ImmunityBio's Stock Plummets After FDA Rejects Bladder Cancer Therapy
The FDA has rejected ImmunityBio's bladder cancer treatment, Anktiva, due to deficiencies with the company's third-party contract manufacturer. The FDA provided recommendations to resolve specific issues but did not request new preclinical or Phase III studies for safety or efficacy. ImmunityBio has requested a meeting with the regulator to address the Complete Response Letter (CRL) and timeline to resolve issues and "seek approval as expeditiously as possible." The company has a potential partner lined up for the commercialization of Anktiva despite the CRL.