Clinical-stage biotechnology company MaaT Pharma (Euronext Paris:MAAT) said on Friday that it will request a re-examination of the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) negative opinion on the conditional marketing authorisation application for MaaT013 (Xervyteg) to treat acute Graft-versus-Host Disease (aGvHD) in adults with gastrointestinal involvement refractory to prior therapies.

The company will also request a Scientific Advisory Group hearing with haematology experts on aGvHD. A new CHMP opinion is expected during the committee's 14-17 September 2026 session following an independent review by newly appointed rapporteurs.

The CHMP concluded that data, primarily from the single-arm ARES study, did not sufficiently attribute the observed efficacy and safety of MaaT013 to the treatment alone because of concomitant therapies used to manage the disease.

MaaT Pharma said the re-examination will not affect its Early Access Program, under which MaaT013 remains available to eligible patients, and confirmed it will continue advancing MaaT033 in a Phase 2 trial and the development of MaaT034.