Omeros (OMER) said Thursday that zaltenibart, its drug candidate to treat complement 3 glomerulopathy, or C3G, was granted rare pediatric disease designation from the US Food and Drug Administration.
C3G is a rare kidney disease mainly affecting children and young adults. With no approved treatment yet, C3G often leads to end-stage renal disease within 10 years of diagnosis, according to Omeros.
The company said phase 3 clinical trials for zaltenibart in C3G are set to begin in 2025.
The FDA previously granted zaltenibart an orphan drug designation for the treatment of paroxysmal nocturnal hemoglobinuria, a rare and fatal blood disease, with phase 3 studies to be initiated later this quarter, Omeros said.
The company's shares were up nearly 2% in recent trading.
Price: 4.20, Change: +0.07, Percent Change: +1.69
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