ImmunityBio's Anktiva Drives Record Revenue Amid Global Expansion Push

ImmunityBio reports $113M in 2025 Anktiva revenue, up 700% YoY, as EU and Saudi approvals fuel growth. Stock hits 52-week high.

ImmunityBio has released financial figures that are capturing investor attention. The company's flagship immunotherapy, Anktiva, generated substantial revenue growth in 2025, even as the biotech firm continues to post net losses fueled by aggressive international expansion and research investments.

Financial Performance Highlights

For the full year 2025, ImmunityBio reported net product revenue for Anktiva of approximately $113 million. This staggering figure represents a year-over-year increase of roughly 700%. The volume of units sold saw an even more dramatic rise, climbing 750% compared to the prior year.

The fourth quarter alone contributed about $38.3 million in net product revenue. This performance marks a 20% sequential increase from the third quarter and a massive 431% jump from the same period last year. Concurrently, the company managed to narrow its quarterly net loss to around $62 million, with a per-share loss of -$0.06. This improvement signifies the third consecutive quarter of betterment in earnings per share.

Trading activity surged on the report's release date, with over 85 million shares changing hands—more than double the average volume of the preceding three months. The stock price reached a new 52-week peak of $11.00, and several reports indicated the company's market capitalization approached $9.7 billion.

Accelerating International Regulatory Progress

This financial update follows a series of significant regulatory achievements across multiple regions. On February 18, ImmunityBio announced that the European Commission granted conditional marketing authorization for Anktiva in combination with BCG for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ. This authorization is valid across all 27 EU member states, plus Iceland, Norway, and Liechtenstein.

According to the company, Anktiva is now approved in four major regulatory jurisdictions covering 33 countries. These include the United States (FDA approval in April 2024), the United Kingdom (MHRA approval in July 2025), Saudi Arabia (accelerated SFDA approval in January), and now the European Union (conditional approval in February). A notable aspect of the Saudi Arabian authorization is that it includes an accelerated conditional approval for Anktiva in combination with checkpoint inhibitors for metastatic non-small cell lung cancer (NSCLC)—representing the therapy's first regulatory clearance beyond bladder cancer.

To support the European launch, ImmunityBio is establishing its commercial infrastructure. A distribution partnership with Accord Healthcare was announced on February 19, alongside the formation of an Irish subsidiary in Dublin to aid commercialization efforts. The company also stated that an 85-person sales team is being prepared for the European market. For its entry into Saudi Arabia, ImmunityBio reported partnerships with Biopharma and Cigalah Healthcare on February 20.

The Cost of Rapid Growth

Despite the explosive revenue growth from its lead product, ImmunityBio has not yet achieved profitability. The net loss for 2025 totaled approximately $351 million. This loss is driven by substantial ongoing investments, particularly in research and development, which alone accounted for about $64 million in the fourth quarter. The company is simultaneously scaling commercial operations in multiple regions, a process that involves significant cash expenditure.

The sustainability of this growth trajectory, as outlined by the company, hinges largely on the smooth operational execution of its expansion into new markets and the success of forthcoming regulatory and indication milestones.

Several key near-term objectives form part of the company's roadmap. These include a planned Biologics License Application (BLA) submission for BCG-naïve bladder cancer patients by the fourth quarter of 2026 (patient recruitment is already reported to be over 85% complete), discussions with the FDA regarding an accelerated approval pathway in lung cancer during 2026, an ongoing FDA review following a resubmission for papillary NMIBC (with additional information submitted in January), and an upcoming FDA meeting concerning recombinant BCG scheduled for March.