NTLA Begins Dosing in Pivotal Study on Hereditary Angioedema Candidate

Zacks01-23

Intellia Therapeutics NTLA announced that it has dosed the first patient in the phase III HAELO study evaluating NTLA-2002, its novel in vivo CRISPR gene editing therapy for the treatment of ...

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The key endpoint of the study is to see the change in the number of HAE attacks from week five through week 28 of treatment.Enrollment of patients in the study is expected to be completed in the second half of 2025. Intellia plans to submit a biologics license application for NTLA-2002 in HAE in 2026. Upon potential approval, the company plans to launch NTLA-2002 in 2027 in the United States.Despite the current treatment options that require chronic administration for disease control, HAE attacks still occur. 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The key endpoint of the study is to see the change in the number of HAE attacks from week five through week 28 of treatment.\nEnrollment of patients in the study is expected to be completed in the second half of 2025. Intellia plans to submit a biologics license application for NTLA-2002 in HAE in 2026. Upon potential approval, the company plans to launch NTLA-2002 in 2027 in the United States.\nIn October 2024, NTLA initiated the HAELO study on NTLA-2002 for treating HAE.\nDespite the current treatment options that require chronic administration for disease control, HAE attacks still occur. NTLA-2002 aims to prevent HAE attacks by suppressing the plasma kallikrein activity.\nIn the past year, shares of Intellia have plunged 56.1% compared with the industry’s decline of 12%.\nImage Source: Zacks Investment Research\nNTLA Developing Another Candidate NTLA-2001\nBesides NTLA-2002, Intellia is developing its investigational in vivo genome-editing candidate, Nexiguran ziclumeran (nex-z, also known as NTLA-2001). The company has collaborated with Regeneron Pharmaceuticals REGN for the development of nex-z.\nNex-z is part of the company’s co-development and co-promotion agreement with Regeneron. While NTLA is the lead party in the deal for nex-z, REGN shares 25% of the development costs and commercial profits.\nEarlier this month, the company announced a strategic reorganization of its portfolio wherein it prioritized the development of nex-z, which is being studied for two indications, ATTR amyloidosis with polyneuropathy (ATTRv-PN) and ATTR amyloidosis with cardiomyopathy (ATTR-CM).\nThe phase III MAGNITUDE study is evaluating the safety and efficacy of nex-z in patients with ATTR amyloidosis with cardiomyopathy. Enrollment is currently ongoing in the study.\nThe phase III MAGNITUDE 2 study is actively screening patients with hereditary ATTR amyloidosis with polyneuropathy, with the first patient expected to be dosed later in the first quarter of 2025.\nNTLA's Zacks Rank & Stocks to Consider\nIntellia currently carries a Zacks Rank #3 (Hold).\nSome better-ranked stocks in the biotech sector are Voyager Therapeutics, Inc. VYGR and Castle Biosciences, Inc. CSTL, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.\nIn the past 60 days, estimates for Voyager Therapeutics’ loss per share have narrowed from $1.72 to $1.58 for 2025. In the past year, shares of VYGR have plunged 27.2%.\nVYGR’s earnings beat estimates in each of the trailing four quarters, the average surprise being 120.87%.\nIn the past 60 days, estimates for Castle Biosciences’ loss per share have narrowed from $1.88 to $1.84 for 2025. In the past year, shares of CSTL have surged 35.1%.\nCSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.\nWant the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report\nRegeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report\nVoyager Therapeutics, Inc. (VYGR) : Free Stock Analysis Report\nIntellia Therapeutics, Inc. (NTLA) : Free Stock Analysis Report\nCastle Biosciences, Inc. (CSTL) : Free Stock Analysis Report\nTo read this article on Zacks.com click here.\nZacks Investment Research","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"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,"deviceId":"web-server-community-laohu8-v3","version":"4.30.2","shortVersion":"4.30.2","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/2505017911"}