Telix Pharmaceuticals Obtains US FDA Priority Review for Cancer Imaging Agent

MT Newswires Live

02/26

The US Food and Drug Administration has accepted Telix Pharmaceuticals' (ASX:TLX) Biologics License Application for its investigational kidney cancer imaging agent TLX250-CDx, and granted a priority review that would pave the way for a commercial launch within the year, according to a Wednesday filing with the Australian bourse.

The imaging agent has been given a Prescription Drug User Fee Act (PDUFA) date of Aug. 27. A PDUFA date provides an estimated timeline of when a decision on a drug application would be made.

TLX250-CDx is said to be the first commercially available imaging agent to accurately and non-invasively diagnose and characterize clear cell renal cell carcinoma, a form of kidney cancer, per the filing.

免责声明：投资有风险，本文并非投资建议，以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请，作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考，不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证，投资者应自行研究并在投资前寻求专业建议。

热议股票

{"basename":"/hans","ssrTDKData":{"titleTemplate":"%s - 老虎证券","title":"老虎证券全球投资理财平台| 一站式投资美股新股港股A股","description":"老虎证券助您一站式投资美股，新股，港股，A股等全球金融理财产品。新加坡华人最信赖的在线投资平台，现在加入即享低费用，24/5 无时差炒美股投资理财！","keywords":"老虎证券,老虎证券开户,老虎券商,老虎证券官网,老虎证券app,tigertrade老虎证券,股票,炒股,新加坡股票交易平台,投资,投资理财","social":{"ogDescription":"老虎证券助您一站式投资美股，新股，港股，A股等全球金融理财产品。新加坡华人最信赖的在线投资平台，现在加入即享低费用，24/5 无时差炒美股投资理财！","ogImage":"https://c1.itigergrowtha.com/portal5/static/media/og-logo.be62fbe1.png","ogUrl":"https://www.itiger.com/hans/news/2514073043"},"companyName":"老虎证券"},"pageData":{"isMobile":false,"isTiger":false,"isTTM":true,"region":"SGP","license":"TBSG","edition":"fundamental"},"isCrawlerRequest":true,"__swrFallback__":{"@#url:\"https://stock-news.skytigris.cn/v3/news\",params:#id:\"2514073043\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2514073043?lang=zh_CN&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-02-26 10:57","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2514073043","market":"hk","top_or_hot":-1,"title":"Telix Pharmaceuticals Obtains US FDA Priority Review for Cancer Imaging Agent","media":"MT Newswires Live","content":"<html><body><p> The US Food and Drug Administration has accepted Telix Pharmaceuticals' (ASX:TLX) Biologics License Application for its investigational kidney cancer imaging agent TLX250-CDx, and granted a priority review that would pave the way for a commercial launch within the year, according to a Wednesday filing with the Australian bourse.</p><p>The imaging agent has been given a Prescription Drug User Fee Act (PDUFA) date of Aug. 27. A PDUFA date provides an estimated timeline of when a decision on a drug application would be made.</p><p>TLX250-CDx is said to be the first commercially available imaging agent to accurately and non-invasively diagnose and characterize clear cell renal cell carcinoma, a form of kidney cancer, per the filing.</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>Telix Pharmaceuticals Obtains US FDA Priority Review for Cancer Imaging Agent</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\">\nTelix Pharmaceuticals Obtains US FDA Priority Review for Cancer Imaging Agent\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1092851196\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/3002d84abbd5ace3c99397c7f95b8d4e);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">MT Newswires Live </p>\n<p class=\"h-time\">2025-02-26 10:57</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html><body><p> The US Food and Drug Administration has accepted Telix Pharmaceuticals' (ASX:TLX) Biologics License Application for its investigational kidney cancer imaging agent TLX250-CDx, and granted a priority review that would pave the way for a commercial launch within the year, according to a Wednesday filing with the Australian bourse.</p><p>The imaging agent has been given a Prescription Drug User Fee Act (PDUFA) date of Aug. 27. A PDUFA date provides an estimated timeline of when a decision on a drug application would be made.</p><p>TLX250-CDx is said to be the first commercially available imaging agent to accurately and non-invasively diagnose and characterize clear cell renal cell carcinoma, a form of kidney cancer, per the filing.</p></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"TLX","symbol_name":"Telix Pharmaceuticals Ltd. (Uplisting)","start_time":0,"source_url":"https://www.mtnewswires.com/","article_id":"2514073043","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2514073043","pubTimestamp":1740538643,"columns":[],"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":"The US Food and Drug Administration has accepted Telix Pharmaceuticals'  Biologics License Application for its investigational kidney cancer imaging agent TLX250-CDx, and granted a priority review that would pave the way for a commercial launch within the year, according to a Wednesday filing with the Australian bourse.The imaging agent has been given a Prescription Drug User Fee Act  date of Aug. 27. A PDUFA date provides an estimated timeline of when a decision on a drug application would be made.TLX250-CDx is said to be the first commercially available imaging agent to accurately and non-invasively diagnose and characterize clear cell renal cell carcinoma, a form of kidney cancer, per the filing.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"TLX":"Telix Pharmaceuticals Ltd. (Uplisting)","TLX.AU":"TELIX PHARMACEUTICALS LTD","BK7067":"生物科技"},"translate_title":"Telix制药癌症显像剂获得美国FDA优先审评","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"TLX":1,"TLX.AU":0.9},"content_text":"The US Food and Drug Administration has accepted Telix Pharmaceuticals' (ASX:TLX) Biologics License Application for its investigational kidney cancer imaging agent TLX250-CDx, and granted a priority review that would pave the way for a commercial launch within the year, according to a Wednesday filing with the Australian bourse.The imaging agent has been given a Prescription Drug User Fee Act (PDUFA) date of Aug. 27. A PDUFA date provides an estimated timeline of when a decision on a drug application would be made.TLX250-CDx is said to be the first commercially available imaging agent to accurately and non-invasively diagnose and characterize clear cell renal cell carcinoma, a form of kidney cancer, per the filing.","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":"","news_rank":0,"symbols":[],"gpt_button":1,"need_auth":false,"code":"91000000","status":"200"}}}