ImmunityBio Inc. reported that it held a Type B end-of-phase meeting with the U.S. Food and Drug Administration, during which regulators outlined the next steps for the company’s supplemental biologics license application for Anktiva (nadofaragene firadenovec) in papillary non-muscle invasive bladder cancer (NMIBC). The FDA requested additional immunogenicity and long-term safety data, as well as updated manufacturing batch records. ImmunityBio has committed to submitting the requested information within 30 calendar days, which could clear the way for a potential approval decision in mid-2026 and open access to an estimated 60,000 annual U.S. patients who relapse after BCG therapy.

Shares of IBRX jumped following the presentation of updated data from the Phase 1 study of CD19-targeted t-haNK cell therapy in Waldenström lymphoma. In the expanded cohort of eight evaluable patients, 75% (6/8) achieved a complete response without the use of chemotherapy or lymphodepletion, with a median duration of response of 9.2 months at last follow-up. The therapy demonstrated a favorable safety profile, with only low-grade cytokine release syndrome observed in two patients. Company executives highlighted that these durable responses support advancement into a pivotal registration trial planned for Q3 2026.