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ALAMEDA, Calif. - Exelixis, Inc. (NASDAQ:EXEL), a biotechnology company with excellent financial health and a market capitalization of $11.7 billion, has shared encouraging results from a phase 1b/2 trial named STELLAR-002, examining the efficacy of zanzalintinib in combination with nivolumab or a fixed-dose combination of nivolumab and relatlimab in patients with previously untreated advanced clear cell renal cell carcinoma (RCC). According to InvestingPro analysis, the company maintains a perfect Piotroski Score of 9, indicating strong operational efficiency and financial stability. The data will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting on May 31, 2025.
The trial included two non-randomized arms with 40 patients each, who had advanced or metastatic RCC and had not received prior systemic therapy. The objective response rate for those treated with zanzalintinib and nivolumab was 63%, with a disease control rate of 90%. For the combination with fixed-dose nivolumab and relatlimab, the objective response rate was 40%, with the same disease control rate. The median progression-free survival was 18.5 months and 13.0 months for the respective combinations.
Dr. Amy Peterson, Exelixis’ Chief Medical Officer, noted the importance of these findings in informing further evaluation of zanzalintinib-based regimens for advanced solid tumors. Jad Chahoud, M.D., M.P.H., who will present the findings, highlighted the durable responses and progression-free survival, advocating for further investigation of this regimen.
Treatment-emergent adverse events of any grade were reported in all patients, with hypertension and diarrhea being the most common grade 3/4 events. Two grade 5 adverse events occurred in each arm, but none were related to the study treatment. A minority of patients discontinued all study drugs due to treatment-related adverse events. The market has responded positively to Exelixis’s clinical developments, with the stock delivering an impressive 108% return over the past year. InvestingPro data shows strong revenue growth of 24.5% in the last twelve months, suggesting robust commercial execution.
Additional results from dose-finding cohorts in the STELLAR-002 study will be discussed on June 2, 2025, exploring the safety and efficacy of zanzalintinib combined with immune checkpoint inhibitors in various advanced solid tumors.
Zanzalintinib is a third-generation oral tyrosine kinase inhibitor targeting VEGF receptors, MET, AXL, and MER, which are implicated in cancer growth and resistance to therapies, including immune checkpoint inhibitors.
Kidney cancer is among the top ten most common cancers in the U.S., with clear cell RCC being the most prevalent form. Advanced RCC, when the cancer has spread beyond the kidney, presents a significant challenge with a low five-year survival rate.
This report is based on a press release statement from Exelixis, Inc. The company appears undervalued according to InvestingPro Fair Value analysis, with 8 analysts recently revising their earnings estimates upward for the upcoming period. For deeper insights into Exelixis’s financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers, along with 13 additional ProTips and extensive financial metrics.
In other recent news, Exelixis reported impressive first-quarter financial results for 2025, exceeding consensus expectations with top-line revenues of approximately $555.4 million and non-GAAP earnings per share of $0.62. This performance led the company to raise its full-year revenue guidance to an estimated range of $2.25 to $2.35 billion. Analysts from various firms have reacted positively to these developments. Stifel raised its price target for Exelixis to $38, citing strong Cabometyx sales and potential future growth from the neuroendocrine tumors (NET) indication. TD Cowen increased its price target to $44, maintaining a Buy rating, based on robust quarterly results and projected sales growth for cabozantinib. Similarly, RBC Capital maintained an Outperform rating with a $40 target, highlighting the company’s successful NET launch and share repurchase program. Lucid Capital Markets adjusted its target to $37, noting Exelixis’s strong financial performance but adopting a cautious outlook pending further data. JMP Securities set the highest price target at $47, attributing it to better-than-expected cabozantinib sales and a positive outlook on Exelixis’s pipeline, particularly the zanza treatment for colorectal cancer.
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