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Legend Biotech Announces U.S. FDA Clearance of IND Application for LB2501, an Investigational CD19/CD20 In Vivo CAR-T Therapy

Legend Biotech Corporation (LEGN)Legend Biotech CorporationFDA / regulatory

Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for LB2501, an investigational in vivo CAR-T therapy designed to generate CD19/CD20 dual-targeting chimeric antigen receptor T (CAR-T) cells directly within the patient, for the treatment of relapsed or refractory B-cell malignancies, including B-cell non-Hodgkin lymphoma.

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Legend Biotech Corporation

Global Cell Therapy Company Legend Biotech develops and commercializes cell therapies for cancer and other serious diseases. CARVYKTI CARVYKTI, or ciltacabtagene autoleucel, is a one-time BCMA-directed CAR T-cell therapy for multiple myeloma developed and commercialized with Johnson & Johnson. Global Manufacturing and Access Legend...

Recent company news

LEGNLegend Biotech Corporation2026-10-15 12:00 EST

Legend Biotech Announces U.S. FDA Clearance of IND Application for LB2501, an Investigational CD19/CD20 In Vivo CAR-T Therapy

LEGNLegend Biotech Corporation2026-10-01 13:00 EST

Legend Biotech Launches Inaugural ELITE Grant Program to Advance the Next Generation of CAR-T Innovation in Multiple Myeloma

LEGNLegend Biotech Corporation2026-09-25 11:00 EST

Legend Biotech Presents CARVYKTI Data Showing Half of Patients with RRMM Remained Progression-Free and Alive Five Years After a Single Infusion

LEGNLegend Biotech Corporation2026-09-15 12:00 EST

Legend Biotech Appoints Ingrid Zhang as Chief Executive Officer

LEGNLegend Biotech Corporation2026-09-10 12:00 EST

Legend Biotech to Present Updated Long-Term and Real-World Evidence from CARVYKTI Clinical Program at the International Myeloma Society Annual Meeting

Stock data

Close
19.01 USD
Market cap
6.74B USD
Exchange
NASDAQ
Sector
CAR-T Therapy, TCR-T Therapy, Antibody Drugs, ADCs, Biopharma
Location
United States