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
VP-315 and YCANTH™. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
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:
- 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
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:
- 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
