What's Happening?
MaaT Pharma has published its half-year 2025 results, highlighting advancements in its hemato-oncology clinical programs. The company reported positive results from a Phase 3 trial for MaaT013 in acute Graft-versus-Host disease (aGvHD), with a 62% gastrointestinal overall response rate at Day 28. MaaT Pharma has submitted a Marketing Authorization application for Xervyteg® to the European Medicines Agency and secured €37.5 million in financing from the European Investment Bank. The company is also evaluating MaaT033 in a Phase 2b trial to improve survival for patients receiving allo-HSCT.
Why It's Important?
MaaT Pharma's progress in developing microbiome-driven therapies for cancer patients represents a significant advancement in hemato-oncology treatment options. The positive trial results and regulatory submissions could lead to new therapeutic options for patients with limited treatment choices, potentially improving survival rates and quality of life. The company's strategic partnerships and financing efforts strengthen its position in the biotechnology sector, supporting continued innovation and development.
What's Next?
MaaT Pharma is preparing for potential market entry of Xervyteg® in Europe, with commercialization expected in the second half of 2026 if approved. The company is also in discussions with the FDA for a dedicated pivotal study in the U.S., aiming to provide early access to Xervyteg® for American patients. As MaaT Pharma continues to expand its clinical programs and partnerships, it may further enhance its leadership in microbiome-based therapies.