Imagion Biosystems Submits IND Application to FDA for MagSense HER2 Imaging Agent

Reuters

Feb 04

<a href="https://laohu8.com/S/IBXXF">Imagion Biosystems</a> Submits IND Application to FDA for MagSense HER2 Imaging Agent

Imagion Biosystems Ltd. has submitted an Investigational New Drug $(IND)$ application to the U.S. Food and Drug Administration (FDA) for its MagSense® HER2 targeted imaging agent. The company plans to initiate a Phase 2 clinical trial to evaluate the imaging agent for detecting nodal metastases in HER2-positive breast cancer patients, pending FDA approval. Enrollment for the trial could begin as early as the first quarter of 2026, based on historical FDA review timelines. Imagion Biosystems has engaged all necessary strategic trial partners and is advancing logistical preparations in compliance with Good Clinical Practices.

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. Imagion Biosystems Ltd. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260203442564) on February 03, 2026, 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.

Most Discussed

1
2
3
4
5
6
7
8
9
10

{"basename":"","ssrTDKData":{"titleTemplate":"%s - Tiger Brokers","title":"Tiger Brokers | Global Stocks, Options & Futures Trading App","description":"Tiger Brokers, one-stop investment in US stocks, SGX stocks, HK stocks, A-shares & other global assets. One of the best stock trading platforms in Singapore.","keywords":"tiger brokers,tiger trade,tiger brokers singapore,broker online,stock trading in singapore,share trading singapore,brokerage firm singapore,trading app,stock broker singapore,stock trading platforms,trading account","social":{"ogDescription":"Tiger Brokers, one-stop investment in US stocks, SGX stocks, HK stocks, A-shares & other global assets. One of the best stock trading platforms in Singapore.","ogImage":"https://c1.itigergrowtha.com/portal5/static/media/og-logo.be62fbe1.png","ogUrl":"https://www.itiger.com/news/2608580538"},"companyName":"Tiger Brokers"},"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:\"2608580538\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2608580538?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2026-02-04 00:30","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2608580538","market":"us","top_or_hot":-1,"title":"Imagion Biosystems Submits IND Application to FDA for MagSense HER2 Imaging Agent","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      <a href=\"https://laohu8.com/S/IBXXF\">Imagion Biosystems</a> Submits IND Application to FDA for MagSense HER2 Imaging Agent\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/IBXN.AU\">Imagion Biosystems Ltd</a>. has submitted an Investigational New Drug <a href=\"https://laohu8.com/S/IND\">$(IND)$</a> application to the U.S. Food and Drug Administration (FDA) for its MagSense® HER2 targeted imaging agent. The company plans to initiate a Phase 2 clinical trial to evaluate the imaging agent for detecting nodal metastases in HER2-positive breast cancer patients, pending FDA approval. Enrollment for the trial could begin as early as the first quarter of 2026, based on historical FDA review timelines. <a href=\"https://laohu8.com/S/IBX.AU\">Imagion Biosystems</a> has engaged all necessary strategic trial partners and is advancing logistical preparations in compliance with Good Clinical Practices.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>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. <a href=\"https://laohu8.com/S/IBXDA.AU\">Imagion Biosystems</a> Ltd. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260203442564) on February 03, 2026, and is solely responsible for the information contained therein.</span></i>\n</p>\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>Imagion Biosystems Submits IND Application to FDA for MagSense HER2 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\">\nImagion Biosystems Submits IND Application to FDA for MagSense HER2 Imaging Agent\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\">2026-02-04 00:30</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      <a href=\"https://laohu8.com/S/IBXXF\">Imagion Biosystems</a> Submits IND Application to FDA for MagSense HER2 Imaging Agent\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/IBXN.AU\">Imagion Biosystems Ltd</a>. has submitted an Investigational New Drug <a href=\"https://laohu8.com/S/IND\">$(IND)$</a> application to the U.S. Food and Drug Administration (FDA) for its MagSense® HER2 targeted imaging agent. The company plans to initiate a Phase 2 clinical trial to evaluate the imaging agent for detecting nodal metastases in HER2-positive breast cancer patients, pending FDA approval. Enrollment for the trial could begin as early as the first quarter of 2026, based on historical FDA review timelines. <a href=\"https://laohu8.com/S/IBX.AU\">Imagion Biosystems</a> has engaged all necessary strategic trial partners and is advancing logistical preparations in compliance with Good Clinical Practices.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>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. <a href=\"https://laohu8.com/S/IBXDA.AU\">Imagion Biosystems</a> Ltd. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260203442564) on February 03, 2026, and is solely responsible for the information contained therein.</span></i>\n</p>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK7007","symbol_name":"医疗保健设备","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260203:nNDL3fhmTg:1","article_id":"2608580538","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2608580538","pubTimestamp":1770136218,"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":"Imagion Biosystems Ltd. has submitted an Investigational New Drug  application to the U.S. Food and Drug Administration  for its MagSense HER2 targeted imaging agent. The company plans to initiate a Phase 2 clinical trial to evaluate the imaging agent for detecting nodal metastases in HER2-positive breast cancer patients, pending FDA approval. Enrollment for the trial could begin as early as the first quarter of 2026, based on historical FDA review timelines. Imagion Biosystems has engaged all necessary strategic trial partners and is advancing logistical preparations in compliance with Good Clinical Practices.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 legal advice. Imagion Biosystems Ltd. published the original content used to generate this ne","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK7007":"医疗保健设备","IBX.AU":"Imagion Biosystems"},"translate_title":"Imagion Biosystems向FDA提交MagSense HER2显像剂IND申请","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"IBX.AU":0.9},"content_text":"Imagion Biosystems Submits IND Application to FDA for MagSense HER2 Imaging Agent\n    \n\nImagion Biosystems Ltd. has submitted an Investigational New Drug $(IND)$ application to the U.S. Food and Drug Administration (FDA) for its MagSense® HER2 targeted imaging agent. The company plans to initiate a Phase 2 clinical trial to evaluate the imaging agent for detecting nodal metastases in HER2-positive breast cancer patients, pending FDA approval. Enrollment for the trial could begin as early as the first quarter of 2026, based on historical FDA review timelines. Imagion Biosystems has engaged all necessary strategic trial partners and is advancing logistical preparations in compliance with Good Clinical Practices.\n      \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. Imagion Biosystems Ltd. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260203442564) on February 03, 2026, 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"}}}