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Could Zanzalintinib's FDA Delay Affect Exelixis' Growth Plans?
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Key Takeaways
Exelixis faces a three-month FDA delay on zanzalintinib's metastatic CRC review, now due March 3, 2027.
The FDA requested more information, and updated safety and efficacy data triggered a major amendment.
Exelixis is advancing zanzalintinib studies in CRC, RCC and meningioma to broaden its oncology portfolio.
Exelixis (EXEL - Free Report) recently suffered a setback in its efforts to get investigational candidate zanzalintinib approved.
On Sept. 10, 2026, Exelixis announced that the FDA had extended the review period for its new drug application (NDA) for zanzalintinib in combination with Roche’s (RHHBY - Free Report) Tecentriq (atezolizumab) for patients with metastatic colorectal cancer (CRC).
The FDA had initially assigned a target action date of Dec. 3, 2026. However, following an FDA request for additional information, Exelixis submitted updated safety and efficacy data. The agency classified the submission as a major amendment, requiring additional time to complete its review.
As a result, the FDA has extended the target action date by three months to March 3, 2027. The delay pushes back a potential regulatory decision for zanzalintinib in metastatic CRC.
Shares of the company have lost 2.8% since the announcement.
Year to date, EXEL stock has gained 29.5% compared with the industry’s growth of 6.3%.
Image Source: Zacks Investment Research
More on EXEL’s Zanzalintinib
Zanzalintinib is a novel oral kinase inhibitor that inhibits the activity of the TAM kinases (TYRO3, AXL, MER), MET and VEGF receptors.
In June 2026, Exelixis reported final phase III STELLAR-303 results showing a non-statistically significant overall survival trend favoring zanzalintinib plus Tecentriq over regorafenib in the non-liver metastases subgroup of previously treated non-MSI-high metastatic colorectal cancer. The study had previously met its other dual primary endpoint of overall survival in the intent-to-treat population, which included all randomized patients regardless of the presence of active liver metastases, as reported in June 2025.
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 has collaborated with Merck (MRK - Free Report) to evaluate zanzalintinib, in combination with subcutaneous Keytruda Qlex, in the planned phase III STELLAR-316 study for resected stage II/III CRC.
Under the agreement, Exelixis will sponsor the STELLAR-316 study, while Merck will provide Keytruda Qlex for use in the same. Keytruda is approved for several types of cancer.
Exelixis expects to initiate STELLAR-316 shortly. 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 — a high-risk population with substantial unmet need.
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.
In May 2026, Exelixis announced the initiation of STELLAR-201, a phase II study evaluating zanzalintinib in patients with recurrent grade I/II/III meningioma with relapse or progression following radiation and/or surgery or those who are not candidates for these therapies.
Where Does EXEL Stand?
EXEL’s lead drug, Cabometyx, is one of the leading prescribed tyrosine kinase inhibitors in RCC. The drug 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 neuroendocrine tumor indication expanded more gradually in the second quarter compared with management’s projections. Exelixis attributed the slower uptake to NET’s relatively indolent nature, less frequent patient scans and longer intervals between therapies.
Zanzalintinib represents the company’s most significant near-term catalyst. A delay in the potential approval of the candidate would be a setback for EXEL’s efforts to build a second commercial oncology franchise and diversify its portfolio beyond cabozantinib.
View the Zacks #1 Rank List
Image: Bigstock
Could Zanzalintinib's FDA Delay Affect Exelixis' Growth Plans?
Key Takeaways
Exelixis (EXEL - Free Report) recently suffered a setback in its efforts to get investigational candidate zanzalintinib approved.
On Sept. 10, 2026, Exelixis announced that the FDA had extended the review period for its new drug application (NDA) for zanzalintinib in combination with Roche’s (RHHBY - Free Report) Tecentriq (atezolizumab) for patients with metastatic colorectal cancer (CRC).
The FDA had initially assigned a target action date of Dec. 3, 2026. However, following an FDA request for additional information, Exelixis submitted updated safety and efficacy data. The agency classified the submission as a major amendment, requiring additional time to complete its review.
As a result, the FDA has extended the target action date by three months to March 3, 2027. The delay pushes back a potential regulatory decision for zanzalintinib in metastatic CRC.
Shares of the company have lost 2.8% since the announcement.
Year to date, EXEL stock has gained 29.5% compared with the industry’s growth of 6.3%.
Image Source: Zacks Investment Research
More on EXEL’s Zanzalintinib
Zanzalintinib is a novel oral kinase inhibitor that inhibits the activity of the TAM kinases (TYRO3, AXL, MER), MET and VEGF receptors.
In June 2026, Exelixis reported final phase III STELLAR-303 results showing a non-statistically significant overall survival trend favoring zanzalintinib plus Tecentriq over regorafenib in the non-liver metastases subgroup of previously treated non-MSI-high metastatic colorectal cancer. The study had previously met its other dual primary endpoint of overall survival in the intent-to-treat population, which included all randomized patients regardless of the presence of active liver metastases, as reported in June 2025.
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 has collaborated with Merck (MRK - Free Report) to evaluate zanzalintinib, in combination with subcutaneous Keytruda Qlex, in the planned phase III STELLAR-316 study for resected stage II/III CRC.
Under the agreement, Exelixis will sponsor the STELLAR-316 study, while Merck will provide Keytruda Qlex for use in the same. Keytruda is approved for several types of cancer.
Exelixis expects to initiate STELLAR-316 shortly. 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 — a high-risk population with substantial unmet need.
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.
In May 2026, Exelixis announced the initiation of STELLAR-201, a phase II study evaluating zanzalintinib in patients with recurrent grade I/II/III meningioma with relapse or progression following radiation and/or surgery or those who are not candidates for these therapies.
Where Does EXEL Stand?
EXEL’s lead drug, Cabometyx, is one of the leading prescribed tyrosine kinase inhibitors in RCC. The drug 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 neuroendocrine tumor indication expanded more gradually in the second quarter compared with management’s projections. Exelixis attributed the slower uptake to NET’s relatively indolent nature, less frequent patient scans and longer intervals between therapies.
Zanzalintinib represents the company’s most significant near-term catalyst. A delay in the potential approval of the candidate would be a setback for EXEL’s efforts to build a second commercial oncology franchise and diversify its portfolio beyond cabozantinib.
EXEL’s Zacks Rank
Exelixis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.