Shares of ImmunityBio Inc. (IBRX) got a nice bump Tuesday. The reason? A group of very important doctors just gave one of its cancer drugs a bigger vote of confidence.
The National Comprehensive Cancer Network (NCCN)—a major alliance of cancer centers that sets treatment standards—updated its official guidelines for bladder cancer. They've now included ImmunityBio's drug, Anktiva, in combination with an older therapy called BCG, as a recommended option for a broader group of patients.
Specifically, the new guideline covers patients with "BCG-unresponsive non-muscle invasive bladder cancer" who have what's called "papillary-only" disease. This expands on a previous recommendation from the NCCN that already included Anktiva for patients with a different subtype of the same cancer. Both recommendations carry a "Category 2A" label, which is a strong endorsement based on lower-level evidence and uniform consensus.
Here's the interesting part: this new guideline recommendation is for a use of Anktiva that the U.S. Food and Drug Administration (FDA) hasn't officially approved yet. The FDA gave Anktiva the green light back in April 2024, but only for use in combination with BCG for patients with carcinoma in situ (CIS), with or without papillary tumors. The NCCN is essentially saying, "We think the data supports using it for this other group too, even if the official label doesn't say so yet."
For a biotech company, that's a big deal. It validates the science and can help convince doctors to use the drug more broadly while the company works on getting the official FDA stamp for this expanded use.
"This update validates the evolving clinical guidance for patients and underscores the importance of immune-based therapies," said Richard Adcock, President and CEO of ImmunityBio. The company says it's working with insurance companies and hospitals to make sure patients can get access to the drug as it's currently approved, which already covers over 100 million insured people in the U.S.
The Long Road to a Broader FDA Approval
Speaking of that expanded FDA approval, ImmunityBio is actively trying to get it. The path hasn't been perfectly smooth.
Last week, the FDA acknowledged it received the company's resubmitted application (called a supplemental Biologics License Application, or sBLA) for using Anktiva in BCG-unresponsive bladder cancer. This comes after the agency sent the company a "Refusal to File" letter back in May 2025 for this exact "papillary disease" indication. That's basically the FDA saying, "We won't even review this application yet because it's incomplete."
Since that setback, ImmunityBio has been in talks with the FDA, which asked for more data. The company submitted updated efficacy numbers in March, leading to this new resubmission. It's a classic biotech regulatory dance: one step back, a few steps of discussion, then hopefully a leap forward.
Building the Factory, Not Just the Drug
In other news from the company, ImmunityBio recently wrapped up two clinical programs, NK2022 and NK2023, focused on a different part of its technology: a personalized cell therapy.
These programs weren't testing if the therapy cures cancer (that's for later trials); they were testing if the company can make it safely, consistently, and on a large scale. That's a huge hurdle for cell therapies. The results were promising: 64 subjects participated with no serious safety issues, and the company showed it could generate up to five billion natural killer cells from a single blood draw from a patient.
Why does that matter? If you can't manufacture a complex therapy reliably, it doesn't matter how well it works in a small lab study. This manufacturing success paves the way for a current phase 1 trial that's combining these engineered immune cells with Anktiva itself, which has shown early signs of fighting tumors in multiple cancers.
