ImmunityBio Shares Surge to New Peak on Strong Commercial Momentum

ImmunityBio's stock surges as ANKTIVA gains EU approval, expands globally, and posts 700% annual revenue growth, while narrowing net losses in 2025.

ImmunityBio's stock reached a new 52-week high today, trading as high as $11.00. This surge is fueled by a powerful combination of robust 2025 financial results and a rapid series of recent regulatory and commercial advancements, primarily centered on its immunotherapy, ANKTIVA.

Commercial Expansion Gains Pace in Key Markets

A cluster of significant catalysts has emerged in recent days, driving substantial investor enthusiasm. On February 18, the European Commission granted conditional marketing authorization for ANKTIVA in combination with BCG for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (Carcinoma in situ). This approval is valid across all 27 EU member states, plus Iceland, Norway, and Liechtenstein. The company notes this makes ANKTIVA the first approved immunotherapy in Europe for this specific indication.

The very next day, ImmunityBio announced a distribution partnership with Accord Healthcare, which plans to deploy an 85-person sales team across 30 European countries. To further support its European commercialization efforts, the company has established an Irish subsidiary in Dublin.

Furthermore, on February 20, the company reported a separate partnership with Biopharma and Cigalah Healthcare for Saudi Arabia and the broader MENA region. The Saudi Food and Drug Authority (SFDA) has already issued a registration certificate inclusive of pricing, with product delivery expected within 60 days. A wholly-owned subsidiary has also been set up in Saudi Arabia to support these operations.

Financial Performance: Revenue Soars, Losses Narrow

The company's fourth quarter and full-year 2025 results provided a solid foundation for the rally. For Q4 2025, ImmunityBio reported a loss per share of -$0.06, which beat market expectations of -$0.08. Quarterly revenue reached approximately $38.3 million.

For its core product, ANKTIVA, the company reported net product revenue of about $113 million for the full year 2025. This represents a staggering growth of approximately 700% compared to the prior year, according to company statements. In the fourth quarter alone, ANKTIVA revenue grew 20% sequentially, supported by a 750% increase in sales volume.

Consequently, the net loss attributable to common shareholders for 2025 improved to $351.4 million, down from $413.6 million in 2024. This improvement was driven by higher product revenue and lower selling, general, and administrative (SG&A) expenses, which decreased to $150.0 million from $168.8 million. Research and development costs, however, rose to $218.6 million from $190.2 million, partly due to a one-time $14.0 million impairment charge on property and equipment. As of December 31, 2025, cash, cash equivalents, and marketable securities totaled $242.8 million.

Pipeline Progress: Lung Cancer Emerges as New Frontier

Beyond its established bladder cancer indication, ANKTIVA is breaking new ground. In January, Saudi Arabia granted accelerated approval for ANKTIVA in combination with checkpoint inhibitors for metastatic non-small cell lung cancer (NSCLC). ImmunityBio states this makes Saudi Arabia the first jurisdiction worldwide to approve ANKTIVA for an indication beyond bladder cancer.

The company plans to file for accelerated approvals in additional countries outside the U.S. for NSCLC in 2026 and intends to engage with the U.S. FDA regarding an accelerated pathway for this indication.

Currently, ANKTIVA (in combination with BCG for the specified bladder cancer indication) is authorized in four major regulatory regions: the U.S. (FDA, April 2024), the United Kingdom (MHRA, July 2025), Saudi Arabia (SFDA, January 2026), and the European Union (EU Commission, February 2026). In total, the company cites authorizations across 33 countries.

Looking ahead, ImmunityBio has outlined several key near-term milestones: an FDA meeting regarding recombinant BCG in March, further regulatory submissions for NSCLC in multiple countries throughout the year, and a planned Biologics License Application (BLA) submission for BCG-naive bladder cancer patients by the fourth quarter of 2026.