MaaT Pharma presents Pivotal ARES Phase 3 results for MaaT013 (Xervyteg) in Acute GvHD at ASH 2025 Annual Congress and Announces 54% 1-Year Overall Survival; Affirms EMA decision on MaaT013 (Xervyteg) expected mid-2026 (update)
- Presentation included previously disclosed primary results from the pivotal ARES Phase 3 single-arm trial evaluating MaaT013 (Xervyteg) in treating refractory severe acute Graft-versus-Host Disease (aGvHD) patients with gastrointestinal involvement following corticosteroid and ruxolitinib failure.
- MaaT Pharma announces final pivotal ARES results including a confirmed 1-year overall survival of 54%.
- Oral presentation and results confirm durable survival benefit in this high-risk patient population known for extremely poor prognosis.
- MaaT013 (Xervyteg) is currently under regulatory review by the European Medicines Agency (EMA) for Market Approval, with a decision expected mid-2026.