Just one day after its stock soared in response to Macau’s approval of its oncology drug Anktiva® as a treatment for certain types of bladder cancer, as of 12:32 p.m. ET today, ImmunityBio (NASDAQ: IBRX) shares are down 22.4%.
The prompt? A warning letter from the U.S. Food & Drug Administration indicating that a television ad promoting Anktiva — as well as comments made by the company’s Global Chief Scientific and Medical Officer and Executive Chairman Dr. Patrick Soon-Shiong during a recent podcast — were both “false and misleading.”
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Were it the first time the FDA had taken such action against ImmunityBio it might be dismissible as a mere misunderstanding, resulting from the company’s officers’ efforts to provide simple answers to an interviewer’s questions.
It wasn’t the first time, however. As today’s warning letter points out, the FDA also addressed similar issues with wholly owned ImmunityBio subsidiary Altor BioScience, LLC in September of last year and then again in January of this year, noting that these previous public presentations of Anktiva’s overstated potential as a cancer drug “were in certain respects, similar to presentations in the TV ad and podcast addressed in this [Tuesday’s] letter.”
The Office of Prescription Drug Promotion (OPDP) specifically argues that the company is making broad efficacy claims that haven’t been verified by clinical trials. The regulator adds that ImmunityBio is implying its drug is a cancer vaccine when it’s strictly a cancer treatment. Unsurprisingly, “OPDP is concerned that, despite receiving these previous Untitled Letters, ImmunityBio continues to promote Anktiva in a similarly misleading manner.”
The irony is, while the advertisement and comments in question may have generated some additional attention for ImmunityBio and Anktiva, it isn’t likely that this attention generated actual additional revenue. Anktiva’s approval here and abroad is limited to a narrow sliver of bladder cancer patients, although for that relatively small number, most oncologists will already be aware that it’s a treatment option.
There’s still measurable risk, however, to the fact that the FDA has now addressed the matter of misleading public statements with ImmunityBio’s management for a third time. That is, if the biopharma company develops a reputation for overstating the efficacy and usability of its drugs, it could raise doubts about future efficacy claims made of ImmunityBio’s other 12 clinical trials underway right now (most of which are tests of Anktiva as a treatment for indications other than bladder cancer).