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Verrica Pharmaceuticals Inc. reports news on its dermatology therapeutics business, including commercialization of YCANTH (VP-102) for molluscum contagiosum and development of cantharidin-based therapy for common warts. Company updates also cover financial results, corporate presentations, commercial leadership and international commercialization activity.
Verrica’s pipeline news centers on VP-315 (ruxotemitide), an oncolytic peptide licensed for dermatologic oncology indications. Recurring disclosures include clinical data presentations in basal cell carcinoma, development plans for non-melanoma skin cancers and collaboration activity tied to YCANTH and its dermatology portfolio.
Verrica Pharmaceuticals announced that its resubmitted New Drug Application (NDA) for VP-102 (0.7% cantharidin topical solution) has been accepted by the FDA, with a PDUFA goal date of June 23, 2021. If approved, VP-102 could be the first FDA-approved treatment for molluscum contagiosum, a viral skin condition affecting around 6 million people in the U.S., mainly children. The NDA is based on positive Phase 3 clinical trial results showing significant clearance of molluscum lesions, with no serious adverse events reported.
Verrica Pharmaceuticals (Nasdaq: VRCA) has announced positive data from post-hoc analyses of its Phase 3 trials for VP-102, a treatment for molluscum contagiosum. Results showed significantly higher clearance rates of lesions across various body regions compared to the vehicle control, starting as early as Day 21. Additionally, in the Phase 2 CARE-1 study for external genital warts (EGW), VP-102 demonstrated a significantly higher clearance rate at Day 63 and Day 84. The FDA is currently reviewing VP-102, which may become the first approved treatment for molluscum contagiosum.
Verrica Pharmaceuticals (Nasdaq: VRCA) has resubmitted the New Drug Application (NDA) for its lead product, VP-102, aimed at treating molluscum contagiosum, a contagious skin disease affecting approximately six million people in the U.S., mainly children. The resubmission responds to a Type A meeting with the FDA and addresses concerns from a previous Complete Response Letter issued in July 2020. If approved, VP-102 will be the first FDA-approved treatment for this condition, marketed as YCANTH™.
Verrica Pharmaceuticals reaffirmed its expectation to resubmit the New Drug Application (NDA) for VP-102, targeting molluscum contagiosum, in Q1 2021. This announcement comes after productive discussions with the FDA addressing prior Chemistry, Manufacturing, and Controls (CMC) issues outlined in a Complete Response Letter received in July. VP-102 is a first-in-class drug-device combination aimed at treating a viral skin disease, currently lacking FDA-approved options. The company is also preparing to complete a Human Factors study by year-end.
Verrica Pharmaceuticals (Nasdaq: VRCA) announced that CEO Ted White will present a business overview at the Jefferies Virtual London Healthcare Conference on November 17, 2020. The presentation will be accessible via live webcast on Verrica's website.
The company is developing VP-102, a potential first-in-class treatment for molluscum contagiosum, with plans to resubmit its NDA in early 2021 following feedback from the FDA. VP-102 has completed Phase 2 studies for common and external genital warts, and Verrica is also working on VP-103 for treating plantar warts.
Verrica Pharmaceuticals announced positive results from its Phase 2 CARE-1 study of VP-102, a topical therapy for external genital warts (EGW). 35% of subjects achieved complete clearance of treatable EGW by Day 84 compared to 2.4% for the vehicle (p=0.0001). The treatment was well-tolerated with no serious adverse events. Approximately 500,000 to 1 million new cases of EGW are diagnosed annually in the U.S. Based on these results, Verrica plans to request an End-of-Phase 2 meeting with the FDA in early 2021.
Verrica Pharmaceuticals (Nasdaq: VRCA) has completed a Type A meeting with the FDA regarding its New Drug Application (NDA) resubmission for VP-102, aimed at treating molluscum contagiosum. The resubmission is expected in Q1 2021 following positive feedback from the FDA. In Q3 2020, Verrica reported a net loss of $10.5 million, an increase from $6.1 million the previous year. R&D expenses rose to $5 million, largely due to higher manufacturing costs. As of September 30, 2020, the company held $71.9 million in cash and equivalents, sufficient to sustain operations through Q4 2021.
Verrica Pharmaceuticals (Nasdaq: VRCA) announced the publication of positive results from its pivotal Phase III CAMP studies on VP-102 for treating molluscum contagiosum in the Journal of the American Medical Association (JAMA) Dermatology. The studies, involving over 500 participants, indicated that 46% in CAMP-1 and 54% in CAMP-2 achieved complete clearance of lesions with VP-102, compared to 18% and 13% respectively for the vehicle group (p<0.001). VP-102 was well tolerated, with no serious adverse events reported. The results may enhance the prospects of VP-102 as a safe FDA-approved treatment for a viral skin infection.
Verrica Pharmaceuticals (VRCA) announced that CEO Ted White will present a business overview at the H.C. Wainwright 22nd Annual Global Investment Conference on September 15, 2020, at 2:00 p.m. ET. The conference will be held virtually, and attendees can access the live webcast on Verrica's website. The company is developing VP-102, a potential first-in-class therapy for molluscum contagiosum, for which an NDA was submitted in September 2019. A Complete Response Letter from the FDA was received on July 13, 2020, regarding this NDA.
Verrica Pharmaceuticals (NASDAQ: VRCA) has secured an exclusive worldwide license from Lytix Biopharma for the development of LTX-315, targeting dermatologic oncology, particularly basal and squamous cell carcinomas. This oncolytic peptide shows promise in inducing immunogenic cell death in tumors. The deal could yield up to $113.5 million and tiered royalties. Clinical advancements aim for an IND submission in 2021. Verrica expects its financial position to support these activities through Q4 2021, reinforcing its commitment to innovative dermatologic treatments.