MAAT Pharma Faces Setback in Authorization for MaaT013

MaaT Pharma, based in Lyon, France, has encountered a potential hurdle in its European approval process for MaaT013 (Xervyteg®), a treatment for acute Graft-versus-Host Disease (aGvHD). During a recent session with the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), the committee issued a "negative trend" opinion. A formal vote is expected in June.

The company plans to request a re-examination following the vote. This process allows for a new scientific assessment by different reviewers. CEO Hervé Affagard expressed commitment to advancing the therapy, citing its potential to meet significant unmet needs for aGvHD patients and support within the hematology community.

MaaT013 combines clinical trial data and real-world results with more than 300 patients treated since 2019. Despite the current setback, MaaT Pharma is implementing cash management strategies to sustain operations and regulatory processes through November 2026.