Delcath Surges 90% on FDA Approval of Cancer Drug Device

Tiger Newspress2023-08-15

Oncology-focused healthcare equipment maker Delcath Systems (NASDAQ:DCTH) surged 90% in morning trading Tuesday after announcing the FDA approval of its Hepzato Kit device as a treatment for a type of liver-dominant eye cancer.

Accordingly, Hepzato Kit which is designed to deliver chemotherapy Hepzato will be available for as a liver-directed therapy for adults with uveal melanoma ((mUM)), a rare form of cancer that affects melanocytes in the eye.

The New York-based medical equipment maker expects to launch the product in Q4 2023.

The FDA’s decision is based on data from the company’s Phase 3 FOCUS Study which indicated a ~36% objective response rate and 14 months of median duration of response in 91 patients who received Hepzato Kit every 6 – 8 weeks, for up to six treatments.

Hepzato Kit comes with a Boxed Warning related to its safety risks, and the drug’s availability will come under the FDA Risk Evaluation and Mitigation Strategy (REMS) program to address the risks.

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/1121881100?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2023-08-15 22:28","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"1121881100","market":"us","top_or_hot":-1,"title":"Delcath Surges 90% on FDA Approval of Cancer Drug Device","media":"Tiger Newspress","content":"<html><head></head><body><p>Oncology-focused healthcare equipment maker Delcath Systems (NASDAQ:DCTH) surged 90% in morning trading Tuesday after announcing the FDA approval of its Hepzato Kit device as a treatment for a type of liver-dominant eye cancer.</p><p class=\"t-img-caption\"><img src=\"https://static.tigerbbs.com/b039a713716ea51e6ee2f8336e3a861b\" tg-width=\"859\" tg-height=\"625\"/></p><p>Accordingly, Hepzato Kit which is designed to deliver chemotherapy Hepzato will be available for as a liver-directed therapy for adults with uveal melanoma ((mUM)), a rare form of cancer that affects melanocytes in the eye.</p><p>The New York-based medical equipment maker expects to launch the product in Q4 2023.</p><p>The FDA’s decision is based on data from the company’s Phase 3 FOCUS Study which indicated a ~36% objective response rate and 14 months of median duration of response in 91 patients who received Hepzato Kit every 6 – 8 weeks, for up to six treatments.</p><p>Hepzato Kit comes with a Boxed Warning related to its safety risks, and the drug’s availability will come under the FDA Risk Evaluation and Mitigation Strategy (REMS) program to address the risks.</p></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>Delcath Surges 90% on FDA Approval of Cancer Drug Device</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\">\nDelcath Surges 90% on FDA Approval of Cancer Drug Device\n</h2>\n\n<h4 class=\"meta\">\n\n2023-08-15 22:28 北京时间&nbsp;&nbsp;&nbsp;<strong>Tiger Newspress</strong>\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Oncology-focused healthcare equipment maker Delcath Systems (NASDAQ:DCTH) surged 90% in morning trading Tuesday after announcing the FDA approval of its Hepzato Kit device as a treatment for a type of...</p>\n\n<a href=\"\">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":"DCTH","symbol_name":"迪卡斯","start_time":0,"source_url":"","article_id":"1121881100","we_media_id":"1079075236","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=1121881100","pubTimestamp":1692109715,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Tiger Newspress","introduction":"Providing stock market headlines, business news, financials and earnings ","home_visible":1,"id":"1079075236","head_image":"https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba"},"summary":"Oncology-focused healthcare equipment maker Delcath Systems  surged 90% in morning trading Tuesday after announcing the FDA approval of its Hepzato Kit device as a treatment for a type of liver-dominant eye cancer.Accordingly, Hepzato Kit which is designed to deliver chemotherapy Hepzato will be available for as a liver-directed therapy for adults with uveal melanoma , a rare form of cancer that affects melanocytes in the eye.The New York-based medical equipment maker expects to launch the produ","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"DCTH":"迪卡斯"},"translate_title":"Delcath在FDA批准癌症药物装置后飙升90%","themeId":"c5bbfdf5f7964880af97c1d6f417052c","isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"DCTH":1.1},"content_text":"Oncology-focused healthcare equipment maker Delcath Systems (NASDAQ:DCTH) surged 90% in morning trading Tuesday after announcing the FDA approval of its Hepzato Kit device as a treatment for a type of liver-dominant eye cancer.Accordingly, Hepzato Kit which is designed to deliver chemotherapy Hepzato will be available for as a liver-directed therapy for adults with uveal melanoma ((mUM)), a rare form of cancer that affects melanocytes in the eye.The New York-based medical equipment maker expects to launch the product in Q4 2023.The FDA’s decision is based on data from the company’s Phase 3 FOCUS Study which indicated a ~36% objective response rate and 14 months of median duration of response in 91 patients who received Hepzato Kit every 6 – 8 weeks, for up to six treatments.Hepzato Kit comes with a Boxed Warning related to its safety risks, and the drug’s availability will come under the FDA Risk Evaluation and Mitigation Strategy (REMS) program to address the risks.","kind":"news","is_publish_news":true,"is_publish_highlight":true,"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":8,"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":"4.29.3","shortVersion":"4.29.3","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/1121881100"}