ImmunityBio Shares Face Headwinds Amid Regulatory Scrutiny

ImmunityBio US45256X1037

ImmunityBio's stock is navigating turbulent waters following a period of exceptional volatility. While recent operational performance has provided a strong foundation for gains, a new controversy surrounding its communications with U.S. regulators now threatens to undermine investor confidence and stall the rally.

The biotech firm recently posted preliminary figures showing remarkable commercial traction. For the fourth quarter of 2025, revenue surged by 431 percent year-over-year to approximately $38.3 million. This performance capped a full year 2025 with total revenue reaching about $113 million, representing a sevenfold increase compared to the previous year. Driving this growth is the accelerating market adoption of its bladder cancer therapy, ANKTIVA.

Financially, the company appears well-positioned to fund its commercialization and research efforts, reporting a cash position of roughly $242.8 million as of year-end 2025.

A Clash of Narratives on FDA Dialogue

The primary source of current market uncertainty stems from conflicting accounts of a key meeting with the U.S. Food and Drug Administration (FDA). On January 20, 2026, ImmunityBio announced that the FDA had requested only supplementary information for a potential resubmission of the ANKTIVA application, explicitly stating that new clinical trials were not required. This was framed as significant progress following the initial "Refuse-to-File" rejection received in May 2025.

However, a report published by STAT News on January 29 presents a starkly different version of events. Citing sources, the report alleges that Chairman and CEO Patrick Soon-Shiong mischaracterized the meeting's outcome. According to these sources, the FDA refused to review the application at all, citing unconvincing clinical data and violations of agency guidelines. For biotechnology investors, whose trust in management is paramount, this discrepancy between corporate statements and media reporting carries substantial weight.

Pipeline Progress Offers a Counterbalance

Amid the regulatory dispute, developments in ImmunityBio's research pipeline have provided bullish catalysts. Updated data from a Phase 2 study investigating a treatment for recurrent glioblastoma, an aggressive brain cancer, showed promise. As of the January 22 cutoff date, 19 out of 23 patients remained alive. Although the median overall survival rate has not yet been reached, the data suggests an effective activation of the immune system.

Volatility and the Path Forward

The equity has experienced extreme price movements. Over the past 30 days, it skyrocketed by nearly 197 percent, inflicting heavy losses on short-sellers; reported mark-to-market losses for these bearish bets approached half a billion dollars. Currently trading at $5.91, the shares have already pulled back noticeably from their 52-week high of $7.34.

All eyes are now on January 31, 2026, when ImmunityBio is scheduled to present updated clinical data at the "Stand Up to Cancer" summit in Pasadena. The market's direction in the coming weeks will likely hinge on whether these scientific updates can outweigh the growing concerns about management's credibility in its dealings with the FDA.

@ boerse-global.de | US45256X1037 IMMUNITYBIO