Drugmaker’s stock tumbles 20% after FDA issues formal warning to executives
The U.S. Food and Drug Administration (FDA) sent a formal warning letter to ImmunityBio, calling recent claims company executives made about Anktiva, its flagship bladder cancer drug, “false or misleading.”
The warning letter, sent on March 13, was made public by the FDA on Tuesday. Shortly after release, ImmunityBio’s stock went into a freefall, crashing over 20% in a single day. It now stands at $7.42 a share.
At the center of the FDA’s complaint are two pieces of media produced by the company, the first being a direct-to-consumer advertisement where ImmunityBio CEO Richard Adcock and Global Chief Scientific and Medical Officer Patrick Soon-Shiong, MD, allegedly make claims about the supposed efficacy of Anktiva in treating or curing bladder cancer that run afoul of federal law.
Similarly, the FDA also took issue with a podcast in which Soon-Shiong, in conversation with Sean Spicer, allegedly made statements that alluded to the ability of Anktiva to cure or prevent bladder cancer, a claim regulators believe “create[s] a misleading impression."
“Furthermore, the TV ad and podcast provide evidence that Anktiva is intended for new uses for which it lacks approval, and for which its labeling does not provide adequate directions for use,” the FDA’s letter reads. “In addition, the podcast was not submitted at the time of initial dissemination or publication as required by [federal law].”
The podcast episode of The Sean Spicer Show titled "Is the FDA BLOCKING life-saving cancer treatments?” is still available online; however ImmunityBio no longer links to it on its website.
The advertisement in question appears to have been purged from the Internet.
Multiple warnings
The FDA added that this is not the first warning it sent to ImmunityBio, revealing that it also sent warnings in September 2025 and January 2026. Its complaints extend to how Anktiva is administered. The agency said “representations made in both the TV ad and podcast provide evidence that Anktiva is intended for use as an injection, including subcutaneously, even though its labeling does not provide adequate directions for use in this manner.”
This latest warning letter also pointed to alleged instances where company executives stated that Anktiva can treat multiple forms of cancer, when it’s only been approved for bladder cancer.
“These violations are concerning from a public health perspective because the promotional communications create a misleading impression that Anktiva, a treatment for a certain type of bladder cancer, can cure and even prevent all cancer,” the FDA wrote.
“Cancer is the second leading cause of death in the United States and a significant public health concern that affects a vulnerable patient population at increased risk of medical complications and adverse outcomes,” the agency added.
The agency also claimed that Adcock and Soon-Shiong failed to “present information relating to warnings and precautions and side effects associated with the drug,” touting only its benefits. Adverse effects linked to Anktiva include infections, pain and pyrexia.
ImmunityBio has not publicly responded to the FDA’s warning letter. HealthExec reached out for comment.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.