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Exelixis Announces Initiation of the STELLAR-303 Phase 3 Pivotal Trial Evaluating XL092 in Patients with Metastatic Colorectal Cancer

2022-06-21 12:00:00

Exelixis, Inc. announced the initiation of STELLAR-303, a phase 3 pivotal trial evaluating XL092 in combination with atezolizumab versus regorafenib in patients with metastatic colorectal cancer (CRC) that is not microsatellite instability-high or mismatch repair-deficient, who have progressed after or are intolerant to the standard of care therapy. XL092 is a next-generation tyrosine kinase inhibitor (TKI) in development for multiple advanced tumor types. STELLAR-303 is a global, multicenter, randomized phase 3 open-label study that will enroll approximately 600 patients with documented RAS status. Patients will be randomized 1:1 to receive either XL092 in combination with atezolizumab or regorafenib. The primary objective of the study is to evaluate the efficacy of the combination in patients with RAS wild-type disease; exploratory endpoints include examining efficacy in those with RAS-mutated disease. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, objective response rate and duration of response per Response Evaluation Criteria in Solid Tumors version 1.1 as assessed by the investigator. Previously announced results from two studies of cabozantinib in combination with immunotherapies for the treatment of advanced CRC supported Exelixis' decision to pursue clinical development of XL092 in this setting. The trial is sponsored by Exelixis, and Roche is supplying atezolizumab.

Exelixis, Inc. and Bioinvent International AB Have Entered into an Option and License Agreement

2022-06-16 04:00:00

Exelixis, Inc. and BioInvent International AB announced that the companies have entered into an option and license agreement focused on the identification and development of novel antibodies for use in IO therapeutics. The collaboration is intended to expand Exelixis’ portfolio of antibody-based therapies and will combine BioInvent’s cancer immunology and antibody biology expertise with Exelixis’ expertise and resources in antibody engineering and antibody-drug conjugate (ADC) technologies, and proven history of developing and commercializing oncology therapeutics. Target and antibody discovery will be performed using BioInvent’s proprietary n-CoDeR® antibody library and patient-centric F.I.R.S.T™ screening platform, which together allow for parallel target and antibody discovery. Under the terms of the agreement, Exelixis will pay BioInvent an upfront fee of $25 million in exchange for rights to select three targets identified using BioInvent’s proprietary F.I.R.S.T platform and n-CoDeR library. BioInvent will be responsible for initial target and antibody discovery activities, and characterization of antibody mechanism of action. Exelixis will have the right to exercise an option to in-license any of the target programs upon identification of a development candidate directed to that target. Upon option exercise, Exelixis will pay BioInvent an option exercise fee and will assume responsibility for all future development and commercialization activities for the development candidate, including potential ADC and bispecific antibody engineering activities. In addition, BioInvent will be eligible for success-based development and commercialization milestones, as well as tiered royalties on the annual net sales of any products that are successfully commercialized under the collaboration.

Exelixis, Inc. Presents at 2022 Jefferies Global Healthcare Conference, Jun-08-2022 01:30 PM

2022-05-31 20:05:00

Exelixis, Inc. Presents at 2022 Jefferies Global Healthcare Conference, Jun-08-2022 01:30 PM. Venue: Marriott Marquis, New York City, New York, United States.

Exelixis, Inc. Presents at William Blair’s 42nd Annual Growth Stock Conference 2022, Jun-07-2022 11:00 AM

2022-05-31 20:05:00

Exelixis, Inc. Presents at William Blair’s 42nd Annual Growth Stock Conference 2022, Jun-07-2022 11:00 AM. Venue: Loews Chicago Hotel, Chicago, Illinois, United States.

Exelixis, Inc. Presents at American Society of Clinical Psychopharmacology 2022 Annual Meeting, Jun-03-2022 03:45 PM

2022-05-27 00:00:00

Exelixis, Inc. Presents at American Society of Clinical Psychopharmacology 2022 Annual Meeting, Jun-03-2022 03:45 PM. Venue: Scottsdale, Ariz, Scarsdale, United States.

Exelixis, Inc. Announces Results from Phase 2 Trial of Cabozantinib in Combination with Pembrolizumab in Patients

2022-05-26 21:00:00

Exelixis, Inc. announced results from a phase 2, investigator-sponsored trial of cabozantinib (CABOMETYX®) in combination with pembrolizumab in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The trial met its primary endpoint of objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 at 54%. The overall clinical benefit rate was 91%. At a median follow-up of 10.6 months, the one-year progression-free survival rate was 54.0% (95% confidence interval [CI]: 31.5-72.0%), and median progression-free survival was 14.6 months. The one-year overall survival (OS) rate was 68.4% (95% CI: 45.1-83.5%; median OS: 22.3 months). For the 17 patients with a PD-L1 combined positive score (CPS) under 20, the one-year OS rate was 54.9% (95% CI: 24.5-77.5%; median OS: 14.6 months). For the 17 patients with a CPS score of 20 or more, the one-year OS rate was 83.6% (95% CI: 48.0-95.7%; median OS: 32.9 months). In this phase 2 trial, eligible patients had recurrent or metastatic HNSCC that was deemed inoperable, with measurable disease per RECIST version 1.1, a life expectancy of at least 3 months and an Eastern Cooperative Group Performance Status of 0 or 1. Of the 36 evaluable patients, 61% had cancer in the oropharynx, 16% in the nasopharynx, 11% in the larynx, 6% in the hypopharynx and 6% in the oral cavity. 89% of patients had received prior radiation therapy and all had received prior chemotherapy. The most frequent adverse events (AEs) were fatigue (44.4%), diarrhea (33.3%), hypothyroidism (33.3%), constipation (30.6%), dry mouth (27.8%), anorexia (25.0%), headache (25.0%), hypertension (25.0%), hyponatremia (25.0%) and oral mucositis (25.0%). Grade 3/4 treatment-related AEs were aspartate aminotransferase (AST) increase (8.3%), hyponatremia (8.3%), gamma-glutamyl transferase increase (5.6%), lipase increase (5.6%), oral mucositis (5.6%), alanine transaminase/AST increase (2.8%), bilirubin increase (2.8%) and hypertension (2.8%). Dose reductions occurred in 47.2% of patients, and AEs leading to discontinuation occurred in 25.0% of patients.

Exelixis, Inc. Provides Earnings Guidance for the Fiscal Year 2022

2022-05-10 20:05:00

Exelixis, Inc. provided earnings guidance for the fiscal year 2022. For the year, the company expected total revenues of $1.525 billion to $1.625 billion. Net product revenues of $1.325 billion - $1.425 billion.

Exelixis, Inc. Presents at RBC Capital Markets Global Healthcare Conference, May-17-2022 08:30 AM

2022-05-04 20:05:00

Exelixis, Inc. Presents at RBC Capital Markets Global Healthcare Conference, May-17-2022 08:30 AM. Venue: InterContinental New York, Barclay hotel, New York, New York, United States. Speakers: Chris Senner, Executive Vice President & Chief Financial Officer.

Exelixis' Partner Ipsen Receives European Commission Approval for CABOMETYX(R) (cabozantinib) for Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer

2022-05-03 12:00:00

Exelixis, Inc. announced that its partner Ipsen received approval from the European Commission (EC) for CABOMETYX(R) (cabozantinib) as a monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy. This approval allows for the marketing of CABOMETYX in this indication in all 27 member states of the European Union, Norway, Liechtenstein and Iceland. The EC approval is based on results from COSMIC-311, the phase 3 pivotal trial that demonstrated significant improvement in progression-free survival (PFS) with CABOMETYX versus placebo in patients with RAI-refractory DTC who progressed after up to two prior VEGFR-targeted therapies. COSMIC-311 was the basis for the U.S. Food and Drug Administration (FDA) approval of CABOMETYX in September 2021 for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic DTC that has progressed following VEGFR-targeted therapy and who are RAI-refractory or ineligible. CABOMETYX is also approved in the European Union as a monotherapy for the treatment of advanced renal cell carcinoma (RCC) in adults who have received prior VEGFR-targeted therapy, for previously untreated intermediate- or poor-risk advanced RCC and for hepatocellular carcinoma (HCC) in adults who have been previously treated with sorafenib. CABOMETYX in combination with OPDIVO(R) (nivolumab) is approved as a first-line treatment for advanced RCC. About COSMIC-311 COSMIC-311 was a multicenter, randomized, double-blind, placebo-controlled phase 3 pivotal trial that enrolled 258 patients at 164 sites globally. Patients were randomized in a 2:1 ratio to receive either CABOMETYX 60 mg or placebo once daily. The primary endpoints were PFS and objective response rate. Exelixis is sponsoring COSMIC-311, and Ipsen is co-funding the trial. More information about this trial is available at ClinicalTrials.gov. About DTC In 2020, over 580,000 new cases of thyroid cancer were diagnosed worldwide.(1) Approximately 44,000 new cases of thyroid cancer will be diagnosed in the U.S. in 2022. Nearly three out of four of these cases will be in women, and the disease is more commonly diagnosed at a younger age compared with most other adult cancers.

American Society Of Clinical Psychopharmacology Inc, American Society of Clinical Psychopharmacology 2022 Annual Meeting, May 31, 2022 through Jun 03, 2022

2022-05-02 11:00:00

American Society Of Clinical Psychopharmacology Inc, American Society of Clinical Psychopharmacology 2022 Annual Meeting, May 31, 2022 through Jun 03, 2022. Venue: Scottsdale, Ariz, Scarsdale, United States.

Exelixis, Inc. to Report Q1, 2022 Results on May 10, 2022

2022-04-26 20:05:00

Exelixis, Inc. announced that they will report Q1, 2022 results After-Market on May 10, 2022

Exelixis, Inc., Q1 2022 Earnings Call, May 10, 2022

2022-04-26 20:05:00

Exelixis, Inc., Q1 2022 Earnings Call, May 10, 2022

Exelixis, Inc. - Shareholder/Analyst Call

2022-04-14 12:48:00

Annual Meeting of Stockholders

Exelixis, Inc., Annual General Meeting, May 25, 2022

2022-04-14 12:48:00

Exelixis, Inc., Annual General Meeting, May 25, 2022, at 09:00 Pacific Standard Time. Agenda: To consider to elect the eleven nominees for director named in the proxy statement accompanying this notice of annual meeting to hold office until the next annual meeting of stockholders and until his or her successor is duly elected and qualified or until his or her earlier death, resignation or removal; to ratify the selection by the audit committee of the board of directors of Ernst & Young LLP as Exelixis’ independent registered public accounting firm for the fiscal year ending December 30, 2022; to amend and restate the Exelixis, Inc. 2017 equity incentive plan to, among other things, increase the number of shares authorized for issuance by 28,500,000 shares; to approve, on an advisory basis, the compensation of Exelixis’ named executive officers, as disclosed in the proxy statement accompanying this notice of annual meeting; and to conduct any other business properly brought before the meeting.

Exelixis, Inc. Announces Initiation of First-In-Human Phase 1 Trial Evaluating XL114 Monotherapy in Patients with Non-Hodgkin’s Lymphoma

2022-04-14 12:00:00

Exelixis, Inc. announced initiation of the dose-escalation stage of the first-in-human phase 1 trial of XL114, a novel anti-cancer compound that inhibits the CARD11-BCL10-MALT1 complex, as a monotherapy in patients with non-Hodgkin’s lymphoma (NHL) who have received prior standard therapies. The objectives of the study are to determine the recommended dose and/or the maximum tolerated dose of XL114 and to evaluate the safety and preliminary efficacy of XL114 in patients with NHL. The dose-escalation stage will determine the recommended dose of XL114 in patients with advanced B- and T-cell NHL. In the cohort-expansion stage, the safety and preliminary efficacy of XL114 will be further evaluated in B-cell NHL-specific expansion cohorts, including patients with activated B-cell-like diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma and chronic lymphocytic leukemia/small lymphocytic lymphoma. The primary endpoint of the expansion stage will be objective response rate based on lymphoma-specific response criteria as assessed by the investigator. As announced last year, Exelixis in-licensed XL114 from Aurigene Discovery Technologies Limited under the companies’ July 2019 collaboration, option and license agreement. Exelixis assumed responsibility for the future clinical development, commercialization and global manufacturing of XL114.

Exelixis, Inc. Announces Charles Cohen to Retire from Board of Directors

2022-04-13 20:05:00

Exelixis, Inc. announced that Charles Cohen, Ph.D. has notified the company of his decision to retire from the Exelixis Board of Directors. Dr. Cohen will not stand for re-election to the Board at the company’s 2022 Annual Meeting of Stockholders, which has been tentatively scheduled for May 25, 2022; his resignation from the Board will take effect that same day.

Exelixis, Inc. Presents at 12th Annual World ADC Conference 2022, Mar-29-2022 through Mar-31-2022

2022-03-30 09:20:00

Exelixis, Inc. Presents at 12th Annual World ADC Conference 2022, Mar-29-2022 through Mar-31-2022. Venue: London, United Kingdom. Presentation Date & Speakers: Mar-30-2022, Raffaella Faggioni, Vice President, Clinical & Translational Pharmacology. Mar-31-2022, Seema Kantak, SVP, Head of Biologics.

Hanson Wade Limited, 12th Annual World ADC Conference 2022, Mar 29, 2022 through Mar 31, 2022

2022-03-29 17:52:00

Hanson Wade Limited, 12th Annual World ADC Conference 2022, Mar 29, 2022 through Mar 31, 2022. Venue: London, United Kingdom.

Exelixis, Inc. Presents at Bank of America 2022 Healthcare Conference, May-11-2022 10:40 AM

2022-03-22 05:03:00

Exelixis, Inc. Presents at Bank of America 2022 Healthcare Conference, May-11-2022 10:40 AM. Venue: Encore Hotel, 3121 Las Vegas Blvd. S, Las Vegas, Nevada, United States. Speakers: Michael M. Morrissey, CEO, President & Director.

RBC Capital Markets, LLC, RBC Capital Markets Global Healthcare Conference, May 17, 2022 through May 18, 2022

2022-03-04 01:06:00

RBC Capital Markets, LLC, RBC Capital Markets Global Healthcare Conference, May 17, 2022 through May 18, 2022. Venue: InterContinental New York, Barclay hotel, New York, New York, United States.

Bank of America Corporation, Bank of America 2022 Healthcare Conference, May 10, 2022 through May 13, 2022

2022-02-17 10:42:00

Bank of America Corporation, Bank of America 2022 Healthcare Conference, May 10, 2022 through May 13, 2022. Venue: Encore Hotel, 3121 Las Vegas Blvd. S, Las Vegas, Nevada, United States.

Jefferies LLC, 2022 Jefferies Global Healthcare Conference, Jun 08, 2022 through Jun 10, 2022

2022-02-14 21:00:00

Jefferies LLC, 2022 Jefferies Global Healthcare Conference, Jun 08, 2022 through Jun 10, 2022. Venue: Marriott Marquis, New York City, New York, United States.

Exelixis, Inc. Provides Sales Guidance for the Year 2022

2022-02-09 18:30:00

Exelixis, Inc. provided sales guidance for the year 2022. For the period, The company expects net sales to be in the range of $1.3 billion and $1.4 billion roughly.

Exelixis, Inc. Presents at 4th Annual Guggenheim Oncology Day, Feb-09-2022 01:30 PM

2022-02-02 21:05:00

Exelixis, Inc. Presents at 4th Annual Guggenheim Oncology Day, Feb-09-2022 01:30 PM.

William Blair & Company, L.L.C., William Blair’s 42nd Annual Growth Stock Conference 2022, Jun 06, 2022 through Jun 09, 2022

2022-01-25 11:00:00

William Blair & Company, L.L.C., William Blair’s 42nd Annual Growth Stock Conference 2022, Jun 06, 2022 through Jun 09, 2022. Venue: Loews Chicago Hotel, Chicago, Illinois, United States.

Guggenheim Securities, LLC, 4th Annual Guggenheim Oncology Day, Feb 09, 2022 through Feb 11, 2022

2022-01-24 11:50:00

Guggenheim Securities, LLC, 4th Annual Guggenheim Oncology Day, Feb 09, 2022 through Feb 11, 2022.

Exelixis, Inc. Appoints Vicki L. Goodman as Executive Vice President, Product Development & Medical Affairs and Chief Medical Officer

2022-01-04 13:00:00

Exelixis, Inc. announced the appointment of Vicki L. Goodman, M.D., as Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer. Dr. Goodman has more than 20 years of oncology experience as a drug development leader at global biopharmaceutical organizations, regulator and clinician. She joins Exelixis from Merck, where she served as Vice President, Clinical Research and Therapeutic Area Head, Late Stage Oncology; her previous tenures in the biopharmaceutical industry include clinical development leadership positions at Bristol Myers Squibb and GlaxoSmithKline. Dr. Goodman joins Exelixis as the company continues to maximize the clinical potential of CABOMETYX® (cabozantinib), its global oncology franchise, while rapidly advancing its pipeline of promising investigational small molecules and biologics to treat cancer.

Exelixis, Inc. Appoints Jacqueline Wright to Its Board of Directors, as Member of the Nominating and Corporate Governance Committee and Risk Committee

2021-12-17 13:00:00

Exelixis, Inc. announced that accomplished technology executive Jacqueline (Jacky) Wright has been elected to the company’s Board of Directors. Ms. Wright’s appointment took effect on December 16, 2021. Ms. Wright has decades of technology experience and is widely recognized for her expertise in digital transformation, both in the public and private sectors. She currently serves as Corporate Vice President & Chief Digital Officer, U.S. Business at Microsoft Corporation, which she joined as a Vice President, IT Strategic Enterprise Services in 2011. From 2017 to 2019, Ms. Wright took leave from Microsoft to serve as Chief Information & Digital Officer at HM Revenue and Customs, the United Kingdom’s tax department, where she led digital transformation efforts preparing the department for the UK’s departure from the European Union. Prior to joining Microsoft, from 2008 to 2011 Ms. Wright served as Vice President & Chief Information Officer, Corporate Functions at BP plc, the multinational energy company. Earlier in her career, Ms. Wright served in Chief Information Officer roles in multiple business segments of General Electric Company and also spent time at Anderson Consulting LLP and Ryder System, Inc., a leader in transportation and logistics. Ms. Wright is a current member of the industry advisory board at the Institute of Coding as well as a member of the data analytics advisory board at Bernard M. Baruch College, City University of New York, where she received her B.B.A. in Computer Information Systems & Accounting. Ms. Wright has also served as a board member for nVent Electric plc, a publicly held provider of electrical connection and protection solutions, since March 2020, and for Russell Reynolds Associates, Inc., a privately held global leadership advisory and search firm, since June 2021. She previously served on the board of trustees of Harvey Mudd College. Ms. Wright was also appointed as a member of the Nominating and Corporate Governance Committee of the Board and as a member of the Risk Committee of the Board.

Exelixis, Inc. Announces Initiation of Phase 1B Trial Evaluating XL092 in Combination with Immuno-Oncology Therapies in Patients with Advanced Solid Tumors

2021-12-15 13:00:00

Exelixis, Inc. announced initiation of the dose-escalation stage of STELLAR-002, a phase 1b trial evaluating XL092 in combination with immuno-oncology therapies in advanced solid tumors. The objective of the study is to evaluate the safety, tolerability and efficacy of XL092, Exelixis’ novel next-generation tyrosine kinase inhibitor, in combination with: nivolumab; nivolumab and ipilimumab; and nivolumab and bempegaldesleukin. Exelixis is sponsoring STELLAR-002, and Bristol-Myers Squibb Company is providing nivolumab, ipilimumab and bempegaldesleukin for use in the trial, in accordance with their clinical trial collaboration and supply agreement announced in June. Nektar Therapeutics will supply bempegaldesleukin to Bristol Myers Squibb through their existing global development and commercialization collaboration. The dose-escalation stage will determine the recommended dose in patients with advanced solid tumors for each of the XL092 combination therapy regimens. Once the recommended dose is established, the trial will begin to enroll tumor-specific expansion cohorts for patients with advanced renal cell carcinoma, urothelial carcinoma and metastatic castration-resistant prostate cancer. The primary efficacy endpoint of the expansion stage will be objective response rates, except for the cohort of patients with metastatic castration-resistant prostate cancer, for which the primary endpoint will be duration of radiographic progression-free survival. XL092 is a next-generation oral tyrosine kinase inhibitor that targets kinases implicated in cancer growth and spread, including VEGF receptors, MET, AXL and MER. In designing XL092, Exelixis sought to build upon its extensive experience with cabozantinib, the company’s medicine, retaining the target profile while improving key characteristics, including pharmacokinetic half-life. XL092 is currently being developed for the treatment of advanced solid tumors, including genitourinary cancers, as a monotherapy and in combination with immune checkpoint inhibitors. XL092 is the first internally discovered Exelixis compound to enter the clinic following the company’s reinitiation of drug-discovery activities. Genitourinary cancers are those that affect the urinary tract, prostate, testicles or penis — parts of the body involved in reproduction and urine production and excretion — and include renal cell carcinoma, castration-resistant prostate cancer and urothelial carcinomas. The American Cancer Society’s 2021 statistics cite kidney cancer as among the top 10 most commonly diagnosed forms of cancer among both men and women in the U.S.2 Clear cell RCC is the most common type of kidney cancer in adults.3 Papillary RCC accounts for about 15% of all renal cell cancers.4,5 If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 13%. Approximately 32,000 patients in the U.S. and over 71,000 worldwide will require systemic treatment for advanced kidney cancer in 2021, with nearly 15,000 patients in need of a first-line treatment in the U.S. According to the ACS, in 2021, approximately 250,000 new cases of prostate cancer will be diagnosed, and 34,000 people will die from the disease.2 Prostate cancer that has spread beyond the prostate and does not respond to androgen-suppression therapies — a common treatment for prostate cancer — is known as metastatic CRPC. Researchers estimate that in 2020, 43,000 people were diagnosed with metastatic CRPC, which has a median survival of less than two years. Urothelial cancers encompass carcinomas of the bladder, ureter and renal pelvis at a ratio of 50:3:1, respectively.11 Bladder cancer occurs mainly in older people, with 90% of patients aged 55 or older.12 With an estimated 84,000 new cases expected to be diagnosed in 2021, bladder cancer accounts for about 5% of all new cases of cancer in the U.S. each year.2,13 It is the fourth most common cancer in men.

Exelixis, Inc. Presents at Piper Sandler 33rd Annual Virtual Healthcare Conference, Nov-29-2021

2021-11-22 15:06:00

Exelixis, Inc. Presents at Piper Sandler 33rd Annual Virtual Healthcare Conference, Nov-29-2021 . Venue: New York, New York, United States.

Exelixis Announces Detailed Results from Phase 3 Cosmic-312 Pivotal Trial of Cabozantinib in Combination with an Immune Checkpoint Inhibitor in Patients with Previously Untreated Advanced Liver Cancer At Esmo Asia Virtual Oncology Week 2021

2021-11-20 11:00:00

Exelixis, Inc. announced detailed results from the first planned analysis of COSMIC-312, the ongoing phase 3 pivotal trial evaluating cabozantinib (CABOMETYX®) in combination with atezolizumab versus sorafenib in patients with previously untreated advanced hepatocellular carcinoma (HCC). New results presented during the 2021 ESMO Virtual Plenary include detailed data for a prespecified interim analysis for the primary endpoint of overall survival (OS) in the intent-to-treat (ITT) population, which was conducted at the same time as the primary analysis for PFS in the PITT population. At a median follow-up of 13.6 months, the interim OS analysis in the ITT population showed a trend that favored cabozantinib in combination with atezolizumab but did not reach statistical significance (HR: 0.90; 96% CI: 0.69-1.18; P=0.438). Median OS was 15.4 months for cabozantinib in combination with atezolizumab (n=432) versus 15.5 months for sorafenib (n=217). The trial is continuing as planned to the final analysis of OS, anticipated in early 2022. In an interim analysis of the secondary endpoint of PFS per RECIST 1.1 by BIRC performed to determine the contribution of cabozantinib to the combination with atezolizumab, cabozantinib monotherapy reduced the risk of disease progression or death in the ITT population by 29% versus sorafenib (HR: 0.71; 99% CI: 0.51-1.01; P=0.0107; pre-specified critical p-value of 0.00451). Median PFS was 5.8 months for cabozantinib (n=188) versus 4.3 months for sorafenib (n=217). Objective response rates per RECIST 1.1 by BIRC in the ITT population were 11% for cabozantinib in combination with atezolizumab, 3.7% for sorafenib and 6.4% for cabozantinib monotherapy. Disease control rates (complete response + partial response + stable disease) were 78%, 65% and 84%, respectively.

Exelixis Announces Enrollment Completion in Phase 3 CONTACT-01 Pivotal Trial of Cabozantinib in Combination with an Immune Checkpoint Inhibitor in Previously Treated Metastatic Non-Small Cell Lung Cancer

2021-11-09 13:00:00

Exelixis, Inc. (Nasdaq: EXEL) announced that enrollment is now completed for CONTACT-01, the global, phase 3 pivotal trial evaluating cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®) in patients with metastatic non-small cell lung cancer (NSCLC) who have been previously treated with an immune checkpoint inhibitor and platinum-containing chemotherapy. CONTACT-01 is a global, multicenter, randomized, phase 3, open-label study that enrolled 366 patients who were randomized 1:1 to the experimental arm of cabozantinib in combination with atezolizumab and the control arm of docetaxel. The primary endpoint of the trial is overall survival. Secondary endpoints include progression-free survival, objective response rate and duration of response. Results from cohort 7 of the phase 1b COSMIC-021 trial informed the CONTACT-01 trial design. CONTACT-01 is sponsored by Roche and co-funded by Exelixis. More information about the trial is available at ClinicalTrials.gov.

Exelixis, Inc. Presents at 4th Annual Evercore ISI HealthCONx Virtual Conference, Dec-01-2021 11:45 AM

2021-11-03 20:05:00

Exelixis, Inc. Presents at 4th Annual Evercore ISI HealthCONx Virtual Conference, Dec-01-2021 11:45 AM.

Exelixis, Inc. Presents at Stifel 2021 Virtual Healthcare Conference, Nov-16-2021 04:40 PM

2021-11-03 20:05:00

Exelixis, Inc. Presents at Stifel 2021 Virtual Healthcare Conference, Nov-16-2021 04:40 PM. Venue: New York, New York, United States.

Exelixis, Inc. Presents at BMO Biopharma Spotlight Series: Emerging Trends & Therapeutics in Oncology, Nov-08-2021 12:10 PM

2021-11-03 20:05:00

Exelixis, Inc. Presents at BMO Biopharma Spotlight Series: Emerging Trends & Therapeutics in Oncology, Nov-08-2021 12:10 PM. Speakers: Michael M. Morrissey, CEO, President & Director.

Exelixis, Inc. Presents at Piper Sandler 33rd Annual Virtual Healthcare Conference: Fireside Chat, Nov-22-2021 10:00 AM

2021-11-03 20:05:00

Exelixis, Inc. Presents at Piper Sandler 33rd Annual Virtual Healthcare Conference: Fireside Chat, Nov-22-2021 10:00 AM.

Exelixis, Inc. Provides Earnings Guidance for the Full Year 2021

2021-11-02 20:05:00

Exelixis, Inc. provides earnings guidance for the full year 2021. For the full year, the company expects total revenue of $1,300 million - $1,350 million.

BMO Capital Markets Corp., BMO Biopharma Spotlight Series: Emerging Trends & Therapeutics in Oncology, Nov 08, 2021

2021-11-01 12:00:00

BMO Capital Markets Corp., BMO Biopharma Spotlight Series: Emerging Trends & Therapeutics in Oncology, Nov 08, 2021.

Piper Sandler Companies, Piper Sandler 33rd Annual Virtual Healthcare Conference: Fireside Chat, Nov 22, 2021

2021-10-25 10:00:00

Piper Sandler Companies, Piper Sandler 33rd Annual Virtual Healthcare Conference: Fireside Chat, Nov 22, 2021.

Exelixis, Inc., Q3 2021 Earnings Call, Nov 02, 2021

2021-10-19 20:05:00

Exelixis, Inc., Q3 2021 Earnings Call, Nov 02, 2021

Exelixis, Inc. to Report Q3, 2021 Results on Nov 02, 2021

2021-10-19 20:05:00

Exelixis, Inc. announced that they will report Q3, 2021 results After-Market on Nov 02, 2021

Exelixis, Inc. Exercises Exclusive Option Under the Companies’ July 2019 Agreement

2021-10-14 12:00:00

Exelixis, Inc. and Aurigene Discovery Technologies Limited (Aurigene) announced that Exelixis has exercised its exclusive option under the companies’ July 2019 agreement to in-license XL114 (formerly AUR104), a novel anti-cancer compound that inhibits the CARD11-BCL10-MALT1 (CBM) signaling pathway, which promotes lymphocyte survival and proliferation. Exelixis has now assumed responsibility for the future clinical development, commercialization and global manufacturing of XL114. Following the U.S. Food and Drug Administration’s (FDA) recent acceptance of its Investigational New Drug (IND) application, Exelixis will soon initiate a phase 1 clinical trial evaluating XL114 monotherapy in patients with Non-Hodgkin’s lymphoma (NHL). At the American Association of Cancer Research Annual Meeting in April of this year, Aurigene presented preclinical data (Abstract 1266) demonstrating that XL114 exhibited potent anti-proliferative activity in a large panel of cancer cell lines ranging from hematological cancers to solid tumors with excellent selectivity over normal cells. In addition, oral dosing of XL114 resulted in significant dose-dependent tumor growth inhibition in diffuse large B-cell lymphoma (DLBCL) and colon carcinoma models. XL114 is the second molecule that Exelixis in-licensed from Aurigene under the companies’ July 2019 collaboration, option and license agreement. Exelixis previously exercised its option to in-license XL102, a potent, selective and orally bioavailable inhibitor of cyclin-dependent kinase 7 (CDK7), from Aurigene in December 2020 and initiated a phase 1 trial of XL102 as a single agent and in combination with other anti-cancer agents in patients with advanced or metastatic solid tumors in January 2021. XL114 was identified to have anti-proliferative activity in cell lines with constitutive activation of CBM signaling, including activated B-cell-like DLBCL (ABC-DLBCL), mantle cell lymphoma and follicular lymphoma cell lines. Further characterization of XL114 in cell-based assays demonstrated a functional role in B-cell (BCR) signaling pathways. Additionally, XL114 showed dose-dependent tumor growth inhibition in an ABC-DLBCL mouse xenograft tumor model. In preclinical development, XL114 also demonstrated a high degree of selectivity against a broad safety pharmacology panel of enzymes and receptors. While the precise molecular mechanism underlying XL114’s function in repressing BCR signaling and MALT1 activation has yet to be characterized, the fatty acid-binding protein 5 (FABP5) has been identified as a prominent XL114-binding target. Under the terms of the July 2019 agreement, Exelixis made an upfront payment of $10 million for exclusive options to obtain an exclusive license from Aurigene to three preexisting programs, including the compounds now known as XL102 and XL114. In addition, Exelixis and Aurigene initiated three Aurigene-led drug discovery programs on mutually agreed upon targets, in exchange for an additional upfront payment of $2.5 million per program. The collaboration was expanded in 2021 to include three additional early discovery programs. Exelixis is also contributing research funding to Aurigene to facilitate discovery and preclinical development work on all nine programs. Exelixis may exercise its option for a program at any time up until the first IND for the program becomes effective. Having exercised options on two programs thus far (XL102 and XL114), if and when Exelixis exercises a future 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 XL114, Exelixis will make an option exercise payment to Aurigene of $10 million. Once Exelixis exercises its option for a program, Aurigene will be eligible for clinical development, regulatory and sales milestones, as well as royalties on future potential sales of the compound. Under the terms of the agreement, Aurigene retains limited development and commercial rights for India and Russia.

Exelixis, Inc. Presents at 30th Annual Credit Suisse Healthcare Conference, Nov-10-2021 01:50 PM

2021-10-01 10:34:00

Exelixis, Inc. Presents at 30th Annual Credit Suisse Healthcare Conference, Nov-10-2021 01:50 PM. Venue: Rancho Palos Verdes, California, United States. Speakers: Andrew Ross Peters, Vice President of Strategy, Christopher J. Senner, Executive VP & CFO, Michael M. Morrissey, CEO, President & Director, Susan T. Hubbard, Executive Vice President of Public Affairs & Investor Relations.

Exelixis Announces Final Results from Phase 3 COSMIC-311 Pivotal Trial of CABOMETYX® in Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer Presented at ESMO 2021

2021-09-20 15:30:00

Exelixis, Inc. announced final results from the phase 3 COSMIC-311 pivotal trial of CABOMETYX® (cabozantinib) in patients with previously treated radioactive iodine-refractory differentiated thyroid cancer (DTC). Following a previous announcement that the trial met one of the two primary endpoints of significant improvement versus placebo in progression-free survival (PFS) assessed by blinded independent radiology committee (BIRC; p<0.0001), the results of the final analysis are being presented during the Mini Oral Session – NETs and Endocrine Tumours at 5:30 p.m. CEST on September 20 at the 2021 European Society of Medical Oncology (ESMO) Congress (LBA67). At a median follow-up of 10.1 months, the significant improvement in PFS with CABOMETYX was maintained, with consistent benefit in subgroups based on prior treatment. At a median follow-up of 10.1 months, CABOMETYX reduced the risk of disease progression or death versus placebo (hazard ratio [HR]: 0.22; 96% confidence interval [CI]: 0.15–0.32) in the intent-to-treat (ITT) population. Median PFS as assessed by BIRC was 11.0 months for patients treated with CABOMETYX (n=170) compared with 1.9 months for patients treated with placebo (n=88). Subgroup analyses demonstrated that CABOMETYX improved PFS versus placebo irrespective of prior exposure to lenvatinib and/or sorafenib: Prior sorafenib/no lenvatinib: median PFS was 16.6 months for patients treated with CABOMETYX (n=63) compared with 3.2 months for placebo (n=33) (HR: 0.13; 95% CI: 0.06–0.26). Prior lenvatinib/no sorafenib: median PFS was 5.8 months for patients treated with CABOMETYX (n=68) compared with 1.9 months for placebo (n=34) (HR: 0.28; 95% CI: 0.16–0.48). Prior sorafenib and lenvatinib: median PFS was 7.6 months for patients treated with CABOMETYX (n=39) compared with 1.9 months for placebo (n=21) (HR: 0.27; 95% CI: 0.13–0.54).

Exelixis, Inc. Announces Detailed Phase 1b Results from Cohort 6 of COSMIC-021 Trial in Patients with Metastatic Castration-Resistant Prostate Cancer Presented at ESMO 2021

2021-09-18 11:30:00

Exelixis, Inc. announced detailed results from the expanded cohort 6 of the phase 1b COSMIC-021 trial of cabozantinib (CABOMETYX®) in combination with atezolizumab in patients with metastatic castration-resistant prostate cancer (CRPC). Cohort 6 included patients with metastatic CRPC who had been previously treated with the novel hormone therapies (NHT) enzalutamide and/or abiraterone acetate used along with prednisone. The data are being presented during the Proffered Paper Session: GU Tumours, Prostate on September 18, 2021 at 1:30 p.m. CEST at the 2021 European Society of Medical Oncology (ESMO) Congress (LBA24). Eligible patients in the trial had measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v 1.1) per investigator assessment, had progressed on prior NHT, and could have received prior docetaxel for metastatic hormone-sensitive disease. The analysis included 132 patients with metastatic CRPC, 101 of whom were high-risk, which was defined as having measurable visceral metastases and/or extrapelvic lymphadenopathy. The median follow-up for all patients was 15.2 months, and the primary endpoint was objective response rate (ORR) by investigator per RECIST 1.1. As previously announced, in the high-risk patient population, investigator-assessed ORR was 27%, including 2% complete responses (CRs). The Blinded Independent Radiology Committee (BIRC)-assessed ORR was 18%, all partial responses (PRs). The disease control rate (CR + PR + stable disease) was 88% by investigator assessment and 84% by BIRC assessment. New detailed results being presented at the 2021 ESMO Congress demonstrate that median progression-free survival per RECIST 1.1 for the high-risk population was 5.6 months (95% confidence interval [CI]: 5.4-8.2) as assessed by investigators and 6.8 months (95% CI: 5.5-9.7) as assessed by BIRC. The exploratory endpoint of overall survival for the high-risk patient population was 18.4 months (95% CI: 13.6-24.7). Tumor PD-L1 status, which was known for 75 patients, was not associated with response. The safety profile was consistent with that previously observed for each single agent. No new safety signals were observed. Discontinuation of both agents due to treatment-related adverse events (AEs) occurred in 10% of patients. Frequent treatment-related AEs were diarrhea (55%), fatigue (43%), nausea (42%) and decreased appetite (34%). Grade 3 or 4 treatment-related AEs occurred in 55% of patients (of which 3% experienced grade 4 AEs), and one grade 5 treatment-related AE was reported. Following discussions with the U.S. Food and Drug Administration (FDA), Exelixis will not pursue a regulatory submission for the combination regimen based on cohort 6 of the COSMIC-021 trial. The CONTACT-02 study, a global phase 3 pivotal trial, initiated enrollment in June 2020 and is evaluating cabozantinib in combination with atezolizumab versus a second NHT in patients with metastatic CRPC who have been previously treated with one NHT. Pending results, CONTACT-02 may serve as a basis for future regulatory applications in this setting.

Exelixis, Inc. Announces U.S. FDA Approval of CABOMETYX® (cabozantinib) for Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer

2021-09-17 20:23:00

Exelixis, Inc. announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX® (cabozantinib) for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior vascular endothelial growth factor receptor (VEGFR)-targeted therapy and who are radioactive iodine-refractory or ineligible. The FDA granted Breakthrough Therapy designation and Priority Review to CABOMETYX and its approval comes more than two months ahead of the Prescription Drug User Fee Act (PDUFA) target action date of December 4, 2021. DTC is the most common type of thyroid cancer in the U.S., and patients who are resistant to radioactive iodine treatment face a poor prognosis. The approval is based on results from COSMIC-311, a phase 3 pivotal trial evaluating CABOMETYX versus placebo in patients with radioactive iodine-refractory DTC who progressed after up to two prior VEGFR-targeted therapies. At a planned interim analysis, CABOMETYX significantly reduced the risk of disease progression or death versus placebo (p<0.0001) in the intent-to-treat population. At a follow-up analysis with a median follow-up of 10.1 months, the median progression-free survival (PFS) as assessed by blinded independent radiology committee was 11.0 months for patients treated with CABOMETYX (n=170) compared with 1.9 months for patients treated with placebo (n=88); hazard ratio (HR): 0.22; 95% confidence interval (CI): 0.15–0.31. These results will be presented at the 2021 European Society of Medical Oncology (ESMO) Congress this month. The most common adverse events (AEs) reported in at least 25% of patients treated with CABOMETYX were diarrhea, palmar-plantar erythrodysesthesia, fatigue, hypertension and stomatitis. Grade 3/4 AEs that occurred in at least 5% of patients were palmar-plantar erythrodysesthesia, hypertension, fatigue, diarrhea and stomatitis. Serious AEs occurred in 34% of patients who received CABOMETYX, and the most common serious AEs reported in at least 2% of patients included diarrhea, pleural effusion, pulmonary embolism and dyspnea. Fatal AEs occurred in 1.6% of patients treated with CABOMETYX arm, including arterial hemorrhage (0.8%) and pulmonary embolism (0.8%). Dose reductions were required in 56% of patients treated with CABOMETYX, and 22% of patients required a second dose reduction. AEs leading to discontinuation of CABOMETYX occurred in 5% of patients.

Exelixis, Inc Announces CABOMETYX in Combination with OPDIVO® Provides Efficacy Benefits Regardless of Prior Nephrectomy in Patients

2021-09-16 06:30:00

Exelixis, Inc. announced results demonstrating efficacy benefits regardless of prior nephrectomy status with CABOMETYX® (cabozantinib) in combination with Bristol Myers Squibb’s OPDIVO® (nivolumab) versus sunitinib for patients with previously untreated advanced renal cell carcinoma (RCC). The data, from a post-hoc exploratory analysis of the phase 3 CheckMate -9ER pivotal trial, will be presented as an ePoster available on demand beginning at September 16 during the 2021 European Society of Medical Oncology (ESMO) Congress (abstract 663P). As previously announced, the phase 3 CheckMate -9ER pivotal trial showed that CABOMETYX in combination with OPDIVO improved overall survival (OS) and doubled median progression-free survival (PFS) and objective response rate (ORR) versus sunitinib in patients with previously untreated advanced RCC. In this new exploratory analysis presented at ESMO 2021, at a median follow-up of 23.5 months, PFS and ORR benefits were observed regardless of prior nephrectomy status. The magnitudes of PFS and ORR benefits associated with CABOMETYX in combination with OPDIVO were greater in the subgroup of patients with prior nephrectomy versus those without prior nephrectomy. See table below for additional details. In CheckMate -9ER, CABOMETYX in combination with OPDIVO was generally well tolerated and reflected the known safety profiles of the tyrosine kinase inhibitor and immunotherapy components in previously untreated advanced RCC. The most common adverse reactions reported in at least 20% of patients treated with CABOMETYX in combination with OPDIVO were diarrhea, fatigue, hepatotoxicity, palmar-plantar erythrodysesthesia, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, dysgeusia, abdominal pain, cough and upper respiratory tract infection. A safety analysis with extended follow-up reported at the 2021 American Society of Clinical Oncology’s Genitourinary Cancers Symposium identified no new safety signals; among patients treated with OPDIVO and CABOMETYX, 6.6% discontinued both agents due to treatment-related adverse events, 9.7% discontinued OPDIVO only and 7.2% discontinued CABOMETYX only.

Exelixis, Inc. Presents at Morgan Stanley 19th Annual Global Healthcare Conference, Sep-09-2021 01:15 PM

2021-09-08 01:42:00

Exelixis, Inc. Presents at Morgan Stanley 19th Annual Global Healthcare Conference, Sep-09-2021 01:15 PM. Venue: New Windsor, United States.

Exelixis, Inc. Announces Passing of Gisela M. Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer

2021-09-06 17:00:00

Exelixis, Inc. announced that Gisela M. Schwab, M.D., the company’s President, Product Development and Medical Affairs and Chief Medical Officer, passed away over the weekend.

Exelixis, Inc. Presents at H.C. Wainwright 23rd Annual Global Investment Conference, Sep-13-2021 07:00 AM

2021-09-02 03:45:00

Exelixis, Inc. Presents at H.C. Wainwright 23rd Annual Global Investment Conference, Sep-13-2021 07:00 AM. Venue: Lotte New York Palace Hotel, New York City, New York, United States.

Exelixis, Inc. Presents at Cantor Global Healthcare 2021 Conference, Sep-29-2021 02:40 PM

2021-09-02 03:45:00

Exelixis, Inc. Presents at Cantor Global Healthcare 2021 Conference, Sep-29-2021 02:40 PM. Venue: New York, United States.

Exelixis, Inc. Presents at Bank of America Global Healthcare Conference, Sep-15-2021 12:35 PM

2021-09-02 03:45:00

Exelixis, Inc. Presents at Bank of America Global Healthcare Conference, Sep-15-2021 12:35 PM. Speakers: Michael M. Morrissey, CEO, President & Director.

Exelixis, Inc. Announces Partner Takeda Pharmaceutical Company Limited and Ono Receive Approval in Japan for CABOMETYX in Combination with Opdivo for the Treatment of Unresectable or Metastatic Renal Cell Carcinoma

2021-08-25 20:05:00

Exelixis, Inc. announced Takeda Pharmaceutical Company Limited (Takeda), its partner responsible for the clinical development and commercialization of CABOMETYX in Japan, and Ono Pharmaceutical Co., Ltd. received approval from the Japanese Ministry of Health, Labor and Welfare to manufacture and market CABOMETYX in combination with OPDIVO as a treatment for unresectable or metastatic renal cell carcinoma. The approval is based on CheckMate -9ER, a phase 3 pivotal trial evaluating CABOMETYX in combination with OPDIVO in previously untreated patients with advanced or metastatic RCC compared with sunitinib. In CheckMate -9ER, CABOMETYX in combination with OPDIVO demonstrated superior overall survival and doubled median progression-free survival and objective response rate versus sunitinib, with a favorable safety profile. Per the terms of Exelixis and Takeda’s collaboration and license agreement, Exelixis is eligible to receive a milestone payment of $20 million from Takeda upon the first commercial sale of CABOMETYX in combination with OPDIVO for the treatment of RCC. Exelixis continues to be eligible to receive additional development, regulatory and first-sale milestones for potential future cabozantinib indications and is also eligible for sales revenue milestones and royalties on net sales of cabozantinib in Japan. Takeda previously received approvals to manufacture and market CABOMETYX in Japan as a treatment for patients with curatively unresectable or metastatic RCC and for patients with unresectable hepatocellular carcinoma that has progressed after prior systemic therapy.

Evercore Inc., 4th Annual Evercore ISI HealthCONx Virtual Conference, Nov 29, 2021 through Dec 03, 2021

2021-08-24 20:29:00

Evercore Inc., 4th Annual Evercore ISI HealthCONx Virtual Conference, Nov 29, 2021 through Dec 03, 2021.

Exelixis, Inc. Presents at European Society for Medical Oncology Virtual Congress 2021, Sep-16-2021

2021-08-23 12:06:00

Exelixis, Inc. Presents at European Society for Medical Oncology Virtual Congress 2021, Sep-16-2021 . Venue: Paris Expo Porte de Versailles, Paris, France.

Exelixis, Inc. and Invenra, Inc. Expand Collaboration to Discover and Develop Novel Biologics in Oncology

2021-08-16 12:05:00

Exelixis, Inc. and Invenra, Inc. announced that they have expanded their discovery and licensing collaboration to include an additional 20 oncology targets. The augmented partnership builds on the two companies’ ongoing collaboration and license agreement to discover and develop mono-specific and multi-specific antibodies for incorporation into novel biologics to treat cancer, which was originally announced in May 2018 and expanded in October 2019. Under the terms of this newly expanded collaboration, Exelixis has agreed to pay Invenra an upfront fee of $15.0 million, as well as additional fees and funding for the option to nominate up to 20 additional targets in oncology. Invenra will be eligible for development, regulatory, and commercial milestones, as well as tiered royalties on net sales of any approved products. Exelixis will own all antibody sequences discovered from the collaboration for all therapeutic uses in oncology and any other disease areas. The expanded collaboration also provides Exelixis with an option to obtain development and commercialization rights to certain of Invenra’s future internal pipeline programs, in exchange for an opt-in fee. Under the terms of the original agreement, announced by the parties on May 2, 2018, Exelixis and Invenra are currently collaborating to discover and develop mono-specific and multi-specific antibodies using Invenra’s antibody and B-Body™ platforms. Invenra is responsible for antibody lead discovery and generation. Exelixis leads investigational new drug (IND)-enabling studies, manufacturing, and clinical development in single-agent and combination therapy regimens, as well as future regulatory and commercialization activities. Invenra is eligible to receive payments based on the achievement of specific pre-clinical, clinical development, and regulatory milestones. Upon successful commercialization of a product, Invenra is eligible to receive milestone payments and royalties. Prior to today’s announcement, the companies expanded their collaboration on October 31, 2019 to generate additional programs.

Exelixis, Inc. Provides Revenue Guidance for the Full Year of Fiscal 2021

2021-08-05 20:05:00

Exelixis, Inc. provided revenue guidance for the full year of fiscal 2021. For the year, the company expects total revenues of $1,300 million to $1,400 million.

Exelixis Announces U.S. FDA Accepts for Priority Review the Supplemental New Drug Application for CABOMETYX (cabozantinib) for Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer

2021-08-05 12:00:00

Exelixis, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for CABOMETYX (cabozantinib) as a treatment for patients 12 years and older with differentiated thyroid cancer (DTC) who have progressed following prior therapy and are radioactive iodine-refractory (if radioactive iodine is appropriate). The FDA granted Priority Review designation and assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 4, 2021. The sNDA is based on the results of COSMIC-311, a phase 3 pivotal trial evaluating CABOMETYX versus placebo in patients with radioactive iodine-refractory DTC who progressed after up to two prior vascular endothelial growth factor receptor (VEGFR)-targeted therapies. At a planned interim analysis, CABOMETYX met one of the trial’s primary endpoints, demonstrating a significant improvement in progression-free survival versus placebo. In February 2021, the FDA granted Breakthrough Therapy Designation to CABOMETYX as a potential treatment for patients with DTC that has progressed following prior therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate) based on these results.

Exelixis, Inc., Q2 2021 Earnings Call, Aug 05, 2021

2021-07-22 20:05:00

Exelixis, Inc., Q2 2021 Earnings Call, Aug 05, 2021

Exelixis, Inc. to Report Q2, 2021 Results on Aug 05, 2021

2021-07-22 20:05:00

Exelixis, Inc. announced that they will report Q2, 2021 results After-Market on Aug 05, 2021

Exelixis, Inc. Presents at William Blair Biotech Focus Conference 2021, Jul-15-2021 02:00 PM

2021-07-09 02:09:00

Exelixis, Inc. Presents at William Blair Biotech Focus Conference 2021, Jul-15-2021 02:00 PM. Speakers: Peter Lamb, Executive VP of Scientific Strategy & Chief Scientific Officer.

Stifel, Nicolaus & Company, Incorporated, Stifel 2021 Virtual Healthcare Conference, Nov 15, 2021 through Nov 17, 2021

2021-07-08 08:44:00

Stifel, Nicolaus & Company, Incorporated, Stifel 2021 Virtual Healthcare Conference, Nov 15, 2021 through Nov 17, 2021. Venue: New York, New York, United States.