New York, March 24, 2026, 11:13 EDT
- ImmunityBio shares were down about 21% in late morning after the FDA challenged an Anktiva TV ad and podcast. 1
- The agency said the materials overstated the drug’s benefits and promoted uses beyond its approved bladder-cancer label. 2
- The warning lands as ImmunityBio pushes a broader FDA filing for papillary bladder disease. 3
ImmunityBio shares sank about 21% on Tuesday after the U.S. Food and Drug Administration warned that a television ad and podcast for its cancer drug Anktiva were false or misleading and violated federal law. The stock was trading near $7.44 in late morning, after opening at $9.10. 1
That lands awkwardly. On March 9, ImmunityBio said the FDA had acknowledged a resubmitted application to widen Anktiva’s use in papillary-only non-muscle invasive bladder cancer, an early-stage form that has not spread into the bladder muscle. Tuesday’s warning also said the agency had already flagged similar promotion issues in 2025 and again in January. 3
Anktiva won U.S. approval in April 2024 with Bacillus Calmette-Guérin, or BCG, for adults with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, or CIS, a high-risk tumor confined to the bladder lining, with or without papillary tumors. The FDA said the drug is labeled for intravesical use only, meaning it is delivered directly into the bladder. 4
In the March 13 warning letter, the FDA said material featuring CEO Richard Adcock and Executive Chairman Patrick Soon-Shiong left the impression that Anktiva could “treat all cancers,” work as a “single jab” and “prevent cancer” after radiation exposure. The agency said those messages strayed well beyond the current label and were not backed by evidence. 2
The agency also attacked how ImmunityBio used data from QUILT-3.032, a single-arm study — a trial without a comparison group. FDA said that design could not support disease-free survival claims, and added that Anktiva is not a vaccine and is not approved in the United States for lung cancer after checkpoint inhibitor failure or for cancer prevention. 2
OPDP, the FDA’s drug-promotion office, said similar issues had been raised in untitled letters sent in September 2025 and January 2026. The warning directs ImmunityBio to act immediately, file a written response within 15 working days and map out corrective communications for the audience that saw the challenged materials. 2
ImmunityBio did not immediately respond to a Reuters request for comment. In a March 9 update, the company said the agency had asked for additional information on the papillary indication but had not requested a new trial before acknowledging the resubmission. 1
The setback lands in a tightly regulated bladder-cancer market. Merck’s Keytruda already has FDA approval for BCG-unresponsive high-risk non-muscle invasive bladder cancer with CIS, with or without papillary tumors, in patients who cannot or will not undergo cystectomy, or bladder-removal surgery. 5
What happens next is less clear. The warning is separate from the pending papillary filing, at least on the face of the documents, but if ImmunityBio has to pull or rewrite marketing while answering the FDA and issuing corrective messages, its commercial push could slow and the broader label-expansion case may face tougher questions. 2
