Verrica Pharmaceuticals Announces That Development Partner, Torii Pharmaceutical, Receives Approval for YCANTH® (TO-208) in Japan for the Treatment of Molluscum Contagiosum
Verrica Pharmaceuticals (NASDAQ:VRCA) announced that its development partner, Torii Pharmaceutical, has received approval from Japan's Ministry of Health for YCANTH® (TO-208) to treat Molluscum Contagiosum. This approval triggers a $10 million milestone payment to Verrica, strengthening its balance sheet with non-dilutive capital.
The approval follows positive Phase 3 trial results in Japan, where YCANTH demonstrated statistically significant efficacy in achieving complete clearance of molluscum lesions compared to placebo. Verrica maintains global rights to YCANTH outside Japan and plans to initiate a global Phase 3 program for common warts treatment by the end of 2025.
Verrica Pharmaceuticals (NASDAQ:VRCA) ha annunciato che il suo partner di sviluppo, Torii Pharmaceutical, ha ottenuto l’approvazione dal Ministero della Salute giapponese per YCANTH® (TO-208) come trattamento del Molluscum Contagiosum. Tale approvazione attiva un pagamento milestone di 10 milioni di dollari a Verrica, rafforzando il bilancio con capitale non diluitivo.
L’approvazione arriva in seguito a risultati positivi della fase 3 in Giappone, dove YCANTH ha dimostrato un’efficacia statisticamente significativa nel raggiungere la completa eliminazione delle lesioni da Molluscum rispetto al placebo. Verrica mantiene i diritti globali su YCANTH al di fuori del Giappone e prevede di avviare un programma globale di fase 3 per il trattamento delle verruche comuni entro la fine del 2025.
Verrica Pharmaceuticals (NASDAQ:VRCA) anunció que su socio de desarrollo, Torii Pharmaceutical, recibió la aprobación del Ministerio de Salud de Japón para YCANTH® (TO-208) para tratar Molluscum Contagiosum. Esta aprobación activa un pago por hito de 10 millones de dólares a Verrica, fortaleciendo su balance con capital no dilutivo.
La aprobación se produce tras resultados positivos de ensayos de Fase 3 en Japón, donde YCANTH demostró eficacia estadísticamente significativa para lograr la eliminación completa de las lesiones de molluscum en comparación con el placebo. Verrica mantiene los derechos globales de YCANTH fuera de Japón y planea iniciar un programa global de Fase 3 para el tratamiento de verrugas comunes antes de finales de 2025.
Verrica Pharmaceuticals (NASDAQ:VRCA)가 개발 파트너인 Torii Pharmaceutical가 일본 보건복지성으로부터 Molluscum Contagiosum 치료제 YCANTH®(TO-208)에 대한 승인을 받았다고 발표했습니다. 이 승인으로 Verrica에 1000만 달러의 마일스톤 지급이 발생하여 비희석 자본으로 재무 상태가 강화됩니다.
이번 승인은 일본에서의 양호한 3상 시험 결과에 따른 것으로, YCANTH가 위약 대비 Molluscum 병변의 완전 제거를 통계적으로 유의하게 달성했음을 보여줍니다. Verrica는 일본 외 지역에 대한 YCANTH의 글로벌 권리를 보유하고 있으며 2025년 말까지 일반사마귀 치료를 위한 글로벌 3상 프로그램을 시작할 계획입니다.
Verrica Pharmaceuticals (NASDAQ:VRCA) a annoncé que son partenaire de développement, Torii Pharmaceutical, a reçu l’approbation du ministère japonais de la Santé pour YCANTH® (TO-208) destiné au traitement du Molluscum Contagiosum. Cette approbation déclenche un versement d’étape de 10 millions de dollars à Verrica, renforçant son bilan grâce à un capital non dilutif.
L’approbation fait suite à des résultats positifs de l’essai de phase 3 au Japon, où YCANTH a démontré une efficacité statistiquement significative pour obtenir l’élimination complète des lésions de Molluscum par rapport au placebo. Verrica conserve les droits mondiaux sur YCANTH en dehors du Japon et prévoit de lancer un programme mondial de phase 3 pour le traitement des verrues courantes d’ici la fin de 2025.
Verrica Pharmaceuticals (NASDAQ:VRCA) gab bekannt, dass ihr Entwicklungspartner Torii Pharmaceutical vom japanischen Gesundheitsministerium die Zulassung für YCANTH® (TO-208) zur Behandlung von Molluscum Contagiosum erhalten hat. Diese Zulassung löst eine Meilensteinzahlung von 10 Mio. USD an Verrica aus und stärkt die Bilanz mit nicht verwässerndem Kapital.
Die Zulassung folgt positiven Phase-3-Ergebnissen in Japan, in denen YCANTH eine statistisch signifikante Wirksamkeit bei der vollständigen Entfernung der Molluscum-Läsionen im Vergleich zum Placebo zeigte. Verrica behält globale Rechte an YCANTH außerhalb Japans und plant, bis Ende 2025 ein globales Phase-3-Programm zur Behandlung von Warzen durchzuführen.
Verrica Pharmaceuticals (ناسداك: VRCA) أعلنت أن شريكها في التطوير، Torii Pharmaceutical، قد حصل على موافقة وزارة الصحة اليابانية على YCANTH® (TO-208) لعلاج Molluscum Contagiosum. هذه الموافقة تتيح دفعة إنجاز بمقدار 10 ملايين دولار إلى Verrica، مما يعزز ميزانيتها برأس مال غير مخفض.
تأتي الموافقة عقب نتائج إيجابية لاختبارات المرحلة 3 في اليابان، حيث أظهر YCANTH فاعلية ذات دلالة إحصائية في تحقيق إزالة كاملة لآفات Molluscum مقارنة بالدواء الوهمي. تحتفظ Verrica بحقوق YCANTH العالمية خارج اليابان وتخطط لبدء برنامج عالمي لمرحلة 3 لعلاج الثآليل الشائعة بحلول نهاية عام 2025.
Verrica Pharmaceuticals（纳斯达克股票代码 VRCA）宣布，其开发伙伴 Torii Pharmaceutical 已获得日本厚生劳动省批准，将 YCANTH®（TO-208）用于治疗 Molluscum Contagiosum。此批准将触发 Verrica 的一个 1000万美元里程碑付款，以非稀释资本加强其资产负债表。
此批准基于日本 Phase 3 试验的积极结果，YCANTH 在实现 Molluscum 病变的完全清除方面相较于安慰剂显示出统计学显著的疗效。Verrica 保留 YCANTH 在日本以外的全球权利，并计划在 2025 年底前启动一个全球性的 Phase 3 计划用于治疗普通疣。
- Approval triggers immediate $10 million milestone payment to Verrica
- Successful Phase 3 trial results showing statistically significant efficacy
- Verrica maintains global rights outside Japan for future expansion
- Planned expansion into common warts indication with Phase 3 program
- None.
Insights
Verrica gains $10M milestone payment and expands YCANTH's global footprint with Japanese approval, strengthening its financial position and commercial strategy.
The Japanese regulatory approval for YCANTH (cantharidin 0.7% topical solution) represents a significant milestone for Verrica Pharmaceuticals in its global commercialization strategy. This approval triggers a
Japan represents an important growth market for molluscum contagiosum treatments, as the condition affects approximately
The approval follows Torii's December 2024 New Drug Application submission, which was supported by positive Phase 3 trial results showing statistically significant complete clearance of molluscum lesions compared to placebo. Importantly, Verrica maintains ownership of global rights to YCANTH outside Japan, preserving significant future commercialization opportunities.
Beyond the immediate financial benefit, this approval enhances Verrica's credibility as they prepare to expand YCANTH's indications. The companies plan to initiate a global Phase 3 program studying YCANTH for common warts by year-end 2025, potentially opening a substantially larger market opportunity. This development pathway demonstrates a methodical approach to building a dermatology platform rather than a single-product strategy.
– Approval triggers
– 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
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
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 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.
FOR MORE INFORMATION, PLEASE CONTACT:
Investors:
John Kirby
Interim Chief Financial Officer
jkirby@verrica.com
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com
FAQ
What milestone payment will Verrica (VRCA) receive for YCANTH approval in Japan?
What were the results of YCANTH's Phase 3 trial in Japan?
When will Verrica begin Phase 3 trials for YCANTH in common warts?
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What is YCANTH approved for in Japan?
