Omeros (OMER) announced that zaltenibart has received rare pediatric disease designation from the FDA for the treatment of complement 3 glomerulopathy, or C3G, an ultra-rare, progressive renal disorder primarily afflicting children and young adults. Caused by dysregulation of the alternative pathway of complement, there is no approved treatment for C3G, which often leads to end-stage renal disease within 10 years of diagnosis. Omeros is also advancing zaltenibart for the treatment of paroxysmal nocturnal hemoglobinuria, an ultra-rare and life-threatening blood disease. Omeros has received orphan drug designation from FDA for zaltenitbart in this indication. Having recently held productive meetings with regulatory authorities – an end-of-phase 2 meeting with FDA and a scientific advice meeting in Europe – Omeros has a clear path to and is focused on initiating phase 3 studies for zaltenibart in PNH later this quarter.
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