ImmunityBio shares plunged sharply in New York trading following the company's disclosure that the U.S. Food and Drug Administration issued a warning letter regarding promotional materials for its bladder cancer therapy Anktiva.
When markets opened on Tuesday the stock fell by as much as 30% before recovering some ground to trade roughly 18% lower shortly before 11:00 a.m. Eastern Time after the company made the FDA correspondence public.
FDA findings
The FDA warning letter, dated March 13, said the company's promotional materials - including a television advertisement and a podcast that featured company executives - contained false and misleading claims about Anktiva's effectiveness and its approved uses.
According to the agency, the promotional content suggested Anktiva could cure and prevent all types of cancer. The FDA noted that such representations are inconsistent with the drug's approved use, which is limited to treating a specific type of bladder cancer in combination with BCG therapy.
The Office of Prescription Drug Promotion identified violations in materials that included appearances by Chief Executive Officer Richard Adcock and Executive Chairman Dr. Patrick Soon-Shiong. The agency cited specific claims that Anktiva could treat all cancers, prevent cancer in individuals exposed to radiation, and act as a single-injection treatment - assertions the FDA said are not supported by clinical data.
The warning letter also called out failures to present risk information properly and the omission of material facts about the drug's approved indication. In addition, the agency stated the podcast was not submitted at the time of initial publication as required by regulations.
Required company response
ImmunityBio has 15 working days to reply to the FDA with a plan to correct the violations and to implement communications to audiences who received the misleading promotional materials. The agency's timeline requires the company to outline corrective measures and address the problematic promotional content.
Market and sector context
The disclosure and subsequent warning letter produced immediate market movement in ImmunityBio's shares, reflecting investor sensitivity to regulatory findings about promotional conduct. The developments touch on regulatory oversight of drug promotion, investor confidence in biotech communications, and the importance of aligning marketing claims with approved indications and supporting clinical data.