ImmunityBio (IBRX) shares dropped over 26% on Tuesday after the U.S. Food and Drug Administration (FDA) issued a warning letter to the biotechnology company, stating false and misleading promotional materials for its bladder cancer drug, ANKTIVA.
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The agency said a recent TV advertisement and a direct‑to‑consumer podcast overstated the drug’s benefits, omitted key safety information, and suggested unapproved uses.
The FDA’s review focused on a broadcast TV ad and a podcast titled “Is the FDA BLOCKING Life Saving Cancer Treatments?” featuring Executive Chairman and Chief Scientific and Medical Officer Dr. Patrick Soon‑Shiong.
FDA Says Ads Overstated Benefits
The agency said the promotional materials suggested Anktiva could treat all cancers, act like a cancer vaccine, help patients who fail checkpoint inhibitors, and even prevent cancer after radiation exposure. None of these uses is FDA‑approved, and the agency said there is no evidence to support them.
Anktiva is approved only when used with BCG for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors. The FDA noted that it has not been shown to work on its own or for other types of cancer.
The agency also noted that the QUILT‑3.032 trial, the basis for Anktiva’s approval, was a single‑arm study, meaning it cannot show long‑term cancer‑free outcomes or disease‑free survival. As a result, claims that the drug can “cure cancer” or prevent recurrence are not supported.
FDA Demands Corrective Action Within 15 Days
The FDA is requiring ImmunityBio to respond within 15 working days, address all concerns, identify any other promotional materials with similar issues, and outline plans to discontinue or fix them.
The agency also seeks a corrective communication plan that provides clear, non-misleading information to the same audiences that saw the original ads. These corrections must avoid promotional language and use the same media channels and frequency as the original materials.
Is IBRX a Good Stock to Buy?
Turning to Wall Street, ImmunityBio stock has a Strong Buy consensus rating based on three Buys assigned over the past three months. The average IBRX stock price target of $13.33 implies 86.69% upside.
