MaaT Pharma MaaT013 phase 3 beats expectations in aGvHD, MAA submission mid-25

MaaT announced that the phase 3 trial of MaaT013 met its primary endpoint in 3L aGvHD with a day 28 GI-ORR of 62%, exceeding our expectations and coming in in-line with our blue-sky scenario being significantly above what was observed in the phase 2 trial, and more or less in line with results from the early access program (EAP). Additionally, the company unexpectedly reported survival data showing a survival probability of 54%, higher than the 15% observed in the literature for off-label options. Given the strong dataset and availability of survival data, MaaT plans to submit MaaT013 for regulatory evaluation in the EU in mid-2025 (previously 2H25). We update our model to increase MaaT013's probability of success (POS) to 80% (from 53%) in Europe, which brings us to a new TP of € 18 (from € 16). We expect a positive share price reaction today and reiterate our BUY rating.