The biotechnology company has been informed by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) of a trend toward a negative opinion regarding its conditional marketing authorization application for MaaT013, following a recent oral explanation.

A formal vote by the CHMP is expected during the June meeting. Subject to the outcome of this vote, MaaT Pharma intends to request a re-examination of the file, a procedure that allows for a new independent scientific assessment of the application by a different panel of rapporteurs. Under the established procedure, the CHMP must conduct this re-examination within 60 calendar days of receiving the company's formal request.

MaaT Pharma stated that it is implementing cash management measures to extend its financial runway until November 2026 (compared to August 2026), thereby covering the upcoming regulatory milestones, including the re-examination process, while continuing to develop its pipeline.