Praxis Precision Medicines Shares Rise on Positive Preliminary Meeting with FDA for Essential Tremor Treatment

Dow Jones

12/05

By Adriano Marchese

Shares is Praxis Precision Medicines rose in premarket trading Friday after it said it expects to submit to U.S. regulators a new drug application next year for its investigational drug to treat essential tremors.

Shares traded 25% higher ahead of the morning bell at $237.10.

The clinical-stage biopharmaceutical company said Thursday that it expects to submit its NDA early in 2026 after a preliminary meeting with the Food and Drug Administration regarding its drug ulixacaltamide.

Ulixacaltamide is Praxis' investigational drug aimed at treating essential tremors, a neurological movement disorder that causes involuntary shaking, most often in the hands, but it also can affect other body parts such as the head or the voice. It is the most common type of tremor and is distinct from Parkinson's disease.

From its meeting with the FDA, Praxis said it has reached an understanding with regulators on the required content of the application and anticipates completing the submission early next year.

Write to Adriano Marchese at adriano.marchese@wsj.com

(END) Dow Jones Newswires

December 05, 2025 06:33 ET (11:33 GMT)

Copyright (c) 2025 Dow Jones & Company, Inc.

應版權方要求，你需要登入查看該內容

登入 / 註冊

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

1
2
3
4
5
6
7
8
9
10

{"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/2589578891"},"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:\"2589578891\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2589578891?lang=zh_TW&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-12-05 19:33","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2589578891","market":"us","top_or_hot":-1,"title":"Praxis Precision Medicines Shares Rise on Positive Preliminary Meeting with FDA for Essential Tremor Treatment","media":"Dow Jones","content":"<font class=\"NormalMinus1\" face=\"Arial\">\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  By Adriano Marchese \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  Shares is <a href=\"https://laohu8.com/S/PRAX\">Praxis Precision Medicines</a> rose in premarket trading Friday after it said it expects to submit to U.S. regulators a new drug application next year for its investigational drug to treat essential tremors. \n</p>\n<p>\n  Shares traded 25% higher ahead of the morning bell at $237.10. \n</p>\n<p>\n  The clinical-stage biopharmaceutical company said Thursday that it expects to submit its NDA early in 2026 after a preliminary meeting with the Food and Drug Administration regarding its drug ulixacaltamide. \n</p>\n<p>\n  Ulixacaltamide is Praxis' investigational drug aimed at treating essential tremors, a neurological movement disorder that causes involuntary shaking, most often in the hands, but it also can affect other body parts such as the head or the voice. It is the most common type of tremor and is distinct from Parkinson's disease. \n</p>\n<p>\n  From its meeting with the FDA, Praxis said it has reached an understanding with regulators on the required content of the application and anticipates completing the submission early next year. \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  Write to Adriano Marchese at adriano.marchese@wsj.com \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  December 05, 2025 06:33 ET (11:33 GMT)\n</p>\n<p>\n  Copyright (c) 2025 Dow Jones &amp; Company, Inc.\n</p>\n</font>","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>Praxis Precision Medicines Shares Rise on Positive Preliminary Meeting with FDA for Essential Tremor Treatment</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\">\nPraxis Precision Medicines Shares Rise on Positive Preliminary Meeting with FDA for Essential Tremor Treatment\n</h2>\n<h4 class=\"meta\">\n<div class=\"head\" \">\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/150f88aa4d182df19190059f4a365e99);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Dow Jones </p>\n<p class=\"h-time smaller\">2025-12-05 19:33</p>\n</div>\n</div>\n</h4>\n</header>\n<article>\n<font class=\"NormalMinus1\" face=\"Arial\">\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  By Adriano Marchese \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  Shares is <a href=\"https://laohu8.com/S/PRAX\">Praxis Precision Medicines</a> rose in premarket trading Friday after it said it expects to submit to U.S. regulators a new drug application next year for its investigational drug to treat essential tremors. \n</p>\n<p>\n  Shares traded 25% higher ahead of the morning bell at $237.10. \n</p>\n<p>\n  The clinical-stage biopharmaceutical company said Thursday that it expects to submit its NDA early in 2026 after a preliminary meeting with the Food and Drug Administration regarding its drug ulixacaltamide. \n</p>\n<p>\n  Ulixacaltamide is Praxis' investigational drug aimed at treating essential tremors, a neurological movement disorder that causes involuntary shaking, most often in the hands, but it also can affect other body parts such as the head or the voice. It is the most common type of tremor and is distinct from Parkinson's disease. \n</p>\n<p>\n  From its meeting with the FDA, Praxis said it has reached an understanding with regulators on the required content of the application and anticipates completing the submission early next year. \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  Write to Adriano Marchese at adriano.marchese@wsj.com \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  December 05, 2025 06:33 ET (11:33 GMT)\n</p>\n<p>\n  Copyright (c) 2025 Dow Jones &amp; Company, Inc.\n</p>\n</font>\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"PRAX","symbol_name":"Praxis Precision Medicines, Inc.","start_time":0,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","article_id":"2589578891","we_media_id":"106","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2589578891","pubTimestamp":1764934380,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Dow Jones","introduction":"Dow Jones publishes the world’s most trusted business news and financial information in a variety of media.","home_visible":0,"id":"106","head_image":"https://static.tigerbbs.com/150f88aa4d182df19190059f4a365e99"},"summary":"Shares is Praxis Precision Medicines rose in premarket trading Friday after it said it expects to submit to U.S. regulators a new drug application next year for its investigational drug to treat essential tremors.Shares traded 25% higher ahead of the morning bell at $237.10.The clinical-stage biopharmaceutical company said Thursday that it expects to submit its NDA early in 2026 after a preliminary meeting with the Food and Drug Administration regarding its drug ulixacaltamide.Ulixacaltamide is Praxis' investigational drug aimed at treating essential tremors, a neurological movement disorder that causes involuntary shaking, most often in the hands, but it also can affect other body parts such as the head or the voice. It is the most common type of tremor and is distinct from Parkinson's disease.From its meeting with the FDA, Praxis said it has reached an understanding with regulators on the required content of the application and anticipates completing the submission early next year.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"PRAX":"Praxis Precision Medicines, Inc.","LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD","BK4139":"生物科技","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)"},"translate_title":"Praxis Precision Medicines股价因与FDA就特发性震颤治疗举行积极初步会议而上涨","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"PRAX":1.5},"content_text":"By Adriano Marchese \n\n\n \n\n\n  Shares is Praxis Precision Medicines rose in premarket trading Friday after it said it expects to submit to U.S. regulators a new drug application next year for its investigational drug to treat essential tremors. \n\n\n  Shares traded 25% higher ahead of the morning bell at $237.10. \n\n\n  The clinical-stage biopharmaceutical company said Thursday that it expects to submit its NDA early in 2026 after a preliminary meeting with the Food and Drug Administration regarding its drug ulixacaltamide. \n\n\n  Ulixacaltamide is Praxis' investigational drug aimed at treating essential tremors, a neurological movement disorder that causes involuntary shaking, most often in the hands, but it also can affect other body parts such as the head or the voice. It is the most common type of tremor and is distinct from Parkinson's disease. \n\n\n  From its meeting with the FDA, Praxis said it has reached an understanding with regulators on the required content of the application and anticipates completing the submission early next year. \n\n\n \n\n\n  Write to Adriano Marchese at adriano.marchese@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  December 05, 2025 06:33 ET (11:33 GMT)\n\n\n  Copyright (c) 2025 Dow Jones & Company, Inc.","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":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":true,"code":"91000000","status":"200"}}}