Why Iovance Biotherapeutics Stock Is Crashing Today
Shares of Iovance Biotherapeutics (NASDAQ: IOVA) were crashing 22.4% lower as of 11:17 a.m. ET on Wednesday. The steep decline came after the company announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the IOV-LUN-202 clinical trial evaluating experimental therapy LN-145 TIL in treating non-small-cell lung cancer (NSCLC).
The FDA's clinical hold was put into effect following a patient death in the IOV-LUN-202 study. Iovance said in a press release that the fatality was "potentially related to the non-myeloablative lymphodepletion pre-conditioning regimen" of the clinical trial.
Iovance stated that it is pausing enrollment of new patients in the IOV-LUN-202 study while the FDA's clinical hold remains in effect. The company will, however, continue to administer LN-145 TIL to patients already in the study who have undergone tumor resection but with "additional precautions and risk mitigations." It will also closely monitor patients who were previously treated with the experimental therapy.
Source Fool.com
