ImmunityBio Faces Securities Lawsuit After FDA Comments on Cancer Claims, Shares Dive

ImmunityBio's Legal Troubles: A Class Action Lawsuit Looms

ImmunityBio, Inc. (NASDAQ: IBRX) finds itself in troubled waters as it faces a securities class action lawsuit that seeks to represent investors who purchased the company's securities between January 19, 2026, and March 24, 2026. This lawsuit is a result of a recent letter from the FDA warning the company about misleading claims made regarding its lead biologic product, Anktiva.

The controversy began when the company’s executive chairman and Chief Scientific and Medical Officer, Dr. Patrick Soon-Shiong, made bold assertions about Anktiva during a podcast. He proclaimed that the FDA-approved immunotherapy, initially sanctioned for the treatment of non-muscle invasive bladder cancer (NMIBC), could be effective against all forms of cancer. His comments encountered swift rebuke as the FDA flagged them as misleading.

The FDA issued a warning letter on March 24, 2026, indicating that both a podcast and a television advertisement by ImmunityBio created the false impression that Anktiva can cure and prevent all types of cancer. Furthermore, the FDA noted that the promotional materials misleadingly suggested that patients treated with Anktiva would be cancer-free for extended periods, a claim that has not been substantiated by any available data.

Consequently, this alarming news has resulted in a staggering decline of over 21% in ImmunityBio’s share price, wiping out nearly $2 billion from the company's market capitalization. As a response to this dramatic drop, national shareholders' rights firm Hagens Berman is now investigating potential violations of federal securities laws by ImmunityBio.

Reed Kathrein, a partner at Hagens Berman, stated, “We are looking into claims that ImmunityBio intentionally misled investors about Anktiva’s efficacy and indications.” This marks a significant moment for the firm, highlighting the responsibility companies hold when representing drug efficacy—especially in the sensitive field of cancer treatment.

ImmunityBio has primarily positioned itself as a biotechnology company dedicated to the development and commercialization of innovative immunotherapies aimed at harnessing the body’s immune system to combat cancer and contagious diseases. With Anktiva being its flagship product, the expectations from investors are understandably high, making these allegations of misleading statements particularly damaging.

Hagens Berman is urging shareholders who have suffered significant losses due to the drop in stock value to come forward. They are also inviting witnesses who may assist in the ongoing investigation to reach out to their attorneys. The firm has set a deadline for lead plaintiff submissions on May 26, 2026.

The FDA’s actions have stirred up public health concerns, indicating that misleading promotional materials could create a harmful perception of the treatment’s benefits. The agency's warning specified that the claims made were not only unsupported but also potentially hazardous to patients who might be led to believe they could forego other treatments based on inflated efficacy claims.

Dr. Soon-Shiong's controversial podcast aired on January 19, 2026, where his optimistic promises about Anktiva raised eyebrows among healthcare professionals and investors alike. Shortly after, the FDA took note, and the financial markets reacted, sending ImmunityBio’s shares tumbling.

For investors, the situation remains tense as they monitor how ImmunityBio will navigate these legal challenges and regulatory scrutiny. The outcomes of this class action lawsuit and the firm’s policy toward investor communication will be closely watched in the upcoming months.

ImmunityBio's saga serves as a reminder of the complexities within the biotech industry, where the lines between innovation, marketing, and ethics can become blurred. The stakes are high, both for investors and patients awaiting potentially life-saving treatments. As the investigation unfolds, further revelations about the company’s internal practices and claims about Anktiva may come to light, impacting both its public image and financial stability.