Posted by Michael Wonder on 19 Apr 2026
Aicuris receives FDA priority review for pritelivir NDA
16 April 2026 - 26 - Aicuris Anti-infective Cures today announced that the US FDA has granted priority review for the new drug application filed for pritelivir.
The submission is based on initial results from the pivotal Phase 3 trial in which pritelivir met its registrational Phase 3 primary outcome for the treatment of refractory herpes simplex virus infection, with or without resistance, in immunocompromised patients.
The FDA has set a PDUFA target date in the fourth quarter of 2026.
