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

Rhea-AI Summary

Verrica Pharmaceuticals (Nasdaq: VRCA) announced that the CHMP of the European Medicines Agency provided positive scientific advice supporting a Marketing Authorization Application (MAA) for YCANTH as a treatment for molluscum contagiosum.

The CHMP concluded that the primary and supportive secondary endpoints from previously completed Phase 3 studies in the U.S. and Japan are adequate and no additional Phase 3 studies are required. Verrica is initiating activities to support an MAA submission that could be filed as early as Q4 2026. The feedback covers adult and pediatric patients aged 2 years and older, and addresses study design, clinical safety data, and nonclinical/literature adequacy.

Positive

• CHMP supports an MAA using existing Phase 3 data
• No additional Phase 3 studies required by CHMP
• Potential MAA filing window of as early as Q4 2026
• Indication scope includes adults and pediatric patients 2 years and older

Negative

• None.

Insights

Regulatory Strategist

EMA/CHMP feedback clears a direct MAA path for YCANTH, enabling a potential EU filing as early as Q4 2026.

Verrica can base an EU Marketing Authorization Application on existing Phase 3 data from the U.S. and Japan because the CHMP found the primary and supportive secondary endpoints, study design, patient population, safety dataset, and nonclinical literature adequate. This removes the need for additional Phase 3 trials and shortens the regulatory timetable compared with starting new pivotal studies.

The main dependencies are completing the MAA dossier and any regulatory dossier formalities, plus alignment on labeling and pediatric extrapolation for patients aged 2 years and older. Key risks include routine review questions from the EMA during validation and review, and time needed to assemble manufacturing, pharmacovigilance, and local clinical documentation. Watch for an actual MAA submission (potentially in Q4 2026) and subsequent CHMP opinion milestones over the next 12–18 months as the concrete timelines to monitor.

– 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 www.verrica.com.

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
jkirby@verrica.com

Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com

FAQ

What did CHMP tell Verrica about YCANTH approval in the EU (Oct 20, 2025)?

CHMP provided positive scientific advice that prior Phase 3 endpoints and data are adequate to support an MAA and no further Phase 3 studies are required.

When could Verrica file an MAA for YCANTH in the European Union (VRCA)?

Verrica said it is initiating submission activities and an MAA could be filed as early as Q4 2026.

Which patient populations does the CHMP feedback cover for YCANTH (VRCA)?

The CHMP feedback covers treatment of molluscum in adult and pediatric patients 2 years of age and older.

Why is the CHMP feedback important for YCANTH and investors in VRCA?

The feedback confirms the acceptability of prior Phase 3 design, safety package, and nonclinical support, clearing a regulatory path toward an EU MAA based on existing data.

Did CHMP require new Phase 3 trials for YCANTH before an EU filing?

No; CHMP concluded that no additional Phase 3 clinical studies are needed to progress toward an MAA filing.