OMS906

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.

Omeros' MASP-3 inhibitor zaltenibart received rare pediatric disease designation from the FDA for treating C3 glomerulopathy (C3G), with Phase 3 trials planned for 2024. Zaltenibart is also being developed for paroxysmal nocturnal hemoglobinuria (PNH), with Phase 3 studies starting this quarter. The PNH market is projected to reach $10.1 billion by 2032, and approval could grant Omeros a priority review voucher.

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.

OMS-906, a monoclonal antibody targeting MASP-3, is under development for PNH, C3G, ICGN, and arthritis. Administered via subcutaneous and intravenous routes, it is a candidate drug by Omeros, a clinical-stage biopharmaceutical company. GlobalData's Likelihood of Approval tool assesses drug progression and approval likelihood based on machine learning and proprietary algorithms.