Track market-moving stories before they get noisy

Key Takeaways Exelixis awaits an FDA decision on zanzalintinib for metastatic colorectal cancer by Dec. 3, 2026.EXEL expanded zanzalintinib studies with Merck across colorectal and renal cell cancer programs.Zanzalintinib is also advancing in lung and prostate cancer studies, broadening its potential use. Shares of Exelixis, Inc. (EXEL - Free Report) have surged 26.8% in three months, outperforming the industry’s gain of 4.5%.  The stock touched a high of $57.57 on July 7.

The stock has outperformed the sector and the S&P 500 Index during this time frame.

EXEL Outperforms Industry, Sector & S&P 500 Index
Image Source: Zacks Investment Research

The broader market recovery and investors' optimism about the company's pipeline momentum are most likely contributing to the rally, notwithstanding the recent pipeline setback. In such a scenario, a deeper assessment of the company's growth drivers and potential risks will be essential to determine whether current levels represent an attractive entry point.

EXEL’s Progress With Lead Candidate ZanzalintinibZanzalintinib is Exelixis' most important late-stage pipeline asset and represents the company's key growth driver as it seeks to diversify beyond its flagship cancer therapy, cabozantinib (marketed as Cabometyx). The next-generation oral investigational tyrosine kinase inhibitor (TKI) targets multiple pathways, giving it potential across several difficult-to-treat cancers.

The company's near-term investment thesis hinges on the regulatory outcome for zanzalintinib.

EXEL’s new drug application seeking approval of zanzalintinib in combination with Roche’s (RHHBY - Free Report) Tecentriq for the treatment of patients with metastatic colorectal cancer (mCRC) is under review in the United States. The targeted population includes patients who were previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, and, if they are RAS wild-type, an anti-epidermal growth factor receptor therapy.

The agency has set a target action date of Dec. 3, 2026.

A positive decision would mark the first approval for zanzalintinib and establish a new commercial growth platform beyond Cabometyx.

The company's recent disappointment stemmed from the final analysis of the dual primary endpoint of overall survival (OS) in the subset of patients without active liver metastases (non-liver metastases, NLM) in the late-stage STELLAR-303 study, evaluating zanzalintinib plus Tecentriq versus regorafenib in previously treated non-microsatellite instability (MSI)-high mCRC.

This showed a non-statistically significant trend in OS favoring the combination in the NLM subpopulation. Median OS was 15.9 months for patients treated with the combination therapy compared with 12.7 months for those receiving regorafenib.    
The disappointing results are a setback in the company’s efforts to get approval for zanzalintinib.

Meanwhile, Exelixis continues to aggressively expand zanzalintinib's development program through strategic partnerships and multiple late-stage clinical studies.

The company recently broadened its collaboration with Merck (MRK - Free Report) to evaluate zanzalintinib in combination with subcutaneous Keytruda Qlex in the planned phase III STELLAR-316 study in patients with resected stage II/III colorectal cancer (CRC).

Exelixis will sponsor the study, while Merck will supply Keytruda Qlex. The study will evaluate zanzalintinib with and without Keytruda Qlex in patients with resected stage II/III CRC who, following definitive therapy, have tested positive for molecular residual disease (MRD+) and have no radiographic evidence of disease.

Exelixis has also partnered with Natera, a global leader in cell-free DNA and precision medicine, whose Signatera molecular residual disease assay will be used to identify eligible patients for STELLAR-316.

The Merck partnership extends beyond colorectal cancer. In April 2026, Merck initiated the phase III LITESPARK-034 trial evaluating zanzalintinib plus Welireg versus Welireg and placebo in previously treated advanced renal cell carcinoma (RCC) patients who progressed after PD-1/L1 and VEGFR-TKI therapies.

This marks the second Merck-sponsored phase III study under the collaboration, following LITESPARK-033 (launched in December 2025), which is assessing the combination against cabozantinib in first-line advanced RCC post-adjuvant immunotherapy.

These studies highlight Merck's confidence in zanzalintinib's potential across multiple RCC treatment settings while substantially expanding Exelixis' long-term growth opportunities.Beyond CRC and RCC, Exelixis is advancing additional indications for zanzalintinib through the planned phase II STELLAR-202 study in squamous non-small cell lung cancer and an expansion cohort in the ongoing phase Ib/II STELLAR-002 trial in metastatic castration-resistant prostate cancer. Success in any of these indications could significantly broaden the drug's commercial opportunity.

Roche’s Tecentriq is a cancer immunotherapy that is approved around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various types of cancer.

EXEL’s Cabometyx Maintains MomentumLead drug Cabometyx is approved for advanced RCC and previously treated hepatocellular carcinoma.

In March 2025, Exelixis obtained FDA approval for the label expansion of Cabometyx for the treatment of adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic and extra-pancreatic neuroendocrine tumors (pNET). The drug was also approved for adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic NET (epNET).  

The Cabometyx franchise continued to gain momentum in 2026, maintaining its position as the leading prescribed TKI in renal cell carcinoma, the top TKI plus immunotherapy combination in first-line RCC, and the leading oral option in second-line and later neuroendocrine tumors.

Invest in EXEL StockWhile the STELLAR-303 results have tempered near-term expectations, zanzalintinib remains Exelixis' most most significant near-term catalyst. The upcoming FDA decision, multiple late-stage trials, and deepening collaborations with Merck and Natera provide several value-creating catalysts.

Positive regulatory and clinical outcomes could meaningfully diversify Exelixis' revenue base beyond Cabometyx and support the company's long-term growth trajectory.

We remain bullish on the stock's prospects and believe it offers additional upside potential. Accordingly, we view the shares favorably for prospective investors, while existing shareholders may consider maintaining their positions to capitalize on further growth opportunities.

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