Full Press Release Details
– Approval triggers $10 million cash milestone payment to Verrica –
– YCANTH®approval in Japan addresses significant unmet need of patients with molluscum –
– Verrica maintains ownership of global rights to YCANTH for all indications in all territories outside of Japan –
WEST CHESTER, Pa., Sept. 19, 2025 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing and selling medications for skin diseases requiring medical interventions, today announced that its development partner, Torii Pharmaceutical Co. Ltd. (“Torii”) has received approval from the Japanese Ministry of Health, Labour and Welfare (“MHLW”) for YCANTH®(TO-208) for the treatment of Molluscum Contagiosum (“molluscum”). Torii became a wholly-owned subsidiary of Shionogi & Co., Ltd., on September 1, 2025.
“We are excited to announce that our development partner, Torii, has received regulatory approval for YCANTH in Japan, enabling individuals who contract molluscum in Japan access to a safe and effective therapy,” said Jayson Rieger, PhD, MBA, President and Chief Executive Officer of Verrica. “As part of our recently amended collaboration and licensing agreement with Torii, approval of YCANTH in Japan has triggered a one-time $10 million milestone cash payment that we expect to receive in the next several weeks. This significant source of non-dilutive capital will immediately strengthen our balance sheet and help support our U.S. commercial activities as we work to establish YCANTH as the new standard of care for the treatment of molluscum.”
Dr. Rieger continued, “We hope that this is the first of many other potential approvals for YCANTH around the world, so that all patients with molluscum may have access to a convenient, proven, safe and effective treatment for their molluscum and we are actively working on opportunities to continue this expansion. We express our thanks and congratulations to the Torii team for their work in securing this important achievement, and we remain excited to partner with Torii on the upcoming global Phase 3 program to study YCANTH for the treatment of common warts, which we expect to begin with the first patient dosed in the U.S. anticipated by the end of 2025.”
Torii filed the New Drug Application for TO-208 in molluscum with MHLW in December 2024. In December 2023, Verrica announced that Torii reported positive top-line results from a confirmatory Phase 3 trial of TO-208 (marketed as YCANTH in the U.S.) for the treatment of molluscum in Japan. The Phase 3 trial was conducted in Japan and was a double blind, randomized and parallel-group comparison study to evaluate the efficacy and safety of TO-208 in comparison to placebo, when applied once every 21 days for up to four applications in patients with molluscum. The top-line results from the trial showed that the proportion of subjects achieving complete clearance of all treatable molluscum lesions at the completion of the confirmatory study, the primary endpoint of efficacy, was statistically significant versus placebo. TO-208 was well tolerated during the study.
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, visitwww.verrica.com.
Forward-Looking StatementsAny 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 receipt of additional non-dilutive capital from Torii, the commercialization of YCANTH and the clinical development and benefits of Verrica’s product candidates, including YCANTH (VP-102) and VP-315 and the timing of the Phase 3 program to study YCANTH for the treatment of common warts. 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.