First Berlin Equity Research has published a research update on MaaT Pharma SACA (ISIN: FR0012634822). Analyst Christian Orquera reiterated his BUY rating and maintained his EUR 17.00 price target.
Abstract
MaaT Pharma presented the final dataset from the pivotal ARES phase 3 trial of Xervyteg (MaaT013) in steroid- and ruxolitinib-refractory gastrointestinal acute Graft-versus-Host Disease (GI-aGvHD) at the American Society of Hematology (ASH) Annual Meeting 2025. The results confirm the previously disclosed efficacy profile with no material change to earlier response rates or survival outcomes. Crucially, the trial now reports mature 12-month overall survival (OS) of 54%, converting the previously estimated survival probability into observed outcome data. This is a remarkable result in an extremely high-risk population. Median OS was not reached, indicating sustained benefit in more than half of treated patients (i.e. median OS is only reached when at least 50% of patients have died). Early response remained strongly predictive of outcome, with 1-year survival of 68% in Day-28 responders versus 28% in non-responders. Safety remained acceptable and consistent with prior readouts. These final data strengthen the overall evidence package and support the Marketing Authorisation Application filed with the EMA in June 2025. A decision remains expected around mid-2026. If approved, Xervyteg would become the first microbiome-based oncology therapy globally and the first authorised third-line option for severe GI-aGvHD. We see this news as de-risking Maat Pharma from both a clinical and regulatory perspective. We maintain our Buy rating and €17.00 price target (upside: 298%).

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