ImmunityBio, Inc. is facing a securities class action lawsuit following an April 1 announcement that the United States Food and Drug Administration (FDA) sent a warning letter to the company regarding allegedly misleading claims about its lead biologic product, Anktiva. The news caused ImmunityBio shares to drop more than 21% on March 24, erasing nearly $2 billion from its market capitalization.
The issue centers on statements made by Dr. Patrick Soon-Shiong, ImmunityBio’s executive chairman and Chief Scientific and Medical Officer, during a January podcast in which he said Anktiva “actually can treat all cancers.” The FDA later stated that both the podcast and a related TV ad were “false or misleading” because they suggested Anktiva could cure or prevent all cancers without sufficient evidence. According to the FDA, “the promotional materials create the misleading impression that Anktiva, a treatment for a certain type of bladder cancer, can cure and even prevent all cancer.” The agency also noted there was no data supporting claims that Anktiva could make patients with non-muscle invasive bladder cancer remain cancer-free long-term.
Reed Kathrein of Hagens Berman Sobol Shapiro LLP said: “We’re investigating claims that ImmunityBio intentionally misled investors about Anktiva efficacy and indications.” The law firm is encouraging investors who suffered losses between January 19 and March 24 to come forward before the May 26 deadline for lead plaintiffs.
The broader implications include questions around corporate accountability in pharmaceutical communications as well as potential impacts on investor confidence in biotechnology firms. Whistleblowers with non-public information are also being encouraged to consider their options under the Securities and Exchange Commission whistleblower program.
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