ImmunityBio Inc. (NASDAQ:IBRX) shares dropped 15% on Tuesday after the U.S. Food and Drug Administration issued a warning letter citing misleading promotional materials related to the company’s bladder cancer therapy, ANKTIVA.
The FDA’s Office of Prescription Drug Promotion said a television advertisement and a podcast featuring company executives included inaccurate claims regarding the drug’s effectiveness and approved uses. According to the agency, the materials implied that ANKTIVA could cure and prevent all types of cancer, even though the treatment is approved only for a specific form of bladder cancer when used alongside BCG therapy.
ANKTIVA is authorized for use in adult patients with BCG-unresponsive nonmuscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors. The treatment is administered intravesically, meaning it is delivered directly into the bladder.
The FDA identified multiple violations in promotional content featuring CEO Richard Adcock and Executive Chairman Dr. Patrick Soon-Shiong. Among them were claims that ANKTIVA could “treat all cancers,” prevent cancer in people exposed to radiation, and serve as a single-dose treatment. The regulator said these statements are not supported by available clinical evidence.
The agency also criticized the company for failing to adequately disclose safety risks and for omitting key details about the drug’s approved indication. In addition, the FDA said the podcast had not been submitted for review when it was first published, as required by regulatory rules.
The latest warning marks the third communication from the FDA to ImmunityBio over similar promotional concerns, following untitled letters issued in September 2025 and January 2026 to the company’s subsidiary, Altor BioScience.
ImmunityBio has been given 15 working days to respond to the warning letter and outline steps to correct the violations, including issuing corrective communications to audiences exposed to the misleading promotions.