Hyloris Announces FDA Acceptance of New Drug Application (NDA) for Valacyclovir Oral Liquid

PDUFA Target Action Date Set at October 12, 2025

Liège, Belgium – 25 February 2025 – 07.15 AM CET –– Regulated Information – Inside information – Hyloris Pharmaceuticals SA (Euronext Brussels: HYL), a specialty biopharma company committed to addressing unmet medical needs through reinventing existing medications, today announces the U.S. FDA has accepted for review the New Drug Application (NDA) for its proprietary Valacyclovir oral suspension. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 12, 2025

Read the full release