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MaaT Pharma Says EU Regulator Maintains Negative Opinion on Xervyteg

MT Newswires·09/18/2026 02:39:10
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02:39 AM EDT, 09/18/2026 (MT Newswires) -- MaaT Pharma (MAAT.PA) said the European Medicines Agency's Committee for Medicinal Products for Human Use maintained its negative opinion on the conditional marketing authorization application for MaaT013, or Xervyteg, for acute graft-versus-host disease with gastrointestinal involvement. The European Commission will issue its final decision following the CHMP opinion that the available clinical data package based on a single-arm trial does not establish the benefit-risk profile of Xervyteg, according to the clinical-stage pharmaceutical company's Friday release. MaaT Pharma said it will shift its focus to advancing the Phoenix randomized phase 3 clinical trial to evaluate Xervyteg against the current standard treatment in patients with corticosteroid- and ruxolitinib-refractory acute graft-versus-host disease. The company is also conducting a strategic review of its assets and taking additional cash preservation measures to extend its cash runway to December from November.