NEW YORK, May 11, 2023 (GLOBE NEWSWIRE) – Kaplan Fox & Kilsheimer LLP (www.kaplanfox.com) is investigating claims on behalf of investors of ImmunityBio, Inc. (“ImmunityBio” or the “Company”) IBRX. Click here to participate in the survey.

If you have purchased ImmunityBio common stock and would like to discuss our investigation, please contact us Click here or contact us by email pmayer@kaplanfox.com or by calling (646) 315-9003.

On May 11, 2023, ImmunityBio announced in a filing with the Securities and Exchange Commission that the Company “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 Ankiva (N-803) in combination with Bacillus Calmette-Guérin (“BCG”) for the treatment of patients with BCG-refractory non-muscle invasive bladder cancer (“NMIBC”) with carcinoma in situ (“ CIS”) with or without Ta or T1 disease.” The letter states that the FDA has decided that it cannot approve the BLA in its current form due to “deficiencies.”[d] on the FDA’s pre-license inspection of the company’s external contract manufacturing organizations” and that “[s]A satisfactory resolution of the observations found during the pre-license inspection is required before the BLA can be approved.

In midday trading on May 11, 2023, ImmunityBio shares fell over 54%.

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