TLDR
- The FDA issued a warning letter to ImmunityBio over a TV ad and podcast that made false claims about its bladder cancer drug ANKTIVA
- The promotional materials wrongly suggested ANKTIVA could treat all cancers — it is only approved for a specific type of bladder cancer with BCG therapy
- The FDA cited CEO Richard Adcock and Executive Chairman Dr. Patrick Soon-Shiong by name in the violations
- This is the third FDA communication to ImmunityBio over similar promotional issues, following letters in September 2025 and January 2026
- The company has 15 working days to respond with a corrective plan or face potential legal action
ImmunityBio’s stock dropped sharply Tuesday after the FDA flagged a TV ad and podcast for making false claims about ANKTIVA’s approved uses, marking the company’s third run-in with regulators over promotional materials.
$IBRX Receives Warning from FDA
My POV:
The FDA does not like the public pressure campaign Dr Pat is running.
Relevant text below:
The podcast originally aired on The Sean Spicer Show on January 19, 2026, and can also be accessed through ImmunityBio’s website.2 The FDA Bad…
— S&J Investments (@SJCapitalInvest) March 24, 2026
The FDA’s Office of Prescription Drug Promotion sent a warning letter to ImmunityBio following a TV commercial and a podcast titled “Is the FDA BLOCKING Life Saving Cancer Treatments?” The agency determined both violated federal law.
The core issue was scope. ANKTIVA is approved for one specific use: treating adult patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors, administered directly into the bladder alongside BCG therapy.
The promotional materials went far beyond that. They suggested ANKTIVA could “treat all cancers,” prevent cancer in people exposed to radiation, and work as a single injection treatment. None of those claims are supported by clinical data or approved by the FDA.
Both CEO Richard Adcock and Executive Chairman Dr. Patrick Soon-Shiong appeared in the materials and were named in the FDA’s letter.
The FDA said the materials misbranded ANKTIVA and made the drug’s distribution a violation of the Federal Food, Drug, and Cosmetic Act.
Not the First Warning
This is not the first time ImmunityBio has been flagged for this kind of issue. The FDA had previously sent untitled letters in September 2025 and January 2026 to Altor BioScience, a subsidiary of ImmunityBio, over similar promotional concerns.
Tuesday’s letter marks the third such communication — and the most serious. An FDA warning letter carries more regulatory weight than an untitled letter and signals the agency’s escalating concern.
The FDA also cited ImmunityBio for failing to properly present risk information in the materials and for omitting key facts about the drug’s approved indication.
The podcast was also not submitted to the FDA at the time of its initial publication, a separate regulatory requirement the company failed to meet.
Market Reaction
IBRX stock fell around 15% to 21% on Tuesday, with some sources reporting the drop as deep as 21% during morning trading hours.
ImmunityBio now has 15 working days to send the FDA a written response outlining a plan to fix the violations.
The company is also required to implement corrective communications targeted at audiences who saw or heard the misleading materials.
The FDA warned that failure to take sufficient action could result in legal consequences.
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