Posted by Michael Wonder on 15 Dec 2025
Sentynl Therapeutics announces FDA acceptance of CUTX-101 NDA resubmission
15 December 2025 - Sentynl Therapeutics today announced that the US FDA has accepted the resubmission of its new drug application for copper histidinate (CUTX-101), intended to treat Menkes disease in paediatric patients.
The resubmission has been accepted as a Class I response and as a result, the Company has received 14 January 2026 as the new PDUFA date.
