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
– EMA concludes that the primary endpoint and supportive secondary endpoints from prior successful Phase 3 studies conducted in the U.S. and Japan are adequate to support a filing for the approval of YCANTH® in the EU and that no additional Phase 3 studies are required –
– Verrica is initiating activities to support this regulatory submission, which could be filed as early as Q4 2026 –
WEST CHESTER, Pa., Oct. 20, 2025 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica” or the “Company”) (Nasdaq: VRCA), a dermatology therapeutics company developing and selling medications for skin diseases requiring medical interventions, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided positive feedback that supports the filing of a Marketing Authorization Application (MAA) for Verrica’s product, YCANTH®, as a treatment for molluscum contagiosum (“molluscum”).
“We are pleased to gain alignment with CHMP with respect to the safety and efficacy data requirements to support an MAA filing for YCANTH in the European Union,” said Jayson Rieger, PhD, MBA, President and Chief Executive Officer of Verrica. “Based on convincing efficacy data from the well-controlled Phase 3 studies successfully conducted in both the U.S. and Japan, the CHMP concluded that no further Phase 3 clinical studies are needed in order to progress toward a filing for approval. The European market for molluscum represents a significant unmet need for millions of potential patients, and this feedback provides Verrica with a key catalyst to explore a broad range of strategic opportunities for realizing the full commercial potential of YCANTH and to treat patients with molluscum in this large and underserved market.”
The Company sought and received positive written feedback from the CHMP to gain scientific advice on the development of YCANTH for the treatment of molluscum in adult and pediatric patients 2 years of age and older. The key issues discussed in the feedback included alignment on:
- The acceptability of the design of the previously-completed Phase 3 studies, including study duration, choice of primary and secondary endpoints and the choice of patient population;
- The clinical safety data package to support MAA filing; and
- The adequacy of nonclinical studies and published literature to support the MAA filing.
About YCANTH® (VP-102)
YCANTH® is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin delivered via a single-use applicator that allows for precise topical dosing and targeted administration for the treatment of molluscum. YCANTH is the first and only healthcare professional-administered product approved by the FDA to treat adult and pediatric patients two years of age and older with molluscum contagiosum — a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children. Approval of YCANTH was based upon the positive results from two Phase 3 clinical trials in approximately 500 patients which demonstrated that YCANTH was a safe and effective therapeutic for the treatment of molluscum. Approximately 225 million lives are eligible to receive YCANTH covered by insurance. Commercially insured patients pay just $25 per YCANTH treatment visit, for up to two applicators. Other uninsured patients may be eligible to receive YCANTH at a reduced cost if certain eligibility requirements are met for patient assistance. Please visit YCANTHPro.com for additional information.
About Verrica Pharmaceuticals Inc.
Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. Verrica’s product YCANTH® (VP-102) (cantharidin), is the first and only healthcare professional-administered treatment approved by the FDA to treat adult and pediatric patients two years of age and older with molluscum contagiosum, a highly contagious viral skin infection affecting approximately 6 million people in the United States, primarily children. YCANTH (VP-102) is also in development to treat common warts, the largest remaining unmet need in medical dermatology. Verrica has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize VP-315 (formerly LTX-315 and VP-LTX-315) for non-melanoma skin cancers including basal cell carcinoma and squamous cell carcinoma. For more information, visit .
Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Verrica’s current beliefs and expectations. These forward-looking statements include statements about the Company’s development and regulatory plans for YCANTH in Europe or other international markets, the timing of the MAA filing, the ability to pursue strategic opportunities for YCANTH in Europe, the clinical development of YCANTH for additional indications, and the benefits of Verrica’s product candidates, including YCANTH. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include risks and uncertainties related to market conditions, satisfaction of customary closing conditions related to the proposed public offering and other risks and uncertainties that are described in Verrica’s Annual Report on Form 10-K for the year ended December 31, 2024, and other filings Verrica makes with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Verrica as of the date of this release, and Verrica assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
FOR MORE INFORMATION, PLEASE CONTACT:
Investors:
John Kirby
Chief Financial Officer
Kevin Gardner
LifeSci Advisors
