Shares of biotechnology company Iovance Biotherapeutics plummeted in premarket trading on Wednesday after the U.S. Food and Drug Administration (FDA) placed a clinical hold on a Phase 2 study of its LN-145 therapy in non-small cell lung cancer. This decision was made following the unfortunate death of a study patient.
Cause for Concern
Iovance, based in San Carlos, California, has been conducting research on LN-145 as a potential treatment option for certain patients with advanced non-small cell lung cancer who have limited treatment options and a poor prognosis following disease progression. The company believes that the patient's death may be linked to the study's non-myeloablative lymphodepletion pre-conditioning regimen.
Impact and Next Steps
In light of the FDA's clinical hold, Iovance will halt enrollment and temporarily pause the treatment regimen for new patients in the study. It is important to note that this clinical hold does not affect any of the company's other ongoing clinical trials.
Shares of Iovance, which closed at $8.89 on Tuesday, experienced a significant drop of 26% and were trading at $6.59 during premarket hours.
Despite this setback, Iovance Biotherapeutics remains committed to advancing its research and development efforts in the field of cancer therapeutics.
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