• In early February 2026, Exelixis, Inc. reported that the FDA accepted its New Drug Application for zanzalintinib plus atezolizumab to treat previously treated adult patients with metastatic colorectal cancer, granting a standard review with a target action date of December 3, 2026.
• The filing draws on phase 3 STELLAR-303 data showing a statistically significant overall survival benefit versus regorafenib, highlighting how Exelixis is extending its kinase-inhibitor expertise beyond cabozantinib into a broader solid-tumor franchise.
• Against this backdrop, we’ll examine how the FDA’s review of the zanzalintinib–atezolizumab combination reshapes Exelixis’s investment narrative in oncology.

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What Is Exelixis' Investment Narrative?

To own Exelixis, you need to believe in a profitable, late‑stage oncology company steadily reinvesting cabozantinib cash flows into a broader solid‑tumor portfolio. The FDA’s acceptance of the zanzalintinib–atezolizumab NDA adds a clearer colorectal cancer pathway to that story, but it does not immediately alter the near term revenue picture, which still leans heavily on CABOMETYX and the company’s 2026 guidance of about US$2.53–2.63 billion in total revenue. Where it does move the needle is on catalysts and risk mix: the December 2026 PDUFA date, the mid‑2026 final STELLAR‑303 readout in non‑liver metastases, and the planned STELLAR‑316 adjuvant trial now sit alongside ongoing buybacks and strong margins as key signposts. At the same time, regulatory, clinical and concentration risks remain central to the investment debate.

However, one concentration risk still stands out that investors should not ignore. Exelixis' shares have been on the rise but are still potentially undervalued. Find out how large the opportunity might be.

Exploring Other Perspectives

Twelve Simply Wall St Community fair values span from the mid US$30s to well above US$200, underscoring how far apart individual views can be. Set against that spread, the new zanzalintinib NDA and upcoming colorectal cancer data could materially influence how future growth and risk are judged.

Explore 12 other fair value estimates on Exelixis - why the stock might be worth over 5x more than the current price!

Build Your Own Exelixis Narrative

Disagree with this assessment? Create your own narrative in under 3 minutes - extraordinary investment returns rarely come from following the herd.

• A great starting point for your Exelixis research is our analysis highlighting 4 key rewards and 1 important warning sign that could impact your investment decision.
• Our free Exelixis research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Exelixis' overall financial health at a glance.

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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.