OMER News & Events

Omeros announced the completion of its initial study in nonhuman primates evaluating the efficacy and safety of its OncotoX-AML cancer therapeutic platform. Omeros' OncotoX-AML therapeutic is first targeting acute myeloid leukemia, an aggressive and highly fatal bone marrow and blood cancer. The effectiveness of current AML treatments, such as chemotherapeutics and antibody-drug conjugates, are limited by substantial side effects. Administration of only one course of OncotoX-AML treatment to immunocompetent primates demonstrated the desired pharmacologic response, specifically marked, selective, reversible, and dose-related reduction in myeloid progenitor cells - the cells that can mutate and lead to AML - by up to 99%. OncotoX-AML was well tolerated, without causing broader or lasting hematologic changes while preserving hematopoietic stem cells. There were no observed safety signals or meaningful changes in blood chemistry values often seen with current AML treatments.

Omeros Corporation announced that the first commercial shipments of Yartemlea to its distributors were completed last week, with orders from transplant centers beginning that same day. Both adult and pediatric patients with stem cell transplant-associated thrombotic microangiopathy, or TA-TMA, are now receiving Yartemlea, including patients who have recently failed prior off-label C5-inhibitor regimens. Yartemlea, which was approved by the U.S. FDA on December 23, 2025, is the first and only approved therapy for TA-TMA. A marketing authorization application for Yartemlea for the treatment of TA-TMA is currently under review by the European Medicines Agency with a decision expected in mid-2026.