6 August 2025 - Galapagos NV (Euronext & NASDAQ: GLPG) today announced that the United States Food and Drug Administration (FDA) has granted RMAT designation to GLPG5101, a second generation anti-CD19/4-1BB CAR-T product candidate for the treatment of relapsed/refractory mantle cell lymphoma (R/R MCL).

Clinical data derived from the ongoing ATALANTA-1 study with GLPG5101 in patients with R/R B-cell Non-Hodgkin Lymphoma (B-NHL), including a subset of patients with MCL, supported the RMAT designation. These data1 demonstrated both high objective and high complete response rates, with a manageable safety profile, including low rates of high-grade cytokine release syndrome (CRS), immune effector cell associated neurotoxicity syndrome (ICANS) and low dropout rates.

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