By Siddhi Mahatole
March 24 (Reuters) – Shares of ImmunityBio fell 26% on Tuesday after the U.S. Food and Drug Administration issued a warning letter that said a television advertisement and podcast promoting the company’s cancer therapy were false or misleading and violated federal law.
ImmunityBio’s Anktiva was approved for a type of bladder cancer in April 2024.
The agency’s letter, issued to the company on March 13, notes that the direct-to-consumer materials, which featured ImmunityBio CEO Richard Adcock and Executive Chairman Patrick Soon-Shiong, created the impression that Anktiva could cure cancer, prevent its return, work as a single-agent therapy, or function as a cancer vaccine.
The FDA has directed ImmunityBio to cease or take down the TV ad and podcast, as well as submit a written response within 15 working days addressing the concerns described in the letter.
ImmunityBio told Reuters in an email that it has started reviewing the agency’s letter and intends to respond within the requested timeframe to address the matter.
Piper Sandler analyst Edward Tenthoff said, “we believe ImmunityBio can comply with these requests and are not changing our Anktiva revenue forecast.”
The company posted global sales for Anktiva of $113 million in 2025. Analysts expects sales of $217.60 million for this year, according to LSEG data.
The FDA in its letter flagged comments Soon-Shiong made in the podcast, where he said “We have now discovered and developed this drug… approved for bladder cancer, but it actually can treat all cancers.”
The agency said the drug’s late-stage study did not provide results on disease-free survival, and it is not aware of the data that support the efficacy claims and representations that Anktiva can “cure” cancer.
The podcast originally aired on The Sean Spicer Show on January 19 and can also be accessed through ImmunityBio’s website, the agency said.
(Reporting by Siddhi Mahatole in Bengaluru; Editing by Devika Syamnath and Shailesh Kuber)
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