Ascendis Soars on Encouraging Data From Dwarfism Drug Study

Zacks09-18 02:12

Shares of Ascendis Pharma ASND rose 17% on Monday after it reported top-line results from the pivotal ApproaCH study that evaluated investigational once-weekly administered TransCon CNP in children ...

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The ApproaCHstudy met its primary endpoint of annualized growth velocity at 52 weeks — children treated with TransCon CNP achieved a mean AGV of 5.89 cm/year compared with 4.41 cm/year in the placebo group.Management also provided sub-group analyses of this data by age groups — children aged two to less than five years and another group aged five to 11 years. Patients in the first group who received TransCon CNP achieved a mean AGV of 6.07 cm/year compared with 5.06 cm/year in placebo. Those who received the drug in the second age group achieved a mean AGV of 5.79 cm/year compared with 4.02 cm/year on placebo.Per Ascendis, treatment with the drug also demonstrated","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","BK4548":"巴美列捷福持仓","BMRN":"拜玛林制药","BVS":"Bioventus Inc.","ASND":"Ascendis Pharma A/S","IE00B19Z3581.USD":"Legg Mason ClearBridge - Value A Acc USD","LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD","IE00B19Z3B42.SGD":"Legg Mason ClearBridge - Value A Acc SGD","BK4585":"ETF&股票定投概念","BK4534":"瑞士信贷持仓","BK4139":"生物科技","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","BK4566":"资本集团","IE00B7SZLL34.SGD":"Legg Mason ClearBridge - Value A Acc SGD-H","BK4535":"淡马锡持仓","BK4121":"生命科学工具和服务","BK4588":"碎股","BK4198":"医疗保健用品","ILMN":"Illumina","IE0002270589.USD":"LEGG MASON CLEARBRIDGE VALUE \"A\" (USD) INC"},"translate_title":"侏儒症药物研究数据令人鼓舞，Ascendis股价飙升","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"ASND":1,"ILMN":1,"BVS":1,"BMRN":0.9},"content_text":"Shares of Ascendis Pharma ASND rose 17% on Monday after it reported top-line results from the pivotal ApproaCH study that evaluated investigational once-weekly administered TransCon CNP in children aged two to 11 years with achondroplasia, the most common form of dwarfism.\nASND Drug Shows AGV Benefit in Achondroplasia Patients\nThe ApproaCH study met its primary endpoint of annualized growth velocity (AGV) at 52 weeks — children treated with TransCon CNP achieved a mean AGV of 5.89 cm/year compared with 4.41 cm/year in the placebo group.\nManagement also provided sub-group analyses of this data by age groups — children aged two to less than five years and another group aged five to 11 years. Patients in the first group who received TransCon CNP achieved a mean AGV of 6.07 cm/year compared with 5.06 cm/year in placebo. Those who received the drug in the second age group achieved a mean AGV of 5.79 cm/year compared with 4.02 cm/year on placebo.\nPer Ascendis, treatment with the drug also demonstrated statistically significant improvement in other secondary endpoints, including height Z-score and changing from baseline AGV.\nBut Why Did BioMarin Stock Dip on TransCon CNP Data\nThere is only one drug approved to treat achondroplasia in the United States and Europe — Voxzogo — which is marketed by BioMarin BMRN. Since its launch in 2021, BMRN has been experiencing a rapid uptake for Voxzogo driven by strong prescription demand. The drug added nearly $337 million to BioMarin’s topline in the first half of 2024, up 67% year over year.\nWhile it is difficult to compare the results of two different clinical studies directly, investors were likely impressed with the once-weekly dosing advantage of TransCon CNP over Voxzogo, which requires daily dosing. This major factor was not only responsible for Ascendis’ share price soaring but also sent BioMarin stock down nearly 18% after the results were announced.\nAscendis’ shares have moved up 10.8% in the year compared with the industry’s 1.0% growth.\nImage Source: Zacks Investment Research\nAscendis’ Future Plans for the Drug\nBased on the ApproaCH study results, management intends to submit a regulatory filing seeking approval for TransCon CNP in achondroplasia with the FDA during first-quarter 2025. It also plans to submit a similar filing with the EMA by third-quarter 2025.\nASND’s Zacks Ranks\nAscendis currently carries a Zacks Rank #3 (Hold).\n\nAscendis Pharma A/S Price\n\nAscendis Pharma A/S price | Ascendis Pharma A/S Quote\n\n \nOur Key Picks in the Biotech Sector\nSome better-ranked stocks in the overall healthcare sector are Bioventus BVS and Illumina ILMN. Each stock presently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.\nIn the past 60 days, estimates for Bioventus’ 2024 earnings per share (EPS) have risen from 27 cents to 40 cents. Estimates for 2025 have increased from 43 cents to 45 cents during the same period. Year to date, shares of Bioventus have surged 109.9%.\nBVS’ earnings beat estimates in three of the last four quarters and missed the mark on one occasion. Bioventus delivered a four-quarter average earnings surprise of 102.86%.\nIn the past 60 days, estimates for Illumina’s 2024 EPS have risen from $1.84 to $3.62. Estimates for 2025 have increased from $3.22 to $4.43 during the same period. Year to date, Illumina’s shares have lost 7.0%.\nEarnings of Illumina beat estimates in each of the last four quarters. Illumina delivered a four-quarter average earnings surprise of 463.46%.\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\nBioMarin Pharmaceutical Inc. (BMRN) : Free Stock Analysis Report\nIllumina, Inc. (ILMN) : Free Stock Analysis Report\nAscendis Pharma A/S (ASND) : Free Stock Analysis Report\nBioventus Inc. (BVS) : 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":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":"4.26.4","shortVersion":"4.26.4","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/2468962873"}