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”) (NASDAQ: IBRX). Click Here to Join Investigation.
If you acquired ImmunityBio common stock and would like to discuss our investigation, please click here or contact us by emailing pmayer@kaplanfox.com or by calling (646) 315-9003.
On May 11, 2023, ImmunityBio disclosed in a filing with the Securities and Exchange Commission that the Company “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 based on “deficiencies relate[d] to the FDA’s pre-license inspection of the Company’s third-party contract manufacturing organizations” and that “[s]atisfactory resolution of the observations noted at the pre-license inspection is required before the BLA may be approved.”
In midday trading on May 11, 2023, ImmunityBio shares fell over 54%.
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If you have any questions about this investigation, please contact:
Pamela A. Mayer
KAPLAN FOX & KILSHEIMER LLP
800 Third Avenue, 38th Floor
New York, New York 10022
(646) 315-9003
E-mail: pmayer@kaplanfox.com
Laurence D. King
KAPLAN FOX & KILSHEIMER LLP
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Oakland, California 94612
(415) 772-4704
Fax: (415) 772-4707
E-mail: lking@kaplanfox.com
