The U.S. Food and Drug Administration issued a warning letter to ImmunityBio Inc. (NASDAQ: IBRX) regarding false and misleading promotional materials for its bladder cancer treatment ANKTIVA.

The FDA's Office of Prescription Drug Promotion determined that a television advertisement and podcast featuring company executives made misleading claims about the drug's effectiveness and approved uses. The promotional materials suggested ANKTIVA could cure and prevent all types of cancer, when the drug is only approved for treating a specific type of bladder cancer in combination with BCG therapy.

ANKTIVA is approved for treating adult patients with BCG-unresponsive nonmuscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors. The drug must be administered intravesically, meaning directly into the bladder.

The FDA cited several violations in promotional materials featuring CEO Richard Adcock and Executive Chairman Dr. Patrick Soon-Shiong. These included claims that ANKTIVA could "treat all cancers," prevent cancer in radiation-exposed individuals, and function as a single injection treatment. The agency noted these representations were not supported by clinical data.

The warning letter also addressed the company's failure to properly present risk information and omission of material facts about the drug's approved indication. Additionally, the FDA noted that the podcast was not submitted at the time of initial publication as required by regulations.

This marks the third FDA communication to ImmunityBio regarding similar promotional issues, following untitled letters in September 2025 and January 2026 sent to the company's subsidiary Altor BioScience.

ImmunityBio has 15 working days to respond to the warning letter with a plan to address the violations and implement corrective communications to audiences who received the misleading promotional materials.