FDA rejects ImmunityBio's BLA for Anktiva (N-803) in bladder cancer; CRL cites manufacturing issues

ImmunityBio, Inc.

FDA issued Complete Response Letter for Anktiva (N-803) + BCG in BCG-unresponsive NMIBC with CIS.
Deficiencies relate to pre-license inspection of third-party contract manufacturing and additional CMC issues.
No new preclinical or Phase 3 studies requested; FDA wants updated duration-of-response data and safety update.
Executive Chairman provides $30M non-convertible debt financing (SOFR+8%, matures Dec 31, 2023).
Partnering discussions for commercialization continue with a large biopharma; no assurance of completion.

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