ImmunityBio Hit by Class Action over ANKTIVA Misbranding, Shares Drop 21%
ImmunityBio faces a securities class action claiming its promotional materials for ANKTIVA misbranded the bladder cancer therapy and touted unapproved subcutaneous use, triggering an FDA warning letter. Shares plunged 21%, a $1.98 decline, on March 24 after regulatory concerns became public about ANKTIVA’s approved intravesical route only.
1. Lawsuit Allegations
Investors allege that ImmunityBio promoted ANKTIVA beyond its FDA-approved intravesical administration by marketing it as a subcutaneous injection and suggesting broader cancer treatment, rendering the drug misbranded under the FD&C Act.
2. FDA Warning Letter
On March 13, the FDA issued a warning letter citing that ANKTIVA’s labeling authorizes intravesical use only, and that any subcutaneous, intravenous or intramuscular routes are unauthorized and pose public health risks.
3. Market Reaction and Class Period
When the warning letter became public on March 24, shares fell $1.98—21%—to close at $7.42; the class action targets investors who bought stock between January 19 and March 24, 2026.
4. Legal Process and Investor Options
Investors may seek lead plaintiff status by May 26, 2026 and could recover losses without out-of-pocket fees; the action asserts foreseeable regulatory risk was concealed, harming shareholders.