Welcome to our dedicated page for Verrica Pharmaceuticals news (Ticker: VRCA), a resource for investors and traders seeking the latest updates and insights on Verrica Pharmaceuticals stock.
About Verrica Pharmaceuticals Inc.
Verrica Pharmaceuticals Inc. (Nasdaq: VRCA) is a dermatology therapeutics company dedicated to developing and commercializing innovative treatments for skin diseases requiring medical interventions. Founded in 2013 and headquartered in West Chester, Pennsylvania, Verrica addresses significant unmet needs in dermatology with a focus on non-invasive, targeted therapies.
Core Products and Pipeline
Verrica's flagship product, YCANTH® (VP-102), is the first and only FDA-approved treatment for molluscum contagiosum, a highly contagious viral skin infection affecting approximately six million people in the United States, primarily children. YCANTH®, a proprietary drug-device combination, delivers a GMP-controlled formulation of cantharidin via a single-use applicator for precise and targeted topical application. The product is also in development for the treatment of common warts and external genital warts, two of the largest remaining unmet needs in dermatology.
Building on its expertise in cantharidin-based therapies, Verrica is advancing VP-103, a second-generation product candidate, for the treatment of plantar warts. Additionally, the company is exploring groundbreaking therapies in dermatologic oncology with VP-315, a first-in-class oncolytic peptide immunotherapy for basal cell carcinoma and other non-melanoma skin cancers. VP-315 leverages "host defense peptide" technology to induce immunogenic cell death, offering a potential non-surgical alternative for millions of patients.
Strategic Collaborations
Verrica has established strategic partnerships to enhance its global reach and development capabilities. Through a licensing agreement with Lytix Biopharma AS, Verrica is developing VP-315 for dermatologic oncology indications, including basal and squamous cell carcinomas. In Japan, Verrica collaborates with Torii Pharmaceutical Co. Ltd. to develop and commercialize YCANTH® (marketed as TO-208 in Japan) for molluscum contagiosum and common warts, addressing a large and underserved patient population.
Market Position and Competitive Landscape
Verrica operates in the dermatology and oncology therapeutics markets, with a focus on conditions that lack FDA-approved treatments. Its innovative use of cantharidin and oncolytic peptides differentiates it from competitors, providing targeted, non-invasive solutions to patients and healthcare providers. By addressing significant unmet needs, such as molluscum contagiosum and basal cell carcinoma, Verrica is positioned as a key player in these specialized markets.
Regulatory and Commercial Milestones
Verrica has achieved several regulatory and commercial milestones, including FDA approval for YCANTH® and its listing in the FDA's Orange Book, granting it exclusivity protections. The company has also successfully settled litigation to remove non-FDA-approved cantharidin products from the U.S. market, reinforcing its commitment to patient safety and regulatory compliance.
Commitment to Innovation
Verrica Pharmaceuticals demonstrates its commitment to innovation through its robust clinical pipeline, strategic partnerships, and focus on addressing unmet medical needs. By leveraging its expertise in dermatology and oncology, Verrica aims to provide meaningful therapeutic advancements that improve patient outcomes and quality of life.
Verrica Pharmaceuticals (Nasdaq: VRCA) has resubmitted the New Drug Application (NDA) for VP-102, aimed at treating molluscum contagiosum, to the FDA. This resubmission addresses deficiencies noted in the Complete Response Letter from September 2021, including inspection issues and user interface recommendations. CEO Ted White anticipates a 2-month review period, with a potential launch of VP-102 as the first FDA-approved treatment for this viral skin disease affecting six million people, primarily children, in the U.S. annually.
Verrica Pharmaceuticals (Nasdaq: VRCA) announced the FDA's acceptance of its IND application for LTX-315, a novel oncolytic peptide for treating basal cell carcinoma, a prevalent form of skin cancer. The Phase 2 trial is expected to begin in Q1 2022. With over 5 million non-melanoma skin cancer diagnoses annually in the U.S., LTX-315 aims to offer a non-surgical treatment option. The drug shows promise in inducing immune responses against tumors and aims to improve patient outcomes compared to current surgical options.
Verrica Pharmaceuticals (Nasdaq: VRCA) reported its third quarter financial results, revealing a net loss of $12.8 million, or $0.47 per share, compared to a loss of $10.5 million, or $0.42 per share, in Q3 2020. The company has received satisfactory resolution on deficiencies at a contract manufacturing organization from the FDA, allowing them to proceed with the approval process for VP-102, targeting molluscum contagiosum. Additionally, Verrica is advancing LTX-315 for basal cell carcinoma, submitting an IND, and expects to start a Phase 2 trial in early 2022.
Verrica Pharmaceuticals (NASDAQ: VRCA) announced on September 20, 2021, that the FDA issued a Complete Response Letter (CRL) for its New Drug Application (NDA) for VP-102, aimed at treating molluscum contagiosum. While the FDA identified general quality deficiencies at the contract manufacturing organization, no specific manufacturing or clinical issues were cited for VP-102. The company remains optimistic about resolving these concerns within 30 business days, highlighting a significant unmet need for an FDA-approved treatment for the six million people affected in the U.S.
Verrica Pharmaceuticals announced its Q2 2021 financial results, showing a net loss of $11.8 million, or $0.43 per share. This reflects a wider loss compared to $9.4 million in Q2 2020. The company recognized $12 million in license revenues from its agreement with Torii Pharmaceutical, with total cash and marketable securities at $90.1 million as of June 30, 2021. Verrica is preparing for a potential launch of its lead product candidate, VP-102, aimed at molluscum contagiosum, with a PDUFA goal date set for September 23, 2021, while also expanding its commercial operations.
Verrica Pharmaceuticals (Nasdaq: VRCA) has appointed Terry Kohler as Chief Financial Officer to enhance its management team in light of the potential commercial launch of VP-102, a treatment for skin diseases. Kohler brings over 20 years of experience, most recently from a global pharmaceutical company with annual revenues exceeding $2 billion. He succeeds Brian Davis, who is leaving the company. This leadership change aims to bolster commercial preparations for the expected launch this fall, as stated by CEO Ted White.
Verrica Pharmaceuticals has announced a three-month extension of the PDUFA goal date for its New Drug Application (NDA) for VP-102, now set for September 23, 2021. This extension allows the FDA additional time to review information on Verrica's training program and distribution model, following comments on a human factors study. Despite the delay, Verrica remains confident in VP-102 as a treatment for molluscum contagiosum, especially after the FDA completed one of two required pre-approval inspections. VP-102 could become the first FDA-approved treatment for this common skin condition affecting six million U.S. children.
Verrica Pharmaceuticals (Nasdaq: VRCA) announced that CEO Ted White will present a business overview at the Jefferies Virtual Healthcare Conference on June 2, 2021, at 2:00 p.m. ET. The event can be accessed via a live webcast. Verrica specializes in dermatology therapeutics, with a focus on late-stage product candidates like VP-102 for treating molluscum, common warts, and external genital warts. Additionally, they are developing VP-103 for plantar warts and have a global licensing agreement with Lytix Biopharma to develop LTX-315 for dermatologic oncology conditions.
Verrica Pharmaceuticals (Nasdaq: VRCA) announced that President and CEO Ted White will present a business overview at the virtual 2021 RBC Capital Markets Global Healthcare Conference on May 19, 2021, at 5:25 p.m. ET. The presentation will include insights into Verrica's dermatology therapeutics, especially their late-stage product candidates, VP-102 for treating molluscum and warts, and VP-103 for plantar warts. Additionally, Verrica has a global license agreement with Lytix Biopharma for developing LTX-315 for dermatologic oncology.
Verrica Pharmaceuticals (Nasdaq: VRCA) reported its first-quarter financial results for 2021, highlighting a significant expansion and preparation for the potential FDA approval of VP-102 for molluscum, with a PDUFA goal date set for June 23, 2021. The company raised $30 million through a public offering and recognized $12 million in license revenues from its agreement with Torii Pharmaceutical for VP-102's development in Japan. The net loss narrowed to $0.9 million from $9.8 million year-over-year, with cash equivalents of $87.7 million supporting operations through mid-2023.
FAQ
What is the current stock price of Verrica Pharmaceuticals (VRCA)?
What is the market cap of Verrica Pharmaceuticals (VRCA)?
What does Verrica Pharmaceuticals specialize in?
What is YCANTH® (VP-102)?
What is VP-315, and what does it treat?
What makes Verrica's treatments unique?
Who are Verrica's strategic partners?
What is molluscum contagiosum?
What is the significance of YCANTH®'s Orange Book listing?
How does Verrica address patient safety?
What conditions does Verrica target beyond molluscum contagiosum?
Where is Verrica Pharmaceuticals headquartered?
