ImmunityBio Reports 700% Revenue Growth, Expands Anktiva to 33 Countries and Lung Cancer
ImmunityBio announced $113 million in net product revenue for Anktiva in 2025, a 700% year-over-year increase, while expanding regulatory authorization to 33 countries and securing first approval for lung cancer treatment in Saudi Arabia.
ImmunityBio, Inc. (NASDAQ: IBRX) announced full-year 2025 financial and operational highlights on February 23, 2026, including approximately $113 million in net product revenue for Anktiva, representing an approximately 700% increase year-over-year. The Company also reported a 750% increase in unit sales volume and a 20% quarter-over-quarter increase in net product revenue, demonstrating sustained commercial momentum.
Anktiva in combination with BCG for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary tumors, is now authorized across four major regulatory jurisdictions encompassing 33 countries: United States (FDA approval in April 2024), United Kingdom (MHRA authorization in July 2025), Kingdom of Saudi Arabia (SFDA accelerated approval for BCG-unresponsive NMIBC CIS in January 2026), and European Union (European Commission conditional marketing authorization covering all 27 EU member states plus Iceland, Norway, and Liechtenstein in February 2026). This global regulatory footprint of 33 countries was established in under two years from initial 2024 FDA approval, representing the most rapid international expansion for an immunotherapy in this indication.
In January 2026, the SFDA granted conditional accelerated approval for Anktiva in combination with checkpoint inhibitors for the treatment of metastatic non-small cell lung cancer (NSCLC), making Saudi Arabia the first jurisdiction globally to authorize Anktiva outside of bladder cancer. The commercial launch in Saudi Arabia is planned within 60 days of approval. Submissions to multiple additional regulatory authorities (Ex-USA) for accelerated approval are planned for 2026, with discussions with the U.S. FDA regarding an accelerated approval pathway also planned for 2026.
The scientific rationale for expanding into additional tumor types in the checkpoint inhibitor relapsed population is supported by data from the QUILT-3.055 Phase 2b basket trial (N=147), which enrolled patients across multiple tumor types. In the NSCLC cohort (N=86), the addition of Anktiva to the same checkpoint inhibitor on which patients had progressed demonstrated a median overall survival of 14.1 months, with 12-month and 18-month survival rates of 57% and 34%, respectively.
The Company is pursuing further label expansion across multiple tumor types and for the treatment of chemotherapy-induced lymphopenia, supported by ongoing clinical trial programs. Multiple issued patents, including U.S. Patent Nos. 9,925,247 and 11,071,774, protect the combination of Anktiva plus checkpoint inhibitor therapy, with patent terms extending beyond 2035. These patents cover the combination of IL-15 receptor agonist therapy with anti-PD-1 and anti-PD-L1 checkpoint inhibitors across multiple tumor types, providing long-term exclusivity protection for Anktiva's expanding combination indications.
ImmunityBio formed a distribution partnership with Accord Healthcare in the European Union, with an 85-person sales force deployed across 30 countries, and established an Irish subsidiary in Dublin to support the European launch. The company is partnering with BioPharma & Cigalah to expand access to Anktiva in Saudi Arabia and, over time, in the Middle East North Africa (MENA) region, and formed a Kingdom of Saudi Arabia subsidiary to support the KSA launch.
The company announced productive discussions with the Saudi Food and Drug Authority regarding the submission of a regulatory package for recombinant BCG, aimed at addressing the global BCG shortage. During these discussions, the Saudi FDA encouraged ImmunityBio to submit a regulatory package for its recombinant BCG (rBCG) to improve access in Saudi Arabia. The company plans to submit this package in the coming weeks, which could significantly impact bladder cancer treatment availability in the region.
In January, ImmunityBio said it plans to submit additional information to the U.S. Food and Drug Administration (FDA) within 30 days following a Type B end-of-phase meeting related to its supplemental biologics license application for Anktiva in papillary non-muscle invasive bladder cancer (NMIBC).
ImmunityBio is set to report earnings on March 2, 2026. The stock carries a Buy Rating with an average price target of $11.80.