Clinical Promise and Regulatory Scrutiny Collide for ImmunityBio

While ImmunityBio unveiled promising new clinical data for a devastating form of brain cancer this week, investor focus has been sharply diverted by allegations of misrepresentation in its dealings with the U.S. Food and Drug Administration (FDA). The dual narratives of scientific progress and regulatory dispute have sent the company's shares into a period of heightened volatility.

The controversy stems from a late-January announcement and a subsequent media report. On January 26, ImmunityBio stated that following a meeting with the FDA six days prior, the regulator had requested "additional information" for a planned label expansion of its drug ANKTIVA in bladder cancer. The company emphasized that no new clinical trials were required and committed to submitting the data within 30 days.

This account was directly challenged three days later by a report from STAT News. Citing informed sources, the publication alleged that CEO Dr. Patrick Soon-Shiong had mischaracterized the outcome of the FDA discussion. The report further noted that the agency had already rejected the application for this specific papillary bladder cancer indication in May 2025—a decision the company had at the time called "inconsistent" with prior FDA feedback. The market is now watching to see if the FDA accepts the data submission, promised by mid-February, or if the conflicting narratives lead to further delays.

Positive Trial Data Presented Amid Tension

Separately, at the Stand Up to Cancer Scientific Summit in Pasadena, the biopharmaceutical firm presented updated results from its Phase 2 study, QUILT-3.078. The trial is evaluating a chemotherapy-free combination of ANKTIVA and CAR-NK cell therapy for recurrent glioblastoma, an aggressive brain cancer.

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As of the January 22 data cutoff, 19 of the 23 enrolled patients, all of whom had exhausted standard treatment options, were still alive. The median overall survival had not yet been reached, with the longest documented survivor living for twelve months. Soon-Shiong highlighted that the non-chemotherapy approach aims to reverse the severe immune deficiency typically seen in these patients.

Financial Moves and International Approval

In a concurrent financial development on January 26, ImmunityBio modified the terms of a $505 million convertible note. The change grants the lender, Nant Capital—an entity controlled by Soon-Shiong—the new ability to convert portions of the debt into company stock at any time, a flexibility that did not previously exist.

On the international front, the company secured a regulatory win in January when Saudi Arabia's drug authority approved ANKTIVA. The therapy has been approved in the United States since April 2024 for a different form of non-muscle invasive bladder cancer.

The coming weeks will be critical for ImmunityBio as it navigates the fallout from the conflicting FDA narratives while attempting to keep investor attention on its clinical advancements.