MaaT Pharma, a leading French biotech company specializing in microbiome-driven therapies, has announced a groundbreaking partnership with Clinigen, a global specialty pharmaceutical services group, to commercialize its innovative therapy, Xervyteg® (MaaT013), for the treatment of acute Graft-versus-Host Disease (aGvHD) across Europe.

This exclusive long-term licensing and distribution agreement signals a significant step forward in the microbiome therapeutics field.

If approved, Xervyteg® would become the first microbiota therapeutic authorized in Europe, marking a pioneering milestone in hemato-oncology globally. The European Medicines Agency (EMA) accepted the marketing authorization application for review in June 2025, with potential approval anticipated by mid-2026.

Under the deal, MaaT Pharma will receive an upfront payment of €10.5 million, with an additional €18 million contingent on reaching regulatory and sales milestones. Furthermore, MaaT Pharma will receive royalties in the mid-thirties percentage on net sales, along with a separate supply agreement to provide Clinigen with the finished product at a predetermined price per unit. This agreement significantly enhances MaaT Pharma’s financial stability, extending its cash runway into January 2026.

Hervé Affagard, CEO and co-founder of MaaT Pharma, emphasized the strategic significance of the collaboration: “This deal is a pivotal step in bridging MaaT Pharma’s innovation with healthcare professionals who care for patients with aGvHD. Clinigen’s hemato-oncology expertise and strong European distribution network uniquely position them to successfully deliver this therapy to patients, maximizing the commercial potential of Xervyteg®.”

Jerome Charton, CEO of Clinigen, echoed the enthusiasm, stating, “We are excited about this partnership, which brings an innovative therapy to patients facing severe unmet medical needs. Our extensive experience in rare diseases and oncology positions us well to ensure rapid and broad access to Xervyteg® across Europe.”

Interest in Xervyteg® is high among the hematology community, as evidenced by a significant increase (+75%) in early access program requests between 2023 and 2024. Clinigen will now oversee this program, allowing MaaT Pharma to prioritize clinical development and regulatory processes.

Xervyteg® represents a new therapeutic class known as Microbiome Ecosystem Therapies™ (MET). It aims to restore the gut microbiome balance disrupted by treatment-induced dysbiosis in aGvHD patients. The therapy leverages pooled-donor microbiota administered via enema, featuring diverse microbial species capable of reducing severe gastrointestinal inflammation—a key factor in steroid-resistant aGvHD.

With EMA approval on the horizon, MaaT Pharma and Clinigen’s partnership exemplifies the growing recognition and potential of microbiome therapies to transform patient care in oncology and rare diseases.