IBRX - ImmunityBio crashes 57% after FDA snub for cancer therapy

2023-05-11 07:44:31 ET

• 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 issues 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 .

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