New York, March 25, 2026, 07:07 EDT.
- The FDA flagged a TV commercial and podcast for misbranding Anktiva, handing ImmunityBio a 15-working-day deadline for a response.
- Shares ended Tuesday at $7.42, dropping 21.1%. Earlier in the session, losses reached as steep as 26%.
- The warning comes as ImmunityBio is trying to expand its U.S. label and take Anktiva into fresh markets like Macau.
ImmunityBio was changing hands around $7.42 early Wednesday, matching Tuesday’s close after a sharp 21.1% drop sparked by an FDA warning letter that criticized the company for allegedly making false or misleading claims about its cancer therapy Anktiva. The shares had plunged as much as 26% during Tuesday’s trading.
The blow is significant: Anktiva essentially props up the entire revenue stream. According to a February filing, the drug accounted for roughly $113 million in ImmunityBio’s 2025 net product revenue—almost the full $113.3 million total. Analysts tracked by LSEG are forecasting $217.6 million in sales for this year.
Here’s the crux. On March 9, ImmunityBio announced it had resubmitted its FDA application to broaden Anktiva’s use for papillary-only bladder cancer, following agency feedback. Less than two weeks later, on March 20, the company said regulators in Macau had approved the therapy. That gives Anktiva its first entry into Asia and pushes its footprint to 34 countries and territories.
The FDA’s March 13 letter, published Tuesday, homed in on a television commercial and a Sean Spicer podcast episode. According to regulators, those promotional spots suggested Anktiva might “cure and even prevent all cancer,” work independently or act as a cancer vaccine—claims that, they said, misbrand the drug under federal law. U.S. Food and Drug Administration
The agency took aim at the pitch’s underlying evidence. According to regulators, the late-stage QUILT-3.032 trial failed to provide interpretable disease-free survival data—meaning, there’s no clear picture of how long patients remain cancer-free post-treatment. The agency also said it was unaware of any proof supporting claims that Anktiva can cure cancer.
ImmunityBio said it’s going through the letter now and intends to respond as required. “We take the warning very seriously and will work cooperatively with the agency to address it,” spokesperson Sarah Singleton told AP. Reuters
Piper Sandler’s Edward Tenthoff didn’t sound the alarm. He expects ImmunityBio will satisfy the FDA’s requirements and isn’t altering his Anktiva revenue outlook.
According to FDA records, Anktiva is cleared in the U.S. for use alongside BCG—a longtime bladder cancer immunotherapy—for adults whose non-muscle invasive bladder cancer with carcinoma in situ hasn’t responded to BCG, whether papillary tumors are present or not. The agency’s warning letter makes it clear: Anktiva isn’t approved in the U.S. for treating every type of cancer, for use in lung cancer patients after checkpoint inhibitors stop working, or for cancer prevention after radiation exposure.
ImmunityBio faces established competition. Merck’s Keytruda and Janssen’s Inlexzo both already have FDA approval in the broader bladder-cancer segment, so ImmunityBio’s challenge is more about how well it delivers as it pushes to expand Anktiva’s reach.
The warning letter injects risk, but stops short of predicting any next steps. The FDA noted it had previously sent untitled letters in September 2025 and January 2026 regarding similar Anktiva presentations. The agency didn’t indicate whether those earlier letters would impact label-expansion applications now under review, but with that track record, uncertainty around those filings has only deepened.
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