FDA Rejects ImmunityBio’s Bladder Cancer Therapy Filing

Shares of ImmunityBio (NASDAQ: 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 the 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.

Though the agency did not request ImmunityBio to conduct any additional studies, it did request for an updated duration of response data and a safety update at the time of BLA resubmission.

Based on the responses received in the CRL, ImmunityBio will request a meeting with the FDA to address the latter’s concerns and plans to re-file the BLA as soon as possible.

In the year so far, ImmunityBio has lost 45.0% compared with the industry’s 5.2% fall.

Image Source: Zacks Investment Research

Management had previously disclosed that it was exploring a …

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