Galapagos(US:GLPG) GlobeNewswireยท2025-08-06 05:30Core Points - The U.S. FDA has granted RMAT designation to GLPG5101, a second generation anti-CD19/4-1BB CAR-T product candidate for relapsed/refractory mantle cell lymphoma [1][2] - RMAT designation aims to accelerate the development and review of promising cell and gene therapies for serious conditions, with GLPG5101 showing preliminary clinical evidence of potential effectiveness [2][3] - Clinical data from the ATALANTA-1 study supports the RMAT designation, demonstrating high objective and complete response rates with a manageable safety profile [3][4] Company Overview - Galapagos is a biotechnology company focused on transforming patient outcomes through innovative science and technology, with operations in Europe, the U.S., and Asia [9] - The company is dedicated to addressing high unmet medical needs and has developed a decentralized cell therapy manufacturing platform to enhance patient experience and treatment delivery [8][9] Study Details - The ATALANTA-1 study is evaluating the safety and efficacy of GLPG5101 in patients with various hematological malignancies, with a primary objective to assess safety and determine recommended dosing [6] - The study includes multiple dose levels and aims to evaluate the Objective Response Rate (ORR) and other secondary endpoints, with patients being followed for 24 months [6] RMAT Designation Benefits - The RMAT designation allows for increased FDA guidance, more frequent interactions, eligibility for accelerated approval, and early discussions on study endpoints, facilitating faster development timelines [4]