Tharimmune Shares Drop Premarket Following FDA Feedback on Plan for Lead Clinical Asset

Dow Jones11-13

By Robb M. Stewart

Tharimmune's shares were under pressure Thursday despite the company's lead clinical asset receiving what it said was positive feedback from the Food and Drug Administration on a simulation modeling plan.

In premarket trading, the shares were down 6% after climbing sharply earlier in the morning. The stock has climbed almost 60% this year, last closing at $3.22.

Tharimmune said the FDA following a review concurred with its proposed modeling plan for its TH104 nalmefene buccal film opioid treatment, and provided guidance on specific technical elements that the company plans to integrate into the finalized modeling.

It said the FDA's feedback further de-risks the TH104 program.

Tharimmune said it presented its initial pharmacokinetic simulation results and a plan for a more detailed pharmacokinetic modeling for FDA review. The modeling plan represents a critical component in advancing TH104 as a prophylactic countermeasure to mitigate respiratory depression caused by fentanyl and other ultrapotent opioids.

Additionally, the company said it is on track to initiate a comprehensive chemistry, manufacturing, and controls plan, focusing on scaling production and ensuring the quality and consistency of the TH104 buccal film product for advanced clinical development and commercial readiness.

Write to Robb M. Stewart at robb.stewart@wsj.com

(END) Dow Jones Newswires

November 13, 2025 09:23 ET (14:23 GMT)

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

At the request of the copyright holder, you need to log in to view this content

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/2583596288?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-11-13 22:23","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2583596288","market":"fut","top_or_hot":-1,"title":"Tharimmune Shares Drop Premarket Following FDA Feedback on Plan for Lead Clinical Asset","media":"Dow Jones","content":"<font class=\"NormalMinus1\" face=\"Arial\">\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  By Robb M. Stewart \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  Tharimmune's shares were under pressure Thursday despite the company's lead clinical asset receiving what it said was positive feedback from the Food and Drug Administration on a simulation modeling plan. \n</p>\n<p>\n  In premarket trading, the shares were down 6% after climbing sharply earlier in the morning. The stock has climbed almost 60% this year, last closing at $3.22. \n</p>\n<p>\n  Tharimmune said the FDA following a review concurred with its proposed modeling plan for its TH104 nalmefene buccal film opioid treatment, and provided guidance on specific technical elements that the company plans to integrate into the finalized modeling. \n</p>\n<p>\n  It said the FDA's feedback further de-risks the TH104 program. \n</p>\n<p>\n  Tharimmune said it presented its initial pharmacokinetic simulation results and a plan for a more detailed pharmacokinetic modeling for FDA review. The modeling plan represents a critical component in advancing TH104 as a prophylactic countermeasure to mitigate respiratory depression caused by fentanyl and other ultrapotent opioids. \n</p>\n<p>\n   Additionally, the company said it is on track to initiate a comprehensive chemistry, manufacturing, and controls plan, focusing on scaling production and ensuring the quality and consistency of the TH104 buccal film product for advanced clinical development and commercial readiness. \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  Write to Robb M. Stewart at robb.stewart@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  November 13, 2025 09:23 ET (14:23 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>Tharimmune Shares Drop Premarket Following FDA Feedback on Plan for Lead Clinical Asset</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\">\nTharimmune Shares Drop Premarket Following FDA Feedback on Plan for Lead Clinical Asset\n</h2>\n\n<h4 class=\"meta\">\n\n\n<div class=\"head\" \">\n\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\">2025-11-13 22:23</p>\n</div>\n\n</div>\n\n\n</h4>\n\n</header>\n<article>\n<font class=\"NormalMinus1\" face=\"Arial\">\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  By Robb M. Stewart \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  Tharimmune's shares were under pressure Thursday despite the company's lead clinical asset receiving what it said was positive feedback from the Food and Drug Administration on a simulation modeling plan. \n</p>\n<p>\n  In premarket trading, the shares were down 6% after climbing sharply earlier in the morning. The stock has climbed almost 60% this year, last closing at $3.22. \n</p>\n<p>\n  Tharimmune said the FDA following a review concurred with its proposed modeling plan for its TH104 nalmefene buccal film opioid treatment, and provided guidance on specific technical elements that the company plans to integrate into the finalized modeling. \n</p>\n<p>\n  It said the FDA's feedback further de-risks the TH104 program. \n</p>\n<p>\n  Tharimmune said it presented its initial pharmacokinetic simulation results and a plan for a more detailed pharmacokinetic modeling for FDA review. The modeling plan represents a critical component in advancing TH104 as a prophylactic countermeasure to mitigate respiratory depression caused by fentanyl and other ultrapotent opioids. \n</p>\n<p>\n   Additionally, the company said it is on track to initiate a comprehensive chemistry, manufacturing, and controls plan, focusing on scaling production and ensuring the quality and consistency of the TH104 buccal film product for advanced clinical development and commercial readiness. \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  Write to Robb M. Stewart at robb.stewart@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  November 13, 2025 09:23 ET (14:23 GMT)\n</p>\n<p>\n  Copyright (c) 2025 Dow Jones &amp; Company, Inc.\n</p>\n</font>\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://dowjonesnews.com/newdjn/logon.aspx?AL=N","article_id":"2583596288","we_media_id":"106","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2583596288","pubTimestamp":1763043780,"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":"Tharimmune's shares were under pressure Thursday despite the company's lead clinical asset receiving what it said was positive feedback from the Food and Drug Administration on a simulation modeling plan.In premarket trading, the shares were down 6% after climbing sharply earlier in the morning. The stock has climbed almost 60% this year, last closing at $3.22.Tharimmune said the FDA following a review concurred with its proposed modeling plan for its TH104 nalmefene buccal film opioid treatment, and provided guidance on specific technical elements that the company plans to integrate into the finalized modeling.It said the FDA's feedback further de-risks the TH104 program.Tharimmune said it presented its initial pharmacokinetic simulation results and a plan for a more detailed pharmacokinetic modeling for FDA review. The modeling plan represents a critical component in advancing TH104 as a prophylactic countermeasure to mitigate respiratory depression caused by fentanyl and other ultra","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4139":"生物科技","THAR":"Tharimmune Inc."},"translate_title":"FDA对主要临床资产计划提出反馈后，Tharimmune股价盘前下跌","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"THAR":0.9},"content_text":"By Robb M. Stewart \n\n\n \n\n\n  Tharimmune's shares were under pressure Thursday despite the company's lead clinical asset receiving what it said was positive feedback from the Food and Drug Administration on a simulation modeling plan. \n\n\n  In premarket trading, the shares were down 6% after climbing sharply earlier in the morning. The stock has climbed almost 60% this year, last closing at $3.22. \n\n\n  Tharimmune said the FDA following a review concurred with its proposed modeling plan for its TH104 nalmefene buccal film opioid treatment, and provided guidance on specific technical elements that the company plans to integrate into the finalized modeling. \n\n\n  It said the FDA's feedback further de-risks the TH104 program. \n\n\n  Tharimmune said it presented its initial pharmacokinetic simulation results and a plan for a more detailed pharmacokinetic modeling for FDA review. The modeling plan represents a critical component in advancing TH104 as a prophylactic countermeasure to mitigate respiratory depression caused by fentanyl and other ultrapotent opioids. \n\n\n   Additionally, the company said it is on track to initiate a comprehensive chemistry, manufacturing, and controls plan, focusing on scaling production and ensuring the quality and consistency of the TH104 buccal film product for advanced clinical development and commercial readiness. \n\n\n \n\n\n  Write to Robb M. Stewart at robb.stewart@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  November 13, 2025 09:23 ET (14:23 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":"","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":true,"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/2583596288","isCrawlerRequest":true}