First Berlin Equity Research has published a research update on MaaT Pharma SACA (ISIN: FR0012634822). Analyst Christian Orquera maintained his ?under review? rating and price target.

Abstract
MaaT Pharma announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has formally adopted a negative opinion on the conditional Marketing Authorisation Application (MAA) for MaaT013 (Xervyteg) in acute Graft-versus-Host Disease (aGvHD), as anticipated following the negative trend communicated after the May Oral Explanation. The outcome is therefore not a surprise. Two procedural developments are worth highlighting. First, the CHMP’s written grounds confirm that the central objection relates to the inability to attribute the observed clinical benefit to MaaT013 alone, given the use of complex concomitant therapies alongside MaaT013 in the management of aGvHD, supporting our view that the key hurdle is causal attribution arising from the single-arm study design rather than fundamental concerns over MaaT013’s benefit-risk profile. Second, MaaT Pharma confirmed that it will seek a re-examination of the CHMP opinion and request a Scientific Advisory Group (SAG) hearing with haematology experts in aGvHD, precisely the procedural shift we identified as the most important element of the appeal process. A second CHMP opinion is expected during the 14-17 September session. Overall, this announcement provides greater procedural clarity without changing the investment case. The re-examination, together with the planned SAG hearing, preserves the optionality of the appeal process, while the expected cash runway through November 2026 remains unchanged. We therefore leave our rating and price target under review.