Strong Full-Year and Quarterly Revenue Growth for CABOMETYX
Full year 2025 U.S. cabozantinib franchise net product revenues grew ~17% to approximately $2.12 billion versus 2024. Q4 2025 U.S. cabozantinib franchise net product revenues grew ~6% year-over-year to $547 million (CABOMETYX net product revenues $544.7 million). Global cabozantinib franchise net product revenues were approximately $754 million in Q4 and $2.89 billion for full year 2025.
CABOMETYX Leadership in Key Indications
CABOMETYX remained the number-one prescribed TKI in renal cell carcinoma (RCC), the leading TKI+IO combination in first-line RCC, and the number-one oral agent in the second-line-plus neuroendocrine tumor (NET) segment. CABO U.S. net revenues for NET exceeded $100 million in 2025.
ZANZA NDA Acceptance and Positive STELLAR-303 Result (ITT)
FDA accepted the NDA for zanzalintinib (ZANZA) in combination with atezolizumab for third-line-plus colorectal cancer based on STELLAR-303. The trial met one of two dual primary endpoints, showing a 20% reduction in the risk of death in the ITT population at final analysis. PDUFA target action date set for December; top-line non-liver-metastases (NLM) OS readout expected midyear.
Expanding ZANZA Development Program with Multiple Pivotal Trials
ZANZA program includes seven ongoing/planned pivotal trials (e.g., STELLAR-316 MRD adjuvant CRC, STELLAR-311 NET vs everolimus, STELLAR-304 non-clear cell RCC vs sunitinib, STELLAR-201 meningioma). Collaboration interest (e.g., Merck LightSPARK 33 and other combos) could broaden development and commercial potential.
Strong Balance Sheet and Active Capital Return
Cash and marketable securities of approximately $1.66 billion at year-end 2025. Repurchased ~$954 million of common stock in FY2025 (retiring ~24 million shares at an average price of $39.61); ~$590 million remaining on the $750 million repurchase authorization.
Early-Stage Pipeline Progress
Four early clinical molecules (XL-309, XP-010, XB-628, XB-371) are in clinical development and progressing. Additional small molecule and ADC programs are advancing, supporting the company’s franchise-building strategy beyond CABO and ZANZA.