Posted by Michael Wonder on 06 Jan 2025
Sentynl Therapeutics announces US FDA acceptance and priority review of new drug application for CUTX-101 (copper histidinate) product candidate for treatment of Menkes disease
6 January 2025 - Six month priority review granted for CUTX-101 copper histidinate with PDUFA target action date set for 30 June 2025.
Sentynl Therapeutics and Fortress Biotech announced that the US FDA has accepted for filing and priority review Sentynl's new drug application for CUTX-101, the product candidate for the treatment of Menkes disease.
