27 March 2026 - Egetis Therapeutics today announced that the US FDA has accepted the filing of its new drug application for Emcitate (tiratricol) for the treatment of MCT8 deficiency. Egetis completed the rolling new drug application in January 2026.
The application has been granted priority review and assigned a PDUFA target action date, or FDA decision date, of 28 September 2026.