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ImmunityBio Resubmits ANKTIVA Bladder Cancer Application to FDA, Advances Saudi Approvals

Mar 09, 2026

ImmunityBio resubmitted its supplemental BLA to the FDA for ANKTIVA in papillary bladder cancer after providing additional data. The company also received encouragement from Saudi regulators to submit a recombinant BCG application and expand ANKTIVA approvals.

ImmunityBio Completes Enrollment in ANKTIVA Plus BCG Trial for Bladder Cancer

Feb 27, 2026

ImmunityBio completed enrollment of 366 patients in its Phase 2 trial of ANKTIVA plus BCG versus BCG alone for BCG-naïve bladder cancer. Interim analysis showed statistically significant improvement in duration of complete response, with the company anticipating a BLA submission by Q4 2026.