The U.S. Food and Drug Administration issued a warning letter to ImmunityBio, Inc. on March 13, 2026, and the letter was released to the public on March 24, 2026. The letter cites the company’s television advertisement and a podcast that promoted its IL‑15 superagonist ANKTIVA with claims that the FDA deemed false or misleading and in violation of federal law.
The FDA’s letter details that ImmunityBio’s promotional materials asserted ANKTIVA could cure or prevent all cancers, could be used as a single jab, and could prevent cancer in individuals exposed to radiation. The letter also notes that the company implied unapproved methods of administration and failed to disclose known risks associated with the drug. The letter references prior “untitled letters” issued in early 2026 and a September 2025 letter, indicating a pattern of regulatory concern over the company’s marketing practices.
The specific promotional materials cited are a television advertisement and the podcast titled “Is the FDA BLOCKING Life Saving Cancer Treatments?” which featured Dr. Patrick Soon‑Shiong and was originally aired on The Sean Spicer Show on January 19, 2026. ImmunityBio was given 15 working days to respond to the letter and to cease the misleading communications and issue corrective messaging.
ANKTIVA is approved in the United States for use in combination with Bacillus Calmette‑Guérin (BCG) in adult patients with BCG‑unresponsive non‑muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. The drug has also received conditional marketing authorization in the European Union, approval in the United Kingdom and Macau SAR, and has been incorporated into updated NCCN Clinical Practice Guidelines for a broader NMIBC population.
The warning letter raises significant regulatory risk for ImmunityBio. The company’s marketing activities may be curtailed, and the FDA has indicated that non‑compliance could lead to legal action or product seizure. Investor confidence has been affected, and the company’s ability to generate future revenue from ANKTIVA could be constrained if marketing is limited or if additional penalties are imposed. The letter also highlights a broader pattern of FDA scrutiny, as ImmunityBio had received earlier letters regarding similar promotional claims.
Financially, ImmunityBio reported a 99.3% gross margin in its most recent quarter, but the company remains unprofitable with negative EBIT. Revenue grew 700% in Q4 2025, driven largely by the commercialization of ANKTIVA. The FDA warning could impact the company’s revenue trajectory by limiting promotional reach and potentially delaying broader adoption of the drug. Management has not yet issued a statement on the letter, but the regulatory action underscores the importance of compliance in the company’s growth strategy.
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