ImmunityBio has achieved a significant regulatory milestone, with the U.S. Food and Drug Administration (FDA) formally acknowledging receipt of its supplemental Biologics License Application (sBLA). The filing seeks approval for ANKTIVA in combination with BCG to treat bladder cancer. This development triggered a notable upward movement in the company’s share price.
Financial Performance: Rapid Revenue Growth Amidst Losses
The commercial trajectory for ANKTIVA is demonstrating remarkable momentum. For the full year 2025, total revenue reached approximately $113 million. This figure represents a staggering 700 percent increase compared to the previous year, driven by the therapy’s expanding market adoption following its initial approvals.
A quarterly breakdown reveals continued acceleration. Fourth-quarter 2025 net product revenue was $38.3 million, marking a 20 percent sequential gain from the third quarter and a 431 percent surge year-over-year.
Despite these substantial revenue gains, ImmunityBio continues to report significant losses. The net loss for the fourth quarter stood at $61.9 million. Over the past twelve months, the cumulative net loss amounts to $351.4 million. The company reported cash and liquidity reserves of roughly $242.8 million.
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Regulatory and Clinical Landscape Strengthens
Beyond the FDA submission, the therapy’s profile received a boost from a leading medical authority. The National Comprehensive Cancer Network (NCCN) updated its 2026 clinical practice guidelines to include the ANKTIVA-BCG combination. It is now listed as a Category 2A recommendation for patients with BCG-unresponsive non-muscle invasive bladder cancer, specifically for those with papillary disease only.
The formal FDA approval for this expanded indication is still pending. The recently accepted sBLA represents the critical next step in that regulatory process.
Market Outlook Tied to Regulatory Success
Market analysts have set a twelve-month price target of $14.80 for ImmunityBio shares. With the stock currently trading around $8.82, this implies substantial potential upside. However, this optimistic outlook remains contingent on a successful outcome of the ongoing FDA review process for the supplemental application.
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