Praxis Stock Surges On FDA Breakthrough Status For Essential Tremor Drug

Benzinga_recent_news12-30 01:23

Praxis Precision Medicines Inc. (NASDAQ:PRAX) stock rose Monday after the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for ulixacaltamide for essential tremor...

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(NASDAQ:PRAX) stock rose Monday after the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for ulixacaltamide for essential tremor...</p>\n\n<a href=\"https://www.benzinga.com/news/fda/25/12/49615360/praxis-stock-surges-on-fda-breakthrough-status-for-essential-tremor-drug\">Source Link</a>\n\n</div>\n","source":"benzinga_recent_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>Praxis Stock Surges On FDA Breakthrough Status For Essential Tremor Drug</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\">\nPraxis Stock Surges On FDA Breakthrough Status For Essential Tremor Drug\n</h2>\n\n<h4 class=\"meta\">\n\n\n2025-12-30 01:23 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://www.benzinga.com/news/fda/25/12/49615360/praxis-stock-surges-on-fda-breakthrough-status-for-essential-tremor-drug><strong>Benzinga_recent_news</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Praxis Precision Medicines Inc. (NASDAQ:PRAX) stock rose Monday after the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for ulixacaltamide for essential tremor...</p>\n\n<a href=\"https://www.benzinga.com/news/fda/25/12/49615360/praxis-stock-surges-on-fda-breakthrough-status-for-essential-tremor-drug\">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":"BK4144","symbol_name":"石油与天然气的储存和运输","start_time":0,"source_url":"https://www.benzinga.com/news/fda/25/12/49615360/praxis-stock-surges-on-fda-breakthrough-status-for-essential-tremor-drug","article_id":"2595734049","we_media_id":null,"thumbnails":["https://cdn.benzinga.com/files/images/story/2025/12/29/FDA_1.jpeg?optimize=medium&dpr=2&auto=webp&width=240"],"rights":{"source":"benzinga_recent_news","url":"https://www.benzinga.com/news/fda/25/12/49615360/praxis-stock-surges-on-fda-breakthrough-status-for-essential-tremor-drug","rn_cache_url":null,"directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2595734049","pubTimestamp":1767028980,"columns":[],"sourceInfo":{"source_id":"benzinga_recent_news","name":"Benzinga"},"weMediaInfo":null,"summary":"Praxis Precision Medicines Inc (NASDAQ: PRAX) stock rose after FDA granted BTD for ulixacaltamide to treat essential tremor.","collect":0,"end_time":0,"defaultTopTitle":"benzinga.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4144":"石油与天然气的储存和运输","ET":"Energy Transfer LP","LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD","BK4590":"PTP","LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","BK4561":"索罗斯持仓","BK4588":"碎股","BK4585":"ETF&股票定投概念","PRAX":"Praxis Precision Medicines, Inc.","BK4139":"生物科技","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","BK4581":"高盛持仓"},"translate_title":"Praxis股价因特发性震颤药物获得FDA突破性地位而飙升","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"PRAX":1,"ET":1},"content_text":"Praxis Precision Medicines Inc. (NASDAQ:PRAX) stock rose Monday after the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for ulixacaltamide for essential tremor (ET).\nEssential Tremor is the most common movement disorder, affecting roughly seven million people in the United States alone, representing a multi-billion dollar commercial opportunity.\nET is characterized by involuntary rhythmic movement in the upper limbs, with or without tremor in other body locations such as the head, vocal cords, or legs.\nAlso Read: Praxis’ Epilepsy Drug Too Good To Continue, FDA Meeting Up Next\n“We recently completed a series of positive interactions with the FDA, that, together with this BTD, are enabling us to advance this promising treatment faster to patients. We are diligently preparing for the filing of the ulixacaltamide NDA, which we expect in early 2026,” said Marcio Souza, president and CEO.\nThe BTD enables expedited development and regulatory review for drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies.\nThe BTD for ulixacaltamide was based on the positive topline data from the Essential3 program, consisting of two pivotal Phase 3 studies of ulixacaltamide in ET.\nIn December 2025, Praxis completed its pre-NDA meeting with the FDA, including the receipt of written feedback and an in-person meeting.\nThe company has aligned with the FDA on the content of the NDA and expects to submit the ulixacaltamide NDA in early 2026.\nPRAX Price Action: Praxis Precision Medicine shares were up 14.24% at $318.08 at the time of publication on Monday. The stock is trading at a new 52-week high, according to Benzinga Pro data.\nRead Next:\nPhoto by Tada Images via Shutterstock","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"2","news_tag":"productRelease","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":"4.35.13","shortVersion":"4.35.13","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/2595734049","isCrawlerRequest":true}