A securities class-action lawsuit was filed against ImmunityBio, Inc. (NASDAQ: IBRX) after an FDA warning over misleading promotional claims for its cancer drug Anktiva caused shares to plummet 21 percent.
The lawsuit, which covers investors who purchased shares between January 19 and March 24, 2026, alleges the company and its executives made false statements about the drug's efficacy. The FDA’s warning letter stated that promotional materials “create the misleading impression that Anktiva, a treatment for a certain type of bladder cancer, can cure and even prevent all cancer.”
On March 24, the day the FDA letter was publicized, ImmunityBio shares fell $1.98 to close at $7.42, a 21.12 percent decline that wiped out nearly $2 billion of the company’s market value. The lead plaintiff deadline for the case is May 26, 2026.
The legal action centers on claims made by ImmunityBio’s Executive Chairman, Dr. Patrick Soon-Shiong, who suggested in a podcast that Anktiva “it actually can treat all cancers.” The FDA has approved Anktiva only for treating a specific type of non-muscle invasive bladder cancer (NMIBC) and only for use in combination with another treatment.
The FDA's Office of Prescription Drug Promotion issued the Warning Letter on March 13, 2026, flagging a TV ad and a podcast from January 19 as containing "false or misleading" statements that misbrand the drug.
The agency took particular issue with the characterization of Anktiva as a "cancer vaccine" and claims it could "cure" cancer, stating, "we are not aware of data that support the efficacy claims." The FDA warned that the "consistent and pervasive misleading efficacy claims" were "especially concerning from a public health perspective, given they grossly misrepresent the benefits of Anktiva."
The class period for the lawsuit opens on January 19, 2026, the date of a podcast where Dr. Soon-Shiong made the challenged claims. Law firms including Hagens Berman and Levi & Korsinsky contend that during this period, the stock traded at artificially inflated prices.
“We’re investigating claims that ImmunityBio intentionally misled investors about Anktiva efficacy and indications,” said Reed Kathrein, the Hagens Berman partner leading the firm’s investigation. The public disclosure of the FDA's letter on March 24 served as the corrective event, triggering the sharp stock decline.
The lawsuit puts ImmunityBio's promotional practices under intense scrutiny and questions the company's internal disclosure controls. For investors, the case will hinge on whether the promotional statements crossed the line from optimistic marketing to material misrepresentation under federal securities laws. The next key date is the May 26 deadline for investors to seek lead plaintiff status.
This article is for informational purposes only and does not constitute investment advice.
