Immunitybio requests an urgent meeting with fda to address the change in the agency's unambiguous guidance on jan 2025 to submit a sbla for nmibc bcg unresponsive papillary disease, following an inconsistent refusal to file letter on may 2, 2025

Culver city, calif.--(business wire)--immunitybio, inc. (nasdaq: ibrx), a leading immunotherapy company, today announced that the company received a refusal to file (rtf) letter from the u.s. food and drug administration (fda) for the supplemental biologics license application (sbla) for use of anktiva plus bacillus calmette-guerin (bcg) in bcg-unresponsive non-muscle invasive bladder cancer (nmibc) for the indication of papillary disease. this rtf letter was received despite reaching unanimous.
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