ImmunityBio Faces Regulatory Crackdown Over Misleading Cancer Drug Claims

The U.S. Food and Drug Administration (FDA) has taken decisive action against ImmunityBio, issuing a formal warning letter over what it deems to be dangerously misleading promotional claims for the company’s bladder cancer drug, Anktiva. The regulatory move highlights a significant gap between the treatment’s approved use and the bold assertions made by the biotech firm’s leadership.

A Sudden Market Reversal

Investors reacted swiftly to the news, sending ImmunityBio’s stock into a steep decline. Shares plummeted more than 20% in Tuesday’s trading session, briefly falling below the $7 mark. This sell-off represents a dramatic reversal for the equity, which had been one of this year’s standout performers with a staggering rally of nearly 300% year-to-date prior to the announcement.

This sharp correction stems from an escalating dispute with regulators. The FDA had previously issued two informal admonishments to an ImmunityBio subsidiary in September 2025 and again this past January. The publication of this formal warning letter indicates that the agency’s patience has run out, and it will no longer tolerate the company’s marketing practices following those earlier notices.

Exaggerated Efficacy and Omitted Risks

Central to the FDA’s criticism are promotional activities featuring Executive Chairman Patrick Soon-Shiong and CEO Richard Adcock. According to the regulator, a television advertisement and a podcast appearance presented a grossly distorted picture of Anktiva’s capabilities. Soon-Shiong incorrectly labeled the drug a “cancer vaccine” capable of treating “all cancers” and even suggested it could work as a preventive measure following radiation exposure. In reality, Anktiva is approved solely for a specific form of bladder cancer.

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The agency also objected to executives describing the therapy as a simple “single injection” under the skin, when the approved administration method requires direct instillation into the bladder. Furthermore, the FDA cited a systematic downplaying of the treatment’s health risks in the advertising materials, with the podcast failing to mention any risks whatsoever.

Corrective Action Deadline and Operational Context

ImmunityBio now has 15 working days to submit a comprehensive plan to address the cited violations. The company must also issue corrective statements to everyone exposed to the misleading promotional content. Failure to comply adequately could result in legal penalties from the regulator.

The stakes for the company are considerable. After generating $113 million in global Anktiva revenue last year, market analysts project that figure could nearly double to approximately $218 million by 2026.

Separate from the marketing controversy, the drug’s regulatory progress continues. ImmunityBio submitted a supplemental application for Anktiva in combination with BCG for an additional bladder cancer patient group on March 9. The FDA has accepted that filing, requesting only additional efficacy data without mandating new clinical trials.