GRABAR LAW OFFICE INVESTIGATES CLAIMS AGAINST OFFICERS AND DIRECTORS OF IMMUNITYBIO, INC. (NASDAQ: IBRX)
ImmunityBio, Inc. 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 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[.]”
A recently filed securities fraud class action Complaint alleges that, ImmunityBio, through certain of its officers and directors, made materially false and misleading statements regarding the Company’s business, operations, and prospects. Specifically, the Complaint alleges 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.
Key allegations of that complaint have now partially survived a motion to dismiss.
Current ImmunityBio shareholders who have held ImmiunityBio shares since on or before March 10, 2021, can seek corporate reforms, the return of funds spent defending litigation back to the company, and a court approved incentive award, at no cost to them.
If you would like to learn more about this matter, you are encouraged to contact us at jgrabar@grabarlaw.com, or call 267-507-6085.