ImmunityBio Faces Class Action Lawsuit After FDA Criticism on Misleading Cancer Claims

ImmunityBio Under Legal Scrutiny

ImmunityBio, Inc. (NASDAQ: IBRX), a biotechnology pioneer, is currently embroiled in a securities class action lawsuit following the FDA's serious allegations about the company's misleading claims regarding its flagship product, Anktiva. The chain of events began when the FDA sent a warning letter to ImmunityBio, targeting statements made by its executive chairman and Chief Scientific and Medical Officer, Dr. Patrick Soon-Shiong. The FDA highlighted that his assertions regarding Anktiva's efficacy for various cancer types were deceptive, leading to a significant reaction in the stock market.

On March 24, 2026, immediate fallout ensued when the company's stock price plummeted more than 21%, resulting in a staggering loss of almost $2 billion in market capitalization. This legal battle has prompted national securities law firm Hagens Berman to launch an investigation into potential violations of federal securities laws. The firm not only seeks to represent impacted investors who purchased ImmunityBio securities within the specified period—from January 19 to March 24, 2026—but also encourages any witnesses who could further this investigation to come forward.

The controversy surged after Soon-Shiong appeared in a January podcast titled "Is the FDA BLOCKING Life Saving Cancer Treatments?" In this broadcast, he boldly claimed that, despite Anktiva's approval for treating non-muscle invasive bladder cancer (NMIBC), it could effectively manage all forms of cancer. Such assertions raised red flags, culminating in the FDA’s assertion that these representations could perilously mislead patients regarding Anktiva's actual capabilities.

In addition to the podcast statements, the FDA's warning also addressed promotional material distributed through a television ad, stating that it falsely implied that Anktiva could cure cancer comprehensively. According to the FDA, the promotional content created a misleading impression that all patients treated with Anktiva would remain cancer-free long-term—claims that are unfounded and not supported by clinical data.

The FDA further criticized the overall presentation of the promotional material, asserting it lacked critical information revealing the complete FDA-approved indications for Anktiva. The organization's serious concerns over the misleading claims extend beyond market implications; they also emphasize a public health perspective, underscoring the danger of misrepresenting medical treatments.

In light of these developments, Hagens Berman is actively investigating claims that ImmunityBio may have intentionally misled investors regarding Anktiva's efficacy. Reed Kathrein, a partner at the firm, stated that they aim to uncover the truth behind the company's promotional strategies, highlighting that any investors with significant losses related to this situation should consider joining the case against ImmunityBio.

As the investigation unfolds, the firm provides resources for investors, including a dedicated case page offering updates and guidance for those affected by the recent downturn. Notably, whistleblowers with insider information have been encouraged to discuss their findings privately, given the potential ramifications of the case and the likelihood that successful whistleblowers could receive financial rewards from the SEC.

ImmunityBio remains focused on developing innovative immunotherapies designed to activate the immune system, providing hope for patients battling cancer and infectious diseases. However, the substantial risk posed by misrepresentation of treatment effectiveness looms large as stakeholders await clarity regarding the legal findings. The coming weeks will be critical for ImmunityBio as they navigate this precarious situation amid growing scrutiny from both the regulatory and investment communities.