A Better Way to Tell a Breakthrough Story: Lessons From the ImmunityBio FDA Letter

When the science is real, the story deserves better protection. 

When does hope become misinformation? Bladder cancer patients with limited options are watching ads and listening to podcasts right now, treating pharmaceutical marketing like medical advice because they have no other source of hope. Marketing that stretches beyond data doesn’t just violate compliance—it violates patients’ trust. 

This week, the FDA issued its first warning letter of 2026 to ImmunityBio. It’s worth pausing on, not because it’s an isolated issue, but because it reflects a pattern many healthcare companies are quietly at risk of repeating. 

The drug at the center of this is Anktiva, approved for a specific and difficult-to-treat form of bladder cancer. The underlying science around IL-15 biology and NK cell activation is genuinely interesting, and the company has a real pipeline around it. 

But the TV ad and podcast made claims far beyond clinical reality:

• Anktiva treats all cancers (it doesn’t) 

• It prevents radiation-induced cancer (no supporting data) 

• It works as a single injection (it requires bladder instillation) 

• No risk information disclosed 

• No indication stated 

This marks the company’s third FDA violation. The stock fell 24% when the letter went public. 

I’ve spent more than 20 years in healthcare communications, and what I see in this situation isn’t recklessness. It’s something more familiar: a scientist-founder who genuinely believes in what his molecule can do, communicating from conviction in a forum that wasn’t built to carry that kind of weight. 

That gap between what a therapy might become and what it is approved to do today is where regulatory risk quietly accumulates. In an environment where executives are expected to be visible, accessible, and compelling across every channel, that gap has never been harder to manage. 

So, what could have been done differently? 

This isn’t about communicating less. Companies with real science should tell  ambitious stories for the patients they can help and the investors and boards that believe in their value. The answer is building architecture that allows that ambition to travel safely. 

Separate the platform story from the promotional message. Investor days, scientific conferences, disease awareness initiatives, and peer-reviewed publicationsare the right venues for talking about what a biology platform might one day mean for cancer broadly. A consumer-facing broadcast ad for an approved bladder cancer drug is a different context entirely, with different rules and different audiences. Both stories can be told. They just need different containers. 

Pre-clear executive media appearances. 

When a founder, chief medical officer, or executive chairman is going on a podcast or sitting for a broadcast interview, someone with regulatory expertise should review likely talking points in advance—not to limit the science, but to protect it. The podcast at the center of this case was never submitted to the FDA when it first aired; a separate compliance requirement the company missed entirely. 

Give executives a simple, clear briefing card. One page: approved indication, approved language, what’s in the pipeline and how to reference it appropriately, and three things that should not be said in any public forum. Most biotech leaders are scientists first. They haven’t spent years memorizing the FDA’s prescription drug promotion rulebook, and they shouldn’t have to. That’s what communications and regulatory teams are for. But preparing executives to carry that out in a compliant way is core to the job. 

Don’t treat risk information as a liability.

Omitting side effects doesn’t make a drug sound more promising. It makes a company look like it has something to hide, and it signals to regulators that the intent is to persuade rather than inform. Balanced communication is not just a compliance requirement. It’s what builds the long-term credibility you need more challenging data readouts come. 

The companies that navigate this well aren’t the ones that go quiet. They’re the ones who build the scaffolding early, before the ad is in production, before the podcast is recorded, before investor enthusiasm finds its way into a consumer channel. 

If you’re looking for the right communications partner to guide you through this complexity, we’d love to chat.