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MaaT Pharma Advances Toward Commercialization And Submits Marketing Authorization Application to the European Medicines Agency for Xervyteg® (MaaT013) in Acute Graft-versus-Host Disease

 

 

  • MaaT Pharma submitted today a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its product candidate MaaT013, under the registered brand name of Xervyteg®.
    Xervyteg® has the potential if approved, to become the first microbiota therapeutic approved by the EMA and the first one in hemato-oncology globally.
  • The MAA submitted to the EMA is based on data from the Pivotal ARES study, evaluating the safety and efficacy of Xervyteg® in adult patients with acute Graft-versus-Host Disease including gastro-intestinal involvement who received two prior lines of therapy and supported by data from the ongoing Early Access Program.
  • MaaT Pharma prepares for a potential 2026 commercial launch through a strategic partnership to address this key unmet need in hemato-oncology.

 

 

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