FDA Clears Intellia Phase 3 ATTRv PN Trial Lifting Key Overhang

Simply Wall St.14:24

FDA lifts clinical hold on Intellia Therapeutics' Phase 3 MAGNITUDE-2 trial of Nexiguran Ziclumeran (Nex-Z) for hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN). Regulators cleared ...

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Regulators cleared ...</p>\n\n<a href=\"https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-ntla/intellia-therapeutics/news/fda-clears-intellia-phase-3-attrv-pn-trial-lifting-key-overh\">Source Link</a>\n\n</div>\n","source":"simplywall_highlight","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 Clears Intellia Phase 3 ATTRv PN Trial Lifting Key Overhang</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 Clears Intellia Phase 3 ATTRv PN Trial Lifting Key Overhang\n</h2>\n\n<h4 class=\"meta\">\n\n\n2026-02-04 14:24 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-ntla/intellia-therapeutics/news/fda-clears-intellia-phase-3-attrv-pn-trial-lifting-key-overh><strong>Simply Wall St.</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>FDA lifts clinical hold on Intellia Therapeutics' Phase 3 MAGNITUDE-2 trial of Nexiguran Ziclumeran (Nex-Z) for hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN). Regulators cleared ...</p>\n\n<a href=\"https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-ntla/intellia-therapeutics/news/fda-clears-intellia-phase-3-attrv-pn-trial-lifting-key-overh\">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":"LU1861559042.SGD","symbol_name":"日兴方舟颠覆性创新基金B SGD","start_time":0,"source_url":"https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-ntla/intellia-therapeutics/news/fda-clears-intellia-phase-3-attrv-pn-trial-lifting-key-overh","article_id":"2608201353","we_media_id":null,"thumbnails":["https://images.simplywall.st/asset/industry/6111000-choice1-main-header/1585186710114"],"rights":{"source":"simplywall_highlight","url":"https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-ntla/intellia-therapeutics/news/fda-clears-intellia-phase-3-attrv-pn-trial-lifting-key-overh","rn_cache_url":null,"directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2608201353","pubTimestamp":1770186280,"columns":[],"sourceInfo":{"source_id":"simplywall_highlight","name":"Simply Wall St."},"weMediaInfo":null,"summary":"FDA lifts clinical hold on Intellia Therapeutics' Phase 3 MAGNITUDE-2 trial of Nexiguran Ziclumeran (Nex-Z) for hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN).\nRegulators cleared trial resumption following agreement on study modifications and enhanced safety monitoring.\nThe decision affects Intellia Therapeutics' (NasdaqGM:NTLA) late stage gene editing pipeline and its progress in ATTRv-PN.\n\nIntellia Therapeutics, traded as NasdaqGM:NTLA, is developing CRISPR based...","collect":0,"end_time":0,"defaultTopTitle":"simplywall.st","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU1861559042.SGD":"日兴方舟颠覆性创新基金B SGD","NTLA":"Intellia Therapeutics Inc","LU1861558580.USD":"日兴方舟颠覆性创新基金B","BK4556":"基因编辑","BK4585":"ETF&股票定投概念","BK4588":"碎股","BK4139":"生物科技","BK4535":"淡马锡持仓"},"translate_title":"FDA批准Intellia 3期ATTRv PN试验解除关键悬念","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"NTLA":0.9},"content_text":"FDA lifts clinical hold on Intellia Therapeutics' Phase 3 MAGNITUDE-2 trial of Nexiguran Ziclumeran (Nex-Z) for hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN). Regulators cleared trial resumption following agreement on study modifications and enhanced safety monitoring. The decision affects Intellia Therapeutics' (NasdaqGM:NTLA) late stage gene editing pipeline and its progress in ATTRv-PN.  Intellia Therapeutics, traded as NasdaqGM:NTLA, is developing CRISPR based therapies that aim to address genetic diseases at their source. The FDA decision on Nex-Z matters because it allows a pivotal ATTRv-PN program to move forward after a safety related pause, which had temporarily stalled one of the company's advanced clinical assets. For investors, the lifting of the hold removes a key near term regulatory overhang on this trial and clarifies the path for ongoing data collection. The agreed study changes and tighter safety oversight will be an important focus as market participants track how Nex-Z progresses through the rest of Phase 3. Stay updated on the most important news stories for Intellia Therapeutics by adding it to your watchlist or portfolio. Alternatively, explore our Community to discover new perspectives on Intellia Therapeutics. NasdaqGM:NTLA Earnings & Revenue Growth as at Feb 2026 How Intellia Therapeutics stacks up against its biggest competitors AdvertisementQuick Assessment  ✅ Price vs Analyst Target: At US$13.05 versus a US$23.86 analyst target, the stock trades about 45% below consensus. ✅ Simply Wall St Valuation: Simply Wall St flags the shares as trading roughly 94.4% below its estimated fair value. ✅ Recent Momentum: The 30 day return of 41.69% shows strong short term momentum into this news.  Check out Simply Wall St's\nin depth valuation analysis for Intellia Therapeutics. Key Considerations  📊 The FDA lifting the hold puts a late stage ATTRv PN asset back on track. This is central to the NTLA gene editing story. 📊 Keep an eye on safety updates, trial timelines and how the share price behaves relative to the US$23.86 target and peer value of US$12.24. ⚠️ The company remains loss making, with a net loss of US$445.81m and negative EPS of US$3.85, so funding and dilution risk stay relevant.  Dig Deeper For the full picture including more risks and rewards, check out the\ncomplete Intellia Therapeutics analysis.  This article by Simply Wall St is general in nature. We provide commentary based on historical data\n    and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your\n    financial situation. We aim to bring you long-term focused analysis driven by fundamental data.\n    Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material.\n    Simply Wall St has no position in any stocks mentioned.New: AI Stock Screener & AlertsOur new AI Stock Screener scans the market every day to uncover opportunities.• Dividend Powerhouses (3%+ Yield)• Undervalued Small Caps with Insider Buying• High growth Tech and AI CompaniesOr build your own from over 50 metrics.Explore Now for FreeHave feedback on this article? Concerned about the content? Get in touch with us directly. 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