FDA acknowledges receipt of ImmunityBio’s resubmitted sBLA for ANKTIVA plus BCG in NMIBC papillary tumors

Reuters03-09

FDA acknowledges receipt of ImmunityBio’s resubmitted sBLA for ANKTIVA plus BCG in NMIBC papillary tumors

ImmunityBio said the FDA has acknowledged receipt of its resubmitted supplemental BLA for ANKTIVA plus BCG in BCG-unresponsive non-muscle invasive bladder cancer with papillary tumors. The resubmission followed FDA feedback requesting updated efficacy data after the agency reviewed additional information provided in February 2026. ImmunityBio said the FDA did not request initiation or design of any new clinical trials.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Immunitybio Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: 202603090730PR_NEWS_USPR_____NY05091) on March 09, 2026, and is solely responsible for the information contained therein.

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