Ascendis Wins FDA Approval For Rare Disease Therapy

Benzinga

Mar 02

Ascendis Pharma A/S (NASDAQ:ASND) shares are up during Monday’s premarket session following the FDA’s approval of Yuviwel (navepegritide; developed as TransCon CNP), the first and only once-weekly ...

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developed as TransCon CNP), the first and only once-weekly ...</p>\n\n<a href=\"https://www.benzinga.com/news/fda/26/03/50962547/ascendis-wins-fda-approval-for-rare-disease-therapy\">Source Link</a>\n\n</div>\n","source":"benzinga_hot_news","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>Ascendis Wins FDA Approval For Rare Disease Therapy</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; 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developed as TransCon CNP), the first and only once-weekly ...</p>\n\n<a href=\"https://www.benzinga.com/news/fda/26/03/50962547/ascendis-wins-fda-approval-for-rare-disease-therapy\">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":"BK4139","symbol_name":"生物科技","start_time":0,"source_url":"https://www.benzinga.com/news/fda/26/03/50962547/ascendis-wins-fda-approval-for-rare-disease-therapy","article_id":"2616833798","we_media_id":null,"thumbnails":["https://cdn.benzinga.com/files/images/story/2026/03/02/FDA_0.jpeg?optimize=medium&dpr=2&auto=webp&width=630"],"rights":{"source":"benzinga_hot_news","url":"https://www.benzinga.com/news/fda/26/03/50962547/ascendis-wins-fda-approval-for-rare-disease-therapy","rn_cache_url":null,"directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2616833798","pubTimestamp":1772456520,"columns":[],"sourceInfo":{"source_id":"benzinga_hot_news","name":"Benzinga"},"weMediaInfo":null,"summary":"Ascendis Pharma A/S  shares are up during Monday’s premarket session following the FDA’s approval of Yuviwel , the first and only once-weekly treatment for children with achondroplasia.The FDA approved Yuviwel, a prodrug designed to increase linear growth in children aged two years and older with achondroplasia, based on data from three randomized clinical trials.Achondroplasia is a rare genetic disorder causing dwarfism, characterized by short limbs, a normal-sized torso, and a large head.Ascendis Pharma plans to make Yuviwel available through prescribing physicians in the U.S. during the early part of the second quarter of 2026.In November, Ascendis Pharma announced that pivotal week 52 results from its ApproaCH Trial of investigational once-weekly TransCon CNP  in children with achondroplasia have been published in JAMA Pediatrics, a journal of the American Medical Association.Additionally, the approval includes a Rare Pediatric Disease Priority Review Voucher, which could expedite ","collect":0,"end_time":0,"defaultTopTitle":"benzinga.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4139":"生物科技","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","BK4217":"自存仓储房地产信托","LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD","ASND":"Ascendis Pharma A/S","BK4585":"ETF&股票定投概念","SMA":"Smartstop Self Storage REIT Inc"},"translate_title":"Ascendis罕见病疗法获FDA批准","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"ASND":1,"SMA":1},"content_text":"Ascendis Pharma A/S (NASDAQ:ASND) shares are up during Monday’s premarket session following the FDA’s approval of Yuviwel (navepegritide; developed as TransCon CNP), the first and only once-weekly treatment for children with achondroplasia.\nThe FDA approved Yuviwel, a prodrug designed to increase linear growth in children aged two years and older with achondroplasia, based on data from three randomized clinical trials.\nAchondroplasia is a rare genetic disorder causing dwarfism, characterized by short limbs, a normal-sized torso, and a large head.\nAscendis Pharma plans to make Yuviwel available through prescribing physicians in the U.S. during the early part of the second quarter of 2026.\nIn November, Ascendis Pharma announced that pivotal week 52 results from its ApproaCH Trial of investigational once-weekly TransCon CNP (navepegritide) in children with achondroplasia have been published in JAMA Pediatrics, a journal of the American Medical Association.\nAdditionally, the approval includes a Rare Pediatric Disease Priority Review Voucher, which could expedite future drug applications. This development marks a significant advancement in treatment options for a condition that affects many children, providing a new avenue for growth in Ascendis Pharma’s portfolio.\nThe stock is currently trading 0.42% below its 20-day simple moving average (SMA) and 2.45% above its 100-day SMA, indicating some short-term weakness but longer-term strength. Over the past 12 months, shares have increased significantly and are currently positioned closer to their 52-week highs than lows.\nThe RSI is at 50.00, which is considered neutral territory, suggesting that the stock is neither overbought nor oversold at this time. Meanwhile, MACD is at 0.15, below its signal line at 0.22, indicating bearish pressure on the stock. The combination of neutral RSI and bearish MACD suggests mixed momentum.\nAnalyst Consensus & Recent Actions: The stock carries a Buy Rating with an average price target of $261.21. Recent analyst moves include:\nASND Price Action: Ascendis Pharma shares were up 3.21% at $241.00 during premarket trading on Monday, according to Benzinga Pro data.\nPhoto by Tada Images via Shutterstock\nTo add Benzinga News as your preferred source on Google, click here.","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":false,"editions":null,"column":"","sentiment":"2","news_tag":"productRelease","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":0,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"}}}