NEW YORK, July 05, 2023 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a securities class action lawsuit has been filed in the United States District Court for the Southern District of California on behalf of all persons or entities who purchased the securities of ImmunityBio, Inc. (“ImmunityBio” or the “Company”) (NASDAQ: IBRX) between May 23, 2022 and May 10, 2023, both dates inclusive (the “Class Period”).
In May 2022, the Company submitted a Biologics License Application (“BLA”) for Anktiva to the U.S. Food and Drug Administration (“FDA”). Following submission of its application, the Company 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, the Company 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, the Company’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 Defendants made false and/or misleading statements and/or failed to disclose that: (i) the Company 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.
Investors who purchased or otherwise acquired shares of ImmunityBio should contact the Firm prior to the August 29, 2023 lead plaintiff motion deadline. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. If you wish to discuss your rights or interests regarding this class action, please contact Thomas J. McKenna, Esq. or Gregory M. Egleston, Esq. of Gainey McKenna & Egleston at (212) 983-1300, or via e-mail at tjmckenna@gme-law.com or gegleston@gme-law.com.
Please visit our website at http://www.gme-law.com for more information about the firm.
