{"id":382693,"date":"2020-11-17T07:33:16","date_gmt":"2020-11-17T12:33:16","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=382693"},"modified":"2020-11-17T07:33:16","modified_gmt":"2020-11-17T12:33:16","slug":"verrica-pharmaceuticals-announces-receipt-of-final-fda-minutes-following-type-a-meeting-regarding-resubmission-of-the-nda-for-vp-102-in-molluscum","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/verrica-pharmaceuticals-announces-receipt-of-final-fda-minutes-following-type-a-meeting-regarding-resubmission-of-the-nda-for-vp-102-in-molluscum\/","title":{"rendered":"Verrica Pharmaceuticals Announces Receipt of Final FDA Minutes Following Type A Meeting Regarding Resubmission of the NDA for VP-102 in Molluscum"},"content":{"rendered":"<h2>\n&#8211; Verrica reaffirms expectation to resubmit its New Drug Application for VP-102 for the treatment of molluscum in the first quarter of 2021 &#8211;<br \/>\n<\/h2>\n<div class=\"mw_release\">\n<p align=\"left\">WEST CHESTER, Penn., Nov.  17, 2020  (GLOBE NEWSWIRE) &#8212; Verrica Pharmaceuticals Inc. (\u201cVerrica\u201d) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that it has received the final meeting minutes from the U.S. Food and Drug Administration (FDA) following the Company\u2019s recent Type A meeting to discuss the steps required for resubmission of the New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum).<\/p>\n<p>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 the United States. There are currently no FDA-approved treatments for molluscum. In July, the Company announced that it had received a Complete Response Letter from the FDA requesting additional Chemistry, Manufacturing and Controls (CMC) information as well as Human Factors validation.<\/p>\n<p>\u201cWe are encouraged by our productive discussion with the FDA and the FDA\u2019s 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,\u201d said Ted White, President and Chief Executive Officer, Verrica. \u201cIn addition, our Human Factors study protocol has been reviewed by the FDA and we are preparing to complete that study by the end of the year. We are pleased to reaffirm our expectation to resubmit the NDA for VP-102 pursuant to the statutory 505(b)(1) regulatory pathway in the first quarter of 2021.\u201d<\/p>\n<p>This news follows Verrica\u2019s recent announcement of positive results for VP-102 for the treatment of external genital warts (EGW) in the Phase 2 CARE-1 trial. As previously announced, Verrica intends to request an End-of-Phase 2 meeting with the FDA for VP-102 in EGW in the first quarter of 2021.<\/p>\n<p>\n        <strong>About Verrica Pharmaceuticals Inc.<\/strong>\n      <\/p>\n<p>Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. The Company\u2019s 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 September 2019. A Complete Response Letter was received from the FDA regarding the NDA for VP-102 on July 13, 2020. In October 2020, Verrica participated in a Type A meeting with the FDA. Verrica expects to resubmit its New Drug Application for VP-102 for the treatment of molluscum in the first quarter of 2021. If approved, VP-102 will be marketed in the United States under the conditionally accepted brand name YCANTH\u2122. For more information, visit www.verrica.com.<\/p>\n<p>\n        <strong>Forward-Looking Statement<\/strong><br \/>\n        <strong>s<\/strong>\n      <\/p>\n<p>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 \u201cbelieve,\u201d \u201cexpect,\u201d \u201cmay,\u201d \u201cplan,\u201d \u201cpotential,\u201d \u201cwill,\u201d and similar expressions, and are based on Verrica\u2019s current beliefs and expectations. These forward-looking statements include expectations regarding the Company\u2019s 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\u2019s 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\u2019s Annual Report on Form 10-K for the year ended\u00a0December 31, 2019, Verrica\u2019s Quarterly Report on Form 10-Q for the quarter ended\u00a0September 30, 2020, and other filings Verrica makes with the\u00a0U.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.<\/p>\n<p>\n        <strong>FOR MORE INFORMATION, PLEASE CONTACT:<\/strong>\n      <\/p>\n<p>Investors:<\/p>\n<p>\n        <strong>A. Brian Davis<\/strong><br \/>\n        <br \/>Chief Financial Officer<br \/>484.453.3300 ext. 103<br \/>info@verrica.com<\/p>\n<p>\n        <strong>William Windham<\/strong><br \/>\n        <br \/>Solebury Trout<br \/>646.378.2946<br \/>wwindham@troutgroup.com<\/p>\n<p>Media:<\/p>\n<p>\n        <strong>Zara Lockshin<\/strong><br \/>\n        <br \/>Solebury Trout<br \/>646.378.2960<br \/>zlockshin@troutgroup.com<\/p>\n<p>      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODA4NzI1OCMzODMwNTc4IzIxMjA3NDg=\" width=\"1\" height=\"1\" \/><br \/>\n      <br \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/ml.globenewswire.com\/release\/track\/ecb99a30-1fdf-45e7-a7ae-4000f8f6be90\" width=\"1\" height=\"1\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>&#8211; Verrica reaffirms expectation to resubmit its New Drug Application for VP-102 for the treatment of molluscum in the first quarter of 2021 &#8211; WEST CHESTER, Penn., Nov. 17, 2020 (GLOBE NEWSWIRE) &#8212; Verrica Pharmaceuticals Inc. (\u201cVerrica\u201d) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that it has received the final meeting minutes from the U.S. Food and Drug Administration (FDA) following the Company\u2019s recent Type A meeting to discuss the steps required for resubmission of the New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (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 &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/verrica-pharmaceuticals-announces-receipt-of-final-fda-minutes-following-type-a-meeting-regarding-resubmission-of-the-nda-for-vp-102-in-molluscum\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Verrica Pharmaceuticals Announces Receipt of Final FDA Minutes Following Type A Meeting Regarding Resubmission of the NDA for VP-102 in Molluscum&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-382693","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Verrica Pharmaceuticals Announces Receipt of Final FDA Minutes Following Type A Meeting Regarding Resubmission of the NDA for VP-102 in Molluscum - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/verrica-pharmaceuticals-announces-receipt-of-final-fda-minutes-following-type-a-meeting-regarding-resubmission-of-the-nda-for-vp-102-in-molluscum\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Verrica Pharmaceuticals Announces Receipt of Final FDA Minutes Following Type A Meeting Regarding Resubmission of the NDA for VP-102 in Molluscum - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"&#8211; Verrica reaffirms expectation to resubmit its New Drug Application for VP-102 for the treatment of molluscum in the first quarter of 2021 &#8211; WEST CHESTER, Penn., Nov. 17, 2020 (GLOBE NEWSWIRE) &#8212; Verrica Pharmaceuticals Inc. (\u201cVerrica\u201d) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that it has received the final meeting minutes from the U.S. Food and Drug Administration (FDA) following the Company\u2019s recent Type A meeting to discuss the steps required for resubmission of the New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (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 &hellip; Continue reading &quot;Verrica Pharmaceuticals Announces Receipt of Final FDA Minutes Following Type A Meeting Regarding Resubmission of the NDA for VP-102 in Molluscum&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/verrica-pharmaceuticals-announces-receipt-of-final-fda-minutes-following-type-a-meeting-regarding-resubmission-of-the-nda-for-vp-102-in-molluscum\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2020-11-17T12:33:16+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODA4NzI1OCMzODMwNTc4IzIxMjA3NDg=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/verrica-pharmaceuticals-announces-receipt-of-final-fda-minutes-following-type-a-meeting-regarding-resubmission-of-the-nda-for-vp-102-in-molluscum\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/verrica-pharmaceuticals-announces-receipt-of-final-fda-minutes-following-type-a-meeting-regarding-resubmission-of-the-nda-for-vp-102-in-molluscum\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Verrica Pharmaceuticals Announces Receipt of Final FDA Minutes Following Type A Meeting Regarding Resubmission of the NDA for VP-102 in Molluscum\",\"datePublished\":\"2020-11-17T12:33:16+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/verrica-pharmaceuticals-announces-receipt-of-final-fda-minutes-following-type-a-meeting-regarding-resubmission-of-the-nda-for-vp-102-in-molluscum\\\/\"},\"wordCount\":851,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/verrica-pharmaceuticals-announces-receipt-of-final-fda-minutes-following-type-a-meeting-regarding-resubmission-of-the-nda-for-vp-102-in-molluscum\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODA4NzI1OCMzODMwNTc4IzIxMjA3NDg=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/verrica-pharmaceuticals-announces-receipt-of-final-fda-minutes-following-type-a-meeting-regarding-resubmission-of-the-nda-for-vp-102-in-molluscum\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/verrica-pharmaceuticals-announces-receipt-of-final-fda-minutes-following-type-a-meeting-regarding-resubmission-of-the-nda-for-vp-102-in-molluscum\\\/\",\"name\":\"Verrica Pharmaceuticals Announces Receipt of Final FDA Minutes Following Type A Meeting Regarding Resubmission of the NDA for VP-102 in Molluscum - 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/verrica-pharmaceuticals-announces-receipt-of-final-fda-minutes-following-type-a-meeting-regarding-resubmission-of-the-nda-for-vp-102-in-molluscum\/","og_locale":"en_US","og_type":"article","og_title":"Verrica Pharmaceuticals Announces Receipt of Final FDA Minutes Following Type A Meeting Regarding Resubmission of the NDA for VP-102 in Molluscum - Market Newsdesk","og_description":"&#8211; Verrica reaffirms expectation to resubmit its New Drug Application for VP-102 for the treatment of molluscum in the first quarter of 2021 &#8211; WEST CHESTER, Penn., Nov. 17, 2020 (GLOBE NEWSWIRE) &#8212; Verrica Pharmaceuticals Inc. (\u201cVerrica\u201d) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that it has received the final meeting minutes from the U.S. Food and Drug Administration (FDA) following the Company\u2019s recent Type A meeting to discuss the steps required for resubmission of the New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (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 &hellip; Continue reading \"Verrica Pharmaceuticals Announces Receipt of Final FDA Minutes Following Type A Meeting Regarding Resubmission of the NDA for VP-102 in Molluscum\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/verrica-pharmaceuticals-announces-receipt-of-final-fda-minutes-following-type-a-meeting-regarding-resubmission-of-the-nda-for-vp-102-in-molluscum\/","og_site_name":"Market Newsdesk","article_published_time":"2020-11-17T12:33:16+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODA4NzI1OCMzODMwNTc4IzIxMjA3NDg=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/verrica-pharmaceuticals-announces-receipt-of-final-fda-minutes-following-type-a-meeting-regarding-resubmission-of-the-nda-for-vp-102-in-molluscum\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/verrica-pharmaceuticals-announces-receipt-of-final-fda-minutes-following-type-a-meeting-regarding-resubmission-of-the-nda-for-vp-102-in-molluscum\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Verrica Pharmaceuticals Announces Receipt of Final FDA Minutes Following Type A Meeting Regarding Resubmission of the NDA for VP-102 in Molluscum","datePublished":"2020-11-17T12:33:16+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/verrica-pharmaceuticals-announces-receipt-of-final-fda-minutes-following-type-a-meeting-regarding-resubmission-of-the-nda-for-vp-102-in-molluscum\/"},"wordCount":851,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/verrica-pharmaceuticals-announces-receipt-of-final-fda-minutes-following-type-a-meeting-regarding-resubmission-of-the-nda-for-vp-102-in-molluscum\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODA4NzI1OCMzODMwNTc4IzIxMjA3NDg=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/verrica-pharmaceuticals-announces-receipt-of-final-fda-minutes-following-type-a-meeting-regarding-resubmission-of-the-nda-for-vp-102-in-molluscum\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/verrica-pharmaceuticals-announces-receipt-of-final-fda-minutes-following-type-a-meeting-regarding-resubmission-of-the-nda-for-vp-102-in-molluscum\/","name":"Verrica Pharmaceuticals Announces Receipt of Final FDA Minutes Following Type A Meeting Regarding Resubmission of the NDA for VP-102 in Molluscum - 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