On December 27, 2023, Iovance announced that, on December 22, 2023, the U.S. Food and Drug Administration (“FDA”) had placed a clinical hold on the Company’s IOV-LUN-202 trial, which was investigating the Iovance’s lead product candidate for the treatment of metastatic non-small cell lung cancer. Iovance advised that the FDA’s decision to place the clinical hold was “in response to a recently reported Grade 5 (fatal) serious adverse event potentially related to the non-myeloablative lymphodepletion pre-conditioning regimen.”

On this news, Iovance’s stock price fell 18.67% to close at $7.23 per share on December 27, 2023.