ImmunityBio Inc. (IBRX) Misled Investors Regarding the Viability and Efficacy of its Drug Candidate
A shareholder filed a class action on behalf of all persons and entities that purchased or otherwise acquired ImmunityBio (NASDAQ: IBRX) securities between May 23, 2022 and May 10, 2023. ImmunityBio is a clinical-stage biotechnology company that develops therapies and vaccines that complement, harness, and amplify the immune system to defeat cancers and infectious diseases. One of ImmunityBio’s key products is Anktiva, for which it uses a third-party contract manufacturing organization (“CMO”) to produce.
According to the complaint, ImmunityBio submitted a Biologics License Application (“BLA”) to for Anktiva to the U.S. Food and Drug Administration (“FDA”). However, during the class period, defendants failed to disclose that: (i) ImmunityBio conducted insufficient due diligence to discover, or else did discover and ignored, Good Manufacturing Practice (“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; and (iv) accordingly, the Company overstated the regulatory approval prospects for the Anktiva BLA.
On May 11, 2023, ImmunityBio announced that the FDA had rejected the BLA for Anktiva, 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 over 55%, to close at $2.79 per share on May 11, 2023.
What Now: Similarly situated shareholders may be eligible to participate in the class action against ImmunityBio Inc. Shareholders who want to act as lead plaintiff for the class must file their motion with the court by August 29, 2023. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. You do not have to participate in the case to be eligible for a recovery. If you choose to take no action, you can remain an absent class member.
All representation is on a contingency fee basis. Shareholders pay no fees or expenses.
