Latest news with #CABOMETYX
Business Wire
2 days ago
- Business
- Business Wire
Exelixis Announces Second Quarter 2025 Financial Results and Provides Corporate Update
ALAMEDA, Calif.--(BUSINESS WIRE)--Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the second quarter of 2025, provided an update on progress toward achieving key corporate objectives, and outlined its commercial, clinical and pipeline development milestones. 'Exelixis continued to execute on our corporate objectives in the second quarter of 2025, delivering on key commercial, development and pipeline milestones,' said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. 'While early in the launch, we're very pleased with the reception that CABOMETYX ® has received in advanced neuroendocrine tumors (NET). Our commercial team rapidly mobilized on the U.S. NET launch following approval in March, capturing a leading share of new patient starts among oral therapies in second-line and later settings with NET representing approximately four percent of our overall CABOMETYX business in the second quarter. We will continue to track the launch trajectory and provide updates to our 2025 full year financial guidance, as appropriate.' Dr. Morrissey continued: 'Turning to the zanzalintinib development program, in June, we announced positive topline results from the STELLAR-303 pivotal study in colorectal cancer. We plan to discuss these results with regulators with the intention of filing for approval in this indication as quickly as possible. In May, we completed enrollment into the STELLAR-304 pivotal study in non-clear cell renal cell carcinoma with top-line results expected in the first half of 2026, depending on study event rates. Based on our evaluation of emerging data from the phase 2 portion of the STELLAR-305 study in advanced squamous cell carcinoma of the head and neck, emerging competition in this indication and assessment of other potentially larger commercial opportunities, we have made the decision not to proceed to the phase 3 portion of the trial. We also initiated the STELLAR-311 pivotal study in advanced NET during the quarter and plan to announce an additional wave of zanzalintinib pivotal trials in the coming months. Finally, our early-stage pipeline is advancing quickly with phase 1 clinical studies ongoing for our XL309, XB010 and XB628 programs, and XB371 moving into clinical investigation. As we look ahead to the second half of the year, I'd like to thank the entire Exelixis team for their continued execution across our business, and for their dedication to our mission to help cancer patients recover stronger and live longer.' Second Quarter 2025 Financial Results Total revenues for the quarter ended June 30, 2025 were $568.3 million, as compared to $637.2 million for the comparable period in 2024. Total revenues for the quarter ended June 30, 2025 included net product revenues of $520.0 million, as compared to $437.6 million for the comparable period in 2024. The increase in net product revenues was primarily due to an increase in sales volume. Collaboration revenues, composed of license revenues and collaboration services revenues, were $48.2 million for the quarter ended June 30, 2025, as compared to $199.6 million for the comparable period in 2024. The decrease in collaboration revenues was primarily related to a $150.0 million commercial milestone recognized during the second quarter of 2024 in connection with Ipsen achieving $600 million in cumulative net sales of cabozantinib in its related license territory over four consecutive quarters. Research and development expenses for the quarter ended June 30, 2025 were $200.4 million, as compared to $211.1 million for the comparable period in 2024. The decrease in research and development expenses was primarily related to decreases in manufacturing costs to support our development candidates and clinical trial costs, partially offset by increases in stock-based compensation, consulting and outside services, and personnel expenses. Selling, general and administrative expenses for the quarter ended June 30, 2025 were $134.9 million, as compared to $132.0 million for the comparable period in 2024. The increase in selling, general and administrative expenses was primarily related to increases in marketing expenses, stock-based compensation, and personnel expenses, partially offset by a decrease in corporate giving. Provision for income taxes for the quarter ended June 30, 2025 was $45.6 million, as compared to $66.7 million for the comparable period in 2024. GAAP net income for the quarter ended June 30, 2025 was $184.8 million, or $0.68 per share, basic and $0.65 per share, diluted, as compared to GAAP net income of $226.1 million, or $0.78 per share, basic and $0.77 per share diluted, for the comparable period in 2024. GAAP net income per share for the quarter ended June 30, 2025 was favorably impacted by lower weighted-average common shares outstanding for the quarter ended June 30, 2025, as compared to the comparable period in 2024, as a result of the stock repurchase programs. Non-GAAP net income for the quarter ended June 30, 2025 was $212.6 million, or $0.78 per share, basic and $0.75 per share, diluted, as compared to non-GAAP net income of $245.6 million, or $0.85 per share, basic and $0.84 per share diluted, for the comparable period in 2024. Non-GAAP Financial Measures To supplement Exelixis' financial results presented in accordance with U.S. Generally Accepted Accounting Principles (GAAP), Exelixis presents non-GAAP net income (and the related per share measures), which excludes from GAAP net income (and the related per share measures) stock-based compensation, adjusted for the related income tax effect for all periods presented. Exelixis believes that the presentation of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors. In particular, Exelixis believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare Exelixis' results from period to period, and to identify operating trends in Exelixis' business. Exelixis has excluded stock-based compensation, adjusted for the related income tax effect, because it is a non-cash item that may vary significantly from period to period as a result of changes not directly or immediately related to the operational performance for the periods presented. Exelixis also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions. These non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. Exelixis encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations, to more fully understand Exelixis' business. Reconciliations between GAAP and non-GAAP results are presented in the tables of this release. 2025 Financial Guidance Exelixis is maintaining the previously provided financial guidance for fiscal year 2025. ____________________ (1) Exelixis' 2025 net product revenues guidance range includes the impact of a U.S. wholesale acquisition cost increase of 2.8% for CABOMETYX effective Jan. 1, 2025. (2) Includes $50.0 million of non-cash stock-based compensation. (3) Includes $80.0 million of non-cash stock-based compensation. Expand Second Quarter 2025 Highlights Cabozantinib Franchise Net Product Revenues and Royalties. Net product revenues generated by the cabozantinib franchise in the U.S. were $520.0 million during the second quarter of 2025, with net product revenues of $517.9 million from CABOMETYX (cabozantinib) and $2.1 million from COMETRIQ ® (cabozantinib). Based upon cabozantinib-related net product revenues generated by Exelixis' collaboration partners during the quarter ended June 30, 2025, Exelixis earned $43.4 million in royalty revenues. Partner Ipsen Received Approval from the European Commission (EC) for CABOMETYX for Patients with Previously Treated Advanced NET. In July, Exelixis announced that its partner Ipsen received approval from the EC for CABOMETYX for adult patients with unresectable or metastatic, well-differentiated pancreatic (pNET) and extra-pancreatic (epNET) neuroendocrine tumors who have progressed following at least one prior systemic therapy other than somatostatin analogues. This approval follows the positive opinion received from the European Medicines Agency's Committee for Medicinal Products for Human Use in June 2025 and allows for the marketing of CABOMETYX in this indication in all 27 member states of the European Union (EU), Norway, Liechtenstein and Iceland. In March, Exelixis received approval from the U.S. Food and Drug Administration (FDA) for CABOMETYX in this setting. These approvals were based on the positive results of the phase 3 CABINET pivotal trial, which evaluated CABOMETYX compared with placebo in two cohorts of patients with previously treated NET: advanced pNET and advanced epNET. Announcement of Positive Top-line Results from the Phase 3 STELLAR-303 Pivotal Trial Evaluating Zanzalintinib in Combination with an Immune Checkpoint Inhibitor in Patients with Metastatic Colorectal Cancer (CRC). In June, Exelixis announced positive top-line results from the phase 3 STELLAR-303 pivotal trial in which the combination of zanzalintinib with atezolizumab (Tecentriq ®) demonstrated a statistically significant improvement in overall survival (OS) versus regorafenib in the intent-to-treat (ITT) population. The STELLAR-303 study is evaluating zanzalintinib in combination with atezolizumab versus regorafenib in patients with metastatic, refractory non-microsatellite instability-high or non-mismatch repair-deficient (non-MSI-H/dMMR) CRC. The ITT population consisted of all randomized patients, regardless of the presence of liver metastases. The top-line findings were from the final analysis conducted by the Independent Data Monitoring Committee of one of the dual primary endpoints of the STELLAR-303 phase 3 trial. The trial will proceed to the planned final analysis for the other dual primary endpoint of OS in patients without liver metastases (non-liver metastases or NLM). The NLM subgroup consisted of patients who did not have active liver metastases at baseline as determined by investigator assessment. Exelixis plans to discuss these results with regulators with the intention of filing for approval in this indication as soon as possible. Detailed results will be presented at a future medical meeting. Presentation of Encouraging Results from Phase 1b/2 STELLAR-002 Trial Evaluating Zanzalintinib in Combination with Immune Checkpoint Inhibitors in Advanced Kidney Cancer at the 2025 American Society of Clinical Oncology Annual Meeting (ASCO 2025). In June, Exelixis presented results from multiple dose-escalation cohorts of patients with advanced solid tumors, and an expansion cohort of patients with previously untreated advanced clear cell renal cell carcinoma (ccRCC) from the phase 1b/2 STELLAR-002 trial evaluating zanzalintinib in combination with either nivolumab (Opdivo ®) or a fixed-dose combination of nivolumab and relatlimab (Opdualag ™) at ASCO 2025. The results from the ccRCC expansion cohort demonstrated encouraging activity across all efficacy parameters, including objective response rate (ORR), progression-free survival (PFS) and disease control rates. The findings from the dose-escalation cohorts showed that the toxicity profile of these combinations was manageable and consistent with each agent administered as monotherapy. Zanzalintinib Pivotal Development Program Updates. Today, Exelixis announced several updates to the zanzalintinib development program, including: STELLAR-304 study enrollment completed in May 2025. STELLAR-304 is a phase 3 pivotal trial evaluating zanzalintinib in combination with nivolumab versus sunitinib in previously untreated patients with advanced non-clear cell renal cell carcinoma (nccRCC). The primary endpoints in the trial are PFS and ORR. Top-line results are expected in the first half of 2026, depending on study event rates. Based on the company's evaluation of emerging data from the phase 2 portion of the STELLAR-305 trial in advanced squamous cell carcinoma of the head and neck (SCCHN), emerging competition in this indication, and assessment of other, potentially larger, commercial opportunities, Exelixis has decided not to proceed to phase 3. Initiation of the STELLAR-311 phase 3 pivotal trial in advanced NET. STELLAR-311 is evaluating zanzalintinib versus everolimus as a first oral therapy in patients with advanced NET, regardless of site of origin. The primary endpoint of the trial is PFS per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by Blinded Independent Central Review. Plans to announce the next wave of zanzalintinib pivotal trials in the coming months. Preclinical Data Presentations from Four Pipeline Programs in Advanced Cancers at the American Association for Cancer Research Annual Meeting (AACR 2025). In April, Exelixis presented preclinical data from four pipeline molecules at AACR 2025. Presentations included data for XL309 and XL495, small molecules that have demonstrated synthetic lethality in the context of certain genetic anomalies found in varying frequencies across a broad array of tumor types. The XL309 findings demonstrated activity of XL309 as monotherapy or in combination with PARP or topoisomerase inhibitors. Data analysis from the XL495 program demonstrated the potential for anti-tumor activity both as monotherapy and in combination with DNA-damaging agents. However, based on early clinical data generated for XL495, Exelixis has discontinued further development of this program. Preclinical data were also presented for the PD-L1 + NKG2A-targeting bispecific antibody XB628 and for the tissue factor (TF)-targeting antibody-drug conjugate (ADC) XB371. Data analysis from the XB628 program demonstrated the molecule's tumor cell killing activity both in vitro and in vivo, supporting advancement of this molecule into clinical development. Findings from XB371 non-clinical experiments demonstrated potent anti-tumor activity in vivo across a range of human tumor xenograft models including colorectal, lung, and pancreatic cancers, supporting the molecule's advancement into phase 1 clinical development. Advancement of XB628 and XB371 Pipeline Programs into Clinical Development. Today, Exelixis provided an update on the recent progress of its early-stage pipeline programs, including XB628 (PD-L1 + NKG2A-targeting bispecific antibody) and XB371 (TF-targeting ADC). In April, Exelixis initiated the phase 1 study of XB628, following the U.S. FDA clearance of its Investigational New Drug (IND) application in March. Exelixis now has three ongoing phase 1 trials for its pipeline programs XL309, XB010 and XB628. Additionally, in July, the U.S. FDA cleared Exelixis' IND application for XB371 and the company plans to initiate the phase 1 study in the coming months. Federal Income Tax Impact from the One Big Beautiful Bill Act. On July 4, 2025, the One Big Beautiful Bill Act was signed into law which, among other provisions, permanently repeals the requirement to capitalize domestic research and experimental (R&E) expenditures for federal income tax purposes for taxable years beginning after December 31, 2024, and allows for the accelerated deduction of any remaining unamortized domestic R&E expenditures. Foreign R&E expenditures are still required to be capitalized and amortized ratably over 15 years. Exelixis estimates its federal cash tax benefit for previously unamortized domestic R&E expenditures is $147 million with no corresponding impact to the federal income tax provision. Positive Developments Across Cabozantinib Patent Estate. Today, Exelixis announced recent positive developments with regards to the company's defense of its cabozantinib patent estate. First, in June and July 2025, the United States Patent and Trademark Office (USPTO) declined to institute Azurity Pharmaceuticals' petitions for inter partes review (IPRs) of U.S. Patent Nos. 11,298,349 and 12,128,039, respectively. Second, in July 2025, Exelixis entered into a settlement agreement with Biocon Pharma Limited, which resolved the patent litigation Exelixis brought in response to Biocon's Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of CABOMETYX prior to the expiration of the applicable patents. Pursuant to the terms of the agreement, Exelixis will grant Biocon a license to market its generic version of CABOMETYX in the U.S. beginning on January 1, 2031, if approved by the FDA and subject to conditions and exceptions common to agreements of this type. Stock Repurchase Program. In August 2024, Exelixis' Board of Directors authorized a stock repurchase program to acquire up to $500 million of the company's common stock before December 31, 2025. In February 2025, the Board of Directors authorized the repurchase of up to an additional $500 million of the company's common stock before December 31, 2025. Under these programs, as of June 30, 2025, Exelixis has repurchased $796.3 million of the company's common stock, at an average price of $36.69 per share. Since the approval of the first stock repurchase program in March 2023, the weighted-average diluted common shares outstanding has decreased from 326.3 million shares to 284.4 million shares as of June 30, 2025. Stock repurchases under these programs may be made from time to time through a variety of methods, which may include open market purchases, in block trades, accelerated share repurchase transactions, exchange transactions, or any combination of such methods. The timing and amount of any stock repurchases under the stock repurchase programs will be based on a variety of factors, including ongoing assessments of the capital needs of the business, alternative investment opportunities, the market price of our common stock and general market conditions. Basis of Presentation Exelixis has adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31. For convenience, references in this press release as of and for the fiscal periods ended July 4, 2025 and June 28, 2024, are indicated as being as of and for the periods ended June 30, 2025 and June 30, 2024. Conference Call and Webcast Exelixis management will discuss the company's financial results for the second quarter 2025 and provide a general business update during a conference call beginning at 5:00 p.m. ET / 2:00 p.m. PT today, Monday, July 28, 2025. To access the conference call, please register using this link. Upon registration, a dial-in number and unique PIN will be provided to join the call. To access the live webcast link, log onto and proceed to the Event Calendar page under the Investors & News heading. A webcast replay of the conference call will also be archived on for one year. About Exelixis Exelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care. Powered by drug discovery and development excellence, we are rapidly evolving our product portfolio to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules, antibody-drug conjugates and other biotherapeutics. This comprehensive approach harnesses decades of robust investment in our science and partnerships to advance our investigational programs and extend the impact of our flagship commercial product, CABOMETYX ® (cabozantinib). Exelixis is driven by a bold scientific pursuit to create transformational treatments that give more patients hope for the future. For information about the company and its mission to help cancer patients recover stronger and live longer, visit follow @ExelixisInc on X (Twitter), like Exelixis, Inc. on Facebook and follow Exelixis on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis' plans to discuss the results of STELLAR-303 with regulators and intention of filing for approval in this indication as soon as possible; anticipated timing for zanzalintinib pivotal data milestones with respect to the STELLAR-304 and STELLAR-311 trials and plans to announce additional zanzalintinib pivotal trials; Exelixis' assessment of other potential commercial growth opportunities; Exelixis' plans to present data from STELLAR-303 at a future medical meeting; Exelixis' plans to initiate the phase 1 study for XB371 in the coming months; the terms of Exelixis' settlement agreement with Biocon Pharma Limited which is subject to FDA approval and subject to conditions and exceptions common to agreements of this type; and Exelixis' scientific pursuit to create transformational treatments that give more patients hope for the future. 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 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, zanzalintinib 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; 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; 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, zanzalintinib and other Exelixis product candidates; 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, including as a result of changing trade policies and tariffs and the related uncertainty thereof; and other factors detailed from time to time under the caption 'Risk Factors' in Exelixis' most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and in Exelixis' other future filings with the Securities and Exchange Commission. 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 and COMETRIQ are registered trademarks of Exelixis, Inc. Opdivo ® is a registered trademark of Bristol Myers Squibb. Opdualag ™ is a trademark of Bristol Myers Squibb. ____________________ (1) Non-cash stock-based compensation used for GAAP reporting in accordance with Accounting Standards Codification Topic 718, Compensation—Stock Compensation. Expand
Yahoo
6 days ago
- Business
- Yahoo
Exelixis' Partner Ipsen Receives European Commission Approval for CABOMETYX® (cabozantinib) for Patients with Previously Treated Advanced Neuroendocrine Tumors
– Approval is based on the phase 3 CABINET pivotal trial, in which CABOMETYX demonstrated a statistically significant and clinically meaningful improvement in progression-free survival versus placebo – – CABOMETYX is the first and only systemic therapy to be approved in the European Union for previously treated neuroendocrine tumors, regardless of tumor site, grade or previous non-somatostatin analogue-based systemic therapy – ALAMEDA, Calif., July 24, 2025--(BUSINESS WIRE)--Exelixis, Inc. (Nasdaq: EXEL) today announced that its partner Ipsen received approval from the European Commission (EC) for CABOMETYX® (cabozantinib) for the treatment of adult patients with unresectable or metastatic, well-differentiated pancreatic (pNET) and extra-pancreatic (epNET) neuroendocrine tumors who have progressed following at least one prior systemic therapy other than somatostatin analogues. This approval follows the positive opinion received from the European Medicines Agency's Committee for Medicinal Products for Human Use in June 2025 and allows for the marketing of CABOMETYX in this indication in all 27 member states of the European Union (EU), Norway, Liechtenstein and Iceland. "The availability of CABOMETYX in the European Union for patients with previously treated advanced neuroendocrine tumors is a significant milestone as there have been limited treatment advancements in the past decade, including very few options shown to improve outcomes across a heterogenous population," said Amy Peterson, M.D., Executive Vice President, Product Development and Medical Affairs, and Chief Medical Officer, Exelixis. "This approval builds on the global CABOMETYX franchise and extends its benefit to even more patients in need of new treatment options. We are proud to partner with Ipsen in our shared commitment to improving the standard of care for people living with advanced, difficult-to-treat cancers." The EC approval is based on results from the phase 3 CABINET pivotal trial, which evaluated CABOMETYX compared with placebo in two cohorts of patients with previously treated NET: advanced pNET and advanced epNET. CABINET was the basis for the U.S. Food and Drug Administration approval of CABOMETYX in March 2025 for the treatment of 1) adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pNET; and 2) adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated epNET. About CABINET (Alliance A021602)CABINET (Randomized, Double-Blinded, Phase III Study of CABozantinib versus Placebo In Patients with Advanced NEuroendocrine Tumors After Progression on Prior Therapy) is sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, and is being led and conducted by the NCI-funded Alliance for Clinical Trials in Oncology with participation from the NCI-funded National Clinical Trials Network, as part of Exelixis' collaboration through a Cooperative Research and Development Agreement with the NCI's Cancer Therapy Evaluation Program. CABINET is a multicenter, randomized, double-blinded, placebo-controlled phase 3 pivotal trial that enrolled a total of 298 patients in two separate cohorts (pNET and epNET) in the U.S. at the time of the final analysis. Patients were randomized 2:1 to cabozantinib (60 mg) or placebo; each cohort was randomized separately and had its own statistical analysis plan. The trial was stopped early after an interim analysis showed superior efficacy associated with cabozantinib as compared to placebo in each of the two cohorts. Patients with epNET had primary tumors arising in the gastrointestinal (GI) tract, lung, unknown primary sites and other organs. Patients must have had measurable disease per RECIST 1.1 criteria and must have experienced disease progression or intolerance after at least one U.S. FDA-approved line of prior systemic therapy other than somatostatin analogs. The primary endpoint in each cohort was PFS per RECIST 1.1 by blinded independent central review. Secondary endpoints included overall survival, objective response rate and safety. More information about this trial is available at About NETNET are cancers that begin in the specialized cells of the body's neuroendocrine system.1 These cells have traits of both hormone-producing endocrine cells and nerve cells.1 It is estimated that 161,000 to 192,000 people in the U.S. are living with unresectable, locally advanced or metastatic NET.2 The number of people diagnosed with NET has been increasing in recent decades.3 Functional NET release peptide hormones that can cause debilitating symptoms, like diarrhea, hypertension and flushing, while symptoms of non-functional NET are related primarily to tumor growth.4,5,6,7,8 Most NET take years to develop and grow slowly, but eventually all patients with advanced or metastatic NET will develop refractory and progressing disease.9,10 NET can start in the pancreas (pNET), where they tend to be more aggressive, with a five-year survival rate of only 23% for advanced disease.1,11 NET can also develop in any part of the body, but most commonly start in the GI tract or in the lungs, where they have historically been referred to as carcinoid tumors and are more recently called epNET.1 The five-year survival rates for advanced GI and lung NET tumors are 68% and 55%, respectively.12,13 For advanced NET patients, treatment options include somatostatin analogs, chemotherapy, molecular targeted therapy and peptide-receptor radionuclide therapy.14 About CABOMETYX® (cabozantinib)In the U.S., CABOMETYX tablets are approved as monotherapy for the treatment of patients with advanced renal cell carcinoma (RCC) and in combination with nivolumab as a first-line treatment for patients with advanced RCC; for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib; for adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible; for the treatment of adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pNET; and adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated epNET. CABOMETYX tablets have also received regulatory approvals in over 65 countries outside the U.S. and Japan, including the EU. In 2016, Exelixis granted Ipsen Pharma SAS exclusive rights for the commercialization and further clinical development of cabozantinib outside of the U.S. 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 U.S. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Hemorrhage: CABOMETYX can cause severe and fatal hemorrhages. The incidence of Grade 3-5 hemorrhagic events was 5% in CABOMETYX patients in RCC, HCC, and DTC studies. Discontinue CABOMETYX for Grade 3-4 hemorrhage and before surgery. Do not administer to patients who have a recent history of hemorrhage, including hemoptysis, hematemesis, or melena. Perforations and Fistulas: Fistulas, including fatal cases, and gastrointestinal (GI) perforations, including fatal cases, each occurred in 1% of CABOMETYX patients. Monitor for signs and symptoms, and discontinue CABOMETYX in patients with Grade 4 fistulas or GI perforation. Thrombotic Events: CABOMETYX can cause arterial or venous thromboembolic event. Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients. Fatal thrombotic events have occurred. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or serious arterial or venous thromboembolic events. Hypertension and Hypertensive Crisis: CABOMETYX can cause hypertension, including hypertensive crisis. Hypertension was reported in 37% (16% Grade 3 and <1% Grade 4) of CABOMETYX patients. In CABINET (n=195), hypertension occurred in 65% (26% Grade 3) 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; when controlled, resume at a reduced dose. Permanently discontinue CABOMETYX for severe hypertension that cannot be controlled with antihypertensive therapy or for hypertensive crisis. Diarrhea: CABOMETYX can cause diarrhea and it occurred in 62% (10% Grade 3) of treated patients. Monitor and manage patients using antidiarrheals as indicated. Withhold CABOMETYX until improvement to ≤ Grade 1; resume at a reduced dose. Palmar-Plantar Erythrodysesthesia (PPE): CABOMETYX can cause PPE and it occurred in 45% of treated patients (13% Grade 3). Withhold CABOMETYX until PPE resolves or decreases to Grade 1 and resume at a reduced dose for intolerable Grade 2 PPE or Grade 3 PPE. Hepatotoxicity: CABOMETYX in combination with nivolumab in RCC can cause hepatic toxicity with higher frequencies of Grades 3 and 4 ALT and AST elevations compared to CABOMETYX alone. With the combination of CABOMETYX and nivolumab, Grades 3 and 4 increased ALT or AST were seen in 11% of patients. Monitor liver enzymes before initiation of treatment and periodically. Consider more frequent monitoring as compared to when the drugs are administered as single agents. Consider withholding CABOMETYX and/or nivolumab, initiating corticosteroid therapy, and/or permanently discontinuing the combination for severe or life-threatening hepatotoxicity. Adrenal Insufficiency: CABOMETYX in combination with nivolumab can cause primary or secondary adrenal insufficiency. Adrenal insufficiency occurred in 4.7% (15/320) of patients with RCC who received CABOMETYX with nivolumab, including Grade 3 (2.2%), and Grade 2 (1.9%) adverse reactions. Withhold CABOMETYX and/or nivolumab and resume CABOMETYX at a reduced dose depending on severity. Proteinuria: Proteinuria was observed in 8% of CABOMETYX patients. Monitor urine protein regularly during CABOMETYX treatment. For Grade 2 or 3 proteinuria, withhold CABOMETYX until improvement to ≤ Grade 1 proteinuria; resume CABOMETYX at a reduced dose. Discontinue CABOMETYX in patients who develop nephrotic syndrome. Osteonecrosis of the Jaw (ONJ): CABOMETYX can cause ONJ and it occurred in <1% of treated patients. 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. Withhold CABOMETYX for development of ONJ until complete resolution; resume at a reduced dose. Impaired Wound Healing: CABOMETYX can cause impaired wound healing. Withhold CABOMETYX for at least 3 weeks prior to elective surgery. Do not administer for at least 2 weeks after major surgery and until adequate wound healing. The safety of resumption of CABOMETYX after resolution of wound healing complications has not been established. Reversible Posterior Leukoencephalopathy Syndrome (RPLS): CABOMETYX can cause RPLS. Perform evaluation for RPLS and diagnose by characteristic finding on MRI any patient presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue CABOMETYX in patients who develop RPLS. Thyroid Dysfunction: CABOMETYX can cause thyroid dysfunction, primarily hypothyroidism, and it occurred in 19% of treated patients (0.4% Grade 3). Assess for signs of thyroid dysfunction prior to the initiation of CABOMETYX and monitor for signs and symptoms during treatment. Hypocalcemia: CABOMETYX can cause hypocalcemia, with the highest incidence in DTC patients. Based on the safety population, hypocalcemia occurred in 13% of CABOMETYX patients (2% Grade 3 and 1% Grade 4). Monitor blood calcium levels and replace calcium as necessary during treatment. Withhold and resume CABOMETYX at a reduced dose upon recovery or permanently discontinue CABOMETYX depending on severity. Embryo-Fetal Toxicity: CABOMETYX can cause fetal harm. Advise pregnant women of the potential risk to a fetus and advise females of reproductive potential to use effective contraception during treatment with CABOMETYX and for 4 months after the last dose. ADVERSE REACTIONS The most common (≥20%) adverse reactions are: CABOMETYX as a single agent: diarrhea, fatigue, PPE, decreased appetite, hypertension, nausea, vomiting, weight decreased, and constipation. CABOMETYX in combination with nivolumab: diarrhea, fatigue, hepatotoxicity, PPE, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, dysgeusia, abdominal pain, cough, and upper respiratory tract infection. DRUG INTERACTIONS Strong CYP3A4 Inhibitors: If coadministration with strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage. Avoid grapefruit or grapefruit juice. Strong or Moderate CYP3A4 Inducers: If coadministration with strong or moderate 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. Avoid CABOMETYX in patients with severe hepatic impairment. Pediatric Use: Physeal widening has been observed in children with open growth plates when treated with CABOMETYX. Physeal and longitudinal growth monitoring is recommended in children (12 years and older) with open growth plates. Consider interrupting or discontinuing CABOMETYX if abnormalities occur. The safety and effectiveness of CABOMETYX in pediatric patients less than 12 years of age have not been established. Please see accompanying full Prescribing Informationhttps:// You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. About ExelixisExelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care. Powered by drug discovery and development excellence, we are rapidly evolving our product portfolio to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules and biotherapeutics. This comprehensive approach harnesses decades of robust investment in our science and partnerships to advance our investigational programs and extend the impact of our flagship commercial product, CABOMETYX® (cabozantinib). Exelixis is driven by a bold scientific pursuit to create transformational treatments that give more patients hope for the future. For information about the company and its mission to help cancer patients recover stronger and live longer, visit follow @ExelixisInc on X (Twitter), like Exelixis, Inc. on Facebook and follow Exelixis on LinkedIn. Forward-Looking StatementsThis press release contains forward-looking statements, including, without limitation, statements related to: the therapeutic potential of CABOMETYX for patients with previously treated advanced neuroendocrine tumors; Exelixis' or its partner Ipsen's ability or plans to support these new indications for patients in Europe; and Exelixis' scientific pursuit to create transformational treatments that give more patients hope for the future. 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: complexities and the unpredictability of the regulatory review and approval processes in the EU and elsewhere; unexpected concerns that may arise as a result of the occurrence of adverse safety events or additional data analyses of clinical trials evaluating cabozantinib; Exelixis' dependence on its relationships with its collaboration partners, including their pursuit of regulatory approvals for partnered compounds in new indications and their adherence to their obligations under relevant collaboration agreements; 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 partners to obtain regulatory approval for cabozantinib in new indications; and other factors detailed from time to time under the caption "Risk Factors" in Exelixis' most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and in Exelixis' other future filings with the Securities and Exchange Commission. 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 and CABOMETYX are registered U.S. trademarks of Exelixis. 1 Neuroendocrine Tumors. Cleveland Clinic website. Available at: Accessed July 2025.2 Population Estimate: Unresectable, Locally Advanced or Metastatic Extra-Pancreatic NET. June 2024 (internal data on file).3 Pathak, S., Starr, J.S., Halfdanarson T., et al. Understanding the increasing incidence of neuroendocrine tumors. Expert Rev Endocrinol Metab. September 2023;18(5):377-385.4 Pancreatic Neuroendocrine Tumors (Islet Cell Tumors) Treatment (PDQ®)–Patient Version. NCI website. Available at: Accessed July 2025.5 What Is a Pancreatic Neuroendocrine Tumor? ACS website. Available at: Accessed July 2025.6 Carcinoid Syndrome. Cleveland Clinic website. Available at: Accessed July 2025.7 Signs and Symptoms of Gastrointestinal Carcinoid Tumors. ACS website. Available at: Accessed July 2025.8 Signs and Symptoms of Lung Carcinoid Tumors. ACS website. Available at: Accessed July 2025.9 McClellan, K., Chen. E.Y., Kardosh A., et al. Therapy Resistant Gastroenteropancreatic Neuroendocrine Tumors. Cancers. 2022;14(19):4769.10 What is a Gastrointestinal Carcinoid Tumor? ACS website. Available at: Accessed July 2025.11 Survival Rates for Pancreatic Neuroendocrine Tumor. ACS website. Available at: Accessed July 2025.12 Survival Rates for Gastrointestinal Carcinoid Tumors. ACS website. Available at: Accessed July 2025.13 Survival Rates for Lung Carcinoid Tumors. ACS website. Available at: Accessed July 2025.14 Neuroendocrine Tumor (NET). NCI website. Available at: Accessed July 2025. View source version on Contacts Investors Contact: Susan Hubbard EVP, Public Affairs and Investor Relations Exelixis, Inc. (650) 837-8194 shubbard@ Media Contact: Claire McConnaughey Senior Director, Public Affairs Exelixis, Inc. (650) 837-7052 cmcconn@
Business Wire
6 days ago
- Business
- Business Wire
Exelixis' Partner Ipsen Receives European Commission Approval for CABOMETYX
ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (Nasdaq: EXEL) today announced that its partner Ipsen received approval from the European Commission (EC) for CABOMETYX ® (cabozantinib) for the treatment of adult patients with unresectable or metastatic, well-differentiated pancreatic (pNET) and extra-pancreatic (epNET) neuroendocrine tumors who have progressed following at least one prior systemic therapy other than somatostatin analogues. This approval follows the positive opinion received from the European Medicines Agency's Committee for Medicinal Products for Human Use in June 2025 and allows for the marketing of CABOMETYX in this indication in all 27 member states of the European Union (EU), Norway, Liechtenstein and Iceland. 'The availability of CABOMETYX in the European Union for patients with previously treated advanced neuroendocrine tumors is a significant milestone as there have been limited treatment advancements in the past decade, including very few options shown to improve outcomes across a heterogenous population,' said Amy Peterson, M.D., Executive Vice President, Product Development and Medical Affairs, and Chief Medical Officer, Exelixis. 'This approval builds on the global CABOMETYX franchise and extends its benefit to even more patients in need of new treatment options. We are proud to partner with Ipsen in our shared commitment to improving the standard of care for people living with advanced, difficult-to-treat cancers.' The EC approval is based on results from the phase 3 CABINET pivotal trial, which evaluated CABOMETYX compared with placebo in two cohorts of patients with previously treated NET: advanced pNET and advanced epNET. CABINET was the basis for the U.S. Food and Drug Administration approval of CABOMETYX in March 2025 for the treatment of 1) adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pNET; and 2) adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated epNET. About CABINET (Alliance A021602) CABINET (Randomized, Double-Blinded, Phase III Study of CAB ozantinib versus Placebo I n Patients with Advanced NE uroendocrine T umors After Progression on Prior Therapy) is sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, and is being led and conducted by the NCI-funded Alliance for Clinical Trials in Oncology with participation from the NCI-funded National Clinical Trials Network, as part of Exelixis' collaboration through a Cooperative Research and Development Agreement with the NCI's Cancer Therapy Evaluation Program. CABINET is a multicenter, randomized, double-blinded, placebo-controlled phase 3 pivotal trial that enrolled a total of 298 patients in two separate cohorts (pNET and epNET) in the U.S. at the time of the final analysis. Patients were randomized 2:1 to cabozantinib (60 mg) or placebo; each cohort was randomized separately and had its own statistical analysis plan. The trial was stopped early after an interim analysis showed superior efficacy associated with cabozantinib as compared to placebo in each of the two cohorts. Patients with epNET had primary tumors arising in the gastrointestinal (GI) tract, lung, unknown primary sites and other organs. Patients must have had measurable disease per RECIST 1.1 criteria and must have experienced disease progression or intolerance after at least one U.S. FDA-approved line of prior systemic therapy other than somatostatin analogs. The primary endpoint in each cohort was PFS per RECIST 1.1 by blinded independent central review. Secondary endpoints included overall survival, objective response rate and safety. More information about this trial is available at About NET NET are cancers that begin in the specialized cells of the body's neuroendocrine system. 1 These cells have traits of both hormone-producing endocrine cells and nerve cells. 1 It is estimated that 161,000 to 192,000 people in the U.S. are living with unresectable, locally advanced or metastatic NET. 2 The number of people diagnosed with NET has been increasing in recent decades. 3 Functional NET release peptide hormones that can cause debilitating symptoms, like diarrhea, hypertension and flushing, while symptoms of non-functional NET are related primarily to tumor growth. 4,5,6,7,8 Most NET take years to develop and grow slowly, but eventually all patients with advanced or metastatic NET will develop refractory and progressing disease. 9,10 NET can start in the pancreas (pNET), where they tend to be more aggressive, with a five-year survival rate of only 23% for advanced disease. 1,11 NET can also develop in any part of the body, but most commonly start in the GI tract or in the lungs, where they have historically been referred to as carcinoid tumors and are more recently called epNET. 1 The five-year survival rates for advanced GI and lung NET tumors are 68% and 55%, respectively. 12,13 For advanced NET patients, treatment options include somatostatin analogs, chemotherapy, molecular targeted therapy and peptide-receptor radionuclide therapy. 14 About CABOMETYX ® (cabozantinib) In the U.S., CABOMETYX tablets are approved as monotherapy for the treatment of patients with advanced renal cell carcinoma (RCC) and in combination with nivolumab as a first-line treatment for patients with advanced RCC; for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib; for adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible; for the treatment of adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pNET; and adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated epNET. CABOMETYX tablets have also received regulatory approvals in over 65 countries outside the U.S. and Japan, including the EU. In 2016, Exelixis granted Ipsen Pharma SAS exclusive rights for the commercialization and further clinical development of cabozantinib outside of the U.S. 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 U.S. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Hemorrhage: CABOMETYX can cause severe and fatal hemorrhages. The incidence of Grade 3-5 hemorrhagic events was 5% in CABOMETYX patients in RCC, HCC, and DTC studies. Discontinue CABOMETYX for Grade 3-4 hemorrhage and before surgery. Do not administer to patients who have a recent history of hemorrhage, including hemoptysis, hematemesis, or melena. Perforations and Fistulas: Fistulas, including fatal cases, and gastrointestinal (GI) perforations, including fatal cases, each occurred in 1% of CABOMETYX patients. Monitor for signs and symptoms, and discontinue CABOMETYX in patients with Grade 4 fistulas or GI perforation. Thrombotic Events: CABOMETYX can cause arterial or venous thromboembolic event. Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients. Fatal thrombotic events have occurred. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or serious arterial or venous thromboembolic events. Hypertension and Hypertensive Crisis: CABOMETYX can cause hypertension, including hypertensive crisis. Hypertension was reported in 37% (16% Grade 3 and <1% Grade 4) of CABOMETYX patients. In CABINET (n=195), hypertension occurred in 65% (26% Grade 3) 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; when controlled, resume at a reduced dose. Permanently discontinue CABOMETYX for severe hypertension that cannot be controlled with antihypertensive therapy or for hypertensive crisis. Diarrhea: CABOMETYX can cause diarrhea and it occurred in 62% (10% Grade 3) of treated patients. Monitor and manage patients using antidiarrheals as indicated. Withhold CABOMETYX until improvement to ≤ Grade 1; resume at a reduced dose. Palmar-Plantar Erythrodysesthesia (PPE): CABOMETYX can cause PPE and it occurred in 45% of treated patients (13% Grade 3). Withhold CABOMETYX until PPE resolves or decreases to Grade 1 and resume at a reduced dose for intolerable Grade 2 PPE or Grade 3 PPE. Hepatotoxicity: CABOMETYX in combination with nivolumab in RCC can cause hepatic toxicity with higher frequencies of Grades 3 and 4 ALT and AST elevations compared to CABOMETYX alone. With the combination of CABOMETYX and nivolumab, Grades 3 and 4 increased ALT or AST were seen in 11% of patients. Monitor liver enzymes before initiation of treatment and periodically. Consider more frequent monitoring as compared to when the drugs are administered as single agents. Consider withholding CABOMETYX and/or nivolumab, initiating corticosteroid therapy, and/or permanently discontinuing the combination for severe or life-threatening hepatotoxicity. Adrenal Insufficiency: CABOMETYX in combination with nivolumab can cause primary or secondary adrenal insufficiency. Adrenal insufficiency occurred in 4.7% (15/320) of patients with RCC who received CABOMETYX with nivolumab, including Grade 3 (2.2%), and Grade 2 (1.9%) adverse reactions. Withhold CABOMETYX and/or nivolumab and resume CABOMETYX at a reduced dose depending on severity. Proteinuria: Proteinuria was observed in 8% of CABOMETYX patients. Monitor urine protein regularly during CABOMETYX treatment. For Grade 2 or 3 proteinuria, withhold CABOMETYX until improvement to ≤ Grade 1 proteinuria; resume CABOMETYX at a reduced dose. Discontinue CABOMETYX in patients who develop nephrotic syndrome. Osteonecrosis of the Jaw (ONJ): CABOMETYX can cause ONJ and it occurred in <1% of treated patients. 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. Withhold CABOMETYX for development of ONJ until complete resolution; resume at a reduced dose. Impaired Wound Healing: CABOMETYX can cause impaired wound healing. Withhold CABOMETYX for at least 3 weeks prior to elective surgery. Do not administer for at least 2 weeks after major surgery and until adequate wound healing. The safety of resumption of CABOMETYX after resolution of wound healing complications has not been established. Reversible Posterior Leukoencephalopathy Syndrome (RPLS): CABOMETYX can cause RPLS. Perform evaluation for RPLS and diagnose by characteristic finding on MRI any patient presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue CABOMETYX in patients who develop RPLS. Thyroid Dysfunction: CABOMETYX can cause thyroid dysfunction, primarily hypothyroidism, and it occurred in 19% of treated patients (0.4% Grade 3). Assess for signs of thyroid dysfunction prior to the initiation of CABOMETYX and monitor for signs and symptoms during treatment. Hypocalcemia: CABOMETYX can cause hypocalcemia, with the highest incidence in DTC patients. Based on the safety population, hypocalcemia occurred in 13% of CABOMETYX patients (2% Grade 3 and 1% Grade 4). Monitor blood calcium levels and replace calcium as necessary during treatment. Withhold and resume CABOMETYX at a reduced dose upon recovery or permanently discontinue CABOMETYX depending on severity. Embryo-Fetal Toxicity: CABOMETYX can cause fetal harm. Advise pregnant women of the potential risk to a fetus and advise females of reproductive potential to use effective contraception during treatment with CABOMETYX and for 4 months after the last dose. ADVERSE REACTIONS The most common (≥20%) adverse reactions are: CABOMETYX as a single agent: diarrhea, fatigue, PPE, decreased appetite, hypertension, nausea, vomiting, weight decreased, and constipation. CABOMETYX in combination with nivolumab: diarrhea, fatigue, hepatotoxicity, PPE, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, dysgeusia, abdominal pain, cough, and upper respiratory tract infection. DRUG INTERACTIONS Strong CYP3A4 Inhibitors: If coadministration with strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage. Avoid grapefruit or grapefruit juice. Strong or Moderate CYP3A4 Inducers: If coadministration with strong or moderate 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. Avoid CABOMETYX in patients with severe hepatic impairment. Pediatric Use: Physeal widening has been observed in children with open growth plates when treated with CABOMETYX. Physeal and longitudinal growth monitoring is recommended in children (12 years and older) with open growth plates. Consider interrupting or discontinuing CABOMETYX if abnormalities occur. The safety and effectiveness of CABOMETYX in pediatric patients less than 12 years of age have not been established. Please see accompanying full Prescribing Information You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. About Exelixis Exelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care. Powered by drug discovery and development excellence, we are rapidly evolving our product portfolio to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules and biotherapeutics. This comprehensive approach harnesses decades of robust investment in our science and partnerships to advance our investigational programs and extend the impact of our flagship commercial product, CABOMETYX ® (cabozantinib). Exelixis is driven by a bold scientific pursuit to create transformational treatments that give more patients hope for the future. For information about the company and its mission to help cancer patients recover stronger and live longer, visit follow @ExelixisInc on X (Twitter), like Exelixis, Inc. on Facebook and follow Exelixis on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements, including, without limitation, statements related to: the therapeutic potential of CABOMETYX for patients with previously treated advanced neuroendocrine tumors; Exelixis' or its partner Ipsen's ability or plans to support these new indications for patients in Europe; and Exelixis' scientific pursuit to create transformational treatments that give more patients hope for the future. 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: complexities and the unpredictability of the regulatory review and approval processes in the EU and elsewhere; unexpected concerns that may arise as a result of the occurrence of adverse safety events or additional data analyses of clinical trials evaluating cabozantinib; Exelixis' dependence on its relationships with its collaboration partners, including their pursuit of regulatory approvals for partnered compounds in new indications and their adherence to their obligations under relevant collaboration agreements; 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 partners to obtain regulatory approval for cabozantinib in new indications; and other factors detailed from time to time under the caption 'Risk Factors' in Exelixis' most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and in Exelixis' other future filings with the Securities and Exchange Commission. 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 and CABOMETYX are registered U.S. trademarks of Exelixis. 1 Neuroendocrine Tumors. Cleveland Clinic website. Available at: Accessed July 2025. 2 Population Estimate: Unresectable, Locally Advanced or Metastatic Extra-Pancreatic NET. June 2024 (internal data on file). 3 Pathak, S., Starr, J.S., Halfdanarson T., et al. Understanding the increasing incidence of neuroendocrine tumors. Expert Rev Endocrinol Metab. September 2023;18(5):377-385. 4 Pancreatic Neuroendocrine Tumors (Islet Cell Tumors) Treatment (PDQ ®)–Patient Version. NCI website. Available at: Accessed July 2025. 5 What Is a Pancreatic Neuroendocrine Tumor? ACS website. Available at: Accessed July 2025. 6 Carcinoid Syndrome. Cleveland Clinic website. Available at: Accessed July 2025. 7 Signs and Symptoms of Gastrointestinal Carcinoid Tumors. ACS website. Available at: Accessed July 2025. 8 Signs and Symptoms of Lung Carcinoid Tumors. ACS website. Available at: Accessed July 2025. 9 McClellan, K., Chen. E.Y., Kardosh A., et al. Therapy Resistant Gastroenteropancreatic Neuroendocrine Tumors. Cancers. 2022;14(19):4769. 10 What is a Gastrointestinal Carcinoid Tumor? ACS website. Available at: Accessed July 2025. 11 Survival Rates for Pancreatic Neuroendocrine Tumor. ACS website. Available at: Accessed July 2025. 12 Survival Rates for Gastrointestinal Carcinoid Tumors. ACS website. Available at: Accessed July 2025. 13 Survival Rates for Lung Carcinoid Tumors. ACS website. Available at: Accessed July 2025. 14 Neuroendocrine Tumor (NET). NCI website. Available at: Accessed July 2025.
Yahoo
15-07-2025
- Business
- Yahoo
Tempus AI Raises 2025 Financial Outlook: What's Backing It?
Tempus AI TEM expects full-year 2025 revenues of $1.25 billion (up from the previous $1.24 billion guidance), which represents approximately 80% annual growth. The company also expects adjusted EBITDA of $5 million for the full year of 2025, an improvement of approximately $110 million over 2024. Robust First-Quarter Performance: Total sales in the first quarter amounted to $255.7 million, which grew 75.4% year over year. Quarterly gross profit increased 99.8% year over year, reaching $155.2 million. The gains were fueled by lab efficiencies, increased adoption of AI tools like Tempus One and xM and a higher mix of data services. These improvements narrowed down adjusted EBITDA loss to $16.2 million, from $43.9 million a year ago. Strategic Collaborations With AstraZeneca & Pathos: Tempus signed a three-year, $200 million data and modeling license agreement with AstraZeneca (AZN) and Pathos to build a multimodal foundation model in oncology, leveraging more than 300 petabytes of rich multimodal healthcare data that Tempus has built over the past decade. Notably, the deal raised the total remaining contract value to greater than $1 billion as of April-end. Upside in Hereditary Testing: Hereditary testing revenues hit $63.5 million on 23% volume growth, outpacing the first-quarter guidance. This growth was driven by the acquisition of Ambry Genetics, a recognized leader in genetic testing. The company anticipates long-term potential in this business beyond oncology, extending to cardiovascular, Alzheimer's and other genetic predispositions. For full-year 2025, Exact Sciences EXAS anticipates total revenues in the range of $3.070-$3.120 billion (previously $3.025-$3.085 billion). The adjusted EBITDA forecast is updated to the $425-$455 million band (up from the earlier range of $410-$440 million). A major catalyst for the guidance hike was the successful launch of Cologuard Plus, the company's next-generation colorectal cancer screening test. The test has already seen rapid adoption, with over 30,000 completed tests. TEM reported first-quarter revenues of $706.8 million, marking a 10.9% year-over-year increase. Adjusted EBITDA surged 61%, while free cash flow reached breakeven, an improvement of $120 million from the prior year. These results gave management the confidence to raise its full-year outlook. Exelixis EXEL raised its full-year 2025 financial guidance following strong first-quarter results, driven by higher demand for CABOMETYX and the recent U.S. FDA approval for its use in treating advanced neuroendocrine tumors (NET). The company expects total revenues in the range of $2.25-$2.35 billion (up from the earlier guidance range of $2.15-$2.25 billion). A major factor behind this upward revision was the FDA approval in March 2025 of CABOMETYX for the treatment of advanced pancreatic and extra-pancreatic NET, making it the first and only systemic treatment approved for previously treated NET regardless of tumor site or grade. Additionally, TEM is optimistic about several upcoming clinical milestones in the second half of the year, including pivotal trial readouts for its next-generation therapy zanzalintinib in colorectal and non-clear cell renal cancers. These developments reinforce Exelixis' strategy to expand its oncology portfolio and transition into a multi-franchise cancer company. In the past year, Tempus AI shares have surged 58.6%, outperforming the industry's 16.8% growth and the S&P 500 composite's 11% improvement. Image Source: Zacks Investment Research TEM currently trades at a forward 12-month Price-to-Sales (P/S) of 7.09X compared to the industry average of 5.82X. Image Source: Zacks Investment Research Earnings estimates for Tempus AI in 2025 and 2026 are showing a mixed picture. Image Source: Zacks Investment Research TEM stock currently carries a Zacks Rank #4 (Sell). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Exelixis, Inc. (EXEL) : Free Stock Analysis Report Exact Sciences Corporation (EXAS) : Free Stock Analysis Report Tempus AI, Inc. (TEM) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
Yahoo
14-07-2025
- Business
- Yahoo
Exelixis to Release Second Quarter 2025 Financial Results on Monday, July 28, 2025
– Conference Call and Webcast to Follow at 5:00 p.m. ET / 2:00 p.m. PT – ALAMEDA, Calif., July 14, 2025--(BUSINESS WIRE)--Exelixis, Inc. (Nasdaq: EXEL) announced today that its second quarter 2025 financial results will be released on Monday, July 28, 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. To access the conference call, please register using this link. Upon registration, a dial-in number and unique PIN will be provided to join the call. To access the live webcast link, log onto and proceed to the Event Calendar page under the Investors & News heading. A webcast replay of the conference call will also be archived on for one year. About Exelixis Exelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care. Powered by drug discovery and development excellence, we are rapidly evolving our product portfolio to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules and biotherapeutics. This comprehensive approach harnesses decades of robust investment in our science and partnerships to advance our investigational programs and extend the impact of our flagship commercial product, CABOMETYX® (cabozantinib). Exelixis is driven by a bold scientific pursuit to create transformational treatments that give more patients hope for the future. For information about the company and its mission to help cancer patients recover stronger and live longer, visit follow @ExelixisInc on X (Twitter), like Exelixis, Inc. on Facebook and follow Exelixis on LinkedIn. Exelixis, the Exelixis logo and CABOMETYX are registered U.S. trademarks. View source version on Contacts Investors Contact: Varant Shirvanian Director, Investor Relations Exelixis, Inc. 650-837-7917 vshirvanian@ Media Contact: Hal Mackins For Exelixis, Inc. 415-994-0040 hal@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
