First Berlin Equity Research has published a research update on MaaT Pharma SACA (ISIN: FR0012634822). Analyst Christian Orquera changed his rating and price target to UNDER REVIEW.

Abstract
MaaT Pharma disclosed on 20 May 2026 that the Committee for Medicinal Products for Human Use (CHMP) of the EMA communicated a “negative trend” opinion on the conditional marketing authorisation application (MAA) for MaaT013 (Xervyteg) in acute GvHD, following the Oral Explanation stage. The formal CHMP vote is expected in June, after which the company has 15 days to file the appeal, which management confirmed it firmly intends to pursue. Management indicated a potential final outcome around September/October 2026. The company has also implemented cash conservation measures extending the runway from August to November 2026, covering the expected appeal timeline. Critically, the objection relates to trial methodology, centred on the difficulty of isolating the treatment effect of MaaT013 within the context of the single-arm design of ARES, rather than on the magnitude of clinical benefit itself. The re-examination nevertheless introduces a potentially meaningful shift, as the file is expected to be reassessed by a new panel advised by practising haemato-oncologists rather than the broader generalist composition of the original CHMP, potentially increasing the weight given to clinical reality and unmet medical need relative to purely methodological considerations. We see three principal strategic levers supporting the appeal: a single-arm precedent (Adstiladrin, 2026), a directly applicable GvHD precedent supported by MaaT013’s >300-patient real-world EAP experience (Rezurock, 2026), and a responder subgroup with 67% one-year survival. A further supporting consideration is the difficulty of conducting a traditional randomised study in this highly refractory setting. Historical reversal rates of 20-30% keep the case binary, but the optionality is meaningful, particularly given the company’s experienced regulatory advisory team, including former CHMP members. We place our rating and price target under review pending the formal CHMP opinion grounds (old: Buy; €17).