MaaT Pharma Receives Negative CHMP Trend Vote for MaaT013 (Xervyteg®) Following Re-Examination for its Conditional Marketing Authorization Application in Europe

On September 14, 2026 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies (MET) dedicated to enhancing survival for patients with cancer through immune modulation, reported that it has been informed by the CHMP of the European Medicines Agency (EMA) of a "negative trend" opinion following the Oral Explanation, as part of the re-examination procedure of its conditional Marketing Authorization Application (MAA) for MaaT013 (Xervyteg) for the treatment of aGvHD, following yesterday’s CHMP oral explanation.

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"We are deeply disappointed by this outcome. Patients suffering from gastrointestinal-aGvHD continue to face a life-threatening condition with significant unmet medical need and limited treatment options," said Hervé Affagard, Chief Executive Officer and co-founder of MaaT Pharma. "Together with the hematology community, we remain committed to these patients and will evaluate all available options to make this potentially important treatment accessible to patients worldwide."

Based on the feedback received post Oral Explanation, the CHMP maintained its view that the available clinical data package, primarily in the absence of a randomized control trial, does not allow sufficient characterization of the benefit/risk of MaaT013 (Xervyteg).

The Company will provide additional details following the formal CHMP opinion, which is expected to be communicated on September 18, 2026. The Company will assess the implications of the decision and evaluate all available options and will provide an update to the market as appropriate.

(Press release, MaaT Pharma, SEP 14, 2026, View Source [SID1234670840])