings extensive experience as a scientist, leader of highly productive Research and Development organizations, and chief executive officer of a fully-integrated, widely respected biopharma company.

    "We are very excited to welcome Mike to our Board," said Leonard Blum, XWPharma President and CEO. "As a seasoned R&D and company leader, his perspective will be invaluable as we prioritize the multiple high potential opportunities our research unit has identified and navigate the evolving landscape of creating first of their kind therapeutics for patients suffering from CNS disorders with compelling unmet needs."

    "Joining XWPharma at this stage and playing a part in its future growth is very exciting for me," added Dr. Morrissey. "The company has assembled an organization with broad experience, a special energy, and a shared commitment to bring forward truly original medicines for treating sleep disorders, major depression, chronic pain and other disease states that continue to present huge and underserved challenges for patients, health care systems, and societies around the world. Its trans-Pacific heritage and operations present intriguing opportunities that may deliver important scientific and medical advances."

    Dr. Morrissey has served as a director and as President and Chief Executive Officer of Exelixis, Inc. (NASDAQ:EXEL) since July 2010. During his tenure, the company has grown its flagship medicine, CABOMETYX® (cabozantinib), into a global oncology franchise for the treatment of multiple forms of cancer. At the same time, Exelixis has begun building a differentiated pipeline behind its lead product through internal drug discovery activities at its growing Alameda campus and targeted business development. Prior to becoming Exelixis' CEO, Dr. Morrissey held positions of increasing responsibility at the company, including serving as its President of Research and Development from January 2007 until July 2010. From 1991 to 2000, Dr. Morrissey held several positions at Berlex Biosciences, last holding the position of Vice President, Discovery Research. Earlier in his career, Dr. Morrissey served as a Senior Scientist and Project Team Leader in Medicinal Chemistry at CIBA-Geigy Corporation. He is the author of numerous scientific publications in medicinal chemistry and drug discovery and an inventor on 70 issued U.S. patents and 25 additional published U.S. patent applications. Dr. Morrissey holds a B.S. (Honors) in Chemistry from the University of Wisconsin and a Ph.D. in Chemistry from Harvard University.

    About XWPharma

    XWPharma (formerly XW Laboratories) is a biopharmaceutical company dedicated to the discovery and development of therapeutics that apply novel platform chemistry to time-regulated neurobiology. XWPharma's expertise in drug design is focused on providing potential first- and best-in-class medicines with differentiated features to address the unmet medical needs of patients suffering from debilitating neurological diseases. XW10172 is a clinical-stage, GABAB agonist in development as an investigational once-nightly therapy intended to regulate the patient's sleep cycle in order to alleviate excessive daytime sleepiness and other consequences of sleep dysfunction associated with neurodegenerative diseases, including Parkinson's disease, and narcolepsy. XW10508 is a glutamatergic NMDA antagonist and AMPA activator in development as an oral, once-daily therapy with potential abuse deterrent properties designed for the treatment of major depressive disorder and chronic pain.   

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  5. – Phase 1 clinical trial expected to begin in Q1 2021 –

    – Under the terms of the companies' agreement, Exelixis will make an option exercise payment of $12 million to Aurigene –

    – Promising preclinical data support further advancement of XL102 (formerly AUR102) alone or in combination with chemotherapy –

    Exelixis, Inc. (NASDAQ:EXEL) and Aurigene today announced that Exelixis has exercised its exclusive option for Aurigene's novel CDK7 inhibitor under the companies' July 2019 agreement. Exelixis has now assumed responsibility for the future clinical development, commercialization, and global manufacturing of the compound now known as XL102 (formerly AUR102). Exelixis also announced that it has submitted an Investigational New Drug Application…

    – Phase 1 clinical trial expected to begin in Q1 2021 –

    – Under the terms of the companies' agreement, Exelixis will make an option exercise payment of $12 million to Aurigene –

    – Promising preclinical data support further advancement of XL102 (formerly AUR102) alone or in combination with chemotherapy –

    Exelixis, Inc. (NASDAQ:EXEL) and Aurigene today announced that Exelixis has exercised its exclusive option for Aurigene's novel CDK7 inhibitor under the companies' July 2019 agreement. Exelixis has now assumed responsibility for the future clinical development, commercialization, and global manufacturing of the compound now known as XL102 (formerly AUR102). Exelixis also announced that it has submitted an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) to evaluate XL102 alone or in combination therapy for the treatment of inoperable locally advanced or metastatic solid tumors. XL102 is a potent, selective, and orally bioavailable covalent inhibitor of cyclin-dependent kinase 7 (CDK7), which is an important regulator of the cellular transcriptional and cell cycle machinery. Aurigene presented positive preclinical data demonstrating that XL102 has potent anti-proliferative activity and induces cell death in a large panel of cancer cell lines at the 32nd EORTC-NCI-AACR (ENA) Symposium (Abstract 170) in October 2020.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201207005499/en/

    "With single-agent and combination potential across a variety of forms of cancer, XL102 is an important addition to the growing Exelixis pipeline," said Peter Lamb, Ph.D., Executive Vice President and Chief Scientific Officer of Exelixis. "Aurigene has done an excellent job advancing the program and maintaining development timelines during a year in which global biopharmaceutical research came under pressure from COVID-19. We are excited to begin clinical development for XL102 following the FDA's recent acceptance of our IND. As we maximize the opportunity for cabozantinib, our lead medicine, we are committed to building a diversified high-value pipeline with the potential to become novel medicines that could one day help patients with cancer recover stronger and live longer."

    "Exelixis' decision to in-license XL102 and file its IND with the FDA provides important validation of Aurigene's discovery and preclinical development capabilities and the value of our partnership with Exelixis overall," said Murali Ramachandra, Ph.D., Chief Executive Officer of Aurigene. "The preclinical data generated to date for XL102 demonstrate that this novel CDK7 inhibitor is orally available and has significant potential to improve care and outcomes for patients with diverse cancer indications, including breast cancer, prostate cancer, leukemia, and lymphoma. We continue to generate additional data from the other programs that are part of our partnership with Exelixis and believe that these programs will provide additional value-creating opportunities for both companies."

    Under the terms of the July 2019 agreement, Exelixis made an upfront payment of $10 million for exclusive options to license three preexisting programs, including the compound now known as XL102, from Aurigene. In addition, Exelixis and Aurigene initiated three Aurigene-led drug discovery programs on mutually agreed upon targets, in exchange for additional upfront option payments of $2.5 million per program. Exelixis is also contributing research funding to Aurigene to facilitate discovery and preclinical development work on all six programs. As the programs mature, Exelixis will have the opportunity to exercise an exclusive option for each program up until the time of IND filing acceptance. If Exelixis decides to exercise an option, it will make an option exercise payment to Aurigene and assume responsibility for that program's future clinical development and commercialization including global manufacturing. To exercise its option for XL102, Exelixis will make an option exercise payment of $12 million. Once Exelixis in-licenses a program, Aurigene will be eligible for clinical development, regulatory, and sales milestones, as well as royalties on sales. Under the terms of the agreement, Aurigene retains limited development and commercial rights for India and Russia.

    About Aurigene

    Aurigene Discovery Technologies Limited is a development stage biotech company engaged in discovery and clinical development of novel and best-in-class therapies to treat cancer and inflammatory diseases and a wholly owned subsidiary of Dr. Reddy's Laboratories Ltd. ((BSE: 500124, NSE: DRREDDY, NYSE:RDY). Aurigene is focused on precision-oncology, oral immune checkpoint inhibitors, and the Th-17 pathway. Aurigene's programs currently in clinical development include an oral ROR-gamma inhibitor AUR101 for moderate to severe psoriasis in phase 2 under a U.S. FDA IND and a PD-L1/VISTA antagonist CA-170 for non-squamous non-small cell lung cancer in phase 2b/3 in India. Additionally, Aurigene has multiple compounds at different stages of pre-clinical development. Aurigene has also partnered with several large and mid-pharma companies in the United States and Europe and has multiple programs in clinical development. For more information, please visit Aurigene's website at www.aurigene.com.

    About Exelixis

    Founded in 1994, Exelixis, Inc. (NASDAQ:EXEL) is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Following early work in model system genetics, we established a broad drug discovery and development platform that has served as the foundation for our continued efforts to bring new cancer therapies to patients in need. Our discovery efforts have resulted in four commercially available products, CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib), COTELLIC® (cobimetinib) and MINNEBRO® (esaxerenone), and we have entered into partnerships with leading pharmaceutical companies to bring these important medicines to patients worldwide. Supported by revenues from our marketed products and collaborations, we are committed to prudently reinvesting in our business to maximize the potential of our pipeline. We are supplementing our existing therapeutic assets with targeted business development activities and internal drug discovery – all to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer. Exelixis is a member of the Standard & Poor's (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies. In November 2020, the company was named to Fortune's 100 Fastest-Growing Companies list for the first time, ranking 17th overall and the third-highest biopharmaceutical company. For more information about Exelixis, please visit www.exelixis.com, follow @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.

    Exelixis Forward-Looking Statements

    This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis' plans to initiate a phase 1 clinical trial of XL102 in the first quarter of 2021; the therapeutic potential of XL102 to improve care and outcomes for patients with diverse cancer indications; the potential for Exelixis' and Aurigene's partnership to provide additional value-creating opportunities for both companies; Exelixis' potential future financial and other obligations under the exclusive collaboration, option and license agreement with Aurigene; and Exelixis' plans to reinvest in its business to maximize the potential of the company's pipeline, including through targeted business development activities and internal drug discovery. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis' current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the continuing COVID-19 pandemic and its impact on Exelixis' research and development operations; the level of costs associated with Exelixis' commercialization, research and development, in-licensing or acquisition of product candidates, and other activities; uncertainties inherent in the drug discovery and product development process; Exelixis' dependence on its relationship with Aurigene, including Aurigene's adherence to its obligations under the exclusive collaboration, option and license agreement and the level of Aurigene's assistance to Exelixis in completing clinical trials, pursuing regulatory approvals or successfully commercializing partnered compounds in the territories where they may be approved; complexities and the unpredictability of the regulatory review and approval processes in the U.S. and elsewhere; Exelixis' and Aurigene's continuing compliance with applicable legal and regulatory requirements; Exelixis' and Aurigene's ability to protect their respective intellectual property rights; market competition; changes in economic and business conditions; and other factors affecting Exelixis and its product pipeline discussed under the caption "Risk Factors" in Exelixis' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 5, 2020, and in Exelixis' future filings with the SEC. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law.

    Exelixis, the Exelixis logo, CABOMETYX, COMETRIQ and COTELLIC are registered U.S. trademarks. MINNEBRO is a registered Japanese trademark.

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