ALNY Reports Sustained 6-Month Efficacy Data From Amyloidosis Study

Zacks11-18

Alnylam Pharmaceuticals ALNY presented new data from its early-stage study of nucresiran (formerly ALN-TTRsc04) for treating transthyretin (ATTR) amyloidosis at a recent medical conference in Chicago....

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The study's primary endpoint is safety and secondary endpoints include the change from baseline in serum TTR over time, as well as characterization of plasma and urine PK of nucresiran.ALNY’s Amyloidosis Drug Shows Sustained 6-Month Efficacy. Per the data from an interim analysis of the phase I ATTR amyloidosis study, it was observed that a single 300 mg or higher dose of nucresiran quickly reduced serum TTR levels with low inter-patient variability, by more than 90% within 15 days, sustained through at least six months. At these dosage strengths, the reduction of mean TTR levels peaked at more than 96% by Day 29. Furthermore, serum TTR levelsremained significantly reduced, with a mean decrease of more than 70% at the one-year m","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU1066053197.SGD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM3\" (SGDHDG) INC","LU1430594728.SGD":"Eastspring Investments - Global Low Volatility Equity AS SGD","GILD":"吉利德科学","ALNY":"阿尔尼拉姆制药公司","BK4583":"猴痘概念","IE000M9KFDE8.USD":"NEUBERGER BERMAN US LARGE CAP VALUE \"A\" (USD) ACC","LU0868494617.USD":"UBS (LUX) EQUITY SICAV - US TOTAL YIELD SUSTAINABLE \"P\" (USD) ACC","BK4532":"文艺复兴科技持仓","BK4592":"伊斯兰概念","PK":"Park Hotels & Resorts Inc.","IE00BKVL7J92.USD":"Legg Mason ClearBridge - US Equity Sustainability Leaders A Acc USD","BK4534":"瑞士信贷持仓","BK4139":"生物科技","BK4533":"AQR资本管理(全球第二大对冲基金)","SG9999001176.USD":"United Global Healthcare Acc USD","LU1585245621.USD":"EASTSPRING INV GLOBAL LOW VOLATILITY EQUITY FUND \"A\" (USD) ACC B","BK4007":"制药","PFE":"辉瑞","LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","BK4566":"资本集团","ALLO":"Allogene Therapeutics Inc.","IE00BLSP4452.SGD":"Legg Mason ClearBridge - Tactical Dividend Income A Mdis SGD-H Plus","SG9999003800.SGD":"Nikko AM Global Dividend Equity Acc SGD-H","LU0306807586.USD":"SCHRODER ISF GLOBAL DIVIDEND MAXIMISER \"A\" (USD) INC QF","SG9999013999.USD":"UOB UNITED GLOBAL HEALTHCARE FUND (USDHDG) INC","BK4578":"CAR-T","SGXZ57979304.SGD":"United Global Healthcare A Acc SGD-H","SG9999001176.SGD":"UOB UNITED GLOBAL HEALTHCARE \"SGD\" (ACC)","LU1839511570.USD":"WELLS FARGO GLOBAL FACTOR ENHANCED EQUITY \"I\" (USD) ACC","LU0456855351.SGD":"JPMorgan Funds - Global Equity A (acc) SGD","IE00B19Z3581.USD":"Legg Mason ClearBridge - Value A Acc USD","BK4568":"美国抗疫概念","LU1023059063.AUD":"BGF WORLD HEALTHSCIENCE \"A2\" (AUDHDG) ACC","LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD","LU1057294990.SGD":"Blackrock World Healthscience A2 SGD-H","SG9999011175.SGD":"Nikko AM Global Dividend Equity Dis SGD-H","IE00BBT3K403.USD":"LEGG MASON CLEARBRIDGE TACTICAL DIVIDEND INCOME \"A(USD) ACC","LU0321505439.SGD":"Schroder ISF Global Dividend Maximiser A Acc SGD","LU0321505868.SGD":"Schroder ISF Global Dividend Maximiser A Dis SGD","IE00BSNM7G36.USD":"NEUBERGER BERMAN SYSTEMATIC GLOBAL SUSTAINABLE VALUE \"A\" (USD) ACC","LU0234572021.USD":"高盛美国核心股票组合Acc","LU0058720904.USD":"联博国际健康护理基金A","LU0985481810.HKD":"SCHRODER ISF GLOBAL EQUITY YIELD \"A\" (HKD) INC M","SG9999002232.USD":"Allianz Global High Payout USD","LU1066051498.USD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM2\" (USD) INC","SG9999002224.SGD":"Allianz Global High Payout SGD","LU1894683264.USD":"AMUNDI FUNDS US EQUITY RESEARCH VALUE \"A2\" (USD) ACC","IE00BZ1G4Q59.USD":"LEGG MASON CLEARBRIDGE US EQUITY SUSTAINABILITY LEADER \"A\"(USD) INC (A)","LU0225771236.USD":"SCHRODER ISF GLOBAL EQUITY YIELD \"A\" (USD) INC MF","BK4218":"酒店及度假村房地产信托"},"translate_title":"ALNY报告淀粉样变性研究的持续6个月疗效数据","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"ALNY":1,"GILD":1,"PK":1,"ALLO":1,"PFE":0.9},"content_text":"Alnylam Pharmaceuticals ALNY presented new data from its early-stage study of nucresiran (formerly ALN-TTRsc04) for treating transthyretin (ATTR) amyloidosis at a recent medical conference in Chicago. Nucresiran is ALNY’s next-generation RNAi therapeutic, which is being developed leveraging the company’s proprietary IKARIA platform.\nThe ongoing phase I study evaluates the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic effects of nucresiran in 48 healthy adult subjects, who have been randomized in a ratio of 3:1 to receive either a single ascending dose of nucresiran or placebo. The study's primary endpoint is safety and secondary endpoints include the change from baseline in serum TTR over time, as well as characterization of plasma and urine PK of nucresiran.\nALNY’s Amyloidosis Drug Shows Sustained 6-Month Efficacy\nPer the data from an interim analysis of the phase I ATTR amyloidosis study, it was observed that a single 300 mg or higher dose of nucresiran quickly reduced serum TTR levels with low inter-patient variability, by more than 90% within 15 days, sustained through at least six months. At these dosage strengths, the reduction of mean TTR levels peaked at more than 96% by Day 29. Furthermore, serum TTR levels remained significantly reduced, with a mean decrease of more than 70% at the one-year mark after a single 300 mg dose. Alnylam reported that the one-year data for the 600 and 900 mg doses are not yet available.\nYear to date, shares of ALNY have gained 23.1% against the industry’s 10.5% decline.\nImage Source: Zacks Investment Research\nManagement is optimistic about nucresiran's ability to minimize interpatient variability in TTR reduction. Its demonstrated durability suggests the potential for biannual or annual dosing, offering a new approach to treating ATTR amyloidosis. Alnylam expects to share late-stage development plans in the first quarter of 2025.\nWe remind the investors that Alnylam had earlier reported nucresiran 300 mg six-month data from the phase I ATTR amyloidosis study at its R&D day last year held in December.\nAlnylam also reported that all tested doses of nucresiran have been well tolerated in the early-stage ATTR amyloidosis study. Adverse events were mostly mild in severity and none were related to treatment with different doses of the candidate.\nALNY’s Marketed Amyloidosis Drugs\nAlnylam currently markets Amvuttra, the company’s lead drug, in the United States for the treatment of adult patients with polyneuropathy of hereditary ATTR (hATTR) amyloidosis. Amvuttra is also available in the EU for treating hATTR amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy. Alnylam also markets Onpattro, which is approved in the United States and EU to treat hATTR amyloidosis in adults.\nPlease note that Amvuttra sales are the primary contributor to Alnylam’s top line. The drug generated sales worth $258.6 million in the third quarter, up 74% on a reported basis. The encouraging uptake of the product is driven by new patients starting treatment as well as several patients switching from Onpattro.\nAlnylam is also currently seeking to expand Amvuttra’s label to include the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM). Regulatory applications are currently under review in the United States as well as in the EU. Subject to approval, the company believes that Amvuttra has the potential to become the new standard of care for the treatment of ATTR-CM. This will expand the eligible patient population for the drug driving substantial growth for the company in the future.\n\nAlnylam Pharmaceuticals, Inc. Price and Consensus\n\nAlnylam Pharmaceuticals, Inc. price-consensus-chart | Alnylam Pharmaceuticals, Inc. Quote\n\nALNY’s Zacks Rank and Stocks to Consider\nAlnylam currently carries a Zacks Rank #3 (Hold).\nSome better-ranked pharma stocks are Allogene Therapeutics ALLO, Pfizer PFE and Gilead Sciences GILD, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.\nAllogene Therapeutics’ loss estimates per share have narrowed from $1.40 to $1.35 for 2024 over the past 60 days, while that for 2025 has narrowed from $1.46 to $1.34. ALLO’s shares have lost 29.3% year to date.\nAllogene Therapeutics’ earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 9.42%.\nPfizer’s earnings estimates have risen from $2.62 to $2.88 per share for 2024 over the past 60 days, while that for 2025 has increased from $2.85 to $2.92. PFE shares have lost 13.9% year to date.\nPfizer’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 74.50%.\nGilead Sciences’ earnings estimates have risen from $3.79 to $4.28 per share for 2024 over the past 60 days, while that for 2025 has increased from $7.24 to $7.40. GILD shares have risen 9.1% year to date.\nGilead Sciences’ earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 15.46%.\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\nAlnylam Pharmaceuticals, Inc. (ALNY) : Free Stock Analysis Report\nPfizer Inc. (PFE) : Free Stock Analysis Report\nGilead Sciences, Inc. (GILD) : Free Stock Analysis Report\nAllogene Therapeutics, Inc. (ALLO) : Free Stock Analysis Report\nTo read this article on Zacks.com click here.\nZacks Investment Research","kind":null,"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":0},"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":"4.29.2","shortVersion":"4.29.2","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/2484234674"}