ImmunityBio Settled With Investors Over FDA Rejection Drama— How to Claim Your Share

Court: S.D. California

Case: 23-CV-01216

ImmunityBio IBRX has agreed to pay $10.5M to settle a lawsuit from investors who say the company hid information about manufacturing issues tied to its cancer drug Anktiva in 2023.

The settlement, announced in January 2025, follows major fallout from the FDA’s decision to reject the company’s Biologics License Application (BLA)—a decision that wiped out over half the company’s market value.

The Hidden Risk Behind Anktiva’s Hype

Back in 2021, ImmunityBio promoted Anktiva as a breakthrough in cancer treatment, projecting strong chances of FDA approval. The company repeatedly reassured investors that the drug’s path to approval was on track.

But that changed on May 11, 2023, when the FDA issued a complete response letter rejecting the BLA—citing serious manufacturing deficiencies at third-party facilities used by ImmunityBio.

The FDA found that those facilities failed to meet critical good manufacturing practice standards, and that these issues would need to be resolved before any resubmission. The news sent IBRX crashing more than 55%, erasing $1.5 billion in market value.

Investors Fight Back After $1.5B Meltdown

Just weeks after the stock crash, shareholders filed a class action lawsuit accusing the company of hiding this manufacturing problems that led to the FDA’s rejection. They claimed that ImmunityBio’s glowing public statements didn’t reflect the regulatory risks —and that this misled the market and inflated the stock price.

A $10.5M Deal to Close the Chapter

After more than a year of litigation, ImmunityBio agreed to resolve the claims with a $10.5M settlement. And, even though the deadline has passed, they’re still accepting late claims from damaged investors. You can find the latest updates and file your claim here.