Core Insights - The European Medicines Agency (EMA) has concluded that prior Phase 3 studies in the U.S. and Japan are sufficient to support a Marketing Authorization Application (MAA) for YCANTH in the EU, with no additional Phase 3 studies required [1][2] - Verrica Pharmaceuticals is initiating activities to support the regulatory submission, which could be filed as early as Q4 2026 [1][2] Company Overview - Verrica Pharmaceuticals Inc. is focused on developing dermatology therapeutics, specifically medications for skin diseases that require medical interventions [4] - YCANTH (VP-102) is a proprietary drug-device combination product that treats molluscum contagiosum, a highly contagious skin disease affecting approximately six million people in the U.S., primarily children [3][4] - YCANTH is the first and only healthcare professional-administered product approved by the FDA for treating molluscum in patients aged two years and older [3][4] Market Opportunity - The European market for molluscum represents a significant unmet need for millions of potential patients, providing a key catalyst for Verrica to explore strategic opportunities for YCANTH [2] - Approximately 225 million lives are eligible to receive YCANTH covered by insurance, with commercially insured patients paying $25 per treatment visit for up to two applicators [3] Clinical Development - The CHMP provided positive feedback on the design of previously completed Phase 3 studies, including study duration, choice of endpoints, and patient population [5] - The clinical safety data package and the adequacy of nonclinical studies were also discussed to support the MAA filing [5]