MaaT Pharma Advances Xervyteg® Commercialization Efforts

MaaT Pharma has submitted a Marketing Authorization Application for Xervyteg® (MaaT013) to the European Medicines Agency in June 2025. Approval could see commercialization in Europe by mid-2026. This marks a significant step in microbiota therapeutic advances in oncology, with Xervyteg® showing promising results in treating acute graft-versus-host disease (aGvHD).

The ARES Phase 3 trial demonstrated a 62% gastrointestinal response rate at Day 28. The company's strategic focus is on European registration and commercialization efforts, while planning the U.S. Phase 3 trial launch in 2026. MaaT Pharma is engaging potential partners to facilitate European market entry.

Additionally, MaaT Pharma continues its Early Access Program and prepares for new studies in the U.S. Final ARES data, including 12-month survival rates, is anticipated by the year's end, strengthening the Xervyteg® dossier.