ImmunityBio Stock Plummets Due to FDA Warning on Misleading Advertising

LootboxPhobia · 2026-03-24T22:53:31+00:00

ImmunityBio stock plummeted due to an FDA warning letter, with the company accused of making false and misleading statements in promoting bladder cancer drug Anktiva, particularly regarding the drug's indications and efficacy. The FDA has required the company to respond and correct the violations within 15 business days.

LootboxPhobia

2026-03-24 22:53:31

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Investing.com – ImmunityBio’s stock price plummeted as much as 30% at the opening of the New York market on Tuesday, then recovered some of the losses, trading down about 18% before 11:00 a.m. The company previously disclosed that the U.S. Food and Drug Administration (FDA) issued a warning letter due to false and misleading advertising related to its bladder cancer drug Anktiva.

The FDA warning letter dated March 13, 2022, pointed out violations in promotional materials, including a TV advertisement and a podcast hosted by company executives, which made misleading claims about the drug’s efficacy and approved uses. These materials implied that Anktiva could cure and prevent all types of cancer, whereas the drug is only approved for treating specific types of bladder cancer and must be used in conjunction with BCG therapy.

The FDA’s Prescription Drug Promotion Office found violations in promotional content involving CEO Richard Adcock and Executive Chairman Patrick Soon-Shiong, including claims that Anktiva can treat all cancers, prevent cancer in radiation-exposed populations, and be administered as a single injection. The agency noted that these statements were not supported by clinical data.

The warning letter also addressed the company’s failure to properly present risk information and omit important facts regarding the drug’s approved indications. The FDA stated that the podcast was not submitted as required when first published.

ImmunityBio must respond to the warning letter within 15 business days, submit a plan to address the violations, and implement corrective communication to audiences who received the misleading promotional materials.

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