ImmunityBio (IBRX) Faces Securities Class Action After FDA Warning Letter About Anktiva Claims; Shares Drop Over 21%

ImmunityBio, Inc. (NASDAQ: IBRX) is facing a securities class action lawsuit seeking to represent investors who purchased or acquired the company’s securities between January 19, 2026 and March 24, 2026. The case follows a U.S. Food and Drug Administration warning letter alleging that promotional claims made by ImmunityBio’s executive chairman and Chief Scientific and Medical Officer, Dr. Patrick Soon-Shiong, about the company’s lead biologic product, Anktiva, were misleading.

FDA warning letter targets Anktiva efficacy claims

According to the report, the FDA sent the warning letter after claims were made by Soon-Shiong in a direct-to-consumer podcast and in a television advertisement. The FDA said the promotional materials created a misleading impression that Anktiva, which is approved for a specific type of bladder cancer, could cure and even prevent all cancer.

The FDA also stated that the promotional materials misleadingly suggested that all non-muscle invasive bladder cancer (NMIBC) patients treated with Anktiva would be cancer-free for the long term, “when this has not been demonstrated.” The agency further said it was “not aware of data that support the efficacy claims and representations that Anktiva can ‘cure’ cancer.”

In addition, the FDA warned that the promotional materials were misleading because they “fail to provide material information regarding Anktiva’s full FDA-approved indication.” The FDA also characterized the company’s “consistent and pervasive misleading efficacy claims and representations presented across promotional materials on different platforms” as especially concerning from a public health perspective.

Share price drops after report of FDA action

The news drove ImmunityBio shares down more than 21% on March 24, 2026, the report said, erasing nearly $2 billion of the company’s market capitalization.

Claims in focus during the class period

The lawsuit centers on the propriety of ImmunityBio’s claims about Anktiva’s efficacy for treating other forms of cancer. The report said that on January 19, 2026, Soon-Shiong appeared on the podcast “Is the FDA BLOCKING Life Saving Cancer Treatments?” and stated that while Anktiva is approved for bladder cancer, “it actually can treat all cancers.”

Investigation and class action details

Hagens Berman, a national shareholders rights firm, said it is investigating whether ImmunityBio intentionally misled investors about Anktiva’s efficacy and indications. Reed Kathrein, a partner leading the investigation at Hagens Berman, said: “We’re investigating claims that ImmunityBio intentionally misled investors about Anktiva efficacy and indications.”

The firm is urging investors who suffered significant losses to submit their losses. The class period is listed as January 19, 2026 through March 24, 2026, and the lead plaintiff deadline is May 26, 2026.

Whistleblower information

The report also referenced the SEC whistleblower program, stating that whistleblowers who provide original information may receive rewards totaling up to 30% of any successful recovery made by the SEC.

Company and product background cited in the report

ImmunityBio describes itself as a biotechnology company focused on developing and commercializing next-generation immunotherapies intended to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases. The report said Anktiva is an FDA-approved immunotherapy used with Bacillus Calmette-Guérin (BCG) to treat non-muscle invasive bladder cancer (NMIBC).

Source: Hagens Berman Sobol Shapiro LLP