Harmony Biosciences to Submit NDA for Narcolepsy Treatment Following Trial Results

MT Newswires Live

11/24

Harmony Biosciences (HRMY) said Monday that it expects to submit a New Drug Application to the US Food and Drug Administration in early 2026 for gastro-resistant Wakix (pitolisant GR) to treat narcolepsy.

The pharmaceutical company said the evaluation is based on a pivotal bioequivalence study, which it said confirmed that the 17.8mg dose of the gastro-resistant drug is bioequivalent to existing 17.8mg Wakix tablets.

Harmony also reported that there were no new safety or tolerability issues, and that topline data from the dosing optimization study of Wakix showed that 100% of patients successfully initiated treatment at the therapeutic dose of 17.8mg, which eliminated the need for dose titration.

免責聲明：投資有風險，本文並非投資建議，以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請，作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考，不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證，投資者應自行研究並在投資前尋求專業建議。

熱議股票

{"basename":"/hant","ssrTDKData":{"titleTemplate":"%s - 老虎證券","title":"老虎证券全球投资理财平台| 一站式投资美股新股港股A股","description":"老虎证券助您一站式投资美股，新股，港股，A股等全球金融理财产品。新加坡华人最信赖的在线投资平台，现在加入即享低费用，24/5 无时差炒美股投资理财！","keywords":"老虎證券,老虎證券開戶,老虎券商,老虎證券官網,老虎證券app,tigertrade老虎證券,股票,炒股,新加坡股票交易平臺,投資,投資理財","social":{"ogDescription":"老虎证券助您一站式投资美股，新股，港股，A股等全球金融理财产品。新加坡华人最信赖的在线投资平台，现在加入即享低费用，24/5 无时差炒美股投资理财！","ogImage":"https://c1.itigergrowtha.com/portal5/static/media/og-logo.be62fbe1.png","ogUrl":"https://www.itiger.com/hant/news/2585460695"},"companyName":"老虎證券"},"pageData":{"isMobile":false,"isTiger":false,"isTTM":true,"region":"SGP","license":"TBSG","edition":"fundamental"},"isCrawlerRequest":true,"__swrFallback__":{"@#url:\"https://stock-news.skytigris.cn/v3/news\",params:#id:\"2585460695\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2585460695?lang=zh_TW&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-11-24 22:08","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2585460695","market":"sh","top_or_hot":-1,"title":"Harmony Biosciences to Submit NDA for Narcolepsy Treatment Following Trial Results","media":"MT Newswires Live","content":"<html><body><p> <a href=\"https://laohu8.com/S/HRMY\">Harmony Biosciences</a> (HRMY) said Monday that it expects to submit a New Drug Application to the US Food and Drug Administration in early 2026 for gastro-resistant Wakix (pitolisant GR) to treat narcolepsy.</p><p>The pharmaceutical company said the evaluation is based on a pivotal bioequivalence study, which it said confirmed that the 17.8mg dose of the gastro-resistant drug is bioequivalent to existing 17.8mg Wakix tablets.</p><p>Harmony also reported that there were no new safety or tolerability issues, and that topline data from the dosing optimization study of Wakix showed that 100% of patients successfully initiated treatment at the therapeutic dose of 17.8mg, which eliminated the need for dose titration.</p></body></html>","source":"mtnewswires_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>Harmony Biosciences to Submit NDA for Narcolepsy Treatment Following Trial Results</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: 12.5px; color: #7E829C; margin: 0;}\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\">\nHarmony Biosciences to Submit NDA for Narcolepsy Treatment Following Trial Results\n</h2>\n<h4 class=\"meta\">\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1092851196\">\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/3002d84abbd5ace3c99397c7f95b8d4e);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">MT Newswires Live </p>\n<p class=\"h-time smaller\">2025-11-24 22:08</p>\n</div>\n</a>\n</h4>\n</header>\n<article>\n<html><body><p> <a href=\"https://laohu8.com/S/HRMY\">Harmony Biosciences</a> (HRMY) said Monday that it expects to submit a New Drug Application to the US Food and Drug Administration in early 2026 for gastro-resistant Wakix (pitolisant GR) to treat narcolepsy.</p><p>The pharmaceutical company said the evaluation is based on a pivotal bioequivalence study, which it said confirmed that the 17.8mg dose of the gastro-resistant drug is bioequivalent to existing 17.8mg Wakix tablets.</p><p>Harmony also reported that there were no new safety or tolerability issues, and that topline data from the dosing optimization study of Wakix showed that 100% of patients successfully initiated treatment at the therapeutic dose of 17.8mg, which eliminated the need for dose titration.</p></body></html>\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"HRMY","symbol_name":"Harmony Biosciences Holdings, Inc.","start_time":0,"source_url":"https://www.mtnewswires.com/","article_id":"2585460695","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2585460695","pubTimestamp":1763993303,"columns":[],"sourceInfo":{"source_id":"mtnewswires_news","name":"MT Newswires"},"weMediaInfo":{"media_name":"MT Newswires Live","introduction":"The most recognized names in North America, Europe and Asia rely on MT Newswires to power their applications. Better news, better service, better price.","home_visible":1,"id":"1092851196","head_image":"https://community-static.tradeup.com/news/3002d84abbd5ace3c99397c7f95b8d4e"},"summary":"Harmony Biosciences  said Monday that it expects to submit a New Drug Application to the US Food and Drug Administration in early 2026 for gastro-resistant Wakix  to treat narcolepsy.The pharmaceutical company said the evaluation is based on a pivotal bioequivalence study, which it said confirmed that the 17.8mg dose of the gastro-resistant drug is bioequivalent to existing 17.8mg Wakix tablets.Harmony also reported that there were no new safety or tolerability issues, and that topline data from the dosing optimization study of Wakix showed that 100% of patients successfully initiated treatment at the therapeutic dose of 17.8mg, which eliminated the need for dose titration.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"HRMY":"Harmony Biosciences Holdings, Inc.","BK4007":"制药"},"translate_title":"Harmony Biosciences将根据试验结果提交治疗发作性睡病的NDA","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"HRMY":1},"content_text":"Harmony Biosciences (HRMY) said Monday that it expects to submit a New Drug Application to the US Food and Drug Administration in early 2026 for gastro-resistant Wakix (pitolisant GR) to treat narcolepsy.The pharmaceutical company said the evaluation is based on a pivotal bioequivalence study, which it said confirmed that the 17.8mg dose of the gastro-resistant drug is bioequivalent to existing 17.8mg Wakix tablets.Harmony also reported that there were no new safety or tolerability issues, and that topline data from the dosing optimization study of Wakix showed that 100% of patients successfully initiated treatment at the therapeutic dose of 17.8mg, which eliminated the need for dose titration.","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":"productRelease","news_rank":0,"symbols":[],"gpt_button":1,"need_auth":false,"code":"91000000","status":"200"}}}