Key Takeaways:
- Exelixis stock surged 26.8% in three months, beating the industry's 4.5% gain
- FDA decision on zanzalintinib for colorectal cancer is set for Dec. 3, 2026
- Merck partnership expands with two phase III trials in renal cell carcinoma
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Exelixis gains 26.8% as FDA review, Merck deals fuel pipeline optimism
Exelixis shares rose 26.8% in three months to $57.57 as investors focused on an FDA review and expanded Merck partnerships for pipeline drug zanzalintinib.
"The broader market recovery and investors' optimism about the company's pipeline momentum are most likely contributing to the rally," Zacks Investment Research said in a July 9 note.
The FDA is reviewing zanzalintinib in combination with Roche's Tecentriq for patients with metastatic colorectal cancer who have received prior chemotherapy. The agency set a target action date of Dec. 3, 2026. A positive decision would mark the first approval for zanzalintinib and establish a new commercial platform beyond Cabometyx, Exelixis' flagship cancer therapy.
The company's recent setback came from the STELLAR-303 study, where zanzalintinib plus Tecentriq showed a non-statistically significant trend in overall survival versus regorafenib in patients without active liver metastases. Median OS reached 15.9 months for the combination compared with 12.7 months for regorafenib.
Merck Partnership Deepens
Exelixis expanded its collaboration with Merck to evaluate zanzalintinib with subcutaneous Keytruda Qlex in the planned phase III STELLAR-316 study for resected stage II/III colorectal cancer. Merck also initiated two phase III trials in renal cell carcinoma — LITESPARK-033 in first-line advanced RCC and LITESPARK-034 in previously treated advanced RCC — both testing zanzalintinib combinations.
Beyond colorectal and renal cancers, Exelixis is advancing zanzalintinib through a planned phase II study in squamous non-small cell lung cancer and an expansion cohort in metastatic castration-resistant prostate cancer.
Cabometyx, approved for advanced RCC, hepatocellular carcinoma and neuroendocrine tumors, maintained its position as the leading prescribed TKI in renal cell carcinoma, the company said.
The STELLAR-303 results tempered near-term expectations, but the upcoming FDA decision and multiple late-stage trials provide several catalysts. Positive regulatory and clinical outcomes could diversify Exelixis' revenue base beyond Cabometyx and support long-term growth. Investors will watch the FDA's Dec. 3, 2026, PDUFA date for zanzalintinib.
This article is for informational purposes only and does not constitute investment advice.
[1] EXEL Stock Soars 26.8% in Three Months: Is There More Room for Growth?[2] Exelixis: STELLAR-303 Results Mixed, STELLAR-304 Success Likely[3] EXEL Stock Soars 26.8% in Three Months: Is There More Room for Growth? - Zacks Investment Research[4] EXEL Stock Soars 26.8% in Three Months: Is There More Room for Growth? - TradingView
