OMEROS CORPORATION

Narsoplimab-treated TA-TMA patients showed a 3-fold reduction in mortality risk (HR=0.32, p<0.00001) compared to non-treated patients. Omeros plans to resubmit its BLA for narsoplimab as the first approved TA-TMA treatment.

Omeros' narsoplimab met its pivotal trial primary endpoint, showing a 3-fold reduction in mortality risk for TA-TMA patients compared to an external control group. The company plans to resubmit its BLA to the FDA for narsoplimab as a potential first-approved treatment for TA-TMA.

FDA granted rare pediatric disease designation to zaltenibart (OMS906) for treating complement 3 glomerulopathy (C3G), a progressive renal disorder affecting children and young adults with no approved treatment. Zaltenibart, an inhibitor of the alternative pathway, targets MASP-3 to prevent C3G progression. Phase 3 trials for both C3G and paroxysmal nocturnal hemoglobinuria (PNH) are anticipated.

Omeros Corporation announced that zaltenibart (OMS906) received rare pediatric disease designation from the FDA for treating complement 3 glomerulopathy (C3G), an ultra-rare renal disorder. Zaltenibart, an inhibitor of MASP-3, blocks the alternative pathway of complement, with Phase 3 trials planned for next year. The designation provides a priority review voucher upon approval, potentially accelerating market entry.

FDA grants rare pediatric disease designation to Omeros' MASP-3 inhibitor zaltenibart for treating C3 glomerulopathy (C3G), an ultra-rare renal disorder. Zaltenibart, blocking MASP-3, is set for Phase 3 trials in C3G and paroxysmal nocturnal hemoglobinuria (PNH). Omeros aims to demonstrate zaltenibart's advantages over other alternative pathway inhibitors.