10:36 AM EDT, 10/24/2024 (MT Newswires) -- 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 ( OMER ).

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 ( OMER ) said.

The company's shares were up nearly 2% in recent trading.

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