FDA Approves Use of Commercially Manufactured GP2 in Greenwich Lifesciences FLAMINGO-01 Trial

Reuters

Jan 22

FDA Approves Use of Commercially Manufactured GP2 in Greenwich Lifesciences FLAMINGO-01 Trial

Greenwich LifeSciences Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the use of the first commercially manufactured lot of GP2 in the company's Phase III clinical trial, FLAMINGO-01. The trial is evaluating GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences. The approved GP2 vials will be used at all 40 U.S. clinical sites participating in the study. The company plans to submit additional manufacturing data as part of its preparations to file a Biological License Application (BLA) in the U.S. under Fast Track Designation, and to regulatory agencies in Europe, the United Kingdom, and Canada.

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. Greenwich Lifesciences Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9630254-en) on January 22, 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/2605529460"},"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:\"2605529460\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2605529460?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2026-01-22 19:00","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2605529460","market":"fut","top_or_hot":-1,"title":"FDA Approves Use of Commercially Manufactured GP2 in Greenwich Lifesciences FLAMINGO-01 Trial","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 Approves Use of Commercially Manufactured GP2 in Greenwich Lifesciences FLAMINGO-01 Trial\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        Greenwich LifeSciences Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the use of the first commercially manufactured lot of GP2 in the company's Phase III clinical trial, FLAMINGO-01. The trial is evaluating GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences. The approved GP2 vials will be used at all 40 U.S. clinical sites participating in the study. The company plans to submit additional manufacturing data as part of its preparations to file a Biological License Application (BLA) in the U.S. under <a href=\"https://laohu8.com/S/FTRK\">Fast Track</a> Designation, and to regulatory agencies in Europe, the United Kingdom, and Canada.\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/GLSI\">Greenwich Lifesciences Inc</a>. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9630254-en) on January 22, 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>FDA Approves Use of Commercially Manufactured GP2 in Greenwich Lifesciences FLAMINGO-01 Trial</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 Approves Use of Commercially Manufactured GP2 in Greenwich Lifesciences FLAMINGO-01 Trial\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\">2026-01-22 19:00</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 Approves Use of Commercially Manufactured GP2 in Greenwich Lifesciences FLAMINGO-01 Trial\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        Greenwich LifeSciences Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the use of the first commercially manufactured lot of GP2 in the company's Phase III clinical trial, FLAMINGO-01. The trial is evaluating GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences. The approved GP2 vials will be used at all 40 U.S. clinical sites participating in the study. The company plans to submit additional manufacturing data as part of its preparations to file a Biological License Application (BLA) in the U.S. under <a href=\"https://laohu8.com/S/FTRK\">Fast Track</a> Designation, and to regulatory agencies in Europe, the United Kingdom, and Canada.\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/GLSI\">Greenwich Lifesciences Inc</a>. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9630254-en) on January 22, 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":"SG9999014013.SGD","symbol_name":"United Global Durable Equities Fund Dis SGD","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260122:nNDL4m3Qlp:1","article_id":"2605529460","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2605529460","pubTimestamp":1769079619,"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":"Greenwich LifeSciences Inc. announced that the U.S. Food and Drug Administration  has approved the use of the first commercially manufactured lot of GP2 in the company's Phase III clinical trial, FLAMINGO-01. The trial is evaluating GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences. The approved GP2 vials will be used at all 40 U.S. clinical sites participating in the study. The company plans to submit additional manufacturing data as part of its preparations to file a Biological License Application  in the U.S. under Fast Track Designation, and to regulatory agencies in Europe, the United Kingdom, and Canada.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. Greenwich Lifesciences Inc. published the original conten","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"SG9999014013.SGD":"United Global Durable Equities Fund Dis SGD","NDAQ":"纳斯达克OMX交易所","SG9999014005.SGD":"United Global Durable Equities Fund Acc SGD","IE00B64PRP62.GBP":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (GBP) ACC","IE00BGHQF748.EUR":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (EUR) ACC","LU2210149790.SGD":"Natixis Thematics Subscription Economy R/A SGD-H","LU0314104364.USD":"MANULIFE GF AMERICAN GROWTH \"AA\" (USD) INC","IE00BKPKM429.USD":"NEUBERGER BERMAN GLOBAL SUSTAINABLE EQUITY \"A\" (USD) ACC","LU2095319765.USD":"Natixis Thematics Subscription Economy R/A USD","SG9999014039.USD":"UNITED GLOBAL DURABLE EQUITIES (USDHDG) INC","IE00B3QW5Z07.USD":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (USD) ACC","BK4588":"碎股","BK4585":"ETF&股票定投概念","SG9999014021.USD":"UNITED GLOBAL DURABLE EQUITIES (USDHDG) ACC","LU2210150020.SGD":"Natixis Thematics Subscription Economy R/A SGD","BK4112":"金融交易所和数据","BK4139":"生物科技","GLSI":"Greenwich Lifesciences Inc"},"translate_title":"FDA批准在Greenwich Lifesciences FLAMINGO-01试验中使用商业生产的GP2","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"GLSI":0.9,"NDAQ":0.9},"content_text":"FDA Approves Use of Commercially Manufactured GP2 in Greenwich Lifesciences FLAMINGO-01 Trial\n    \n\n        Greenwich LifeSciences Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the use of the first commercially manufactured lot of GP2 in the company's Phase III clinical trial, FLAMINGO-01. The trial is evaluating GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences. The approved GP2 vials will be used at all 40 U.S. clinical sites participating in the study. The company plans to submit additional manufacturing data as part of its preparations to file a Biological License Application (BLA) in the U.S. under Fast Track Designation, and to regulatory agencies in Europe, the United Kingdom, and Canada.\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. Greenwich Lifesciences Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9630254-en) on January 22, 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"}}}