Published on 12 May 2023 on Zacks via Yahoo Finance

FDA Rejects ImmunityBio's (IBRX) Bladder Cancer Therapy Filing

Shares of ImmunityBio IBRX were down 55.1% on Thursday after management announced that FDA issued a complete response letter (“CRL”) to its biologics license application (“BLA”) seeking approval for combination use of its lead pipeline candidate, Anktiva (N-803), in patients with a certain type of bladder cancer.

The BLA sought approval for a combination of Anktiva (N-803) with Bacillus Calmette-Guérin (“BCG”) vaccine to treat patients with BCG-unresponsive non-muscle invasive bladder cancer (“NMIBC”) with carcinoma in situ (“CIS”) with or without Ta or T1 disease.

Per management, the CRL was issued as the FDA identified deficiencies during its pre-license inspection of the company’s third-party contract manufacturing firms. For the BLA to be approved, ImmunityBio needs to resolve these deficiencies to the agency’s satisfaction.