MaaT Pharma Faces Uncertainty Following CHMP Setback

First Berlin Equity Research has issued an update on MaaT Pharma SACA, maintaining its 'under review' rating and price target. This comes after the CHMP (Committee for Medicinal Products for Human Use) issued a negative opinion on MaaT013 (Xervyteg), challenging its benefit-risk profile based on current data. The European approval path for MaaT013 is now effectively closed.

MaaT Pharma's focus shifts to PHOENIX, a global phase 3 trial of MaaT013. The FDA supports this trial, with initial patient enrollment expected in the first half of 2027, conditional on funding and regulatory clearance. The company's cash reserve of €17.1 million at the end of June extends its operational runway only until December 2026, necessitating further capital for PHOENIX.

The company is actively seeking financing and partnerships, including exploring opportunities for MaaT034. Until a secure funding path is confirmed, questions about MaaT Pharma's long-term viability remain.