NEW YORK, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against ImmunityBio, Inc. (NASDAQ: IBRX) on behalf of long-term stockholders following a class action complaint that was filed against ImmunityBio on June 30, 2023 with a Class Period from May 23, 2022 to May 10, 2023. Our investigation concerns whether the board of directors of ImmunityBio have breached their fiduciary duties to the company.
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 are a long-term stockholder of ImmunityBio, 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, by 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 and California. 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.
Contact Information:
Bragar Eagel & Squire, P.C.
Brandon Walker, Esq.
Marion Passmore, Esq.
(212) 355-4648
investigations@bespc.com
www.bespc.com
