Clinical-stage biotechnology company MaaT Pharma (Euronext Paris:MAAT) disclosed on Tuesday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative trend opinion following an Oral Explanation meeting as part of the re-examination of its conditional Marketing Authorisation Application for MaaT013 (Xervyteg) to treat acute graft-versus-host disease (aGvHD).

The company said the remaining concerns primarily relate to the attribution of clinical benefit and safety in the absence of a randomised controlled trial. The CHMP maintained that the available clinical data package does not provide sufficient characterisation of MaaT013's benefit-risk profile.

A formal CHMP opinion is expected on 18 September 2026, after which MaaT Pharma will assess the implications of the decision and evaluate available options.

MaaT Pharma CEO and co-founder Hervé Affagard said the company remains committed to patients with gastrointestinal aGvHD, citing the condition's life-threatening nature, significant unmet medical need and limited treatment options.