OMER · Omeros Corporation
AI read · Neutral
The AI's read
The European decision closes the approval route for now. Omeros says reviewers did not see patient data it submitted. It plans to end free compassionate use and seek paid named-patient access, but that access is not yet in place. Current patients can finish treatment, and a possible EU sales partner depended on approval. The U.S. picture points the other way. The drug is approved, sales reached $32.2 million in the second quarter, and Medicare's added payment began October 1. Omeros also plans studies in 2 other uses. The European loss and U.S. growth point in opposite directions, so this report alone does not show one clear overall direction.