News Release Details
Verrica Pharmaceuticals Announces Receipt of Final FDA Minutes Following Type A Meeting Regarding Resubmission of the NDA for VP-102 in Molluscum
VP-102 is a first-in-class, proprietary drug-device combination for the treatment of molluscum, a viral skin disease affecting approximately six million people, primarily children, in
“We are encouraged by our productive discussion with the FDA and the FDA’s written meeting minutes, which reflect alignment on the steps to address the CMC issues raised in the CRL as well as the path forward for resubmission of the NDA and the potential approval of VP-102 to treat patients with molluscum,” said
This news follows Verrica’s recent announcement of positive results for VP-102 for the treatment of external genital warts (EGW) in the Phase 2
About
Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. The Company’s late-stage product candidate, VP-102, is a potential first-in-class drug-device combination product containing a topical therapy for the treatment of molluscum contagiosum. In addition, Verrica has successfully completed a Phase 2 study of VP-102 for the treatment of common warts and a Phase 2 study of VP-102 for the treatment of external genital warts. The Company is also developing VP-103, its third cantharidin-based product candidate, for the treatment of plantar warts. Verrica submitted an NDA for VP-102 for the treatment of molluscum in
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 expectations regarding the Company’s expectations with regard to its interactions and communications with the FDA, the timing for its resubmission of the NDA for VP-102 in the first quarter of 2021, the potential approval of the NDA for VP-102 following resubmission, the potential benefits and potential commercialization of VP-102 for the treatment of molluscum, if approved, and the potential benefits and clinical development plan for VP-102 for the treatment of EGW. 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 uncertainties inherent in the drug development process and the regulatory approval process, Verrica’s reliance on third parties over which it may not always have full control, uncertainties related to the COVID-19 pandemic and other risks and uncertainties that are described in Verrica’s Annual Report on Form 10-K for the year ended December 31, 2019, Verrica’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, and other filings Verrica makes with the U.S. Securities and Exchange Commission. 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.
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Investors:
Chief Financial Officer
484.453.3300 ext. 103
info@verrica.com
Solebury Trout
646.378.2946
wwindham@troutgroup.com
Media:
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646.378.2960
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Source: Verrica Pharmaceuticals Inc.