What's Going On With Aquestive Therapeutics Stock After FDA Update For Lead Allergic Treatment?

Benzinga_recent_news02-03

On Monday, Aquestive Therapeutics, Inc. (NASDAQ:AQST) received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) seeking approval of ...

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(NASDAQ:AQST) received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) seeking approval of ...</p>\n\n<a href=\"https://www.benzinga.com/news/fda/26/02/50309975/whats-going-on-with-aquestive-therapeutics-stock-after-fda-update-for-lead-allergic-treatment\">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>What's Going On With Aquestive Therapeutics Stock After FDA Update For Lead Allergic 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\">\nWhat's Going On With Aquestive Therapeutics Stock After FDA Update For Lead Allergic Treatment?\n</h2>\n\n<h4 class=\"meta\">\n\n\n2026-02-03 02:12 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://www.benzinga.com/news/fda/26/02/50309975/whats-going-on-with-aquestive-therapeutics-stock-after-fda-update-for-lead-allergic-treatment><strong>Benzinga_recent_news</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>On Monday, Aquestive Therapeutics, Inc. (NASDAQ:AQST) received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) seeking approval of ...</p>\n\n<a href=\"https://www.benzinga.com/news/fda/26/02/50309975/whats-going-on-with-aquestive-therapeutics-stock-after-fda-update-for-lead-allergic-treatment\">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":"LENZ","symbol_name":"Therapeutics","start_time":0,"source_url":"https://www.benzinga.com/news/fda/26/02/50309975/whats-going-on-with-aquestive-therapeutics-stock-after-fda-update-for-lead-allergic-treatment","article_id":"2608891904","we_media_id":null,"thumbnails":["https://cdn.benzinga.com/files/images/story/2026/02/02/Peanut-Allergy.jpeg?optimize=medium&dpr=2&auto=webp&width=240"],"rights":{"source":"benzinga_recent_news","url":"https://www.benzinga.com/news/fda/26/02/50309975/whats-going-on-with-aquestive-therapeutics-stock-after-fda-update-for-lead-allergic-treatment","rn_cache_url":null,"directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2608891904","pubTimestamp":1770055920,"columns":[],"sourceInfo":{"source_id":"benzinga_recent_news","name":"Benzinga"},"weMediaInfo":null,"summary":"Aquestive received an FDA rejection for its allergy film due to safety and use issues. The company plans new studies and targets resubmission in 2026.","collect":0,"end_time":0,"defaultTopTitle":"benzinga.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LENZ":"Therapeutics","BK4585":"ETF&股票定投概念","BK4139":"生物科技","BK4218":"酒店及度假村房地产信托","BK4530":"医药外包概念","LU0390134368.USD":"FRANKLIN GLOBAL GROWTH \"A\" (USD) ACC","LU0757428866.USD":"THREADNEEDLE (LUX) GLOBAL SMALLER COMPANIES \"AE\" (USD) ACC","IE00BFMHRM44.USD":"NEUBERGER BERMAN GLOBAL EQUITY MEGATRENDS \"A\" (USD) ACC","LU1815336091.USD":"THREADNEEDLE (LUX) GLOBAL SMALLER COMPANIES \"AUP\" (USD) INC","CRL":"查尔斯河","LU0029874061.USD":"TEMPLETON GLOBAL SMALLER COMPANIES \"A\" YDIS INC","BK4588":"碎股","BK4181":"酒店及度假村房地产投资信托","HF":"绝对收益主动型ETF-DGA","BK4007":"制药","BK4539":"次新股","BK4121":"生命科学工具和服务","LU0128526141.USD":"TEMPLETON GLOBAL SMALLER COMPANIES \"A\" ACC","PK":"Park Hotels & Resorts Inc.","AQST":"Aquestive Therapeutics Inc."},"translate_title":"FDA更新铅过敏治疗后，Aquestive Therapeutics股票发生了什么变化？","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"HF":1,"AQST":1,"CRL":1,"LENZ":1.5,"PK":1},"content_text":"On Monday, Aquestive Therapeutics, Inc. (NASDAQ:AQST) received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) seeking approval of Anaphylm (dibutepinephrine) Sublingual Film for Type I allergic reactions, including anaphylaxis, in patients weighing 30kg or more (approximately 66 pounds).  \nIn January, the FDA identified deficiencies in Anaphylm's NDA that preclude discussion of labeling and post-marketing commitments at this time.\n“While it is unfortunate to have received a CRL…We are encouraged that the issues in the letter are limited to human factors and a supportive PK study, once human factors are addressed, and we noted several labeling comments that will inform the final label for Anaphylm, if approved by the FDA,” said Daniel Barber, President and CEO of Aquestive.\nIn the CRL, which focuses on administration and labeling guidance, the FDA cited deficiencies in the Anaphylm human factors (HF) validation study.\nThese included instances of difficulty opening the pouch and incorrect film placement, which, if unaddressed, the FDA believes could cause significant safety issues in the setting of anaphylaxis.\nTo resolve the FDA’s concerns, the company has modified the pouch opening, instructions for use, pouch and carton labeling, and plans to rapidly conduct a new HF validation study with these modifications.\nThe company also plans to further address potential tolerability issues in its resubmission.\nComparability data submitted as part of the Anaphylm NDA, such as bracketing, repeat dose, and sustainability, were not questioned in the CRL. There were also no CMC issues noted in the CRL.\nDue to the requirements related to HF, clinical pharmacology requested a single pharmacokinetics (PK) study to understand the impact of any modifications to packaging and labeling. The FDA indicated that the HF and PK studies can be conducted in parallel. No additional studies were requested in the CRL.\nAquestive Therapeutics estimates resubmission in the early third quarter of 2026, assuming completion of the HF and PK studies and typical response times from the FDA. The company plans to request a rapid review by the FDA.\nThe company expects to submit its marketing authorization application in Europe as well as its New Drug Submission in Canada in the second half of 2026. The company also expects to receive feedback from the Medicines and Healthcare Products Regulatory Agency in the U.K. in the first quarter of 2026.\nAnalyst Lachlan Hanbury-Brown expects Anaphylm’s approval decision in the first half of 2027.\nAQST Price Action: Aquestive Therapeutics shares were up 45.25% at $4.28 at the time of publication on Monday, according to Benzinga Pro data.\nPhoto via Shutterstock","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":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,"tenantId":"TBGLOBAL","deviceId":"web-server-community-laohu8-v3","version":"4.36.2","shortVersion":"4.36.2","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/2608891904","isCrawlerRequest":true}