ImmunityBio’s Legal and Commercial Realities Diverge Sharply

ImmunityBio finds itself navigating a stark dichotomy. While the biotech firm reports its strongest commercial quarter to date, it is simultaneously defending against a coordinated legal assault from shareholders. The catalyst was a regulatory rebuke from the U.S. Food and Drug Administration (FDA) in March, which triggered a massive single-day selloff in the company’s stock.

On March 24, 2026, the FDA issued a warning letter concerning promotional claims made by Executive Chairman Patrick Soon-Shiong about ANKTIVA, the company’s flagship bladder cancer immunotherapy. The agency flagged a podcast from January 19 and a referenced TV advertisement as “false or misleading,” specifically taking issue with suggestions the drug could treat “virtually all cancers.” The market’s reaction was severe: ImmunityBio shares plummeted 21% that day to close at $7.42, wiping out approximately $2 billion in market capitalization.

This event has sparked a consolidated securities fraud class action, Douglas v. ImmunityBio, in federal court in Central California. While multiple law firms—including Kessler Topaz, Robbins Geller, and Hagens Berman—are involved, they are focusing their efforts on this single case. Investors who purchased securities between January 19 and March 24, 2026, have until May 26, 2026, to apply for lead plaintiff status.

In a stark contrast to its legal troubles, the company’s underlying business is firing on all cylinders. Preliminary net product revenue for the first quarter of 2026 reached approximately $44.2 million. This figure represents a staggering 168% increase over the same period last year and a sequential gain of 15% from the fourth quarter of 2025. For full-year 2025, the company reported $113 million in total revenue, a roughly 700% surge from 2024.

Should investors sell immediately? Or is it worth buying ImmunityBio?

Operational momentum extends beyond sales. ANKTIVA is now approved or authorized in five regulatory jurisdictions, covering about 34 countries. The pivotal QUILT-2.005 clinical trial, with 366 patients, is fully enrolled, and an independent data monitoring committee has confirmed it is statistically powered to meet its primary endpoint. A supplemental Biologics License Application is slated for submission later in 2026. Furthermore, the National Comprehensive Cancer Network updated its guidelines in March 2026 to recommend ANKTIVA plus BCG for a broader group of patients with non-muscle invasive bladder cancer.

Financially, ImmunityBio appears well-positioned for a protracted legal fight. The company ended the first quarter with a robust liquidity position of $380.9 million in cash, cash equivalents, and marketable securities.

Management has already taken steps to address the FDA’s concerns. On April 6, 2026, the company submitted a comprehensive response to the FDA’s Office of Prescription Drug Promotion. Actions included removing the cited podcast, requesting its deletion by third parties, and confirming the flagged TV commercial never aired. ImmunityBio also announced the implementation of stricter internal review processes and external regulatory monitoring.

The central question for investors now rests on a legal interpretation. The court’s assessment of the company’s disclosure obligations surrounding Soon-Shiong’s statements will determine whether this lawsuit becomes a manageable operational cost or a more significant structural burden. For now, ImmunityBio presents the rare picture of a company breaking revenue records while under a multi-front legal siege.