10:48 AM EDT, 07/16/2024 (MT Newswires) -- Sellas Life Sciences Group ( SLS ) said Tuesday that the US Food and Drug Administration granted a rare pediatric disease designation to the company's SLS009 for the treatment of acute myeloid leukemia in children.
SLS009, a CDK9 inhibitor, was granted rare pediatric disease designation for the treatment of pediatric acute lymphoblastic leukemia last month, the company said.
A rare pediatric disease designation could provide Sellas with a priority review voucher for any subsequent marketing application if a new drug application for SLS009 is approved by the FDA, the company said. The voucher can also be sold to other parties.
The company said it is preparing to enroll patients for a phase 2 trial of SLS009 in children with acute myeloid leukemia.
SLS009 was also granted orphan drug and fast track designations for the treatment of acute myeloid leukemia, the company added.
Sellas shares were nearly 1% higher in mid-morning trading on Tuesday.
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