ImmunityBio ($IBRX) $10.5M Investor Settlement
ImmunityBio ($IBRX) has agreed to a $10.5M settlement with investors to resolve claims that it misled them about manufacturing deficiencies that led to the FDA’s rejection of its Anktiva Biologics License Application (BLA).
In 2021, ImmunityBio promoted Anktiva as a breakthrough cancer treatment, with high chances of getting FDA approval. However, on May 11, 2023, the company disclosed that the FDA had rejected its BLA due to manufacturing deficiencies. This news caused $IBRX to drop over 55%, wiping out $1.5B in market value. On June 30, 2023, investors filed a lawsuit, claiming ImmunityBio failed to disclose these critical manufacturing issues.
March 2021: ImmunityBio stated Anktiva as a promising cancer treatment.
May 11, 2023: The company revealed that the FDA rejected Anktiva’s BLA, citing manufacturing deficiencies; $IBRX fell over 55%.
June 30, 2023: Investors filed a lawsuit, claiming ImmunityBio failed to disclose manufacturing issues.
January 28, 2025: ImmunityBio agreed to pay a $10.5M settlement.
ImmunityBio touted Anktiva as a breakthrough immunotherapy that was expected to secure FDA approval without major obstacles. The company repeatedly emphasized the drug’s potential, assuring investors that Anktiva was on track for approval.
However, ImmunityBio failed to disclose critical manufacturing issues at its third-party contract manufacturing facilities, which posed significant regulatory risks.
On May 11, 2023, the FDA issued a complete response letter rejecting the BLA, stating that it could not approve the drug in its current form due to deficiencies observed during its pre-license inspection of ImmunityBio’s third-party contract manufacturing organizations.
The FDA’s findings raised concerns about compliance with good manufacturing practices, which the company would need to address before resubmitting the application. Following this news, $IBRX plummeted over 55%, wiping out $1.5B in market value.
As a result, on June 30, 2023, investors filed a lawsuit, claiming ImmunityBio misled them about the regulatory risks and manufacturing issues that ultimately led to the FDA rejection.
ImmunityBio has agreed to a $10.5M settlement with $IBRX investors to resolve claims that it misled them about manufacturing deficiencies that led to the FDA’s rejection of its Anktiva Biologics License Application (BLA).
If you were damaged due to this situation, you can file for a payout and get your share of the settlement. You can check if you are eligible and other details in the FAQ section below.