ImmunityBio Stock Price Plummets as FDA Issues Warning Over Misleading Advertising

LootboxPhobia · 2026-03-24T21:23:16+00:00

ImmunityBio Inc. received an FDA warning for false promotion of its bladder cancer treatment drug ANKTIVA, resulting in a 15% stock price decline. The FDA pointed out that the company claimed the drug could treat multiple types of cancer and failed to provide risk information and relevant data as required. This is the third warning the FDA has issued against the company.

LootboxPhobia

2026-03-24 21:23:16

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Investing.com – ImmunityBio Inc. (NASDAQ:IBRX) stock dropped 15% on Tuesday after the U.S. Food and Drug Administration (FDA) issued a warning letter regarding false and misleading promotional materials about the company’s bladder cancer treatment drug ANKTIVA.

The FDA’s Prescription Drug Promotion Office found that a television advertisement and a podcast featuring company executives made misleading claims about the drug’s effectiveness and approved uses. These materials implied that ANKTIVA could cure and prevent all types of cancer, when in fact the drug is only approved for use in combination with BCG therapy to treat specific types of bladder cancer.

ANKTIVA is approved for adult patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, regardless of whether they have papillary tumors. The drug must be administered via intravesical instillation, meaning directly injected into the bladder.

The FDA identified multiple violations in promotional materials involving CEO Richard Adcock and Executive Chairman Dr. Patrick Soon-Shiong. These violations included claims that ANKTIVA can “treat all cancers,” prevent cancer in radiation-exposed populations, and work as a single-injection therapy. The agency noted that these statements are not supported by clinical data.

The warning letter also states that the company failed to properly present risk information and omitted important facts about the drug’s approved indications. The FDA pointed out that the podcast was not submitted in accordance with regulations when first released.

This is the third time the FDA has issued a notice to ImmunityBio regarding similar promotional issues, following informal letters sent to the company’s subsidiary, Altor BioScience, in September 2025 and January 2026.

ImmunityBio is required to respond to the warning letter within 15 business days, submit a plan to address the violations, and conduct corrective communications to audiences who received the misleading materials.

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