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Shares of ImmunityBio (IBRX) tanked nearly 25% on Tuesday after the U.S. Food and Drug Administration (FDA) issued a warning letter to the pharmaceutical company, raising concerns about the promotion of its bladder cancer treatment, ANKTIVA.
“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 letter read.
The FDA highlighted a TV advertisement and a podcast featuring founder Patrick Soon-Shiong, which made strong claims about ANKTIVA’s ability to “treat all cancers.” The regulator said the representations in the TV ad and podcast are “misleading.”
The FDA has asked ImmunityBio to respond within 15 days, fix the misleading promotions, and warned that failure to comply could lead to legal action.
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