Maat Pharma SA

MaaT Pharma said it was informed of a negative trend opinion from the Committee for Medicinal Products for Human Use following an Oral Explanation meeting held on September 14, 2026, as part of the re-examination of its conditional Marketing Authorization Application for MaaT013, also known as Xervyteg, for the treatment of acute Graft-versus-Host Disease. A formal CHMP opinion is expected on September 18, 2026. The company said the remaining concerns relate primarily to the attribution of clinical benefit and safety in the absence of a Randomized Control Trial, and that the CHMP maintained its view that the available clinical data package does not allow sufficient characterization of the benefit and risk of MaaT013. Chief Executive Officer and co-founder Hervé Affagard said the company is deeply disappointed and remains committed to patients with gastrointestinal aGvHD, adding that it will evaluate all available options to make the treatment accessible worldwide. MaaT Pharma said it will assess the implications of the decision and provide further updates following the formal CHMP opinion.