Praxis' Epilepsy Drug Too Good To Continue, FDA Meeting Up Next

Benzinga12-06

Praxis Precision Medicines Inc. (NASDAQ:PRAX) stock rose Friday after the company shared results from the registrational cohort of the EMBOLD study evaluating relutrigine for the treatment of patients...

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(NASDAQ:PRAX) stock rose Friday after the company shared results from the registrational cohort of the EMBOLD study evaluating relutrigine for the treatment of patients...</p>\n\n<a href=\"https://www.benzinga.com/analyst-stock-ratings/analyst-color/25/12/49237801/praxis-epilepsy-drug-too-good-to-continue-fda-meeting-up-next\">Source Link</a>\n\n</div>\n","source":"benzinga_hot_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' Epilepsy Drug Too Good To Continue, FDA Meeting Up Next</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' Epilepsy Drug Too Good To Continue, FDA Meeting Up Next\n</h2>\n\n<h4 class=\"meta\">\n\n\n2025-12-06 02:10 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://www.benzinga.com/analyst-stock-ratings/analyst-color/25/12/49237801/praxis-epilepsy-drug-too-good-to-continue-fda-meeting-up-next><strong>Benzinga</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Praxis Precision Medicines Inc. (NASDAQ:PRAX) stock rose Friday after the company shared results from the registrational cohort of the EMBOLD study evaluating relutrigine for the treatment of patients...</p>\n\n<a href=\"https://www.benzinga.com/analyst-stock-ratings/analyst-color/25/12/49237801/praxis-epilepsy-drug-too-good-to-continue-fda-meeting-up-next\">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":"LU0889565916.HKD","symbol_name":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","start_time":0,"source_url":"https://www.benzinga.com/analyst-stock-ratings/analyst-color/25/12/49237801/praxis-epilepsy-drug-too-good-to-continue-fda-meeting-up-next","article_id":"2589814643","we_media_id":null,"thumbnails":["https://cdn.benzinga.com/files/images/story/2025/12/05/Praxis-Precision-Medicines--Inc-.jpeg?optimize=medium&dpr=2&auto=webp&width=630"],"rights":{"source":"benzinga_hot_news","url":"https://www.benzinga.com/analyst-stock-ratings/analyst-color/25/12/49237801/praxis-epilepsy-drug-too-good-to-continue-fda-meeting-up-next","rn_cache_url":null,"directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2589814643","pubTimestamp":1764958200,"columns":[],"sourceInfo":{"source_id":"benzinga_hot_news","name":"Benzinga"},"weMediaInfo":null,"summary":"Praxis Precision Medicines Inc.  stock rose Friday after the company shared results from the registrational cohort of the EMBOLD study evaluating relutrigine for the treatment of patients with SCN2A and SCN8A developmental and epileptic encephalopathies .The Data Monitoring Committee recommended stopping the study early for efficacy.The FDA has confirmed a meeting to review the data and discuss next steps in the coming weeks. Praxis will make a determination on the timing for filing an NDA for relutrigine after the meeting.The EMBOLD topline results will be presented at the American Epilepsy Society Annual Meeting at the Georgia World Congress Center on Saturday.On Thursday, Praxis Precision Medicines also completed its pre-NDA  meeting with the FDA, including receipt of written feedback and an in-person meeting.Praxis has gained alignment from the agency on the content of the NDA and expects to complete its NDA submission in early 2026.PRAX Price Action: Praxis Precision Medicine shar","collect":0,"end_time":0,"defaultTopTitle":"benzinga.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","PRAX":"Praxis Precision Medicines, Inc.","BK4139":"生物科技","LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD"},"translate_title":"Praxis的癫痫药物太好了，无法继续，FDA将召开下一次会议","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"PRAX":1},"content_text":"Praxis Precision Medicines Inc. (NASDAQ:PRAX) stock rose Friday after the company shared results from the registrational cohort of the EMBOLD study evaluating relutrigine for the treatment of patients with SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs).\nThe Data Monitoring Committee recommended stopping the study early for efficacy.\nThe FDA has confirmed a meeting to review the data and discuss next steps in the coming weeks. Praxis will make a determination on the timing for filing an NDA for relutrigine after the meeting.\nAlso Read: Short Seller Alleges Praxis Precision’s Potential $3 Billion Drug ‘A House Of Cards’\nThe EMBOLD topline results will be presented at the American Epilepsy Society Annual Meeting at the Georgia World Congress Center on Saturday.\nOn Thursday, Praxis Precision Medicines also completed its pre-NDA (New Drug Application) meeting with the FDA, including receipt of written feedback and an in-person meeting.\nPraxis has gained alignment from the agency on the content of the NDA and expects to complete its NDA submission in early 2026.\nHC Wainwright wrote on Friday that relutrigine has been overlooked and underappreciated by investors for some time, though it is expected to begin to change after EMBOLD data.\nAnalyst Douglas Tsao sees relutrigine as a blockbuster in the SCN8A and SCN2A populations alone, which could expand much further in the broader DEE population being tested in the EMERALD study.\nHC Wainwright anticipates priority review for relutrigine, with approval next year is highly likely.\n“We can’t recall an instance where a biotech company got its first two approvals of drugs developed organically and both with blockbuster potential within a span of just a few months. The success of EMBOLD also significantly derisks and accelerates the development of relutrigine in broader DEEs,” HC Wainwright analyst wrote on Friday.\nThe analyst increased the probability of success for relutrigine to 80% from 60% and raised the projected peak sales to $2.8 billion from $760 million.\nThe analyst maintains the Buy rating for Praxis Precision, while increasing the price forecast from $258 to $340.\nIn August, Praxis shared topline results from its Phase 2 RADIANT study evaluating vormatrigine in patients with focal onset seizures and generalized epilepsy.\nThe trial showed a median seizure reduction of around 56.3%, with 60% of the patients achieving at least a 50% reduction in seizures.\nPRAX Price Action: Praxis Precision Medicine shares were up 30.84% at $248.56 at the time of publication on Friday. The stock is trading at a new 52-week high, according to Benzinga Pro data.\nRead Next:\nPhoto via Shutterstock","kind":"news","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":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":"4.35.10","shortVersion":"4.35.10","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/2589814643","isCrawlerRequest":true}