New York, March 24, 2026, 11:13 EDT
- ImmunityBio stock slid roughly 21% in late morning trading as the FDA raised issues with an Anktiva TV commercial and podcast.
- The agency flagged the materials for exaggerating the drug’s benefits and pitching it for uses outside its approved bladder-cancer indication.
- ImmunityBio is moving forward with a wider FDA submission for papillary bladder disease, even as the company faces this warning.
ImmunityBio stock tumbled roughly 21% this day, dragged down after the U.S. Food and Drug Administration accused the company’s TV ad and podcast for Anktiva of making false or misleading claims that breach federal law. Shares hovered around $7.44 late morning, well below the day’s $9.10 open.
That’s a tough spot. Back on March 9, ImmunityBio announced the FDA had accepted its resubmitted bid to expand Anktiva’s label to include papillary-only non-muscle invasive bladder cancer, a type still confined to the bladder lining. The agency’s warning this Tuesday noted it had already raised similar marketing concerns, first in 2025, and again in January.
Anktiva secured U.S. approval in April 2024 alongside Bacillus Calmette-Guérin, or BCG. The nod covers adults with non-muscle invasive bladder cancer that hasn’t responded to BCG—specifically, cases involving carcinoma in situ (CIS), a high-risk tumor that stays within the bladder lining, with or without papillary tumors. According to the FDA, the product is restricted to intravesical use, so administration happens directly into the bladder.
The FDA’s March 13 warning letter flagged material with CEO Richard Adcock and Executive Chairman Patrick Soon-Shiong, saying it gave the impression that Anktiva could “treat all cancers,” serve as a “single jab,” and even “prevent cancer” after radiation. None of that is supported by evidence, the agency said, and these claims go far beyond what’s actually on the drug’s label. U.S. Food and Drug Administration
The agency criticized ImmunityBio’s reliance on data from QUILT-3.032, a single-arm trial lacking a control group. According to the FDA, that kind of study can’t be used to back disease-free survival claims. The FDA also clarified: Anktiva isn’t a vaccine, and it does not have approval in the United States for lung cancer following checkpoint inhibitor failure or for cancer prevention.
OPDP, the FDA’s office overseeing drug promotion, pointed to similar problems noted in untitled letters from September 2025 and January 2026. The warning orders ImmunityBio to take immediate action, submit a written reply within 15 working days, and lay out a plan for corrective communications targeting the audience exposed to the cited materials.
ImmunityBio hasn’t yet replied to Reuters’ request for comment. Back on March 9, the company noted that regulators wanted extra details about the papillary indication, though no new trial was required prior to the resubmission being acknowledged.
The blow comes in a bladder-cancer market bound by tight regulations. Merck’s Keytruda is already cleared by the FDA for BCG-unresponsive high-risk non-muscle invasive bladder cancer with CIS—with or without papillary tumors—for patients unable or unwilling to go through cystectomy, or bladder removal.
What comes after this isn’t straightforward. The warning letter stands apart from the papillary filing for now, judging by the paperwork. But if ImmunityBio ends up pausing or reworking its marketing as it responds to the FDA and sends out clarifications, that could drag on its commercial rollout. The wider label expansion argument might also hit stiffer resistance.
