Core Insights - Exelixis is developing zanzalintinib, a next-generation oral investigational tyrosine kinase inhibitor (TKI) targeting receptor tyrosine kinases involved in cancer growth, with recent studies showing positive data [1] Study Results - In June 2025, Exelixis announced positive top-line results from the STELLAR-303 study, a phase III trial involving 901 patients with metastatic colorectal cancer, comparing zanzalintinib plus Tecentriq against regorafenib [2] - The STELLAR-303 study met one of its dual primary endpoints, showing a statistically significant improvement in overall survival (OS) for the intent-to-treat population treated with zanzalintinib plus Tecentriq compared to regorafenib [3] - Enrollment for the STELLAR-304 study was completed in May 2025, evaluating zanzalintinib in combination with Opdivo versus sunitinib in advanced non-clear cell renal cell carcinoma [4] - Exelixis has opted not to proceed with the phase III portion of the STELLAR-305 trial based on emerging data and competition in advanced squamous cell carcinoma [5] - The company initiated the phase III STELLAR-311 study in advanced neuroendocrine tumors, comparing zanzalintinib to everolimus [6] Competitive Landscape - The competitive environment for renal cell carcinoma (RCC) is intensifying, with significant competition for Exelixis's lead drug, Cabometyx, from various immunotherapy-TKI combinations [7] - Keytruda, approved for advanced RCC, accounts for approximately 50% of Merck's pharmaceutical sales, highlighting the competitive pressure in the market [10] Financial Performance - Exelixis shares have increased by 14% year-to-date, contrasting with a 0.9% decline in the biotech industry [11] - The company's shares are currently trading at a price/sales ratio of 4.09x forward sales, above its historical mean of 3.64x and the biotech industry's average of 1.59x [13] - The bottom-line estimate for 2025 has risen from $2.64 to $2.68, while the estimate for 2026 has decreased from $3.13 to $3.09 over the past 30 days [14]

Core Viewpoint - Exelixis (EXEL) has demonstrated strong performance in the biotech sector, with a 35.2% increase in stock price over the past three months, significantly outperforming the industry growth of 11.8% [1][7]. Pipeline and Study Updates - The stock received a boost from positive results in the late-stage STELLAR-303 study for zanzalintinib, a promising pipeline candidate [2][3]. - The STELLAR-303 study involved 901 patients with previously non-microsatellite instability-high metastatic colorectal cancer, comparing zanzalintinib in combination with Tecentriq against the standard drug regorafenib [4][5]. - Zanzalintinib is a third-generation oral TKI that targets various receptor tyrosine kinases involved in cancer progression [5]. - The study met one of its primary endpoints, showing a statistically significant improvement in overall survival for the treatment group [5][6]. - Exelixis plans to continue the trial for further analysis of the second primary endpoint related to patients without liver metastases [6]. Product Performance and Revenue Guidance - Exelixis' lead drug, Cabometyx, remains a top TKI for renal cell carcinoma, with strong sales driven by label expansions and high demand [10][11]. - The company raised its 2024 revenue guidance by $100 million, supported by Cabometyx's momentum and pipeline advancements [8][11]. - Recent label expansions for Cabometyx are expected to further enhance sales, particularly in treating neuroendocrine tumors [12][13]. Collaborative Efforts - Exelixis is collaborating with Merck to evaluate zanzalintinib in combination with Keytruda for head and neck squamous cell carcinoma in a late-stage study [9]. Pipeline Expansion - The company is making significant progress in expanding its oncology portfolio beyond Cabometyx, with plans to submit an investigational new drug application for XB371 to the FDA in 2025 [14][15]. Valuation and Estimates - Exelixis shares are currently trading at a price/sales ratio of 5.03x forward sales, higher than the biotech industry's average of 1.57x [16]. - The bottom-line estimate for 2025 has increased to $2.64 per share, with a positive trend in earnings estimates over the past 60 days [18][19]. Investment Outlook - Exelixis is viewed as a strong investment opportunity due to its robust fundamentals, growth prospects, and efforts to enhance shareholder value [20].