ImmunityBio's bladder cancer therapy rejected by FDA, stock plummets.

The FDA has declined to approve ImmunityBio's combination therapy for bladder cancer due to deficiencies in the company's application related to manufacturing issues. The company's shares slumped nearly 57% in premarket trading, and it reiterated doubts about its ability to remain in business. The FDA did not request any new preclinical or late-stage clinical trials to evaluate the safety or efficacy of the therapy, but requested the company to provide more data and a safety update in its resubmission. ImmunityBio plans to request a meeting with the FDA to address the matter and seek approval as fast as possible.