IBRX.US
id: 716
ImmunityBio ($IBRX) $10.5M Investor Settlement
The settlement terms have been submitted to the court for approval.
S.D. California
Court23-CV-01216
Case number03/10/2021
Class period Start05/10/2023
Class period EndImmunityBio 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).
Outline
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.
Timeline
- 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.
Background
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.
What Can Investors Expect Now?
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.
Case Status
Stipulative Settlement
Alleged Offence
Misleading Statements,
Failure to Disclose,
Negligence,
Omissions
Suspected Party
Directors,
Management,
Service Provider
Security Type
Stocks
Trade Direction
Long
Payout per Share
0.14
Filing date
06/30/2023
Lead Plaintiff Deadline
08/29/223
Plaintiffs
Zachary Salzman
Attorneys
Holzer & Holzer, LLC (Atlanta, GA), Pomerantz LLP (Los Angeles, CA), Kaplan Fox & Kilsheimer LLP (Pamela A. Mayer, Laurence D. King)
Defendants
Richard Adcock, David C. Sachs, Patrick Soon-Shiong
Judge
Hon. Roger T. Benitez
Administrator
EPIQ
Settlement agreement date
2025-01-28
Attorney fee
$3,700,000
Trades matching type
FIFO
+$10,500,000
Cash Settlement Amount