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Biologics License Application

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ImmunityBio's bladder cancer therapy rejected by FDA, stock plummets.
biotech2 years ago

ImmunityBio's bladder cancer therapy rejected by FDA, stock plummets.

The FDA has rejected ImmunityBio's biologics license application for a specific bladder cancer, citing deficiencies related to an inspection of a third-party contract manufacturer. The rejection caused the biotech's shares to tumble about 50%. ImmunityBio's Anktiva, or N-803, will need a satisfactory resolution of the observations before a BLA approval.