ImmunityBio, Inc.

Before the market opened on May 11, 2023, ImmunityBio, Inc. “announce[d] that it has received a complete response letter from the U.S. Food and Drug Administration (“FDA”) on May 9, 2023 regarding its Biologics License Application (“BLA”) for its product candidate, Anktiva™ (N-803) in combination with Bacillus Calmette-Guérin (“BCG”) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (“NMIBC”) with carcinoma in situ (“CIS”) with or without Ta or T1 disease. The letter indicates that the FDA has determined that it cannot approve the BLA in its present form, and the FDA has made recommendations to address the issues raised.”

The FDA letter cited deficiencies related to the Regulator’s pre-license inspection of the Company’s third-party contract manufacturing organizations that must be satisfactorily resolved before the BLA may be approved.

Shares of ImmunityBio stock plunged more than 50% in premarket trading and were down as much as 58% in early intraday trading once the market opened on May 11, 2023.

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