Aicuris Receives FDA Priority Review for Pritelivir NDA (The Manila Times) - Apr 16, 2026 - "
The U.S. Food and Drug Administration has granted Priority Review for Aicuris' New Drug Application for pritelivir, a novel helicase primase inhibitor developed to treat refractory herpes simplex virus infections, with or without resistance (R±R), in immunocompromised patients;
The Prescription Drug User Fee Act (PDUFA) Target Date is in Q4 2026;
The submission is based on positive pivotal Phase 3 data demonstrating superior complete lesion healing and a favorable safety profile compared to investigator's choice therapy
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FDA filing • PDUFA • Priority review • Herpes Simplex • Infectious Disease
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