BioCryst Unveils Data Showing ORLADEYO Cuts HAE Attacks in Children in Yearlong Trial

Reuters11-06

BioCryst Unveils Data Showing ORLADEYO Cuts HAE Attacks in Children in Yearlong Trial

BioCryst Pharmaceuticals Inc. has announced new data from the ongoing APeX-P clinical trial evaluating ORLADEYO® (berotralstat) in pediatric patients with hereditary angioedema $(HAE)$ aged 2 to under 12 years. The results, presented at the Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI) in November 2025, show early and sustained reductions in monthly HAE attack rates over one year of treatment with once-daily ORLADEYO oral granules. The company also highlighted findings on the negative psychosocial impact of HAE and emergency care visits on children and their caregivers. A New Drug Application for ORLADEYO oral granules as prophylaxis in this pediatric population is currently under review by the U.S. Food and Drug Administration, with a decision expected by the end of 2025. If approved, ORLADEYO would be the first targeted oral prophylactic therapy for HAE patients aged 2 to under 12 years.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. BioCryst Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9570032-en) on November 06, 2025, and is solely responsible for the information contained therein.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap

Leave a comment

{"i18n":{"language":"en_US"},"isChannel":false,"data":{"share":"https://ttm.financial/m/news/2581093327?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-11-06 21:00","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2581093327","market":"us","top_or_hot":-1,"title":"BioCryst Unveils Data Showing ORLADEYO Cuts HAE Attacks in Children in Yearlong Trial","media":"Reuters","content":"<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      BioCryst Unveils Data Showing ORLADEYO Cuts HAE Attacks in Children in Yearlong Trial\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        BioCryst Pharmaceuticals Inc. has announced new data from the ongoing APeX-P clinical trial evaluating ORLADEYO® (berotralstat) in pediatric patients with hereditary angioedema <a href=\"https://laohu8.com/S/HAE\">$(HAE)$</a> aged 2 to under 12 years. The results, presented at the Annual Scientific Meeting of the American College of Allergy, Asthma &amp; Immunology (ACAAI) in November 2025, show early and sustained reductions in monthly HAE attack rates over one year of treatment with once-daily ORLADEYO oral granules. The company also highlighted findings on the negative psychosocial impact of HAE and emergency care visits on children and their caregivers. A New Drug Application for ORLADEYO oral granules as prophylaxis in this pediatric population is currently under review by the U.S. Food and Drug Administration, with a decision expected by the end of 2025. If approved, ORLADEYO would be the first targeted oral prophylactic therapy for HAE patients aged 2 to under 12 years.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. BioCryst Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9570032-en) on November 06, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>","source":null,"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>BioCryst Unveils Data Showing ORLADEYO Cuts HAE Attacks in Children in Yearlong Trial</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\">\nBioCryst Unveils Data Showing ORLADEYO Cuts HAE Attacks in Children in Yearlong Trial\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1032215980\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Reuters </p>\n<p class=\"h-time\">2025-11-06 21:00</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      BioCryst Unveils Data Showing ORLADEYO Cuts HAE Attacks in Children in Yearlong Trial\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        BioCryst Pharmaceuticals Inc. has announced new data from the ongoing APeX-P clinical trial evaluating ORLADEYO® (berotralstat) in pediatric patients with hereditary angioedema <a href=\"https://laohu8.com/S/HAE\">$(HAE)$</a> aged 2 to under 12 years. The results, presented at the Annual Scientific Meeting of the American College of Allergy, Asthma &amp; Immunology (ACAAI) in November 2025, show early and sustained reductions in monthly HAE attack rates over one year of treatment with once-daily ORLADEYO oral granules. The company also highlighted findings on the negative psychosocial impact of HAE and emergency care visits on children and their caregivers. A New Drug Application for ORLADEYO oral granules as prophylaxis in this pediatric population is currently under review by the U.S. Food and Drug Administration, with a decision expected by the end of 2025. If approved, ORLADEYO would be the first targeted oral prophylactic therapy for HAE patients aged 2 to under 12 years.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. BioCryst Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9570032-en) on November 06, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BCRX","symbol_name":"BioCryst制药","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20251106:nNDL6Sp6xw:1","article_id":"2581093327","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2581093327","pubTimestamp":1762434019,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"BioCryst Pharmaceuticals Inc. has announced new data from the ongoing APeX-P clinical trial evaluating ORLADEYO  in pediatric patients with hereditary angioedema  aged 2 to under 12 years. The results, presented at the Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology  in November 2025, show early and sustained reductions in monthly HAE attack rates over one year of treatment with once-daily ORLADEYO oral granules. The company also highlighted findings on the negative psychosocial impact of HAE and emergency care visits on children and their caregivers. A New Drug Application for ORLADEYO oral granules as prophylaxis in this pediatric population is currently under review by the U.S. Food and Drug Administration, with a decision expected by the end of 2025. If approved, ORLADEYO would be the first targeted oral prophylactic therapy for HAE patients aged 2 to under 12 years.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BCRX":"BioCryst制药","LU2210149790.SGD":"Natixis Thematics Subscription Economy R/A SGD-H","IE00B64PRP62.GBP":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (GBP) ACC","IE00B3QW5Z07.USD":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (USD) ACC","BK4588":"碎股","LU2095319765.USD":"Natixis Thematics Subscription Economy R/A USD","IE00BKPKM429.USD":"NEUBERGER BERMAN GLOBAL SUSTAINABLE EQUITY \"A\" (USD) ACC","BK4547":"WSB热门概念","BK4585":"ETF&股票定投概念","BK4112":"金融交易所和数据","BK4139":"生物科技","IE00BGHQF748.EUR":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (EUR) ACC","LU2210150020.SGD":"Natixis Thematics Subscription Economy R/A SGD","NDAQ":"纳斯达克OMX交易所","LU0314104364.USD":"MANULIFE GF AMERICAN GROWTH \"AA\" (USD) INC"},"translate_title":"BioCryst公布的数据显示ORLADEYO在为期一年的试验中减少了儿童HAE发作","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"BCRX":0.9,"NDAQ":0.9},"content_text":"BioCryst Unveils Data Showing ORLADEYO Cuts HAE Attacks in Children in Yearlong Trial\n    \n\n        BioCryst Pharmaceuticals Inc. has announced new data from the ongoing APeX-P clinical trial evaluating ORLADEYO® (berotralstat) in pediatric patients with hereditary angioedema $(HAE)$ aged 2 to under 12 years. The results, presented at the Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI) in November 2025, show early and sustained reductions in monthly HAE attack rates over one year of treatment with once-daily ORLADEYO oral granules. The company also highlighted findings on the negative psychosocial impact of HAE and emergency care visits on children and their caregivers. A New Drug Application for ORLADEYO oral granules as prophylaxis in this pediatric population is currently under review by the U.S. Food and Drug Administration, with a decision expected by the end of 2025. If approved, ORLADEYO would be the first targeted oral prophylactic therapy for HAE patients aged 2 to under 12 years.\n      \n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. BioCryst Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9570032-en) on November 06, 2025, and is solely responsible for the information contained therein.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"dataReport","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"},"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":"4.35.9","shortVersion":"4.35.9","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/2581093327","isCrawlerRequest":true}