Galapagos (GLPG) Up on FDA Nod to Begin Phase I/II Lymphoma Study

Core Viewpoint - Shares of Galapagos NV are experiencing a rise following FDA clearance for its investigational new drug application for GLPG5101, aimed at treating relapsed/refractory non-Hodgkin lymphoma [1] Company Overview - Galapagos NV is a clinical-stage company focused on developing innovative therapies, including GLPG5101, an autologous CD19 CAR-T cell therapy administered as a single intravenous dose [2] - The company has a robust pipeline that includes small molecules and cell therapies in oncology and immunology, with ongoing studies for other candidates targeting leukemia and myeloma [7] Clinical Study Details - The ATALANTA-1 study will assess the feasibility, safety, and efficacy of GLPG5101 for relapsed/refractory non-Hodgkin lymphoma in the U.S., with early data from ongoing EU studies showing promising results [3][5] - The phase I portion of the trial aims to evaluate safety and initial effectiveness to determine appropriate dosage, while the phase II portion will focus on the objective response rate and other secondary outcomes [4][5] Market Performance - Year to date, shares of Galapagos have declined by 38.8%, contrasting with a 1.6% growth in the industry [5]