NEW YORK–(BUSINESS WIRE)–#A–Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, reminds investors that a class action lawsuit has been filed against ImmunityBio, Inc. (“ImmunityBio” or the “Company”) (NASDAQ: IBRX) in the United States District Court for the Southern District of California on behalf of all persons and entities who purchased or otherwise acquired ImmunityBio securities between May 23, 2022 and May 10, 2023, both dates inclusive (the “Class Period”). Investors have until August 29, 2023 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
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ImmunityBio is a clinical-stage biotechnology company that engages in developing therapies and vaccines that complement, harness, and amplify the immune system to defeat cancers and infectious diseases in the U.S. and Europe. The Company offers immunotherapy and cell therapy platforms, including, inter alia, antibody cytokine fusion protein N-803, commercially referred to as “Anktiva”. The Company uses third-party contract manufacturing organizations (“CMOs”) to produce certain of its product candidates, including Anktiva.
In May 2022, ImmunityBio submitted a Biologics License Application (“BLA”) for Anktiva to the U.S. Food and Drug Administration (“FDA”). Following submission of its application, ImmunityBio consistently assured investors that “[w]e have established Good Manufacturing Practice (GMP) manufacturing capacity at scale with cutting-edge cell manufacturing expertise and ready-to-scale facilities[.]”
On May 11, 2023, during pre-market hours, ImmunityBio announced that the FDA had rejected the BLA for Anktiva in its present form, citing “deficiencies relat[ing] to the FDA’s pre-license inspection of the Company’s third-party contract manufacturing organizations.”
On this news, ImmunityBio’s stock price fell $3.43 per share, or 55.14%, to close at $2.79 per share on May 11, 2023.
The complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) ImmunityBio conducted insufficient due diligence to discover, or else did discover and ignored, GMP deficiencies at its third-party CMOs for Anktiva; (ii) one or more of the Company’s third-party CMOs for Anktiva did in fact suffer from GMP deficiencies; (iii) the foregoing deficiencies was likely to cause the FDA to reject the Anktiva BLA in its present form; (iv) accordingly, the Company overstated the regulatory approval prospects for the Anktiva BLA; and (v) as a result, the Company’s public statements were materially false and misleading at all relevant times.
If you purchased or otherwise acquired ImmunityBio shares and suffered a loss, are a long-term stockholder, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker or Marion Passmore by email at investigations@bespc.com, telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.
About Bragar Eagel & Squire, P.C.:
Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York, California, and South Carolina. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.
Contacts
Bragar Eagel & Squire, P.C.
Brandon Walker, Esq.
Marion Passmore, Esq.
(212) 355-4648
investigations@bespc.com
www.bespc.com