Wedoany.com Report-Dec.31, The U.S. Food and Drug Administration (FDA) has officially approved Yartemlea, a drug developed by Omeros (OMER.O), for the treatment of a serious complication known as transplant-associated thrombotic microangiopathy (TA-TMA) that can occur in adults and children aged two years and older following stem cell transplantation. This decision marks Yartemlea as the first drug approved by the FDA for treating TA-TMA, offering patients a new therapeutic option.

TA-TMA is a condition in which blood vessels are damaged and inflammation is triggered due to an overactive immune system during or after stem cell transplantation. This inflammation promotes the formation of micro-thrombi, which can subsequently damage vital organs such as the kidneys and, in severe cases, even be life-threatening. Yartemlea, a monoclonal antibody drug, has a unique mechanism of action that blocks the MASP-2 protein, which plays a key role in the immune system, thereby effectively alleviating the symptoms of TA-TMA. Previously, the FDA had refused to approve Yartemlea due to an inability to determine its clear therapeutic effect, requesting that Omeros provide more data. Following in-depth research, a trial involving 28 patients showed that Yartemlea, as a first-line treatment, improved the survival rate in 61% of high-risk TA-TMA patients. This data provided strong support for the FDA's final approval.

Following the FDA's approval, Omeros' stock surged nearly 70% in early trading, reflecting broad market recognition of the drug's potential. HC Wainwright analyst Brandon Folkes noted that the FDA's decision removes previous uncertainties, allowing investors to refocus on the value potential brought by Yartemlea's approval and Omeros' broader product pipeline. Omeros anticipates that Yartemlea will soon be available on the market, bringing hope to patients. At the same time, the company also expects the European Medicines Agency to make a decision by mid-2026, further expanding Yartemlea's market reach.