Neurotech International (ASX:NTI) has received a rare pediatric disease designation from the US Food and Drug Administration (FDA) for its lead drug candidate, NTI164, for the treatment of Rett syndrome, according to a Wednesday filing with the Australian bourse.
This milestone adds to NTI164's previously granted orphan drug designation, strengthening the company's position in developing therapies for rare neurological disorders, the filing said.
The FDA's decision was based on Rett syndrome being a serious, life-threatening, and rare condition, the filing added.