Legend Biotech Corp (LEGN) News & EventsLEGNLegend Biotech Corp

Legend Biotech's LB2501 Receives FDA Clearance for Clinical Trials

Legend Biotech announced that the FDA has cleared the investigational new drug, or IND, application for LB2501, an investigational in vivo CAR-T therapy designed to generate CD19/CD20 dual-targeting chimeric antigen receptor T cells directly within the patient, for the treatment of relapsed or refractory B-cell malignancies, including B-cell non-Hodgkin lymphoma. The planned U.S. Phase 1/2 study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of LB2501. The clearance represents an advancement of Legend Biotech's strategy to develop the next generation of CAR-T therapies through innovative in vivo cell engineering. LB2501 is designed as an off-the-shelf, single-infusion therapy that generates CAR-T cells directly within the patient, potentially avoiding several manufacturing steps required for conventional autologous CAR-T therapies. The therapy is being evaluated without lymphodepleting chemotherapy.

Legend Biotech Reports Five-Year Follow-Up Data on Carvykti

Legend Biotech announced five-year follow-up data from Cartitude-2 Cohort A evaluating Carvykti in patients with relapsed/refractory multiple myeloma after one to three prior lines of therapy after a median follow-up of 60.7 months. These data were presented at the 2026 International Myeloma Society, IMS, Annual Meeting in Glasgow, Scotland. The data showed that five years after a single Carvykti infusion, 10 of 20 patients remained alive and progression-free without maintenance therapy. With extended follow-up, patients continued to experience durable clinical benefit, with a median PFS of 60.5 months. Median overall survival was not reached at the time of analysis, and 69.2% of patients were alive at five years. With a median follow-up of 60.7 months, 10 of 20 patients remained alive and progression-free without further anti-myeloma treatment greater than or equal to 5 years after Carvykti infusion.

Legend Biotech Appoints Ingrid Zhang as CEO

Legend Biotech (LEGN) announced that its board of directors has appointed Ingrid Zhang as CEO, effective September 15. Ingrid Zhang succeeds Alan Bash, who has served as interim CEO since July and will resume his role as president, Carvykti. Most recently, she served as chief commercial officer for Novartis (NVS).