MaaT Pharma: EMA Issues Negative Opinion on Xervyteg, Reassessment Requested
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a negative opinion on Thursday regarding the conditional marketing authorization for MaaT013 (Xervyteg), intended for the treatment of acute graft-versus-host disease. MaaT Pharma, a biotechnology company listed on Euronext Paris, intends to request a reassessment of the case.
Rejection of Authorization Request for GvHD Treatment
The CHMP of the European Medicines Agency adopted a negative opinion on Friday on the conditional authorization request for MaaT013, marketed under the brand Xervyteg, for the treatment of acute graft-versus-host disease (aGvHD) with gastrointestinal involvement in adults following the failure of prior treatments. This negative opinion confirms the negative trend announced on May 20, 2026, following an oral explanation before the committee, during which this trend was communicated. The CHMP maintained its position that, given the use of concomitant therapies to manage aGvHD, the data dossier, primarily based on the monocentric ARES study, does not allow a sufficient attribution of the observed clinical effect and safety profile to the treatment studied alone.
Request for Reassessment and Opinion from a Scientific Advisory Group
MaaT Pharma has confirmed its intention to request a reassessment of the CHMP's opinion. The reassessment procedure includes the designation of a new rapporteur and co-rapporteur who will conduct a new and independent evaluation of the dossier. The company will also request the convening of a Scientific Advisory Group (SAG) consisting of hematology experts to provide insights to the CHMP on the clinical reality of managing aGvHD with complex concomitant therapies and on the unmet needs in a population facing the severity of the disease and the absence of another effective third-line therapy available.
Second Opinion Expected in September 2026
According to the procedural timelines of the EMA, a new opinion from the CHMP is expected within 60 days following the validation of the reassessment request, with a second decision scheduled during the CHMP session of September 2026 (14-17 September). MaaT Pharma remains confident in the clinical profile of MaaT013, particularly in light of data from the ARES study, results from the CHRONOS study, and elements from its active early access program in 13 countries, which has treated more than 300 patients since 2019. The reassessment does not affect the ongoing early access program, and MaaT013 remains available for eligible patients.
