ANKTIVA revenue doubling yearly with three label expansions pending, but a prior RTF and a Jan 2027 PDUFA on single-arm data define the approval risk

ImmunityBio is a commercial-stage biopharmaceutical company whose lead product, ANKTIVA, is an approved targeted cancer drug for bladder cancer that is not yet approved for several additional patient populations the company is seeking to add to its label.

ANKTIVA, an IL-15 superagonist approved for BCG-unresponsive bladder cancer, generated $50.7M in Q2 2026 revenue, up 92% year-over-year across eight consecutive growth quarters. Whether the thesis compounds depends on FDA approving the papillary-only sBLA in January 2027 and accepting single-arm Phase 2 data for the BCG-naïve expansion. The FDA's May 2025 Refuse-to-File on the same papillary dataset, later reversed, is the sharpest risk: the agency has already signaled it may demand randomized evidence.