ImmunityBio’s Founder Fights Back as Legal Deadline Looms

ImmunityBio is navigating a stark divide. While its commercial engine, driven by the cancer drug Anktiva, is firing on all cylinders, the company faces intensifying regulatory and legal challenges that have erased billions in market value. Founder Patrick Soon-Shiong is now publicly contesting the U.S. Food and Drug Administration’s allegations, setting the stage for a critical period ahead.

The core dispute centers on marketing claims. In March 2026, the FDA issued a formal warning letter, alleging ImmunityBio presented Anktiva as a potential treatment for all cancers. The drug is approved solely for a specific form of bladder cancer: BCG-unresponsive, non-muscle invasive bladder cancer. The agency cited a television advertisement and a January podcast appearance as examples of “false or misleading” promotion.

Soon-Shiong has mounted a vigorous defense. He contends the cited TV spot never actually aired. Furthermore, he characterizes his podcast discussion as scientific discourse, not a sales pitch. In a formal response submitted to the FDA on April 6, 2026, the company stood by its position while outlining corrective steps. These include removing the podcast from its websites and third-party platforms, implementing stricter review processes for promotional materials, and mandating compliance training for leadership.

The regulatory warning triggered immediate financial fallout. On March 24, 2026, ImmunityBio’s stock plummeted 21% in a single session, wiping out nearly $2 billion in market capitalization. The share price now hovers around $7.30, a dramatic retreat from its earlier year-to-date rally of over 268%. This volatility has sparked a wave of legal action. Several law firms, including Kessler Topaz Meltzer & Check, Kaplan Fox, and Hagens Berman, are investigating or have filed proposed class actions alleging securities fraud. They represent investors who purchased shares between January 19 and March 24, 2026. The deadline to register as a lead plaintiff in these suits is May 26, 2026.

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

Operationally, the picture is remarkably strong. For the full year 2025, Anktiva revenue surged 700% to $113 million. This momentum continued into the first quarter of 2026, where preliminary net product revenue hit approximately $44.2 million—a 168% year-over-year increase and a 15% sequential gain from Q4 2025. Analysts at Piper Sandler project 2026 revenue could reach $195 million. The company’s financial position is robust, with an estimated $380.9 million in cash and equivalents as of March 31, 2026, bolstered by a recent $100 million financing round from Oberland Capital, $75 million of which was non-dilutive.

On the clinical front, an independent data monitoring committee recently confirmed that the key registration study, QUILT-2.005, for bladder cancer treatment remains statistically well-powered. ImmunityBio plans to submit a supplemental Biologics License Application for broader indications later in 2026.

The coming weeks will be decisive. ImmunityBio must manage the converging timelines of legal proceedings and its ongoing dialogue with the FDA, all while capitalizing on its formidable commercial traction. The company’s ability to reconcile its scientific ambitions with regulatory boundaries will be tested.