Galapagos Receives FDA RMAT designation for GLPG5101 in r/r MCL
Galapagos announced that the FDA has granted RMAT designation to GLPG5101 (CD19- CAR-T) to treat relapsed/refractory mantle cell lymphoma (r/r MCL). This is based on the strong data that GLPG5101 has demonstrated in the MCL cohort in the phase 1/2 (ATLANTA-1) trial in r/r NHL, and comes with a number of potential benefits including eligibility for accelerated approval, and could further support external discussions as Galapagos explores strategic alternatives for the cell therapy business. Accumulate and € 37 TP maintained.Galapagos is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action, addressing disease areas of high unmet medical need. Execution on its proprietary drug target discovery platform has delivered a pipeline that consists of three Phase 2, three Phase 1, five pre-clinical, and 20 discovery programs in inflammation, cystic fibrosis, or CF, osteoarthritis, and other indications. Co.'s highly flexible platform offers applicability across a broad set of therapeutic areas. Co.'s programs include filgotinib, GLPG1837, GLPG1690, GLPG2222, GLPG1972.
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