Clinical-stage biotechnology company MaaT Pharma (Euronext Paris:MAAT) confirmed on Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has maintained its negative opinion on the company's application for conditional marketing authorisation for MaaT013 (Xervyteg) following re-examination.

The CHMP said the available clinical data from a single-arm trial were insufficient to adequately characterise MaaT013's benefit-risk profile in adults with gastrointestinal acute Graft-versus-Host Disease (aGvHD) refractory to prior therapies.

MaaT Pharma plans to advance PHOENIX, a randomised, controlled Phase 3 trial comparing MaaT013 with best available therapy, which is intended to generate additional evidence for potential regulatory submissions in the United States, Europe and other markets.

Feedback from a Type C interaction with the US Food and Drug Administration (FDA) supports advancing PHOENIX as a registrational Phase 3 trial and provides a framework for finalising the protocol and progressing US development activities.

Subject to funding and regulatory clearance, the approximately 138-patient trial could begin with first patient enrolment in the first half of 2027 and is planned across the US, Europe and other regions.

The European Commission is expected to issue its final decision on the marketing authorisation application following the CHMP opinion.

MaaT Pharma is also conducting a strategic review of its assets and implementing additional cash-preservation measures, extending its cash horizon from November to December 2026 based on current operational assumptions.