On January 20, 2026, ImmunityBio held a Type B end-of-phase meeting with the U.S. Food and Drug Administration to discuss its supplemental biologics license application for Anktiva in papillary non–muscle invasive bladder cancer. During the meeting, FDA reviewers provided detailed feedback on the company’s Phase III clinical data, which showed a 68% complete response rate at 12 months in patients unresponsive to BCG therapy. Regulators highlighted the need for additional long-term safety data and requested clarification on manufacturing controls for the viral vector, but confirmed that the overall design of ImmunityBio’s application is sufficient to support regulatory approval if these items are addressed within the next review cycle.

ImmunityBio has committed to submitting the requested information to the FDA within 30 days, targeting a final submission by February 19, 2026. The supplemental package will include updated safety analyses from the ongoing open-label extension study, which has enrolled an additional 45 patients across 12 U.S. sites and reported no new Grade 3 or higher adverse events. Management indicated that, if accepted, the FDA could grant accelerated approval by mid-2026, enabling Anktiva to reach an estimated 50,000 eligible patients in the United States. Investors should watch for confirmation of acceptance from the agency and any revisions to projected commercialization timelines, as these factors will directly influence ImmunityBio’s revenue forecasts and cash-burn projections for the remainder of the year.