Welcome to our dedicated page for Exelixis news (Ticker: EXEL), a resource for investors and traders seeking the latest updates and insights on Exelixis stock.
Company Overview
Exelixis Inc (EXEL) is a biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative small molecule therapies that target various forms of cancer. As a major contributor in the oncology sector, it leverages its deep expertise in drug development to address complex unmet medical needs. The company has established a robust development platform that enables the transformation of scientific innovation into effective therapeutic solutions.
Core Business and Therapy Portfolio
Exelixis focuses primarily on oncology, offering therapies that are designed to improve the care and outcomes of patients with different types of cancer. Its flagship molecules have been developed across multiple cancer indications such as metastatic medullary thyroid cancer, kidney cancer, and liver cancer. The dual branding of its key product into distinct therapies illustrates the company’s strategy to address diverse clinical requirements. Additionally, its collaboration with a global pharmaceutical partner further highlights the company's role in bringing combination therapies to market, particularly in the treatment of melanoma.
Strategic Collaborations and Development Platform
The company has built a multifaceted clinical research framework that integrates both internal research and strategic external alliances. Key partnerships, including one with a leading pharmaceutical company and more recent collaborative efforts with Sairopa, augment its clinical development capabilities. For instance, the alliance with Sairopa has facilitated research into innovative cancer immunotherapies, such as the development of an anti-SIRPα antibody. This collaboration underscores Exelixis’ commitment to leveraging cutting-edge science to develop next-generation therapies that potentially modulate the immune system's response to cancer.
Market Position and Business Model
Exelixis positions itself as a specialized player within the oncology space, where its core business model revolves around the commercialization of small molecule therapies through both direct sales and strategic licensing agreements. The firm has demonstrated sustained expertise in navigating regulatory landscapes and establishing commercially viable products. Its business model is characterized by verified clinical success, a broad research pipeline, and a strategic focus on partnerships that enhance its ability to innovate and deliver impactful cancer treatments.
Clinical Development and Commercialization Strategy
The company’s clinical development strategy combines rigorous research protocols with smart partnerships to accelerate product development. By engaging in early-phase clinical assessments and phase-transition collaborations, Exelixis ensures that its portfolio remains robust and diversified. Its emphasis on large-scale commercialization is supported by established regulatory approvals and a comprehensive understanding of the market dynamics in oncology. Investors and market observers note the company’s careful balance between research innovation and commercial execution, which is integral to its sustained market relevance.
Industry Impact and Expertise
Exelixis has made a significant impact on the biopharmaceutical industry by focusing on high-impact areas of cancer treatment. Its expertise in small molecule design and targeted therapy development has set industry benchmarks. The company’s operations exemplify the integration of advanced scientific research with practical clinical applications, providing a model for translational medicine in oncology. With a commitment to continuous improvement and adherence to rigorous research standards, Exelixis remains a trusted name among healthcare professionals, researchers, and industry analysts.
Key Highlights
- Innovative Research: Extensive clinical development in small molecule therapies for cancer.
- Strategic Alignments: Collaborations with major pharmaceutical companies and clinical-stage developers enhance its research footprint.
- Regulatory Acumen: Proven ability to navigate regulatory requirements for global market approval.
- Diverse Portfolio: A broad range of therapies addressing multiple cancer types.
Conclusion
With a solid foundation in advanced oncology research and a dynamic strategy that integrates innovative clinical practices and strategic partnerships, Exelixis Inc exemplifies a dedicated effort to push the boundaries of cancer treatment. The company continues to transform scientific discovery into practical health solutions, maintaining an evergreen role in the complex landscape of biopharmaceutical innovation.
Exelixis (NASDAQ: EXEL) has received FDA approval for CABOMETYX® (cabozantinib) to treat previously treated advanced neuroendocrine tumors (NET). The approval covers two specific indications: advanced pancreatic NET (pNET) and extra-pancreatic NET (epNET) in adults and pediatric patients 12 years and older.
The approval is based on the phase 3 CABINET trial results, which showed significant improvement in progression-free survival compared to placebo. CABOMETYX becomes the first and only FDA-approved systemic treatment for previously treated NET, regardless of primary tumor site, grade, somatostatin receptor expression, and functional status.
The National Comprehensive Cancer Network has updated its guidelines to include cabozantinib as a category 1 preferred regimen for well-differentiated advanced NET and category 2A for other forms. The safety profile was consistent with previous findings, though higher hypertension incidence was noted compared to other tumor types.
Exelixis (NASDAQ: EXEL) will present preclinical data for four pipeline molecules at the AACR Annual Meeting 2025 in Chicago. The presentations will showcase both small molecule and biotherapeutic development candidates for advanced solid tumors.
The pipeline includes:
- XL495: A PKMYT1 inhibitor showing potential anti-tumor activity, currently in phase 1 clinical trials
- XB371: A tissue factor-targeting antibody-drug conjugate with planned FDA application in 2025
- XL309: A USP1 inhibitor active in BRCA 1/2 mutations, currently in phase 1 trials
- XB628: A first-in-class PD-L1 x NKG2A bispecific antibody with FDA-cleared IND application
Exelixis (Nasdaq: EXEL) has announced its participation in three major investor conferences this March. The company will engage in fireside chat presentations at:
- TD Cowen 45th Annual Health Care Conference in Boston on March 4 at 9:50 a.m. ET
- Barclays 27th Annual Global Healthcare Conference in Miami on March 11 at 1:30 p.m. ET
- 2025 Leerink Partners Global Healthcare Conference in Miami on March 12 at 10:40 a.m. ET
All presentations will be accessible via webcast through the company's website at www.exelixis.com under the Investors & News section's Event Calendar page. Replay recordings will remain available for a minimum of 30 days after the events.
Exelixis (NASDAQ: EXEL) has announced a new $500 million stock repurchase program authorized by its Board of Directors, to be completed by December 31, 2025. The company plans to initiate this program after completing its current $500 million repurchase program, which is expected to conclude in Q2 2025.
This marks Exelixis' fourth stock repurchase program since March 2023, with the company having already returned over $1.2 billion to shareholders through these initiatives as of the end of fiscal year 2024. The repurchases may be executed through various methods, including open market purchases, block trades, and accelerated share repurchase transactions. The timing and volume of repurchases will be determined by factors including capital needs, alternative investments, stock price, and market conditions.
Exelixis (EXEL) announced final five-year follow-up results from the CheckMate -9ER trial evaluating CABOMETYX combined with Opdivo versus sunitinib in advanced kidney cancer patients. After 67.6 months median follow-up, the combination showed improved progression-free survival (PFS; HR: 0.58) and overall survival (OS; HR: 0.79) compared to sunitinib.
Key findings include median PFS of 16.4 vs 8.3 months and median OS of 46.5 vs 35.5 months for the combination vs sunitinib, respectively. The objective response rate was 55.7% for the combination versus 27.4% for sunitinib. The efficacy benefits were observed across different patient subgroups, including those with organ metastases and different risk classifications.
Safety profile remained manageable with no new safety signals reported, though Grade 3/4 adverse events were higher in the combination group (68%) versus sunitinib (55%).
Exelixis (NASDAQ: EXEL) has announced its participation in the upcoming Citi 2025 Virtual Oncology Leadership Summit. The company's management will engage in a fireside chat scheduled for Wednesday, February 19 at 2:00 p.m. ET / 11:00 a.m. PT.
The presentation will be accessible via webcast on www.exelixis.com under the Investors & News section's Event Calendar page. For those unable to attend live, a replay of the session will remain available on the same platform for a minimum of 30 days following the event.
Exelixis (EXEL) reported strong financial results for Q4 and FY 2024. Total revenues reached $567M for Q4 and $2.17B for FY 2024. The cabozantinib franchise achieved $1.81B in U.S. net product revenues for FY 2024, including $515M in Q4.
Key financial metrics include GAAP diluted EPS of $0.48 for Q4 and $1.76 for FY 2024, while non-GAAP diluted EPS was $0.55 and $2.00 respectively. The company maintains its 2025 guidance with total revenues projected at $2.15B-$2.25B.
Notable developments include a pending FDA decision for CABOMETYX in advanced neuroendocrine tumors with a PDUFA date of April 3, 2025, and anticipated zanzalintinib pivotal data milestones in 2025. The company also continues its stock repurchase program, having bought back $205.6M of common stock at an average price of $33.62 per share.
Exelixis (NASDAQ: EXEL) has announced it will release its fourth quarter and full year 2024 financial results on Tuesday, February 11, 2025, after market close. The company's management will host a conference call and webcast at 5:00 p.m. ET / 2:00 p.m. PT to discuss the results and provide a business update.
Investors can access the conference call by registering through a provided link, which will generate a unique PIN and dial-in number. The webcast will be available on the company's website under the Investors & News section's Event Calendar page, with a replay accessible for one year.
Exelixis (NASDAQ: EXEL) has released results from the phase 1b/2 STELLAR-001 trial evaluating zanzalintinib alone or combined with atezolizumab in previously-treated metastatic colorectal cancer patients. The study included 107 patients randomized 1:1, with median prior therapy lines of 3.0 and 2.5 respectively.
Key findings show improved progression-free survival (PFS) and overall survival (OS) when combining the treatments, particularly in patients without liver metastases. In this subgroup, median PFS increased from 3.3 to 8.2 months, and the 6-month survival rate reached 87.8% for the combination versus 64.7% for zanzalintinib alone.
Regarding safety, Grade 3/4 treatment-related adverse events occurred in 40% of patients on zanzalintinib alone and 48% on the combination therapy. Common side effects included nausea, diarrhea, fatigue, and hypertension. The company expects data from the related STELLAR-303 trial in the second half of 2025.
Exelixis (NASDAQ: EXEL) has announced positive results from a subgroup analysis of the phase 3 CABINET study evaluating cabozantinib in patients with gastrointestinal neuroendocrine tumors (GI NET). The analysis showed that cabozantinib reduced the risk of disease progression or death by 50% compared to placebo.
The study included 116 patients, with primary tumor locations predominantly in the ileum/cecum (54%) and small intestine (20%). Median progression-free survival was 8.5 months with cabozantinib versus 5.6 months with placebo. One patient achieved partial response with cabozantinib, while 48 patients achieved stable disease compared to 30 with placebo.
The FDA is currently reviewing Exelixis's supplemental New Drug Application for cabozantinib in advanced neuroendocrine tumors, with a target action date of April 3, 2025. Common grade 3/4 adverse events included hypertension (19%), diarrhea (13%), and fatigue (10%).
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