MaaT Pharma: Negative CHMP Voting Trend on MaaT013 (Xervyteg)
The Lyon-based biotech company has been informed of a negative voting trend from the European Committee for Medicinal Products for Human Use regarding MaaT013 (Xervyteg), following an oral hearing.
The formal opinion of the European Medicines Agency body is expected on September 18, 2026.
A Negative Trend Following the Oral Hearing
MaaT Pharma indicated that it was informed of a negative voting trend during the oral hearing, as part of the re-examination procedure for its conditional marketing authorization application for MaaT013 (Xervyteg).
This drug candidate is being developed for the treatment of acute graft-versus-host disease (aGvHD). According to feedback received during this hearing, the remaining concerns primarily relate to the attribution of clinical benefit and safety in the absence of a randomized controlled trial.
The CHMP maintained its position that the available clinical data do not allow for a sufficiently comprehensive characterization of the product's benefit-risk ratio.
The CHMP's Formal Opinion Expected on September 18, 2026
The Company indicated that it will communicate a new update following the adoption of the CHMP's formal opinion, expected on September 18, 2026.
MaaT Pharma clarified that it will assess the implications of this decision as well as all available options, and will inform the market accordingly. "We are deeply disappointed by this outcome," declared Hervé Affagard, Chief Executive Officer and co-founder of MaaT Pharma, adding that the Company "will evaluate all available options in order to make this potentially important treatment accessible to patients worldwide."
A Product Without Marketing Authorization to Date
MaaT013 (Xervyteg) is currently undergoing regulatory review with the competent authorities and has not, to date, obtained marketing authorization.
The product has received orphan drug designation from the Food and Drug Administration in the United States and from the European Medicines Agency.
