Jim Cramer, host of "Mad Money," shared his thoughts on several stocks during his lightning round. He expressed caution about ImmunityBio, citing its financial losses and the potential risks if it fails to obtain desired approvals. Cramer expressed enthusiasm for Trane and recommended buying Walmart at its current level, although he noted that Costco is a better option. He liked Air Lease Corp but suggested that those interested in the company should also consider investing in Boeing.
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.
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.
The FDA has rejected ImmunityBio's biologics license application for a specific bladder cancer, citing deficiencies related to an inspection of a third-party contract manufacturer. The rejection caused the biotech's shares to tumble about 50%. ImmunityBio's Anktiva, or N-803, will need a satisfactory resolution of the observations before a BLA approval.
