ImmunityBio, Inc. (NASDAQ:IBRX) shares are trading lower after the FDA issued a warning to the company over misleading Anktiva promotions.
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FDA Flags Misleading Promotional Claims
The U.S. Food and Drug Administration determined that a direct-to-consumer TV ad and podcast promoting Anktiva were false or misleading and misbranded the drug under federal law.
The FDA said the materials 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.
The agency also cited concerns that the promotional content implied unapproved methods of administration and failed to adequately disclose risks associated with the drug.
Additionally, the FDA noted that some promotional materials were not submitted as required at the time of dissemination.
The FDA requested that ImmunityBio take immediate action to address the violations, including discontinuing misleading communications and issuing corrective messaging.
ImmunityBio Stock Falls
IBRX Price Action: At the time of publication, ImmunityBio shares are trading 21.60% lower at $7.37, according to data from Benzinga Pro.
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