FDA Grants Breakthrough Therapy Designation to Immix Biopharma's NXC-201 for AL Amyloidosis

Reuters01-28

FDA Grants Breakthrough Therapy Designation to <a href="https://laohu8.com/S/IMMX">Immix Biopharma</a>'s NXC-201 for AL Amyloidosis

Immix Biopharma Inc. has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for its therapy NXC-201, intended for the treatment of relapsed/refractory AL Amyloidosis. The designation was granted based on positive interim results from the Phase 2 NEXICART-2 clinical trial, which were presented at the American Society of Hematology $(ASH)$ 2025 annual meeting. Final data from the trial are expected later this year, with a planned Biologics License Application (BLA) submission to follow. Currently, NXC-201 is the only therapy in active development with FDA Breakthrough Therapy Designation for relapsed/refractory AL Amyloidosis.

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. Immix Biopharma Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9643845-en) on January 28, 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.

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/2606714464?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2026-01-28 21:45","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2606714464","market":"us","top_or_hot":-1,"title":"FDA Grants Breakthrough Therapy Designation to Immix Biopharma's NXC-201 for AL Amyloidosis","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 Grants Breakthrough Therapy Designation to <a href=\"https://laohu8.com/S/IMMX\">Immix Biopharma</a>'s NXC-201 for AL Amyloidosis\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        Immix Biopharma Inc. has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for its therapy NXC-201, intended for the treatment of relapsed/refractory AL Amyloidosis. The designation was granted based on positive interim results from the Phase 2 NEXICART-2 clinical trial, which were presented at the American Society of Hematology <a href=\"https://laohu8.com/S/ASH\">$(ASH)$</a> 2025 annual meeting. Final data from the trial are expected later this year, with a planned Biologics License Application (BLA) submission to follow. Currently, NXC-201 is the only therapy in active development with FDA Breakthrough Therapy Designation for relapsed/refractory AL Amyloidosis.\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. Immix Biopharma Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9643845-en) on January 28, 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 Grants Breakthrough Therapy Designation to Immix Biopharma's NXC-201 for AL Amyloidosis</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 Grants Breakthrough Therapy Designation to Immix Biopharma's NXC-201 for AL Amyloidosis\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\">2026-01-28 21:45</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 Grants Breakthrough Therapy Designation to <a href=\"https://laohu8.com/S/IMMX\">Immix Biopharma</a>'s NXC-201 for AL Amyloidosis\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        Immix Biopharma Inc. has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for its therapy NXC-201, intended for the treatment of relapsed/refractory AL Amyloidosis. The designation was granted based on positive interim results from the Phase 2 NEXICART-2 clinical trial, which were presented at the American Society of Hematology <a href=\"https://laohu8.com/S/ASH\">$(ASH)$</a> 2025 annual meeting. Final data from the trial are expected later this year, with a planned Biologics License Application (BLA) submission to follow. Currently, NXC-201 is the only therapy in active development with FDA Breakthrough Therapy Designation for relapsed/refractory AL Amyloidosis.\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. Immix Biopharma Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9643845-en) on January 28, 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":"LU0314104364.USD","symbol_name":"MANULIFE GF AMERICAN GROWTH \"AA\" (USD) INC","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260128:nNDL2kWV5R:1","article_id":"2606714464","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2606714464","pubTimestamp":1769607912,"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":"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. Immix Biopharma Inc. published the original content used to generate this news brief via GlobeNewswire  on January 28, 2026, and is solely responsible for the information contained therein.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU0314104364.USD":"MANULIFE GF AMERICAN GROWTH \"AA\" (USD) INC","LU2095319765.USD":"Natixis Thematics Subscription Economy R/A USD","BK4139":"生物科技","IE00BKPKM429.USD":"NEUBERGER BERMAN GLOBAL SUSTAINABLE EQUITY \"A\" (USD) ACC","SG9999014039.USD":"UNITED GLOBAL DURABLE EQUITIES (USDHDG) INC","IE00B3QW5Z07.USD":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (USD) ACC","IMMX":"Immix Biopharma, Inc","LU2210149790.SGD":"Natixis Thematics Subscription Economy R/A SGD-H","LU2210150020.SGD":"Natixis Thematics Subscription Economy R/A SGD","SG9999014021.USD":"UNITED GLOBAL DURABLE EQUITIES (USDHDG) ACC","BK4588":"碎股","SG9999014005.SGD":"United Global Durable Equities Fund Acc SGD","BK4112":"金融交易所和数据","NDAQ":"纳斯达克OMX交易所","BK4585":"ETF&股票定投概念","IE00BGHQF748.EUR":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (EUR) ACC","IE00B64PRP62.GBP":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (GBP) ACC","SG9999014013.SGD":"United Global Durable Equities Fund Dis SGD"},"translate_title":"FDA授予Immix Biopharma的NXC-201治疗AL淀粉样变性突破性疗法称号","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"IMMX":0.9,"NDAQ":0.9},"content_text":"FDA Grants Breakthrough Therapy Designation to Immix Biopharma's NXC-201 for AL Amyloidosis\n    \n\n        Immix Biopharma Inc. has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for its therapy NXC-201, intended for the treatment of relapsed/refractory AL Amyloidosis. The designation was granted based on positive interim results from the Phase 2 NEXICART-2 clinical trial, which were presented at the American Society of Hematology $(ASH)$ 2025 annual meeting. Final data from the trial are expected later this year, with a planned Biologics License Application (BLA) submission to follow. Currently, NXC-201 is the only therapy in active development with FDA Breakthrough Therapy Designation for relapsed/refractory AL Amyloidosis.\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. Immix Biopharma Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9643845-en) on January 28, 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"},"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,"tenantId":"TBGLOBAL","deviceId":"web-server-community-laohu8-v3","version":"4.36.2","shortVersion":"4.36.2","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/2606714464","isCrawlerRequest":true}