FDA Accepts Arcutis Supplemental Application for ZORYVE Cream in Young Children with Plaque Psoriasis

Reuters11-17

FDA Accepts Arcutis Supplemental Application for ZORYVE Cream in Young Children with Plaque Psoriasis

Arcutis Biotherapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) cream 0.3% for the treatment of plaque psoriasis in children ages 2 to 5. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026. If approved, ZORYVE cream 0.3% will become the first and only topical PDE4 inhibitor indicated for plaque psoriasis in children as young as two years old. The application is supported by data from clinical studies demonstrating the product's safety, tolerability, and efficacy in this age group. No other organizations are mentioned as recipients of grant or regulatory approval in this announcement.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Arcutis Biotherapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9576478-en) on November 17, 2025, and is solely responsible for the information contained therein.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap

Leave a comment

{"i18n":{"language":"en_US"},"isChannel":false,"data":{"share":"https://ttm.financial/m/news/2584625872?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-11-17 21:00","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2584625872","market":"fut","top_or_hot":-1,"title":"FDA Accepts Arcutis Supplemental Application for ZORYVE Cream in Young Children with Plaque Psoriasis","media":"Reuters","content":"<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      FDA Accepts Arcutis Supplemental Application for ZORYVE Cream in Young Children with Plaque Psoriasis\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        <a href=\"https://laohu8.com/S/ARQT\">Arcutis Biotherapeutics Inc.</a> announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) cream 0.3% for the treatment of plaque psoriasis in children ages 2 to 5. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026. If approved, ZORYVE cream 0.3% will become the first and only topical PDE4 inhibitor indicated for plaque psoriasis in children as young as two years old. The application is supported by data from clinical studies demonstrating the product's safety, tolerability, and efficacy in this age group. No other organizations are mentioned as recipients of grant or regulatory approval in this announcement.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Arcutis Biotherapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9576478-en) on November 17, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>","source":null,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>FDA Accepts Arcutis Supplemental Application for ZORYVE Cream in Young Children with Plaque Psoriasis</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nFDA Accepts Arcutis Supplemental Application for ZORYVE Cream in Young Children with Plaque Psoriasis\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1032215980\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Reuters </p>\n<p class=\"h-time\">2025-11-17 21:00</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      FDA Accepts Arcutis Supplemental Application for ZORYVE Cream in Young Children with Plaque Psoriasis\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        <a href=\"https://laohu8.com/S/ARQT\">Arcutis Biotherapeutics Inc.</a> announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) cream 0.3% for the treatment of plaque psoriasis in children ages 2 to 5. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026. If approved, ZORYVE cream 0.3% will become the first and only topical PDE4 inhibitor indicated for plaque psoriasis in children as young as two years old. The application is supported by data from clinical studies demonstrating the product's safety, tolerability, and efficacy in this age group. No other organizations are mentioned as recipients of grant or regulatory approval in this announcement.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Arcutis Biotherapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9576478-en) on November 17, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"IE00B3QW5Z07.USD","symbol_name":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (USD) ACC","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20251117:nNDLc3V1Lv:1","article_id":"2584625872","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2584625872","pubTimestamp":1763384426,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Arcutis Biotherapeutics Inc. announced that the U.S. Food and Drug Administration  has accepted its supplemental New Drug Application  for ZORYVE  cream 0.3% for the treatment of plaque psoriasis in children ages 2 to 5. The FDA has set a Prescription Drug User Fee Act  target action date of June 29, 2026. If approved, ZORYVE cream 0.3% will become the first and only topical PDE4 inhibitor indicated for plaque psoriasis in children as young as two years old. The application is supported by data from clinical studies demonstrating the product's safety, tolerability, and efficacy in this age group. No other organizations are mentioned as recipients of grant or regulatory approval in this announcement.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or leg","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"IE00B3QW5Z07.USD":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (USD) ACC","LU2095319765.USD":"Natixis Thematics Subscription Economy R/A USD","NDAQ":"纳斯达克OMX交易所","IE00BKPKM429.USD":"NEUBERGER BERMAN GLOBAL SUSTAINABLE EQUITY \"A\" (USD) ACC","IE00BGHQF748.EUR":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (EUR) ACC","LU2210150020.SGD":"Natixis Thematics Subscription Economy R/A SGD","BK4588":"碎股","BK4112":"金融交易所和数据","BK4139":"生物科技","BK4585":"ETF&股票定投概念","ARQT":"Arcutis Biotherapeutics Inc.","IE00B64PRP62.GBP":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (GBP) ACC","LU2210149790.SGD":"Natixis Thematics Subscription Economy R/A SGD-H","LU0314104364.USD":"MANULIFE GF AMERICAN GROWTH \"AA\" (USD) INC"},"translate_title":"FDA接受Arcutis补充申请ZORYVE乳膏治疗幼儿斑块型银屑病","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"NDAQ":0.9,"ARQT":0.9},"content_text":"FDA Accepts Arcutis Supplemental Application for ZORYVE Cream in Young Children with Plaque Psoriasis\n    \n\nArcutis Biotherapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) cream 0.3% for the treatment of plaque psoriasis in children ages 2 to 5. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026. If approved, ZORYVE cream 0.3% will become the first and only topical PDE4 inhibitor indicated for plaque psoriasis in children as young as two years old. The application is supported by data from clinical studies demonstrating the product's safety, tolerability, and efficacy in this age group. No other organizations are mentioned as recipients of grant or regulatory approval in this announcement.\n      \n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Arcutis Biotherapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9576478-en) on November 17, 2025, and is solely responsible for the information contained therein.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.35.12","shortVersion":"4.35.12","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2584625872","isCrawlerRequest":true}