This section highlights FDA-related milestones and regulatory updates for drugs developed by Verrica Pharmaceuticals (VRCA).
Over the past two years, Verrica Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
YCANTH™ and VP-315. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
YCANTH™ (cantharidin) FDA Regulatory Timeline and Events
YCANTH™ (cantharidin) is a drug developed by Verrica Pharmaceuticals for the following indication: For molluscum contagiosum, which is primarily a pediatric disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- YCANTH™ (cantharidin)
- Announced Date:
- October 20, 2025
- Indication:
- For molluscum contagiosum, which is primarily a pediatric disease.
Announcement
Verrica Pharmaceuticals Inc. 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").
AI Summary
Verrica announced CHMP positive feedback supporting an MAA for YCANTH® to treat molluscum in the European Union.
The CHMP confirmed that the Phase 3 study design—including trial duration, endpoint selection, and patient population—for adult and pediatric patients two years and older is adequate. It also agreed that the clinical safety package and existing nonclinical studies meet requirements, so no further Phase 3 trials are needed.
With this guidance, Verrica is launching submission preparations and expects to file the MAA as early as the fourth quarter of 2026.
YCANTH is a proprietary drug-device that delivers a cantharidin formulation via a single-use applicator. This system allows precise topical dosing for targeted treatment of molluscum lesions.
This positive scientific advice addresses a significant unmet need in Europe and sets the stage for Verrica to explore strategic opportunities to bring YCANTH to millions of patients.
Read Announcement- Drug:
- YCANTH™ (cantharidin)
- Announced Date:
- October 20, 2025
- Estimated Event Date Range:
- October 1, 2026 - December 31, 2026
- Target Action Date:
- Q4 2026
- Indication:
- For molluscum contagiosum, which is primarily a pediatric disease.
Announcement
Verrica is initiating activities to support this regulatory submission, which could be filed as early as Q4 2026
AI Summary
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that data from Verrica’s Phase 3 studies in the U.S. and Japan are sufficient to support a Marketing Authorization Application (MAA) for YCANTH in the EU. The CHMP agreed that the study design, endpoints and patient populations are acceptable and that no additional Phase 3 trials are required.
Verrica is now initiating activities to support this MAA submission, which could be filed as early as the fourth quarter of 2026. This preparation involves aligning regulatory strategies, gathering necessary documentation and engaging with EU stakeholders. Positive CHMP feedback provides a clear path to approval and allows Verrica to explore strategic opportunities to bring YCANTH to millions of patients in need across Europe.
Read Announcement- Drug:
- YCANTH™ (cantharidin)
- Announced Date:
- September 19, 2025
- Indication:
- For molluscum contagiosum, which is primarily a pediatric disease.
Announcement
Verrica Pharmaceuticals Inc. 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.
AI Summary
Verrica Pharmaceuticals Inc. announced that its development partner Torii Pharmaceutical Co. Ltd. received approval from Japan’s Ministry of Health, Labour and Welfare for YCANTH® (TO-208) to treat molluscum contagiosum. As of September 1, 2025, Torii is a wholly-owned subsidiary of Shionogi & Co., Ltd. This approval fulfills an important unmet need for patients with molluscum in Japan.
Under the companies’ collaboration agreement, the approval triggers a one-time $10 million milestone payment to Verrica. This non-dilutive capital will strengthen Verrica’s balance sheet and support its U.S. commercial efforts to establish YCANTH as the new standard of care for molluscum.
Verrica retains global rights to YCANTH for all indications outside Japan. The company plans to leverage this success and pursue additional approvals worldwide, aiming to make the treatment available to more patients suffering from molluscum contagiosum.
Read Announcement- Drug:
- YCANTH™ (cantharidin)
- Announced Date:
- April 7, 2025
- Indication:
- For molluscum contagiosum, which is primarily a pediatric disease.
Announcement
errica Pharmaceuticals Inc provided a business update.
AI Summary
Verrica Pharmaceuticals Inc. recently provided a business update highlighting strong demand for its product, YCANTH®. In the first quarter of 2025, the company saw its dispensed applicator units increase to 10,102, marking a 16.7% rise compared to the fourth quarter of 2024. This growth is significant, as it is the first time the quarterly count has exceeded 10,000 units.
The update emphasized that distributor inventory levels have normalized after recent commercial restructuring. With inventory now closely matching demand, Verrica expects that the dispensed applicator units will be a better indicator of gross revenue. CEO Jayson Rieger pointed to improved market access and a more focused commercial team, positioning the company for sustainable revenue growth in 2025 and beyond as YCANTH® continues to gain traction among prescribers.
Read Announcement
VP-315 FDA Regulatory Timeline and Events
VP-315 is a drug developed by Verrica Pharmaceuticals for the following indication: For the Treatment of Basal Cell Carcinoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VP-315
- Announced Date:
- October 7, 2025
- Indication:
- For the Treatment of Basal Cell Carcinoma
Announcement
Verrica Pharmaceuticals announced that it will be presenting both an oral presentation and a poster on VP-315, its oncolytic peptide for the treatment of basal cell carcinoma (BCC), at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting taking place November 5–9, 2025, in National Harbor, Maryland.
AI Summary
Verrica Pharmaceuticals announced it will present both an oral presentation and a poster on VP-315, its oncolytic peptide for basal cell carcinoma (BCC), at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting, November 5–9, 2025, in National Harbor, Maryland. The abstract goes live on the SITC website around November 4 at 9 a.m. ET.
The oral presentation (Abstract #529) appears in Concurrent Session 205b: Rapid Oral Abstract Session – Clinical, where Kenneth Y. Tsai, MD, PhD, will discuss an exploratory analysis of local immune activation in the tumor microenvironment 12 weeks after VP-315 treatment. The poster features the same title and author list.
VP-315 is a potential first-in-class oncolytic chemotherapeutic peptide injected directly into tumors to trigger immunogenic cell death and boost T cell responses. Verrica holds an exclusive license for VP-315 in BCC and squamous cell carcinoma, and Phase 1/2 trials have shown positive tumor-specific immune responses. These SITC presentations will share new data on its non-surgical approach for BCC.
Read Announcement- Drug:
- VP-315
- Announced Date:
- January 21, 2025
- Indication:
- For the Treatment of Basal Cell Carcinoma
Announcement
Verrica Pharmaceuticals announced the presentation of three posters that were presented at the 2025 Winter Clinical Dermatology Conference, which was held from January 17-19, in Miami, Florida.
AI Summary
Verrica Pharmaceuticals announced the presentation of three posters at the 2025 Winter Clinical Dermatology Conference held from January 17-19 in Miami, Florida. The posters detailed data from Part 2 of a Phase 2 multicenter study testing their investigational oncolytic peptide, VP-315, for treating basal cell carcinoma. One key poster highlighted a calculated 97% Objective Response Rate (ORR) based on a post-hoc analysis, showing a significant reduction in tumor size and disease progression control.
The other posters focused on safety, tolerability, and antitumor efficacy data, with results indicating that approximately 51% of treated tumors achieved complete histologic clearance, while tumors with residual disease saw an average 71% size reduction. These findings, gathered from 82 patients with 91 tumors, support the potential of VP-315 as an alternative non-surgical therapy for basal cell carcinoma.
Read Announcement- Drug:
- VP-315
- Announced Date:
- August 14, 2024
- Indication:
- For the Treatment of Basal Cell Carcinoma
Announcement
Verrica Pharmaceuticals Inc. announced preliminary positive results from Part 2 of its Phase 2 clinical trial studying VP-315, a potential first-in-class oncolytic peptide, for the treatment of basal cell carcinoma.
AI Summary
Verrica Pharmaceuticals Inc. announced promising preliminary results from Part 2 of its Phase 2 trial studying VP-315, a potential first-in-class oncolytic peptide for basal cell carcinoma treatment. In the study, all patients treated with VP-315 saw a tumor size reduction, with an overall decline of about 86% in treated lesions. Notably, 51% of lesions achieved complete histological clearance, while the remaining tumors experienced an average shrinkage of around 71%. The treatment was well-tolerated, with no treatment-related serious adverse events reported and mostly mild to moderate skin reactions observed. These findings are significant as they suggest that VP-315 could offer a non-surgical, targeted treatment option for a cancer type that affects millions in the U.S. annually. The results support further development and could lead to improved outcomes and new treatment approaches for basal cell carcinoma patients.
Read Announcement- Drug:
- VP-315
- Announced Date:
- August 6, 2024
- Indication:
- For the Treatment of Basal Cell Carcinoma
Announcement
Verrica Pharmaceuticals Inc. provide an overview of topline results from Part 2 of the Phase 2 trial of VP-315 for the treatment of basal cell carcinoma.
AI Summary
Verrica Pharmaceuticals Inc. announced that it will host a conference call and live webcast on August 14, 2024, at 8:30 a.m. ET to discuss its second quarter financial results and share key updates on its research progress. During the call, the company will provide an overview of topline results from Part 2 of the Phase 2 trial of VP-315. This trial evaluates VP-315, a treatment aimed at combating basal cell carcinoma, a common form of non-melanoma skin cancer. The trial is part of Verrica’s broader efforts to develop new medications for skin diseases that require medical intervention. Interested individuals can participate in the call via telephone or access the live webcast on Verrica’s investor relations website. This update highlights Verrica’s ongoing commitment to advancing innovative dermatology therapeutics and improving treatment options for patients with skin cancer.
Read Announcement
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