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ImmunityBio, a biotechnology company developing next-generation immunotherapies, is facing regulatory scrutiny over how it promotes its FDA-approved bladder cancer treatment, Anktiva, and the scope of its claimed efficacy.
The dispute centers on the propriety of ImmunityBio’s claims that Anktiva—approved for use with Bacillus Calmette-Guérin (BCG) to treat non-muscle invasive bladder cancer (NMIBC)—can be used to treat other forms of cancer.
On January 19, 2026, a direct-to-consumer podcast titled “Is the FDA BLOCKING Life Saving Cancer Treatments?” aired featuring Soon-Shiong. During the podcast, he said that while Anktiva is approved for bladder cancer, “it actually can treat all cancers.” The FDA later flagged additional statements made during the podcast as misleading.
On March 24, 2026, financial press reports said the FDA sent a warning letter to ImmunityBio regarding claims made in the podcast and a TV advertisement.
According to the warning letter, “the FDA has determined that the TV ad and podcast are false or misleading.” The FDA said 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.”
The FDA also warned that the promotional materials “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.” The FDA further stated it is “not aware of data that support the efficacy claims and representations that Anktiva can 'cure' cancer.”
In addition, the FDA said the promotional materials were misleading because they “fail to provide material information regarding Anktiva's full FDA-approved indication.” The agency also characterized the company’s messaging as “consistent and pervasive misleading efficacy claims and representations presented across promotional materials on different platforms,” calling them especially concerning from a public health perspective due to what it described as a gross misrepresentation of Anktiva’s benefits.
The news drove ImmunityBio’s share price down by more than 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, a Hagens Berman partner leading the firm’s investigation.
The firm said it is seeking information from investors who may have substantial losses and from witnesses who may be able to assist with the investigation.
The firm also encouraged potential whistleblowers with non-public information regarding ImmunityBio to consider their options, including the SEC Whistleblower program. It noted that whistleblowers who provide original information may receive rewards totaling up to 30% of any successful recovery made by the SEC.
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