MaaT Pharma: Negative EMA Opinion on Xervyteg, Focus on Phoenix Trial
Following the negative opinion from the CHMP on its graft-versus-host disease treatment, the Lyon-based biotech is concentrating its development efforts on a global Phase 3 trial, with clinical preparation advancing in the United States, and extending its funding horizon by one month.
CHMP Confirms Negative Opinion on MaaT013
MaaT Pharma announced on September 18, 2026 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency maintained its negative opinion on the conditional marketing authorization application for MaaT013, whose commercial name is Xervyteg.
This product is aimed at treating acute graft-versus-host disease in adult patients with refractory gastrointestinal involvement to previous lines of treatment. The opinion, adopted following the re-examination procedure, confirms the voting trend communicated on September 15, 2026 following the oral hearing.
In its formal opinion, the CHMP considered that the available clinical data, derived from a single-arm study, do not allow for a sufficient characterization of the benefit/risk profile of MaaT013. The European Commission is expected to render its final decision following this opinion, in accordance with the applicable regulatory procedure.
The company indicated that future product developments will now focus on advancing the randomized clinical trial PHOENIX, subject to obtaining the necessary funding and regulatory approvals.
PHOENIX, a Global Phase 3 Trial Prepared from the United States
MaaT Pharma presented, as part of the re-examination procedure, the PHOENIX project, a global controlled and randomized Phase 3 trial designed to generate the additional data requested by regulatory authorities.
This is an open-label trial evaluating MaaT013 against a pre-selected best available treatment, in patients with acute graft-versus-host disease refractory to corticosteroids and ruxolitinib. The study is expected to include approximately 138 patients, randomized in a 1:1 ratio. Its primary efficacy endpoint will be the overall response rate across all organs on day 28, accompanied by secondary efficacy and safety endpoints.
Feedback received following a Type C meeting with the Food and Drug Administration supports the advancement of PHOENIX as a Phase 3 trial intended for registration, and provides a framework for finalizing the protocol. The company is continuing clinical preparation in the United States, particularly through a feasibility assessment with investigator sites. Subject to necessary funding and approvals, first patient enrollment is anticipated in the first half of 2027.
Strategic Review of Assets and Cash Runway Extended Until December 2026
MaaT Pharma announced it is conducting a strategic review of its assets while implementing additional cash preservation measures.
These measures aim to extend its funding horizon until December 2026, compared to November 2026 previously, based on current operational assumptions. The company is also exploring options to pursue a development plan for MaaT013 focused on the United States, as part of a potentially global registration strategy.
Founded in 2014 and based in Lyon, MaaT Pharma has been listed on Euronext Paris since 2021. The drug candidate received orphan drug designation from the FDA in the United States and from the EMA.
