Exelixis (EXEL): A High-Growth Oncology Play with Strong Clinical and Financial Momentum

Exelixis (NASDAQ: EXEL) has emerged as a compelling long-term investment in the oncology sector, driven by a dual engine of robust financial performance and transformative clinical progress. With Q1 2025 results underscoring its commercial strength and a pipeline anchored by pivotal trial updates, the company is well-positioned to capitalize on its leadership in targeted therapies and immuno-oncology combinations.

Financial Momentum: Cabozantinib Fuels Record Revenue

Exelixis delivered a standout Q1 2025 performance, reporting total revenue of $555.4 million, a 30.6% year-over-year increaseExelixis Posts Strong Q1 2025 Results, Raises Full-Year Guidance^[1]. This growth was spearheaded by its flagship product, Cabozantinib (CABOMETYX), which generated U.S. net product revenues of $513.3 million, up 35.6% from the prior yearExelixis Announces First Quarter 2025 Financial Results and ...^[2]. The drug's success stems from its dominance in the renal cell carcinoma (RCC) market, particularly the cabo/nivo combination, which has become a standard of care for advanced RCC patientsEarnings call transcript: Exelixis beats Q1 2025 ...^[3]. Additionally, early adoption of CABOMETYX in neuroendocrine tumors (NET) post-U.S. regulatory approval has added a new revenue streamExelixis Inc (EXEL) Q1 2025 Earnings Call Highlights^[4].

The company's financial strength is further reflected in its non-GAAP earnings per share of $0.62, exceeding analyst expectationsExelixis, Inc. (EXEL) Q1 FY2025 earnings call transcript^[5]. Exelixis has raised its full-year 2025 revenue guidance to $2.25–$2.35 billion, a $100 million increase from prior projections, signaling confidence in sustained momentumExelixis Announces Second Quarter 2025 Financial Results and Business Updates^[6].

Clinical Catalysts: Zanzalutinib Advances as a Next-Generation Franchise

While Cabozantinib solidifies Exelixis' near-term growth, zanzalutinib is emerging as a high-impact catalyst for long-term value creation. The drug's STELLAR-303 phase 3 trial in metastatic colorectal cancer (CRC) delivered statistically significant improvements in overall survival when combined with atezolizumab, outperforming regorafenib in both the intent-to-treat population and non-liver metastases subgroupsExelixis Announces Zanzalintinib in Combination with an Immune Checkpoint Inhibitor Improved Overall Survival in STELLAR-303 Phase 3 Pivotal Trial in Patients with Metastatic Colorectal Cancer^[7]. These results have prompted the company to initiate discussions with regulatory authorities for potential approval in this indicationSTELLAR-304: a phase III study of zanzalintinib (XL092) plus nivolumab in advanced non-clear cell renal cell carcinoma^[8].

Parallel progress is being made in non-clear cell renal cell carcinoma (nccRCC), where the STELLAR-304 trial is fully enrolled and on track for top-line results in H1 2026STELLAR-304: a phase III study of zanzalintinib (XL092) plus nivolumab in advanced non-clear cell renal cell carcinoma^[9]. This phase 3 study is evaluating zanzalutinib plus nivolumab versus sunitinib in treatment-naïve patients, with progression-free survival and objective response rate as primary endpointsStellar 304^[10]. A positive outcome here could position zanzalutinib as a first-line therapy in a $2 billion+ marketExelixis Announces Second Quarter 2025 Financial Results and Business Updates^[11].

Exelixis is also expanding zanzalutinib's potential through combination studies, including a collaboration with Merck to explore its use with the HIF2α inhibitor Welireg in clear cell RCCSTELLAR-304: a phase III study of zanzalintinib (XL092) ...^[12]. These trials underscore the company's strategic focus on leveraging zanzalutinib's mechanism as a multi-targeted tyrosine kinase inhibitor (TKI) across diverse oncology settings.

Strategic Positioning: A Dual-Franchise Growth Model

Exelixis' investment case is further strengthened by its dual-franchise model, with Cabozantinib and zanzalutinib forming the backbone of its commercial and pipeline strategy. The former's entrenched role in RCC and NET, coupled with the latter's progress in CRC and nccRCC, creates a revenue and margin diversification that mitigates single-product risk.

Moreover, the company's execution track record—including rapid regulatory approvals and strong physician adoption—demonstrates its ability to translate clinical data into market share. With a $100 million revenue guidance increase and a pipeline of four phase 3 trials in oncology, Exelixis is uniquely positioned to outperform peers in both near-term earnings and long-term innovation.

Conclusion: A Bullish Outlook for Long-Term Investors

For investors seeking exposure to the high-growth oncology sector, Exelixis offers a rare combination of proven commercial execution, high-impact clinical catalysts, and strategic pipeline diversification. The Q1 2025 results validate its financial resilience, while the STELLAR-303 and STELLAR-304 trials provide clear milestones for future value creation. As the company advances toward potential approvals in CRC and nccRCC, Exelixis is poised to redefine its role in the oncology landscape—and deliver outsized returns for patient- and shareholder alike.