Pomerantz Appointed Lead Counsel in Shareholder Suit Against ImmunityBio

Pomerantz has been named Lead Counsel in a securities class action against the pharmaceutical company ImmunityBio. The suit alleges that ImmunityBio failed to disclose serious deficiencies in its manufacturing processes which ultimately led the FDA to reject its application for approval of its premier drug candidate.

ImmunityBio is a biopharmaceutical company that specializes in harnessing the body’s own immune system to fight infectious diseases and cancers. One of their leading product candidates is Anktiva, a cell fusion protein intended as a treatment for bladder cancer. Anktiva had produced strong results in Phase 3 trials, leading ImmunityBio to seek FDA approval. ImmunityBio used a third-party manufacturer to produce the key ingredient in Anktiva, and because of the sensitive nature of the material, it is important that manufacturers adhere to current good manufacturing practices in order to ensure the safety of the final product. According to the lawsuit, ImmunityBio was aware that the third-party manufacturer had a history of manufacturing practice violations, leading to a failed FDA inspection in February 2023. However, none of this was disclosed to investors until May 2023, when ImmunityBio announced the FDA had rejected Anktiva. Following this news, ImmunityBio’s stock dropped 55%.

Richard Adcock, David C. Sachs, and Patrick Soon-Shiong are also named as defendants in the lawsuit.