Omeros: Breakthrough in the Treatment of TA-TMA Leads to Stock Price Surge

The stock of Omeros Corporation recorded an impressive increase to $12.54, representing a rise of $5.08 or 68.1%. This sharp rise in stock price is associated with the announcement that the primary goal in the treatment of transplant-associated thrombotic microangiopathy (TA-TMA) made significant progress by targeting the lectin pathway of complement activation. The results showed a threefold lower risk of death for patients who received narsoplimab compared to those without this treatment. An independent group conducted the analysis and compared the survival rates of 28 patients treated with narsoplimab to over 100 high-risk TA-TMA patients. The studies revealed a hazard ratio of 0.32 with a p-value of less than 0.00001 and a confidence interval of 0.23 to 0.44. According to Omeros, these data strengthen the therapeutic efficacy of narsoplimab. Omeros now plans to resubmit the approval application to the U.S. Food and Drug Administration (FDA) for the first therapy against TA-TMA. Additionally, the company aims to submit a market approval application to the European Medicines Agency (EMA) in the second quarter of 2025. TA-TMA is a serious complication following hematopoietic stem cell transplantation and often leads to multiorgan failure and death. Currently, there are few treatment options, and no drugs are specifically approved for this condition. Experts, including Professor Alessandro Rambaldi from the University of Milan, praise the potential of narsoplimab to meet this medical need. The active substance, which targets the enzyme MASP-2, could also serve to treat disorders with endothelial dysfunction, such as acute respiratory distress syndrome. Ongoing investigations and sensitivity analyses are intended to further support the regulatory submissions. The company also intends to publish the study results from 2025 in scientific journals. So far, no significant safety issues with narsoplimab have been identified in clinical trials.