Zanzalintinib - (STELLAR-304)

January 11, 2026: Exelixis, Inc. (NASDAQ: EXEL) reported preliminary unaudited FY2025 results and issued FY2026 guidance, alongside a 2026 catalyst outlook. FY2025 total revenue was approximately $2.320B with U.S. net product revenue of ~$2.123B (cabozantinib franchise). FY2026 guidance: total revenue $2.525B–$2.625B; net product revenue $2.325B–$2.425B (including a 3% U.S. WAC increase for CABOMETYX/COMETRIQ effective Jan 1, 2026). Full Q4/FY2025 results are expected after market close Feb 10, 2026. Exelixis will present at the J.P. Morgan 2026 Healthcare Conference on Jan 12, 2026.

Key pipeline/regulatory catalysts:

• Zanzalintinib (with atezolizumab) in previously treated metastatic colorectal cancer: FDA is reviewing the NDA (potential first commercial launch); filing based on Phase 3 STELLAR-303, which met one dual primary endpoint with statistically significant OS benefit vs regorafenib in the ITT population.
• STELLAR-303: final analysis of the second dual primary endpoint (OS in patients without liver metastases) expected mid-2026.
• STELLAR-304 (zanzalintinib+nivolumab vs sunitinib in 1L advanced non-clear cell RCC): topline results expected mid-2026.
• STELLAR-311 (zanzalintinib vs everolimus in advanced NET): enrolling.
• LITESPARK-033 (zanzalintinib+belzutifan) initiated Dec 2025; another Merck-sponsored pivotal trial anticipated early 2026.
• STELLAR-316 (adjuvant CRC, MRD+ using Natera’s Signatera): initiation expected mid-2026.
• STELLAR-201 (recurrent meningioma): initiation expected mid-2026.

R&D: Phase 1 programs ongoing (XL309, XB010, XB628, XB371); two potential INDs in 2026 (XL557; XB773).