Exelixis Q2 2026 results detail zanzalintinib pipeline progress, narrows guidance
The FDA's PDUFA date for zanzalintinib in metastatic colorectal cancer remains December 3, 2026, as new trials advance and guidance tightens.
Exelixis reported second quarter 2026 financial results on August 5, 2026, alongside updates across its zanzalintinib and cabozantinib programs.
On regulatory status, in February 2026 the FDA accepted the company's NDA for zanzalintinib in combination with atezolizumab, for patients with metastatic colorectal cancer previously treated with certain chemotherapy regimens, with a PDUFA target action date of December 3, 2026.1 That followed mixed trial results: in June 2026, Exelixis reported final overall survival results from the non-liver metastases subgroup of the phase 3 STELLAR-303 trial, showing a non-statistically significant trend favoring zanzalintinib plus atezolizumab over regorafenib.1 The trial had already met its other dual primary endpoint, overall survival in the intention-to-treat population, as announced in June 2025.1
On new trials, Exelixis said it remains on track to initiate the phase 3 STELLAR-316 pivotal trial of zanzalintinib in mid-20261, run with Merck and Natera in MRD-positive resected colorectal cancer, using Natera's Signatera assay to identify MRD-positive patients for enrollment.1 Separately, Merck initiated LITESPARK-034, a global phase 3 trial of zanzalintinib with WELIREG, in April 2026, following the first paired trial, LITESPARK-033, started in December 2025.1 For renal cell carcinoma, Exelixis said in May 2026 that topline results from the STELLAR-304 trial are expected in the second half of 2026, depending on event rates.1 The company also initiated STELLAR-201, a phase 2 trial of zanzalintinib in recurrent Grade I/II/III meningioma, in May 2026.1
On finances, Exelixis narrowed 2026 total revenue guidance to $2.500-$2.550 billion from a prior $2.525-$2.625 billion, and lowered R&D expense guidance to $825-$875 million from $875-$925 million.1 Guidance excludes any revenue from a potential zanzalintinib launch.1 Total revenues for the quarter were $628.7 million, versus $568.3 million a year earlier.1 Exelixis repurchased $311.6 million of stock during the quarter at an average price of $47.85 per share.1
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