The FDA Warned ImmunityBio About Misleading ANKTIVA Claims. It's the Third Time.

What the FDA found

The FDA's Office of Prescription Drug Promotion (OPDP) determined that a television advertisement and a podcast featuring Executive Chairman Dr. Patrick Soon-Shiong made claims that ANKTIVA could "treat all cancers," prevent cancer in radiation-exposed individuals, and function as a single-injection treatment. None of these claims are supported by clinical data.

ANKTIVA is approved for a narrow indication: treating adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors. The drug must be administered intravesically (directly into the bladder) in combination with BCG therapy. The FDA noted that the promotional materials "create a misleading impression that ANKTIVA, a treatment for a certain type of bladder cancer, can cure and even prevent all cancer."

The agency also cited ImmunityBio for failing to properly present risk information and for omitting material facts about the drug's approved indication. The podcast was not submitted to the FDA at the time of initial publication, as required by regulation.

ImmunityBio has 15 working days to respond with a plan to address the violations and issue corrective communications.

The pattern is the problem

This is not a first offense. As the warning letter notes, the FDA previously addressed similar issues with ImmunityBio's wholly owned subsidiary Altor BioScience in September 2025 and again in January 2026. Those earlier communications (untitled letters, a less severe regulatory action than a formal warning letter) cited promotional materials that were "in certain respects, similar to presentations in the TV ad and podcast addressed in this letter."

The escalation from untitled letters to a formal warning letter is itself significant. The OPDP stated that it "is concerned that, despite receiving these previous Untitled Letters, ImmunityBio continues to promote Anktiva in a similarly misleading manner." A warning letter carries greater legal weight and can serve as a predicate for enforcement action if the company fails to comply.

The common thread across all three incidents is the company's leadership. Dr. Soon-Shiong, ImmunityBio's founder and the inventor of the blockbuster drug Abraxane, has been personally featured in the promotional materials the FDA found objectionable. CEO Richard Adcock was also cited in connection with the misleading claims.

The commercial reality

The irony of the situation is that the misleading promotions are unlikely to have generated meaningful incremental revenue. ANKTIVA's approved indication covers a relatively small patient population, and most oncologists treating BCG-unresponsive NMIBC are already aware of the drug. The promotional materials were aimed at a general audience: a television ad and a podcast. These are not the channels through which urologists make prescribing decisions.

But the reputational cost may prove more consequential than any direct commercial impact. ImmunityBio has 12 clinical trials underway, most of which are testing ANKTIVA in indications beyond bladder cancer (including glioblastoma, non-small cell lung cancer, and pancreatic cancer). If the company develops a reputation for overstating the efficacy of its drugs, it could raise doubts about future clinical claims and complicate the regulatory path for those additional indications.

To be sure, the underlying science has not changed. ANKTIVA received FDA approval in April 2024, earned EU approval in February 2026, and secured the world's first approval for metastatic non-small cell lung cancer in Saudi Arabia in January 2026. Preliminary product revenue for fiscal 2025 reached $113 million, a 700 percent year-over-year increase. But a company burning approximately $92 million per quarter with a cash runway of roughly $242.8 million cannot afford to alienate the regulator that controls its path to broader approvals.

The stock and the valuation

Tuesday's 24 percent decline brought IBRX to approximately $7.17, down from $9.40 at the prior close. The stock remains up 255 percent year to date, reflecting the string of international regulatory wins and revenue growth that preceded the FDA's warning. But it now sits 77 percent below its all-time high of $31.52, reached in March 2021.

Wall Street's consensus remains bullish: all five analysts covering the stock rate it a Buy, with a median price target of $13.50 and a high of $23 (set just one day before the FDA warning by D. Boral Capital's Jason Kolbert). At $7.17, the stock trades 47 percent below the median target. Expect those targets to face scrutiny in the coming days.

Insider activity offers a less encouraging signal. Over the past six months, ImmunityBio insiders have executed eight open-market transactions, all of which were sales. Barry J. Simon sold approximately 402,000 shares for an estimated $3.8 million, and Christobel Selecky sold 100,000 shares for roughly $688,000. Zero insider purchases were recorded.

What comes next

The near-term question is straightforward: will ImmunityBio comply with the FDA's demands within the 15-day window, and will the corrective communications satisfy the agency? Failure to do so could result in enforcement action, including seizure of promotional materials or injunctive relief.

The longer-term question is harder. ImmunityBio's clinical pipeline is genuinely promising, and its international expansion has been impressive. But the company's leadership has now been warned three times in seven months about the same category of violation. The FDA's patience is not unlimited, and the promotional conduct of Dr. Soon-Shiong and his executive team is now a material risk factor that sits alongside the company's cash burn, negative equity position, and ongoing Delaware Chancery Court litigation over allegations of personal enrichment through related-party financing transactions.

The drug works for what it is approved to do. The problem is that the people running the company keep saying it does more.