MaaT Pharma has been informed by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) of a ‘negative trend’ opinion on its conditional Marketing Authorisation Application (MAA) for MaaT013 (Xervyteg) for the treatment of acute Graft-Versus-Host Disease (aGvHD), following its recent CHMP oral explanation.

The CHMP formal vote is expected at the upcoming June Meeting, and subject to the formal vote, the company intends to request a re-examination of the application, a standard procedure enabling a new independent scientific assessment by a different set of reviewers. The EMA’s procedure provides that the CHMP shall re-examine its opinion within 60 calendar days following receipt of the company’s official request for re-examination.

Hervé Affagard, CEO and Co-Founder, MaaT Pharma, said, “We continue to strongly believe in the potential for registration of MaaT013 (Xervyteg). We remain committed to working closely with the EMA to progress this application, encouraged by the therapy’s potential to address the significant unmet medical need in patients with aGvHD and by the continued support from the hematology community. Our application remains under review, and we are fully committed to engaging constructively in the re-examination process.”

For context, the CHMP feedback shared during the Oral Explanation reflects challenges, in the company’s view, expected for first-in-class therapies based on a novel therapeutic approach, particularly those based on a single-arm pivotal trial. The application for MaaT013 (Xervyteg) is assessed under the Conditional Marketing Authorisation (CMA) pathway, which is designed to facilitate earlier access to medicines addressing unmet medical needs while confirmatory data is generated post-approval.

The company is taking cash management measures to extend its financial visibility into November 2026 (vs August 2026), covering the upcoming regulatory milestones including the re-examination process, while continuing to advance its pipeline.

MaaT013 (Xervyteg) is supported by clinical data from the pivotal ARES study, and real-world data with the ongoing Early Access Program active in 13 countries and with 300+ patients globally treated to date since 2019. Data supporting MaaT013 (Xervyteg) has previously been presented at major international congresses and in peer-reviewed publications.