• Omeros Corporation has initiated site activation for its Phase 3 clinical trials of zaltenibart (OMS906) in paroxysmal nocturnal hemoglobinuria (PNH), with data for regulatory submission expected in Q4 2026.
• Zaltenibart offers a significant advantage over current PNH therapies with convenient once-every-eight-weeks dosing and ability to inhibit both intravascular and extravascular hemolysis, potentially achieving normal hemoglobin levels.
• The Phase 3 program includes head-to-head comparisons against C5 inhibitors eculizumab and ravulizumab across 120 clinical sites in 30 countries, targeting a global PNH market projected to reach $11.7 billion by 2034.