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Galapagos NV Announces U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to GLPG5101 for the Treatment of Relapsed/Refractory Mantle Cell Lymphoma
Mechelen, Belgium; August 6, 2025, 7:30 CET; regulated information – inside information – 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). The RMAT designation was established under the U.S. 21st Century Cures Act to accelerate development and review of promisi
About this update from Lakefront Biotherapeutics
[{"type":"image","alt":"Galapagos NV","displaySize":"","headline":null,"caption":"Galapagos NV","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":55,"url":"https://media.zenfs.com/en/globenewswire.com/231a79f212c8051361274fdd509bada9"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/n2iAy9u_uXZxYevnIzv00A--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTc3O2NmPXdlYnA-/https://media.zenfs.com/en/globenewswire.com/231a79f212c8051361274fdd509bada9","width":300,"height":55}},"lazy":false},{"type":"text","content":"Mechelen, Belgium; August 6, 2025, 7:30 CET; regulated information – inside information – 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). ","length":381,"tagName":"p"},{"type":"text","content":"The RMAT designation was established under the U.S. 21st Century Cures Act to accelerate development and review of promising cell and gene therapies for serious or life-threatening conditions. To qualify for RMAT designation, GLPG5101 demonstrated preliminary clinical evidence suggesting it has the potential to treat, modify, reverse, or cure a serious or life-threatening disease.","length":383,"tagName":"p"},{"type":"text","content":"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.","length":466,"tagName":"p"},{"type":"text","content":"“This designation reflects the promising clinical activity and safety profile observed in our ongoing Phase 1/2 study and supports our commitment to delivering an effective and timely treatment option to patients in need,” said Omotayo Fasan, M.D., Clinical Development Program Head at Galapagos. “With RMAT status allowing for closer collaboration with the FDA, this will enable additional opportunities for accelerated development and assessment time...