BP2202 / BrightPath Biotherap - LARVOL DELTA

U.S. FDA Orphan Drug Designation Granted to BP2202 for the Treatment of Multiple Myeloma (BrightPath Biotherapeutics Press Release) - "BrightPath Biotherapeutics...announced that its iPS cell-derived BCMA CAR-NKT cell therapy candidate, BP2202 (the 'Drug'), has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma, as of July 2, 2025 (U.S. EST)...'We are planning to initiate a clinical trial of BP2202 in the U.S. The ODD granted by the FDA underscores the significant unmet medical need for off-the-shelf, allogeneic CAR-T cell therapies that are readily available when needed for patients with multiple myeloma...'"

Orphan drug • Multiple Myeloma