ImmunityBio resubmits sBLA to FDA for Anktiva plus BCG

ImmunityBio (IBRX) announced that the U.S. FDA has acknowledged receipt of its supplemental Biologics License Application for Anktiva plus Bacillus Calmette-Guerin in BCG-unresponsive non-muscle invasive bladder cancer with papillary tumors. The resubmission follows ongoing discussions with the FDA beginning in January 2026, during which the Agency requested additional data to support its review. The request did not include the initiation or design of any new clinical trials. ImmunityBio submitted the requested information in February 2026. After reviewing the additional data, the FDA provided feedback in March requesting updated efficacy data. The company subsequently resubmitted the sBLA for patients with papillary-only NMIBC, including updated long-term follow-up data, and the Agency has acknowledged receipt of the filing.