GlobeNewswire·Oct 20, 2025, 4:05 PM ET

Verrica Pharmaceuticals Receives Positive Feedback from the European Medicines Agency (EMA) Supporting a Clear Regulatory Path Forward to File for Approval of YCANTH® in the European Union

The European Medicines Agency (EMA) CHMP concluded that primary and supportive secondary endpoints from prior successful Phase 3 studies in the U.S. and Japan are adequate to support a Marketing Authorization Application (MAA) for YCANTH® in the EU.
No additional Phase 3 clinical studies are required for the European filing.
Verrica Pharmaceuticals Inc. is initiating activities to support the regulatory submission, which could be filed as early as Q4 2026.
The CHMP provided positive written feedback regarding the acceptability of Phase 3 study designs, clinical safety data packages, and nonclinical studies for treating molluscum contagiosum in patients aged 2 years and older.
YCANTH® is a proprietary drug-device combination product containing cantharidin delivered via a single-use applicator for targeted topical administration.
YCANTH® is the first and only FDA-approved healthcare professional-administered treatment for molluscum contagiosum in adult and pediatric patients aged 2 years and older.
The drug was approved based on two Phase 3 clinical trials involving approximately 500 patients that demonstrated safety and efficacy.
Approximately 225 million lives are eligible for insurance-covered YCANTH® treatment, with commercially insured patients paying $25 per visit for up to two applicators.
Verrica is also developing YCANTH® for common warts and has a worldwide license agreement with Lytix Biopharma AS to commercialize VP-315 for non-melanoma skin cancers.