Verastem Completes Rolling NDA Submission to US FDA for Drug Combination to Treat Rare Ovarian Cancer

MT Newswires Live11-01

Verastem (VSTM) said late Thursday that it has completed a rolling new drug application to the US Food and Drug Administration for the combination of avutometinib and defactinib to treat people with recurrent KRAS mutant low-grade serous ovarian cancer, who were given at least one previous systemic therapy.

The company said it has filed the application through the regulator's accelerated approval track and requested priority review due to the combination's potential to address significant unmet medical need among people with the disease.

The regulator's filing decision is expected before the end of of this year, with potential for regulatory approval by the middle of next year, Verastem said.

Price: 3.86, Change: +0.10, Percent Change: +2.66

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/2480893608?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2024-11-01 21:45","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2480893608","market":"us","top_or_hot":-1,"title":"Verastem Completes Rolling NDA Submission to US FDA for Drug Combination to Treat Rare Ovarian Cancer","media":"MT Newswires Live","content":"<html><body><p> <a href=\"https://laohu8.com/S/VSTM\">Verastem</a> (VSTM) said late Thursday that it has completed a rolling new drug application to the US Food and Drug Administration for the combination of avutometinib and defactinib to treat people with recurrent KRAS mutant low-grade serous ovarian cancer, who were given at least one previous systemic therapy.</p><p>The company said it has filed the application through the regulator's accelerated approval track and requested priority review due to the combination's potential to address significant unmet medical need among people with the disease.</p><p>The regulator's filing decision is expected before the end of of this year, with potential for regulatory approval by the middle of next year, Verastem said.</p><p>Price: 3.86, Change: +0.10, Percent Change: +2.66</p></body></html>","source":"mtnewswires_news","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>Verastem Completes Rolling NDA Submission to US FDA for Drug Combination to Treat Rare Ovarian Cancer</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\">\nVerastem Completes Rolling NDA Submission to US FDA for Drug Combination to Treat Rare Ovarian Cancer\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-11-01 21:45 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://www.mtnewswires.com/><strong>MT Newswires Live</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Verastem (VSTM) said late Thursday that it has completed a rolling new drug application to the US Food and Drug Administration for the combination of avutometinib and defactinib to treat people with ...</p>\n\n<a href=\"https://www.mtnewswires.com/\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4139","symbol_name":"生物科技","start_time":0,"source_url":"https://www.mtnewswires.com/","article_id":"2480893608","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2480893608","pubTimestamp":1730468758,"sourceInfo":{"source_id":"mtnewswires_news","name":"MT Newswires"},"weMediaInfo":{"media_name":"MT Newswires Live","introduction":"The most recognized names in North America, Europe and Asia rely on MT Newswires to power their applications. Better news, better service, better price.","home_visible":1,"id":"1092851196","head_image":"https://community-static.tradeup.com/news/3002d84abbd5ace3c99397c7f95b8d4e"},"summary":"Verastem  said late Thursday that it has completed a rolling new drug application to the US Food and Drug Administration for the combination of avutometinib and defactinib to treat people with recurrent KRAS mutant low-grade serous ovarian cancer, who were given at least one previous systemic therapy.The company said it has filed the application through the regulator's accelerated approval track and requested priority review due to the combination's potential to address significant unmet medical need among people with the disease.The regulator's filing decision is expected before the end of of this year, with potential for regulatory approval by the middle of next year, Verastem said.Price: 3.86, Change: +0.10, Percent Change: +2.66","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4139":"生物科技","VSTM":"Verastem"},"translate_title":"Verastem完成向美国FDA提交药物组合治疗罕见卵巢癌的滚动NDA","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"VSTM":1},"content_text":"Verastem (VSTM) said late Thursday that it has completed a rolling new drug application to the US Food and Drug Administration for the combination of avutometinib and defactinib to treat people with recurrent KRAS mutant low-grade serous ovarian cancer, who were given at least one previous systemic therapy.The company said it has filed the application through the regulator's accelerated approval track and requested priority review due to the combination's potential to address significant unmet medical need among people with the disease.The regulator's filing decision is expected before the end of of this year, with potential for regulatory approval by the middle of next year, Verastem said.Price: 3.86, Change: +0.10, Percent Change: +2.66","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"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":"4.29.1","shortVersion":"4.29.1","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/2480893608"}