Lawsuit troubles may face ImmunityBio
ImmunityBio faces a class action lawsuit from an Atlanta law firm that alleges the company misled investors about a drug that was later rejected by the FDA.
The suit was filed in a California federal court June 30 by Holzer and Holzer, Inc. against the San Diego-based company, which began leasing the former Athenex facility in the town of Dunkirk in February 2022.
The lawsuit seeks to recover unspecified damages for people who invested in ImmunityBio between May 23, 2022, and May 10, 2023.
The lawsuit alleges ImmunityBio made false and/or misleading statements, and failed to disclose material adverse facts, about a drug called Anktiva.
It states, “ImmunityBio conducted insufficient due diligence to discover, or else did discover and ignored, good manufacturing practice deficiencies at its third-party contract manufacturing organizations for its product, Anktiva.”
Although these deficiencies were likely to lead to rejection of the drug, ImmunityBio overstated the business projects for it, the lawsuit claims. The FDA did reject the drug, a bladder cancer therapy, and ImmunityBio announced it May 11.
The suit quotes ImmunityBio press releases and SEC filings that touted Anktiva prior to its rejection.
The only mention of the Dunkirk facility in the lawsuit comes in a quote from ImmunityBio’s 2022 year-end report to the SEC.
“In September 2022, we initiated a workforce reduction at the Dunkirk facility as a result of upcoming construction at the project, which we believe may take approximately 12 to 18 months,” ImmunityBio’s report stated. “We believe this facility will provide us with a state-of-the-art biotech production center that will substantially expand and diversify our existing manufacturing capacity in the U.S. and the ability to scale production across all of our key platforms.”