Tonix Pharmaceuticals Says US FDA Will Not Require Committee Meeting to Discuss NDA for Fibromyalgia Treatment

MT Newswires Live

2025/03/24

Tonix Pharmaceuticals (TNXP) said Monday that the US Food and Drug Administration will not require an advisory committee meeting regarding its new drug application for TNX-102 SL, a product candidate to treat fibromyalgia.

The biopharmaceutical company said the drug candidate is on track to meet the FDA's prescription drug user fee act goal of Aug. 15.

Shares of the company were up 16% in recent Monday premarket activity.

免责声明：投资有风险，本文并非投资建议，以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请，作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考，不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证，投资者应自行研究并在投资前寻求专业建议。

热议股票

{"basename":"/hans","ssrTDKData":{"titleTemplate":"%s - 老虎证券","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":"老虎证券,老虎证券开户,老虎券商,老虎证券官网,老虎证券app,tigertrade老虎证券,股票,炒股,新加坡股票交易平台,投资,投资理财","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/hans/news/2521572323"},"companyName":"老虎证券"},"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:\"2521572323\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2521572323?lang=zh_CN&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-03-24 20:43","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2521572323","market":"sg","top_or_hot":-1,"title":"Tonix Pharmaceuticals Says US FDA Will Not Require Committee Meeting to Discuss NDA for Fibromyalgia Treatment","media":"MT Newswires Live","content":"<html><body><p> Tonix Pharmaceuticals (TNXP) said Monday that the US Food and Drug Administration will not require an advisory committee meeting regarding its new drug application for TNX-102 SL, a product candidate to treat fibromyalgia.</p><p>The biopharmaceutical company said the drug candidate is on track to meet the FDA's prescription drug user fee act goal of Aug. 15.</p><p>Shares of the company were up 16% in recent Monday premarket activity.</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>Tonix Pharmaceuticals Says US FDA Will Not Require Committee Meeting to Discuss NDA for Fibromyalgia 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: 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\">\nTonix Pharmaceuticals Says US FDA Will Not Require Committee Meeting to Discuss NDA for Fibromyalgia Treatment\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1092851196\">\n\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\">2025-03-24 20:43</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html><body><p> Tonix Pharmaceuticals (TNXP) said Monday that the US Food and Drug Administration will not require an advisory committee meeting regarding its new drug application for TNX-102 SL, a product candidate to treat fibromyalgia.</p><p>The biopharmaceutical company said the drug candidate is on track to meet the FDA's prescription drug user fee act goal of Aug. 15.</p><p>Shares of the company were up 16% in recent Monday premarket activity.</p></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4139","symbol_name":"生物科技","start_time":0,"source_url":"https://www.mtnewswires.com/","article_id":"2521572323","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2521572323","pubTimestamp":1742820239,"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":"Tonix Pharmaceuticals  said Monday that the US Food and Drug Administration will not require an advisory committee meeting regarding its new drug application for TNX-102 SL, a product candidate to treat fibromyalgia.The biopharmaceutical company said the drug candidate is on track to meet the FDA's prescription drug user fee act goal of Aug. 15.Shares of the company were up 16% in recent Monday premarket activity.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4139":"生物科技","TNXP":"Tonix Pharmaceuticals Holding Co","BK4583":"猴痘概念"},"translate_title":"Tonix Pharmaceuticals称美国FDA不会要求召开委员会会议讨论纤维肌痛治疗NDA","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"TNXP":1},"content_text":"Tonix Pharmaceuticals (TNXP) said Monday that the US Food and Drug Administration will not require an advisory committee meeting regarding its new drug application for TNX-102 SL, a product candidate to treat fibromyalgia.The biopharmaceutical company said the drug candidate is on track to meet the FDA's prescription drug user fee act goal of Aug. 15.Shares of the company were up 16% in recent Monday premarket activity.","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":"","news_rank":0,"symbols":[],"gpt_button":1,"need_auth":false,"code":"91000000","status":"200"}}}