ImmunityBio has entered February with significant operational momentum, driven by surging revenue, greater clarity from U.S. regulators, and initial international approvals for its immunotherapy, ANKTIVA. Following an extremely volatile January that saw shares rally over 190%, investor attention is now shifting to the next regulatory milestone: the potential speed of a planned label expansion in the United States.
Preliminary 2025 Revenue Soars on ANKTIVA Demand
The company has reported unaudited preliminary figures for its 2025 fiscal year, revealing net product revenue of approximately $113 million. This represents a staggering increase of 700% compared to the prior year.
Growth accelerated further in the fourth quarter, with revenue reaching $38.3 million. This figure marks a 20% sequential increase over the third quarter. ImmunityBio attributes this sharp rise to the rapid commercial uptake of ANKTIVA (nogapendekin alfa inbakicept) for the treatment of non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). The company concluded the year with a strong cash position, reporting $242.8 million in cash and cash equivalents.
FDA Provides Clear Path Forward, No New Trials Required
A key development was the outcome of a Type B End-of-Phase meeting with the U.S. Food and Drug Administration (FDA). The discussion centered on the pathway for resubmitting a supplemental Biologics License Application (sBLA) for ANKTIVA in BCG-unresponsive NMIBC with papillary tumors.
Critically, the FDA confirmed that no new clinical studies will be required for the resubmission. Instead, the agency has requested additional analyses from existing trial data. ImmunityBio has stated it intends to provide these analyses within 30 days.
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International Expansion Begins with Saudi Arabian Approvals
Adding to the positive news flow, ImmunityBio secured its first international approvals in Saudi Arabia during January. The Saudi regulatory authority cleared ANKTIVA for use in NMIBC with CIS. Notably, it also granted approval for the drug in combination with checkpoint inhibitors for metastatic non-small cell lung cancer (NSCLC). The company states this marks the first global approval for ANKTIVA in lung cancer.
Pipeline Advancement: Updated Glioblastoma Data
Beyond its focus on bladder cancer, ImmunityBio is advancing programs in other solid tumors. In late January, the company released updated Phase 2 data from the QUILT-3.078 trial in recurrent glioblastoma, which combines ANKTIVA with an “off-the-shelf” CAR-NK cell therapy. In the treated cohort, the median overall survival (OS) had not yet been reached.
Following these announcements, the stock has remained volatile. The powerful rally seen at the start of the year was followed by profit-taking in late January. The immediate focus for the market is now the next step in the FDA process, as ImmunityBio prepares to submit the required supplemental analyses within the announced timeframe.
Key Financial and Regulatory Highlights:
– Preliminary 2025 Revenue: Approximately $113 million (+700% year-over-year)
– Q4 2025 Revenue: $38.3 million (+20% quarter-over-quarter)
– Year-End Liquidity: $242.8 million in cash and equivalents
– FDA Status: Path defined for sBLA resubmission for papillary NMIBC; no new trials requested
– International: Saudi Arabia approvals for NMIBC and NSCLC combination therapy (January)
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