Omeros Corporation has announced the submission of a Marketing Authorization Application $(MAA)$ to the European Medicines Agency $(EMA)$ for narsoplimab, aiming to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). This MAA submission includes analyses demonstrating a 61% response rate and a significant improvement in overall survival compared to a well-matched external control group. Narsoplimab has been granted orphan drug designation by the EMA, allowing for a centralized review process covering all EU member states and certain European Economic Area countries. The review process is set to commence in mid-July, with a final decision expected by mid-2026. This submission follows the acceptance of the resubmission of the Biologics License Application $(BLA.AU)$ for narsoplimab by the U.S. FDA, with a target action date set for September 25, 2025.