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Apr 6, 2026 12:00 PM

FDA Flags Anktiva Claims While ImmunityBio Pushes Regulatory Fixes

ImmunityBio Inc (NASDAQ:IBRX) shares were up during Monday’s premarket session, but dipped as the company addresses compliance issues raised by the U.S. Food and Drug Administration (FDA).

The FDA issued a warning to ImmunityBio, alleging that the company made unsupported claims that Anktiva could cure or prevent cancer and suggested effectiveness beyond its approved use, including treatment for multiple cancers and use as a standalone therapy.

ImmunityBio subsequently initiated a comprehensive review of all promotional materials and external communications claims with its legal and regulatory teams.

The actions included mandatory executive training, expanded Promotional ...