$2 billion. That’s how much market value ImmunityBio shed in a single trading session after the FDA’s Office of Prescription Drug Promotion published its warning letter on March 13.
The trigger isn’t a sales rep gone rogue or a misleading print ad. The FDA flagged statements made by the Executive Chairman himself, Patrick Soon-Shiong, on a TV ad and a podcast. He said Anktiva is “approved for bladder cancer, but it actually can treat all cancers” and is on “the path to curing the cancer.” He called it “the most important molecule that could cure cancer.” OPDP wasn’t impressed.
Anktiva is approved for exactly one indication: non-muscle invasive bladder cancer with carcinoma in situ, used in combination with BCG. It got that nod in April 2024. It is not approved for “all cancers.” It is not approved for cancer prevention. It hasn’t been shown to keep treated patients cancer-free long-term.
The fallout was immediate. Shares fell 21%. Hagens Berman filed a securities class action within days. The FDA has given ImmunityBio 15 days to respond — to either explain why the materials don’t violate the rules, or to commit to pulling them and issuing corrections.
This is the first full OPDP warning letter of 2026, and OPDP picked the highest-profile target it could find. The signal to other biotechs: the agency is watching podcasts and TV interviews, not just print ads. The Executive Chairman is not above the promotional rules.
ImmunityBio’s response is due by month-end.
— Sarah Chen