ImmunityBio Responds to FDA Warning Letter Regarding ANKTIVA Promotional Materials

On April 6, 2026, ImmunityBio, Inc. submitted a comprehensive response to a Warning Letter issued by the FDA's Office of Prescription Drug Promotion (OPDP) on March 13, 2026. The FDA's concerns centered on promotional communications for ANKTIVA® (nogapendekin alfa inbakicept-pmln), specifically a podcast and a television advertisement. ImmunityBio clarified that the television advertisement was never broadcast or disseminated to the public. To address concerns regarding the podcast, which featured Founder Dr. Patrick Soon-Shiong, the company has removed the content from its website and requested its removal from third-party platforms. The company is implementing several corrective actions to ensure future compliance, including enhanced internal protocols, expanded Promotional Review Committee (PRC) oversight, mandatory executive training, and the engagement of external regulatory counsel to audit high-visibility communications. ImmunityBio emphasized that the statements in the podcast were intended to convey aspirational views on the company's broader IL-15 platform and investigational pipeline rather than the specific approved indication for ANKTIVA.