Shares of ImmunityBio (NASDAQ: IBRX) gained 3% on Monday following the companys submission of a comprehensive reply to the U.S. Food and Drug Administration concerning promotional compliance issues flagged by the agency.
The FDAs Office of Prescription Drug Promotion raised questions on March 13, 2026, about two pieces of promotional content - a television advertisement and a podcast - and ImmunityBio provided detailed responses addressing both matters.
Regarding the television spot referenced in the FDAs communication, ImmunityBio stated that the advertisement "was never broadcast, aired, or disseminated to the public." The company said it removed the podcast identified by the agency from its corporate website and has formally requested that third-party hosting platforms remove the episode.
Alongside those immediate actions, ImmunityBio described a broader compliance effort. The company said it has launched a comprehensive review of its promotional materials and is implementing enhanced advertising compliance measures to reduce the risk of future issues.
Corrective measures outlined by the company include:
- Mandatory executive training on promotional compliance;
- Expanded protocols for the Promotional Review Committee;
- Engagement of external regulatory counsel to audit future high-visibility communications.
In a statement quoted by the company, President and CEO Richard Adcock said, "ImmunityBio takes promotional compliance with the utmost seriousness. We are dedicated to maintaining a clear distinction between our investigational pipeline aspirations and the promoted indications for our approved therapies."
ImmunityBio also provided context for comments made during a podcast appearance by Founder and Executive Chairman Dr. Patrick Soon-Shiong, saying those remarks were intended as aspirational and forward-looking opinions about the company's drug development pipeline.
The company reiterated the regulatory status of its approved product, noting that ANKTIVA is approved with Bacillus Calmette-Gu E9rin for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors.
The filing and the company's announced remedial steps followed the FDAs March 13, 2026 correspondence and correspond with ImmunityBios stated intention to tighten oversight of promotional communications. The full outcome of the FDAs review of the company's response has not been disclosed by either party.