MaaT Pharma to Challenge Negative CHMP Verdict for MaaT013

MaaT Pharma, a biotechnology company specializing in Microbiome Ecosystem Therapies, announced its plan to request a re-examination after receiving a negative opinion from the CHMP of the European Medicines Agency (EMA) regarding MaaT013, branded as Xervyteg®, for acute Graft-versus-Host Disease (aGvHD). This decision aligns with a trend noted in May 2026.

The company will seek the appointment of a new rapporteur and co-rapporteur for an independent evaluation, expecting a revised opinion from the CHMP in September 2026. Additionally, MaaT Pharma plans to convene a Scientific Advisory Group with experts on aGvHD to address the complexities of treatment and lack of options.

Despite the setback, MaaT Pharma remains confident in MaaT013's clinical efficacy, bolstered by data from the ARES and CHRONOS studies and real-world applications. The ongoing Early Access Program remains unaffected, ensuring availability to eligible patients.