ImmunityBio Faces Class Action Lawsuit Following FDA Warning on Efficacy Claims
ImmunityBio Faces Class Action Lawsuit
ImmunityBio, Inc. (NASDAQ: IBRX) is currently navigating a challenging legal landscape, facing a securities class action lawsuit initiated by investors who claim to have incurred substantial losses. This lawsuit seeks to represent individuals who acquired ImmunityBio's securities during a period defined as from January 19, 2026, to March 24, 2026. The turmoil began when the Food and Drug Administration (FDA) issued a warning letter to ImmunityBio regarding misleading claims made by its executive chairman and Chief Scientific and Medical Officer, Dr. Patrick Soon-Shiong, concerning the company's lead product, Anktiva.
On March 24, 2026, the FDA's warning highlighted that Soon-Shiong's claims regarding Anktiva — an FDA-approved immunotherapy designed for treating non-muscle invasive bladder cancer (NMIBC) — were misleading. Specifically, the FDA pointed to statements made during a direct-to-consumer podcast and a television advertisement, wherein Soon-Shiong suggested that Anktiva could treat all types of cancers, not just NMIBC. These assertions, lacking scientific backing, were described by the FDA as creating a false impression of the drug's efficacy.
The repercussions of this announcement were swift and severe, as ImmunityBio's stock plummeted by over 21% in a single day, wiping out nearly $2 billion in market capitalization. This dramatic decline has caught the attention of Hagens Berman, a national shareholder rights law firm that specializes in representing investors in class action lawsuits. They are actively investigating the extent of the alleged misinformation and its impact on investors who may qualify for the class action.
Hagens Berman is urging affected investors to come forward with information regarding their losses, aiming to establish the connection between the misleading claims and the subsequent financial damage incurred. In addition, they are welcoming any whistleblowers who possess non-public information related to these events, as such insights may prove crucial to the ongoing investigation.
As of now, the class action's lead plaintiff deadline is set for May 26, 2026, inviting those investor shareholders who believe they were harmed by ImmunityBio's actions to submit their claims for review. Hagens Berman has also created a dedicated webpage that details the situation, including frequently asked questions and updates on the legal proceedings, ensuring that investors are well-informed about the developments in the case.
Regulatory Concerns
The FDA's warning letter specified multiple instances where ImmunityBio’s promotional materials misrepresented Anktiva’s capabilities, stating that the claims made did not align with any known data supporting the efficacy declarations. The letter included points emphasizing that these misleading assertions not only violate federal securities laws but also carry significant public health implications, considering the potential for misguiding patients seeking effective cancer treatment.
The firm leading the investigation, Hagens Berman, is spearheaded by partner Reed Kathrein, who expressed concern over the apparent intent to mislead investors. The firm has stated, "We are investigating claims that ImmunityBio intentionally misled investors about Anktiva efficacy and indications."
In light of these developments, ImmunityBio faces a difficult road ahead, as the integrity of its product claims and investor relationships hang in the balance. For now, affected investors are encouraged to remain vigilant and informed, and consider engaging with legal professionals who may assist in navigating the complexities of this class action process.
About Hagens Berman
Hagens Berman Sobol Shapiro LLP, known for its commitment to corporate accountability, represents a wide range of clients, including investors and whistleblowers. The firm has successfully recovered over $2.9 billion for clients harmed by corporate misconduct, and continues to monitor the situation closely regarding ImmunityBio. To find more information about their efforts or to participate in the class action, visit their dedicated IBRX case page or contact them directly via email or phone.
In summary, the ImmunityBio incident underscores the critical importance of transparency and accuracy in corporate communications, especially in sectors as sensitive as biotechnology and pharmaceuticals. Stakeholders and potential investors should pay heed to the developments surrounding this case as it unfolds.