Legend Biotech Receives FDA Clearance for Dual-Targeting CAR-T Therapy Trials

Key Facts

1The U.S. FDA cleared the Investigational New Drug application for LB2501, enabling Phase 1/2 clinical trials.

The U.S. Food and Drug Administration cleared Legend Biotech Corporation's Investigational New Drug application for LB2501, enabling the commencement of Phase 1/2 clinical trials. GlobeNewswire reported that the clearance allows the company to evaluate the safety and efficacy of the therapy, which is designed to target B-cell malignancies by engineering CAR-T cells directly within the patient.

LEGN closed at $19.04 on October 14, 2026, prior to the announcement of the regulatory milestone. The stock traded between a session low of $17.75 and a high of $19.73 on that date, as the company prepares to advance its in vivo cell engineering platform into clinical stages for non-Hodgkin lymphoma patients.