Stock Loses 50% In One Trading Session - Why Are ImmunityBio Shares Tanking Today?

The FDA has issued a complete response letter to ImmunityBio Inc's IBRX Anktiva (N-803), in combination with Bacillus Calmette-Guérin (BCG) for BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (CIS) with or without Ta or T1 disease. 

The regulatory agency assigned a target action date of May 23, 2023.

The deficiencies are related to the FDA's pre-license inspection of the company's third-party contract manufacturing organizations, the company said in an SEC filing. 

Satisfactory resolution of the observations noted at the pre-license inspection is required before the BLA may be approved. 

The FDA further recommended additional Chemistry, Manufacturing, and Controls issues and assays to be resolved.

The FDA requested no new preclinical studies or Phase 3 clinical trials to evaluate safety or efficacy. The FDA requested that the company provide an updated duration of response data of the efficacy population as identified by the FDA in the company's resubmission, as well as a safety update.

ImmunityBio's Executive Chairman and Global Chief Scientific and Medical Officer agreed to provide immediate non-convertible debt financing to the company for $30 million.

As previously disclosed, the company has been exploring partnering with a large biopharmaceutical company to commercialize N-803 for intravesical administration. 

Price Action: IBRX shares are down 51.30% at $3.03 on the last check Thursday.