ImmunityBio Inc. (NASDAQ: IBRX) announced it submitted a response to the U.S. Food and Drug Administration regarding promotional compliance issues raised on March 13, 2026, related to a television advertisement and a podcast.

The biotechnology company confirmed that a television advertisement cited in the FDA correspondence was never broadcast, aired, or disseminated to the public. ImmunityBio removed an identified podcast from its corporate website and requested its removal from third-party hosting platforms.

The FDA's Office of Prescription Drug Promotion raised concerns about promotional materials for ANKTIVA, the company's approved immunotherapy for treating adult patients with BCG-unresponsive non-muscle invasive bladder cancer.

"ImmunityBio takes promotional compliance with the utmost seriousness," said Richard Adcock, president and CEO. "We are dedicated to maintaining a clear distinction between our investigational pipeline aspirations and the promoted indications for our approved therapies."

The company initiated a comprehensive review of promotional materials and external communications with its legal and regulatory teams. ImmunityBio is implementing corrective measures including mandatory executive training, expanded promotional review protocols, and engagement of external regulatory counsel to audit future communications.

The FDA concerns stemmed from statements made during a podcast appearance by founder and executive chairman Dr. Patrick Soon-Shiong. ImmunityBio stated these remarks were intended to convey aspirational opinions regarding the company's drug development pipeline and underlying science.

The company clarified that references to the IL-15 molecule as promising were based on a 2007 National Cancer Institute assessment, and discussions focused on investigational applications currently being studied under FDA-authorized programs.