ImmunityBio's Legal and Expansion Timelines Converge Under Scrutiny

ImmunityBio navigates FDA warning letter lawsuits and a major NY facility deadline, while its cancer drug Anktiva drives 168% revenue growth in Q1 2026.

ImmunityBio finds itself navigating a complex landscape where record-breaking commercial success is colliding with significant legal and regulatory challenges. The biotech firm's stock is under pressure from multiple directions, even as its flagship cancer therapy drives unprecedented revenue growth.

A third major law firm, Kessler Topaz Meltzer & Check, filed a securities fraud class action on April 12, 2026, in the U.S. District Court for the Central District of California. This lawsuit, targeting the company and its Executive Chairman Patrick Soon-Shiong, covers the period from January 19 to March 24, 2026. It joins similar actions previously announced by Hagens Berman and Kaplan Fox & Kilsheimer. Investors have until May 26, 2026, to seek lead plaintiff status in the consolidated case.

The litigation stems from a U.S. Food and Drug Administration (FDA) warning letter dated March 24, 2026. The agency took issue with claims made by Soon-Shiong in a podcast that the drug Anktiva (also styled ANKTIVA) could "cure and even prevent all cancers." The FDA also stated a television advertisement misleadingly suggested all treated patients would remain cancer-free long-term without supporting evidence. The stock plummeted over 21% on the day the letter became public, erasing nearly $2 billion in market value.

In response, ImmunityBio submitted a comprehensive reply to the FDA on April 6, removed the podcast from its website, and confirmed the contested TV ad never aired. The company has also implemented stricter internal compliance processes and introduced external regulatory oversight.

Simultaneously, the company is facing a hard deadline from the state of New York regarding a long-dormant manufacturing facility in Dunkirk. After acquiring the site following the bankruptcy of previous owner Athenex, ImmunityBio has signed a new lease with drastically different terms. Annual rent is now $525,000, a steep increase from a nominal one-dollar fee. The agreement mandates production must commence with at least 100 employees by the end of December 2028. If achieved, ImmunityBio can purchase the facility for one dollar in early 2029, with employment targets rising to 450 people by 2032. Local officials have indicated the state will seek other manufacturers if these milestones are missed.

Financing this expansion is supported by a remarkably strong operational performance. For the first quarter of 2026, ImmunityBio reported preliminary net product revenue of approximately $44.2 million. This represents a staggering 168% increase year-over-year and a 15% sequential gain from Q4 2025. The company has posted rising revenue every quarter since Anktiva's launch. Cash and equivalents stood at an estimated $380.9 million as of the quarter's end.

On the clinical front, progress continues. The pivotal BCG-naïve CIS study (QUILT-2.005) for bladder cancer is fully enrolled, and a supplemental Biologics License Application (sBLA) submission is firmly planned for later in 2026. Anktiva is now approved in five regulatory jurisdictions covering approximately 34 countries.

With the May 26 lawsuit deadline looming and the pending filing of its full Form 10-Q for Q1, ImmunityBio's stock remains in a state of heightened volatility, caught between its potent commercial trajectory and mounting external pressures.