ImmunityBio crashes 57% after FDA snub for cancer therapy

• ImmunityBio (NASDAQ:IBRX) lost ~57% in the pre-market trading Thursday after disclosing that the FDA rejected a marketing application for its product candidate Anktiva as a combination therapy for a type of bladder cancer.
• Issuing a so-called complete response letter on May 9, the agency has cited shortcomings related to third-party contract manufacturing organizations as reasons for its decision, the company added.
• With its Biologics License Application, ImmunityBio (IBRX) had sought FDA approval for Anktiva (N-803) in combination with Bacillus Calmette-Guérin (“BCG”) as a treatment for BCG-unresponsive non-muscle invasive bladder cancer.
• “The letter indicates that the FDA has determined that it cannot approve the BLA in its present form, and the FDA has made recommendations to address the issues raised,” ImmunityBio (IBRX) noted.
• The FDA has also pointed to manufacturing issues that the company has to resolve and requested that it update certain safety and efficacy data for the Anktiva combo in its resubmissions.

More on Anktiva

• ImmunityBio rises after data from late-stage bladder cancer trial for Anktiva
• ImmunityBio: Extensive Pipeline, NDA Expected For Anktiva This Quarter