Mechelen, Belgium — August 6, 2025 — Leads & Copy — Galapagos NV (Euronext & NASDAQ: GLPG) announced today that the United States Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (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, established under the U.S. 21st Century Cures Act, aims to accelerate the development and review of promising cell and gene therapies for serious or life-threatening conditions. GLPG5101 qualified for RMAT designation based on preliminary clinical evidence suggesting its potential to treat, modify, reverse, or cure a serious or life-threatening disease.
Clinical data from the ongoing ATALANTA-1 study, which evaluated GLPG5101 in patients with R/R B-cell Non-Hodgkin Lymphoma (B-NHL), including a subset of patients with MCL, supported the RMAT designation. The data demonstrated high objective and complete response rates, along with a manageable safety profile, including low rates of high-grade cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS), as well as low dropout rates.
According to Omotayo Fasan, M.D., Clinical Development Program Head at Galapagos, the RMAT status allows for closer collaboration with the FDA, creating additional opportunities for accelerated development and assessment timelines.
Galapagos intends to report updated data from the ATALANTA-1 study at a future medical conference.
About Galapagos
Galapagos is a biotechnology company with operations in Europe, the U.S., and Asia, dedicated to transforming patient outcomes through life-changing science and innovation for more years of life and quality of life. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class medicines. With capabilities from lab to patient, including a decentralized cell therapy manufacturing platform, we are committed to challenging the status quo and delivering results for our patients, employees, and shareholders. Our goal is to meet current medical needs, and to anticipate and shape the future of healthcare, ensuring that our innovations reach those who need them most.
Contact:
Marieke Vermeersch
+32 479 490 603
media@glpg.com
Glenn Schulman
+1 412 522 6239
ir@glpg.com
