ImmunityBio Faces FDA Decision on Bladder-Cancer Application, Risk Remains
The FDA accepted ImmunityBio’s application to expand Anktiva’s use with BCG in papillary-only, BCG-unresponsive non-muscle invasive bladder cancer, setting a Jan. 6, 2027 decision date. ImmunityBio reported $44.2 million in first-quarter net product revenue and held $380.9 million in cash and equivalents. Shares last traded at $7.76, down 2.8%. The filing is supported by data from 80 patients in a Phase 2/3 trial.