ImmunityBio Faces Securities Class Action After FDA Warning Over Anktiva Claims; Shares Fall Over 21%

ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases. The company’s Anktiva is an FDA-approved immunotherapy used with Bacillus Calmette-Guérin ("BCG") to treat non-muscle invasive bladder cancer ("NMIBC"). The lawsuit is focused on the propriety of ImmunityBio’s claims about Anktiva’s efficacy for treating other forms of cancer. On January 19, 2026, a direct-to-consumer podcast ("Is the FDA BLOCKING Life Saving Cancer Treatments?") aired, featuring Soon-Shiong. During the podcast, he said in part that, while Anktiva is approved for bladder cancer, "it actually can treat all cancers." Soon-Shiong made other questionable claims about Anktiva, which together were flagged by the FDA as misleading. On March 24, 2026, the financial press reported that the FDA sent a warning letter to ImmunityBio over claims made in the podcast and a TV ad. The warning letter states the "FDA has determined that the TV ad and podcast are false or misleading." The FDA explained, "the promotional materials create the misleading impression that Anktiva, a treatment for a certain type of bladder cancer, can cure and even prevent all cancer." In addition, the FDA warned that "the representations in the TV ad and podcast misleadingly suggest that Anktiva will allow all NMIBC patients treated with Anktiva to be cancer-free for the long term, when this has not been demonstrated" and "we are not aware of data that support the efficacy claims and representations that Anktiva can 'cure' cancer." The FDA also said ImmunityBio’s promotional materials were misleading because "they fail to provide material information regarding Anktiva’s full FDA-approved indication." Lastly, the FDA warned that ImmunityBio’s "consistent and pervasive misleading efficacy claims and representations presented across promotional materials on different platforms are especially concerning from a public health perspective, given they grossly misrepresent the benefits of Anktiva." This news drove the price of ImmunityBio shares down over 21% on March 24, 2026, erasing nearly $2 billion of the company’s market capitalization. "We’re investigating claims that ImmunityBio intentionally misled investors about Anktiva efficacy and indications," said Reed Kathrein, the Hagens Berman partner leading the firm’s investigation. If you invested in ImmunityBio and have substantial losses, or have knowledge that may assist the firm’s investigation, submit your losses now If you’d like more information and answers to frequently asked questions about the ImmunityBio case and the firm’s investigation, read more » Whistleblowers: Persons with non-public information regarding ImmunityBio should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email [email protected]