Articles from Exelixis, Inc.

Exelixis, Inc. (Nasdaq: EXEL) announced today that its fourth quarter and full year 2024 financial results will be released on Tuesday, February 11, 2025 after the markets close. At 5:00 p.m. ET / 2:00 p.m. PT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update. Access to the event is available via the Internet from the company’s website.

Exelixis, Inc. (Nasdaq: EXEL) today announced results from an expansion cohort of the phase 1b/2 STELLAR-001 trial evaluating zanzalintinib alone or in combination with atezolizumab (Tecentriq®) in patients with previously-treated metastatic colorectal cancer (CRC). The findings will be presented during Poster Session C: Cancers of the Colon, Rectum and Anus, at 7:00 a.m. PT on January 25 at the American Society of Clinical Oncology 2025 Gastrointestinal Cancers Symposium (ASCO GI 2025).

Exelixis, Inc. (Nasdaq: EXEL) today announced results from a subgroup analysis of the phase 3 CABINET pivotal study of patients with extra-pancreatic neuroendocrine tumors (epNET) arising in the gastrointestinal (GI) tract. The analysis showed cabozantinib was associated with an improvement in progression-free survival (PFS) compared with placebo in patients with advanced GI neuroendocrine tumors (NET), which was a subgroup of the epNET cohort. These results are being presented today during Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract, at 11:30 a.m. PT on January 24 at the American Society of Clinical Oncology 2025 Gastrointestinal Cancers Symposium (ASCO GI 2025).

Exelixis, Inc. (Nasdaq: EXEL) today announced its preliminary unaudited financial results for the fiscal year 2024, provided financial guidance for fiscal year 2025 and delivered an update on its business. Exelixis anticipates 2025 will be a year of clinical and regulatory execution and continued growth for its cabozantinib franchise, as well as multiple data readouts for zanzalintinib and across its diversified pipeline of small molecules and biotherapeutics with the potential to improve standards of care for patients with cancer.

Exelixis, Inc. (Nasdaq: EXEL) today announced it has been notified by the U.S. Food and Drug Administration (FDA) that the supplemental New Drug Application (sNDA) for cabozantinib (CABOMETYX®) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic (epNET) will no longer be the subject of discussion at an Oncologic Drugs Advisory Committee meeting. The sNDA remains under consideration by FDA with a Prescription Drug User Fee Act action date of April 3, 2025.

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 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025 at 5:15 p.m. PT / 8:15 p.m. PT.

Exelixis, Inc. (Nasdaq: EXEL) today announced that company management will participate in fireside chats at the following investor conferences in December:

Exelixis, Inc. (Nasdaq: EXEL) today announced that the U.S. Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (CABOMETYX®) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. The sNDA is based on the final results of the phase 3 CABINET pivotal trial, conducted by the National Cancer Institute's National Clinical Trials Network, evaluating cabozantinib compared with placebo in advanced pNET and advanced epNET. In August 2024, Exelixis announced that the FDA granted orphan drug designation to cabozantinib for the treatment of pNET and assigned a Prescription Drug User Fee Act target action date of April 3, 2025.

Exelixis, Inc. (Nasdaq: EXEL) today announced that company management will participate in fireside chats at the following investor conferences in November:

Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the third quarter of 2024, provided an update on progress toward achieving key corporate objectives, and detailed its recent and anticipated commercial, clinical and pipeline development milestones.

Exelixis, Inc. (Nasdaq: EXEL) announced today that its third quarter 2024 financial results will be released on Tuesday, October 29, 2024 after the markets close. At 5:00 p.m. ET / 2:00 p.m. PT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update. Access to the event is available via the Internet from the company’s website.

Exelixis, Inc. (Nasdaq: EXEL) today announced that in the lawsuit Exelixis, Inc. (Exelixis) vs. MSN Laboratories Private Limited et al. (MSN), Civil Action No. 22-00228 (Consolidated), the U.S. District Court for the District of Delaware ruled in Exelixis’ favor, rejecting MSN’s challenge to three Orange Book-listed patents related to cabozantinib, including U.S. Patents No. 11,091,439 (crystalline salt); 11,091,440 (pharmaceutical compositions); and 11,098,015 (methods of treatment). The District Court’s decision in Exelixis’ favor on the validity of these patents follows an earlier Stipulation entered on June 21, 2022, that MSN’s proposed generic cabozantinib product (Abbreviated New Drug Application [ANDA] No. 213878) infringes the ’439, ’440, and ’015 patents, which expire on January 15, 2030.

Exelixis, Inc. (Nasdaq: EXEL) and Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced that the companies have entered into a clinical development collaboration to evaluate the combination of Exelixis’ investigational tyrosine kinase inhibitor (TKI) zanzalintinib with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in a phase 3 pivotal trial for the treatment of patients with head and neck squamous cell carcinoma (HNSCC), and zanzalintinib with WELIREG® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, in a phase 1/2 trial and two phase 3 pivotal trials for the treatment of patients with renal cell carcinoma (RCC).

Exelixis, Inc. (Nasdaq: EXEL) today announced updated and final data from CABINET, a phase 3 pivotal trial evaluating cabozantinib (CABOMETYX®) versus placebo in two cohorts of patients with previously treated neuroendocrine tumors: one cohort with advanced pancreatic neuroendocrine tumors (pNET) and one cohort with advanced extra-pancreatic NET (epNET). These data are being presented today at the 2024 European Society for Medical Oncology Congress (ESMO 2024) during the Proffered Paper Session: NETs and Endocrine Tumours at 2:45 p.m. CET and were simultaneously published in the New England Journal of Medicine (NEJM).

Exelixis, Inc. (Nasdaq: EXEL) today announced detailed final overall survival (OS) results from CONTACT-02, a phase 3 pivotal study evaluating cabozantinib (CABOMETYX®) in combination with atezolizumab (Tecentriq®) compared with a second novel hormonal therapy (NHT) in patients with metastatic castration-resistant prostate cancer (mCRPC) and measurable extra-pelvic soft tissue disease who have progressed on one prior NHT. These data are being presented today at the 2024 European Society for Medical Oncology Congress (ESMO 2024) during the Proffered Paper Session: GU Tumours, Prostate at 2:45 p.m. CEST.

Exelixis, Inc. (Nasdaq: EXEL) today announced that company management will participate in fireside chats at the following investor conferences in September:

Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the second quarter of 2024, provided an update on progress toward achieving key corporate objectives, and detailed its recent and anticipated commercial, clinical and pipeline development milestones.

Exelixis, Inc. (Nasdaq: EXEL) today announced that its supplemental New Drug Application (sNDA) for cabozantinib (CABOMETYX®) has been accepted in the U.S. for: 1) the treatment of adults with previously treated, locally advanced/unresectable or metastatic, well- or moderately differentiated pancreatic neuroendocrine tumors (pNET), and 2) the treatment of adults with previously treated, locally advanced/unresectable or metastatic, well- or moderately differentiated extra-pancreatic NET (epNET). The U.S. Food and Drug Administration (FDA) also granted orphan drug designation to cabozantinib for the treatment of pNET. The FDA assigned a standard review with a Prescription Drug User Fee Act target action date of April 3, 2025.

Exelixis, Inc. (Nasdaq: EXEL) announced today that its second quarter 2024 financial results will be released on Tuesday, August 6, 2024 after the markets close. At 5:00 p.m. ET / 2:00 p.m. PT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update. Access to the event is available via the Internet from the company’s website.

Exelixis, Inc. (Nasdaq: EXEL) today announced that company management will participate in a fireside chat at the William Blair 44th Annual Growth Stock Conference on Tuesday, June 4 at 4:20 p.m. ET / 3:20 p.m. CT / 1:20 p.m. PT in Chicago.

Exelixis, Inc. (Nasdaq: EXEL) today announced that it has entered into a Settlement and License Agreement (Agreement) with Cipla Ltd. and Cipla USA, Inc. (collectively Cipla). This settlement resolves two patent litigations brought by Exelixis in response to Cipla’s Abbreviated New Drug Application (ANDA) seeking approval to market generic versions of CABOMETYX® (cabozantinib) tablets prior to the expiration of the applicable patents. The first case (Civil Action No. 23-287), filed on March 16, 2023, relates to Cipla’s ANDA for a 60 mg cabozantinib dosage strength. The second case (Civil Action No. 24-565-RGA), filed on May 9, 2024, relates to a recent amendment to Cipla’s ANDA, for the primary purpose of seeking additional approval for 20 mg and 40 mg cabozantinib dosage strengths.

Exelixis, Inc. (Nasdaq: EXEL) today announced that members of the company’s management team will participate in fireside chats at the following investor conferences in May:

Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the first quarter of 2024, provided an update on progress toward achieving key corporate objectives, and detailed its recent and anticipated commercial, clinical and pipeline development milestones.

Exelixis, Inc. (Nasdaq: EXEL) announced today that its first quarter 2024 financial results will be released on Tuesday, April 30, 2024 after the markets close. At 5:00 p.m. ET / 2:00 p.m. PT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update. Access to the event is available via the Internet from the company’s website.

Exelixis, Inc. (Nasdaq: EXEL) today announced that members of the company’s management team will participate in fireside chats at the following investor conferences in March:

Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the fourth quarter and fiscal year of 2023, provided an update on progress toward achieving key corporate objectives, and outlined its commercial, clinical and pipeline development milestones.

Exelixis, Inc. (Nasdaq: EXEL) today announced that members of the company’s management team will participate in fireside chats at the following investor conferences in February:

Exelixis, Inc. (Nasdaq: EXEL) today announced detailed results from CONTACT-02, a phase 3 pivotal study evaluating cabozantinib (CABOMETYX®) in combination with atezolizumab compared with a second novel hormonal therapy (NHT) in patients with metastatic castration-resistant prostate cancer (mCRPC) and measurable extra-pelvic soft tissue disease who have progressed on one prior NHT. The detailed findings are being presented during Oral Abstract Session A: Prostate Cancer at 7:55 a.m. PST on January 25 at the American Society of Clinical Oncology 2024 Genitourinary Cancers Symposium (ASCO GU).

Exelixis, Inc. (Nasdaq: EXEL) announced today that its fourth quarter and fiscal year 2023 financial results will be released on Tuesday, February 6, 2024 after the markets close. At 5:00 p.m. ET / 2:00 p.m. PT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update. Access to the event is available via the Internet from the company’s website.

Exelixis, Inc. (Nasdaq: EXEL) today announced it has successfully defended European Patent number EP2593090 (c-MET Modulator Pharmaceutical Compositions) against three opponents, STADA Arzneimittel AG, Teva Pharmaceutical Industries Ltd., and Generics (U.K.) Ltd. in a hearing before the Opposition Division of the European Patent Office (EPO). The three-member panel of the Opposition Division rejected all grounds of opposition, thus upholding the patent as granted. The patent at issue, which expires on July 18, 2031, covers tablet formulations of cabozantinib, including the tablet formulation approved as CABOMETYX® (cabozantinib) tablets by the European Medicines Agency. The decision is specific to the European patent at issue and is subject to appeal to the EPO Technical Boards of Appeal.

Exelixis, Inc. (Nasdaq: EXEL) today announced its preliminary unaudited financial results for the fiscal year 2023, provided financial guidance for fiscal year 2024 and delivered an update on its business. Exelixis expects 2024 to be a year of pipeline progress as it advances its portfolio of promising biotherapeutics and small molecule candidates recently highlighted at its 2023 R&D Day and pursues potential near-term label expansion opportunities for CABOMETYX® (cabozantinib).

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 42nd Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2024 at 4:30 p.m. PT / 7:30 p.m. ET.

Exelixis, Inc. (Nasdaq: EXEL) today announced that it will webcast the Exelixis 2023 R&D Day: Science & Strategy event taking place on Tuesday, December 12, 2023, from 9:00 a.m. to 12:30 p.m. EST. During the event, featured speakers will review the progress of the company’s growing research and development pipeline, highlight recent clinical updates and elaborate on the company’s continued efforts to serve more patients with cancer and generate sustainable, long-term value for shareholders.

Exelixis, Inc. (Nasdaq: EXEL) today announced the initiation of STELLAR-305, a phase 2/3 pivotal trial evaluating zanzalintinib in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated PD-L1-positive recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).

Exelixis, Inc. (Nasdaq: EXEL) today announced that company management will participate in a fireside chat at the Piper Sandler 35th Annual Healthcare Conference on Tuesday, November 28 at 11:00 am ET / 8:00 am PT.

Exelixis, Inc. (Nasdaq: EXEL) today announced initial results from an expansion cohort of STELLAR-001 evaluating single-agent zanzalintinib in patients with previously treated clear cell renal cell carcinoma (ccRCC). STELLAR-001 is a phase 1b trial evaluating zanzalintinib alone and in combination with atezolizumab in patients with locally advanced or metastatic solid tumors. The findings are being presented today at 2:35 p.m. CST during the Oral Abstracts session at the 2023 International Kidney Cancer Symposium (IKCS): North America.

Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the third quarter of 2023 and provided an update on progress toward achieving key corporate objectives, as well as commercial, clinical and pipeline development milestones.

Exelixis, Inc. (Nasdaq: EXEL) today announced detailed results from CABINET, a phase 3 pivotal trial evaluating cabozantinib (CABOMETYX®) compared with placebo in two cohorts of patients with previously treated neuroendocrine tumors: one cohort of patients with advanced pancreatic neuroendocrine tumors (pNET) and a second cohort of patients with advanced extra-pancreatic NET (epNET). The study met the primary objective for each cohort, demonstrating that cabozantinib provided dramatic improvements in median progression-free survival (PFS) for the patients in the pNET and epNET cohorts. The data are being presented today at 8:40 a.m. CET during the Proffered Paper Session – NETs and Endocrine Tumours at the 2023 European Society of Medical Oncology (ESMO) Congress (LBA53) by the Alliance for Clinical Trials in Oncology. CABINET is sponsored by the National Cancer Institute (NCI), part of National Institutes of Health, and is led by the NCI-funded Alliance for Clinical Trials in Oncology and conducted by the NCI-funded National Clinical Trials Network Group.

Exelixis, Inc. (Nasdaq: EXEL) announced today that its third quarter 2023 financial results will be released on Wednesday, November 1, 2023 after the markets close. At 5:00 p.m. ET / 2:00 p.m. PT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update. Access to the event is available via the Internet from the company’s website.

Exelixis, Inc. (Nasdaq: EXEL) and Insilico Medicine (“Insilico”) today announced that the companies have entered into an exclusive license agreement granting Exelixis global rights to develop and commercialize ISM3091, a potentially best-in-class small molecule inhibitor of USP1, which has emerged as a synthetic lethal target in the context of BRCA-mutated tumors.

Exelixis, Inc. (Nasdaq: EXEL) today announced that the Alliance for Clinical Trials in Oncology independent Data and Safety Monitoring Board (DSMB) unanimously recommended to unblind and stop the phase 3 CABINET pivotal trial early due to a dramatic improvement in efficacy that was observed at an interim analysis. CABINET is evaluating cabozantinib (CABOMETYX®) compared with placebo in patients with either advanced pancreatic neuroendocrine tumors (pNET) or advanced extra-pancreatic neuroendocrine tumors (also referred to as carcinoid tumors) who experienced progression after prior systemic therapy. Cabozantinib substantially prolonged the time without disease progression or death in both of the trial’s cohorts. CABINET is sponsored by the National Cancer Institute (NCI) and is led by The Alliance for Clinical Trials in Oncology. Detailed findings will be presented at an upcoming medical meeting and discussed with the U.S. Food and Drug Administration (FDA).

Exelixis, Inc. (Nasdaq: EXEL) today announced it has appointed Amy Peterson, M.D., its next Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer. Dr. Peterson is a veteran oncology drug development leader whose experience includes senior clinical development and operational roles at Genentech, Medivation, BeiGene and CytomX. She joins Exelixis as the company accelerates development of its product pipeline and builds on the success of its global cabozantinib oncology franchise.

Exelixis, Inc. (Nasdaq: EXEL) and Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the global phase 3 CONTACT-02 pivotal trial met one of two primary endpoints, demonstrating a statistically significant improvement in progression-free survival (PFS) at the primary analysis. CONTACT-02 is evaluating cabozantinib (CABOMETYX®) in combination with atezolizumab compared with a second novel hormonal therapy in patients with metastatic castration-resistant prostate cancer (mCRPC) and measurable soft tissue disease who have been previously treated with one novel hormonal therapy. At a prespecified interim analysis for the primary endpoint of overall survival (OS) that occurred at the same time as the primary analysis of PFS, a trend toward improvement of OS was observed; however, the data were immature and did not meet the threshold for statistical significance. Therefore, the trial will continue to the next analysis of OS as planned.

Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the second quarter of 2023 and provided an update on progress toward achieving key corporate objectives, as well as commercial, clinical and pipeline development milestones.

Exelixis, Inc. (Nasdaq: EXEL) today announced that it has entered into a Settlement and License Agreement (Agreement) with Teva Pharmaceuticals Development, Inc. and Teva Pharmaceuticals USA, Inc. (collectively Teva). This settlement resolves patent litigation brought by Exelixis in response to Teva’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of CABOMETYX® (cabozantinib) tablets prior to the expiration of the applicable patents.

Exelixis, Inc. (Nasdaq: EXEL) announced today that its second quarter 2023 financial results will be released on Tuesday, August 1, 2023 after the markets close. At 5:00 p.m. ET / 2:00 p.m. PT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update. Access to the event is available via the Internet from the company’s website.

Exelixis, Inc. (Nasdaq: EXEL) today announced that members of the company’s management team will participate in fireside chats at the following investor conferences in June:

Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the first quarter of 2023 and provided an update on progress toward achieving key corporate objectives, as well as commercial, clinical and pipeline development milestones.

Exelixis, Inc. (Nasdaq: EXEL) (the “Company”) today announced that Lance Willsey, M.D. has informed the Board of Directors of his decision to resign from the Board, effective immediately. The Board recommends shareholders vote in favor of its remaining 10 director nominees and will not contest the election of Farallon Capital Management’s (“Farallon”) additional nominee, David Johnson, at the upcoming 2023 Annual Meeting of Shareholders, to be held on May 31, 2023.

Exelixis, Inc. (Nasdaq: EXEL) today announced that company management will participate in a fireside chat at the BofA Securities 2023 Healthcare Conference on Wednesday, May 10 at 1:40 p.m. ET / 10:40 a.m. PT.

Exelixis, Inc. (Nasdaq: EXEL) (the “Company”) today announced that it has filed its definitive proxy materials with the Securities and Exchange Commission (“SEC”) in connection with its 2023 Annual Meeting of Stockholders (the “Annual Meeting”), which will be held on May 31, 2023. Shareholders of record as of April 3, 2023, will be entitled to vote at the meeting.

Exelixis, Inc. (Nasdaq: EXEL) announced today that its first quarter 2023 financial results will be released on Tuesday, May 9, 2023 after the markets close. At 5:00 p.m. ET / 2:00 p.m. PT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update. Access to the event is available via the Internet from the company’s website.

Exelixis, Inc. (Nasdaq: EXEL) (the “Company”) today announced that Carl Feldbaum, Esq. and Vincent Marchesi, M.D., Ph.D., two long-standing and valued members of the Board of Directors, will not stand for re-election at the Company’s 2023 Annual Meeting of Stockholders (the “Annual Meeting”). As part of its ongoing refreshment program, the Board is recommending Tomas Heyman, current Chief Executive Officer of Interlaken Therapeutics and former President of Johnson & Johnson’s Corporate Venture Capital Group, and Robert Oliver, former President and Chief Executive Officer of Otsuka America Pharmaceutical, for election as independent directors at the Company’s Annual Meeting to fill Mr. Feldbaum’s and Dr. Marchesi’s seats.

Exelixis, Inc. (Nasdaq: EXEL) (the “Company”) today issued the following statement in response to the letter issued by Farallon Capital Management, L.L.C. (“Farallon”):

Exelixis, Inc. (Nasdaq: EXEL) today announced that the company’s Board of Directors has authorized the repurchase of up to $550 million of the company’s common stock before the end of 2023.

Exelixis, Inc. (Nasdaq: EXEL) today announced that company management will provide a corporate overview at the 2023 Guggenheim Healthy Altitudes Summit on Thursday, March 16, 2023 at 10:00 a.m. ET / 8:00 a.m. MT / 7:00 a.m. PT.

Exelixis, Inc. (Nasdaq: EXEL) today announced that the phase 3 CONTACT-03 study did not meet its primary endpoint of progression-free survival (PFS). CONTACT-03 evaluated cabozantinib (CABOMETYX®) in combination with atezolizumab versus cabozantinib alone in patients with locally advanced or metastatic clear cell or non-clear cell (papillary or unclassified only) renal cell carcinoma (RCC) who progressed during or after immune checkpoint inhibitor therapy (either combination or monotherapy).

Exelixis, Inc. (Nasdaq: EXEL) today announced that members of the company’s management team will participate in fireside chats at the following investor conferences in March:

Exelixis, Inc. (Nasdaq: EXEL) and Sairopa B.V. (Sairopa) today announced that the U.S. Food and Drug Administration (FDA) has cleared Sairopa’s Investigational New Drug (IND) Application to evaluate the safety and pharmacokinetics of ADU-1805 in adults with advanced solid tumors. As a monoclonal antibody active against all human alleles of SIRPα, ADU-1805 has the potential to address a broader patient population than other SIRPα-directed therapies.

Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the fourth quarter and full year of 2022 and provided an update on progress toward achieving key corporate objectives, as well as commercial, clinical and pipeline development milestones.

Exelixis, Inc. (Nasdaq: EXEL) today announced that members of the company’s management team will participate in fireside chats at the following investor conferences in February:

Exelixis, Inc. (Nasdaq: EXEL) announced today that its fourth quarter and full year 2022 financial results will be released on Tuesday, February 7, 2023 after the markets close. At 5:00 p.m. ET / 2:00 p.m. PT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update. Access to the event is available via the Internet from the company’s website.

Exelixis, Inc. (Nasdaq: EXEL) today announced that in the lawsuit Exelixis, Inc. (Exelixis) v. MSN Laboratories Private Limited et al. (MSN), Action No. 19-2017 (Consolidated), the U.S. District Court for the District of Delaware ruled in Exelixis’ favor, rejecting MSN’s challenge to the cabozantinib compound patent (U.S. 7,579,473). The District Court’s decision follows an earlier Stipulation and Order of October 1, 2021, that MSN’s proposed generic cabozantinib product (Abbreviated New Drug Application [ANDA] No. 213878) infringes the ’473 patent.

Exelixis, Inc. (Nasdaq: EXEL) today announced its preliminary unaudited financial results for the fourth quarter and full year 2022, provided financial guidance for full year 2023, and delivered an update on its business. Exelixis expects 2023 to be a year of significant growth and execution as it continues to expand and develop its pipeline of promising biotherapeutics and small molecules and pursues potential near-term label-expansion opportunities for CABOMETYX® (cabozantinib).

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 41st Annual J.P. Morgan Healthcare Conference on Monday, January 9, 2023 at 8:15pm ET / 5:15pm PT.

Exelixis, Inc. (Nasdaq: EXEL) today announced the initiation of STELLAR-304, a phase 3 pivotal trial evaluating zanzalintinib in combination with nivolumab versus sunitinib in patients with advanced non-clear cell renal cell carcinoma (nccRCC). Zanzalintinib, which was adopted as the generic name for XL092, is a next-generation tyrosine kinase inhibitor (TKI) in development for multiple advanced tumor types.

Exelixis, Inc. (Nasdaq: EXEL) today announced that the CONTACT-01 study did not meet its primary endpoint of overall survival at the final analysis. CONTACT-01 is a phase 3 trial evaluating cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®) versus docetaxel in patients with metastatic non-small cell lung cancer (NSCLC) without actionable mutations who experienced disease progression on or after treatment with an immune checkpoint inhibitor and platinum-containing chemotherapy.

Exelixis, Inc. (Nasdaq: EXEL) today announced initial results from the ongoing dose-escalation stage of QUARTZ-101, a phase 1 clinical trial evaluating XL102, a potent, selective, irreversible and orally bioavailable small molecule cyclin-dependent kinase 7 (CDK7) inhibitor, in patients with advanced solid tumors. The data are being presented on Thursday, December 8 during the poster session (abstract P4-01-35) at 7:00 a.m. CST at the 2022 San Antonio Breast Cancer Symposium (SABCS).

Exelixis, Inc. (Nasdaq: EXEL) today announced that company management will participate in a fireside chat at the virtual JMP Securities Hematology and Oncology Summit on Wednesday, December 7, 2022 at 12:00 pm ET / 9:00 am PT.

Exelixis, Inc. (Nasdaq: EXEL) today announced that members of the company’s management team will participate in fireside chats at the following investor conferences in November:

Exelixis, Inc. (Nasdaq: EXEL) and Catalent, Inc. (NYSECTLT) today announced a new license agreement under which Catalent’s Redwood Bioscience subsidiary will grant Exelixis an exclusive license to three target programs with lead antibody and/or ADC candidates. The ADC candidates have been developed using Catalent’s proprietary SMARTag® technology, and each of the licensed antibodies has potential for development as an ADC or other biologic therapy using a variety of technologies to which Exelixis has access through its partner network. In September 2020, Exelixis and Catalent entered into a separate agreement under which Catalent is applying its SMARTag bioconjugation platform to build ADCs using monoclonal antibodies from Exelixis’ growing preclinical pipeline.

Exelixis, Inc. (Nasdaq: EXEL) and Sairopa B.V. (Sairopa) today announced that the companies have entered into an exclusive clinical development and option agreement for ADU-1805, a potentially best-in-class monoclonal antibody that targets SIRPα. SIRPα expressed on myeloid cells interacts with CD47 present on the surface of cancer cells and blocks the ability of macrophages to clear tumor cells via phagocytosis and inhibits tumor antigen presentation to T-cells. Blocking SIRPα has the potential to improve the immune system’s ability to attack tumors by addressing a significant immune-suppressive component of the tumor microenvironment. ADU-1805 is active against all human alleles of SIRPα, which may allow it to address a broader patient population than other SIRPα-directed therapies. ADU-1805 has also been optimized to bind preferentially to SIRPα vs. other SIRP family members, which may enhance its ability to stimulate immune cells.

Exelixis, Inc. (Nasdaq: EXEL) and Cybrexa Therapeutics (Cybrexa) today announced that the companies have entered into an exclusive collaboration agreement providing Exelixis the right to acquire CBX-12 (alphalex™ exatecan), a clinical-stage, first-in-class peptide-drug conjugate (PDC) that utilizes Cybrexa’s proprietary alphalex technology to enhance delivery of exatecan to tumor cells. CBX-12 is designed to increase the efficacy and reduce the toxicity of topoisomerase I inhibition by delivering exatecan, a highly potent, second-generation topoisomerase I inhibitor, directly to the tumor cells. This collaboration underscores Exelixis’ commitment to expanding its clinical pipeline building upon its biotherapeutics and targeted drug therapy expertise.

Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the third quarter of 2022 and provided an update on progress toward achieving key corporate objectives, as well as commercial, clinical and pipeline development milestones.

Exelixis, Inc. (Nasdaq: EXEL) today announced promising initial results from the ongoing dose-escalation stage of JEWEL-101, a phase 1 study evaluating XB002, Exelixis’ next-generation tissue factor-targeting antibody-drug conjugate. The data are being presented on Friday, October 28 during the Antibody-drug Conjugates Poster Session (abstract 256) at 10:00 a.m. CEST at the 34th Symposium on Molecular Targets and Cancer Therapeutics hosted by the European Organisation for Research and Treatment of Cancer (EORTC), the National Cancer Institute (NCI) and the American Association for Cancer Research (AACR).