Harmony Biosciences Reports Positive Bioequivalence Results for Pitolisant Gastro-Resistant Formulation

Reuters11-24

<a href="https://laohu8.com/S/HRMY">Harmony Biosciences</a> Reports Positive Bioequivalence Results for Pitolisant Gastro-Resistant Formulation

Harmony Biosciences Holdings Inc. announced positive results from a pivotal bioequivalence study evaluating its gastro-resistant (GR) formulation of pitolisant. The study demonstrated that the 17.8 mg pitolisant GR formulation is bioequivalent to the existing 17.8 mg WAKIX® (pitolisant) tablets, with comparable AUC and Cmax values. The company also reported that a dosing optimization study showed 100% of patients were able to initiate treatment at the therapeutic dose without the need for titration. No new safety or tolerability issues were observed in the studies. Harmony plans to submit a New Drug Application for pitolisant GR in early 2026, with a targeted PDUFA date in the first quarter of 2027. Results from these studies have already been announced.

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. Harmony Biosciences Holdings Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251124261066) on November 24, 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/2585462974?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-11-24 21:05","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2585462974","market":"fut","top_or_hot":-1,"title":"Harmony Biosciences Reports Positive Bioequivalence Results for Pitolisant Gastro-Resistant Formulation","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      <a href=\"https://laohu8.com/S/HRMY\">Harmony Biosciences</a> Reports Positive Bioequivalence Results for Pitolisant Gastro-Resistant Formulation\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        Harmony Biosciences Holdings Inc. announced positive results from a pivotal bioequivalence study evaluating its gastro-resistant (GR) formulation of pitolisant. The study demonstrated that the 17.8 mg pitolisant GR formulation is bioequivalent to the existing 17.8 mg WAKIX® (pitolisant) tablets, with comparable AUC and Cmax values. The company also reported that a dosing optimization study showed 100% of patients were able to initiate treatment at the therapeutic dose without the need for titration. No new safety or tolerability issues were observed in the studies. Harmony plans to submit a New Drug Application for pitolisant GR in early 2026, with a targeted PDUFA date in the first quarter of 2027. Results from these studies have already been announced.\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. Harmony Biosciences Holdings Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251124261066) on November 24, 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>Harmony Biosciences Reports Positive Bioequivalence Results for Pitolisant Gastro-Resistant Formulation</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\">\nHarmony Biosciences Reports Positive Bioequivalence Results for Pitolisant Gastro-Resistant Formulation\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\">2025-11-24 21:05</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      <a href=\"https://laohu8.com/S/HRMY\">Harmony Biosciences</a> Reports Positive Bioequivalence Results for Pitolisant Gastro-Resistant Formulation\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        Harmony Biosciences Holdings Inc. announced positive results from a pivotal bioequivalence study evaluating its gastro-resistant (GR) formulation of pitolisant. The study demonstrated that the 17.8 mg pitolisant GR formulation is bioequivalent to the existing 17.8 mg WAKIX® (pitolisant) tablets, with comparable AUC and Cmax values. The company also reported that a dosing optimization study showed 100% of patients were able to initiate treatment at the therapeutic dose without the need for titration. No new safety or tolerability issues were observed in the studies. Harmony plans to submit a New Drug Application for pitolisant GR in early 2026, with a targeted PDUFA date in the first quarter of 2027. Results from these studies have already been announced.\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. Harmony Biosciences Holdings Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251124261066) on November 24, 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":"BK4007","symbol_name":"制药","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20251124:nNDL5wVlz2:1","article_id":"2585462974","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2585462974","pubTimestamp":1763989520,"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":"Harmony Biosciences Holdings Inc. announced positive results from a pivotal bioequivalence study evaluating its gastro-resistant  formulation of pitolisant. The study demonstrated that the 17.8 mg pitolisant GR formulation is bioequivalent to the existing 17.8 mg WAKIX  tablets, with comparable AUC and Cmax values. The company also reported that a dosing optimization study showed 100% of patients were able to initiate treatment at the therapeutic dose without the need for titration. No new safety or tolerability issues were observed in the studies. Harmony plans to submit a New Drug Application for pitolisant GR in early 2026, with a targeted PDUFA date in the first quarter of 2027. Results from these studies have already been announced.Disclaimer: This news brief was created by Public Technologies  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 inter","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4007":"制药","HRMY":"Harmony Biosciences Holdings, Inc."},"translate_title":"Harmony Biosciences报告Pitolisant胃耐药制剂的积极生物等效性结果","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"HRMY":0.9},"content_text":"Harmony Biosciences Reports Positive Bioequivalence Results for Pitolisant Gastro-Resistant Formulation\n    \n\n        Harmony Biosciences Holdings Inc. announced positive results from a pivotal bioequivalence study evaluating its gastro-resistant (GR) formulation of pitolisant. The study demonstrated that the 17.8 mg pitolisant GR formulation is bioequivalent to the existing 17.8 mg WAKIX® (pitolisant) tablets, with comparable AUC and Cmax values. The company also reported that a dosing optimization study showed 100% of patients were able to initiate treatment at the therapeutic dose without the need for titration. No new safety or tolerability issues were observed in the studies. Harmony plans to submit a New Drug Application for pitolisant GR in early 2026, with a targeted PDUFA date in the first quarter of 2027. Results from these studies have already been announced.\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. Harmony Biosciences Holdings Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251124261066) on November 24, 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,express","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":"4.35.12","shortVersion":"4.35.12","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/2585462974","isCrawlerRequest":true}