Applied Therapeutics Stock Plummets 73%. The FDA Delivers This Crushing Blow. -- Barrons.com

Dow Jones

29 Nov 2024

By George Glover

Applied Therapeutics stock was tanking Friday after regulators said they were unable to green light a drug to treat a rare genetic disease.

Shares in the biotech company plunged 73% to $2.33, wiping out $730 million in valuation. The small-cap Russell 2000 index was up 0.6%.

The massive losses came after Applied Therapeutics said it had received a letter from the Food and Drug Administration in which the agency declined to approve a drug to treat the metabolic disorder Classic Galactosemia. The company said the FDA had cited "deficiencies in the clinical application" of the drug, which it's marketing as govorestat.

Founder and CEO Shoshana Shendelman said she was "disappointed by the FDA's decision," adding that Applied Therapeutics would "work with the FDA to address the concerns" raised in its letter.

It looks like a crushing blow for the stock. As of Wednesday's close, shares in Applied Therapeutics were up 135% in 2024, but Friday's losses mean they're now trading in the red for the year.

Write to George Glover at george.glover@dowjones.com

This content was created by Barron's, which is operated by Dow Jones & Co. Barron's is published independently from Dow Jones Newswires and The Wall Street Journal.

(END) Dow Jones Newswires

November 29, 2024 10:48 ET (15:48 GMT)

Copyright (c) 2024 Dow Jones & Company, Inc.

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.

Most Discussed

1
2
3
4
5
6
7
8
9
10

{"basename":"","ssrTDKData":{"titleTemplate":"%s - Tiger Brokers","title":"Tiger Brokers | Global Stocks, Options & Futures Trading App","description":"Tiger Brokers, one-stop investment in US stocks, SGX stocks, HK stocks, A-shares & other global assets. One of the best stock trading platforms in Singapore.","keywords":"tiger brokers,tiger trade,tiger brokers singapore,broker online,stock trading in singapore,share trading singapore,brokerage firm singapore,trading app,stock broker singapore,stock trading platforms,trading account","social":{"ogDescription":"Tiger Brokers, one-stop investment in US stocks, SGX stocks, HK stocks, A-shares & other global assets. One of the best stock trading platforms in Singapore.","ogImage":"https://c1.itigergrowtha.com/portal5/static/media/og-logo.be62fbe1.png","ogUrl":"https://www.itiger.com/news/2487661025"},"companyName":"Tiger Brokers"},"pageData":{"isMobile":false,"isTiger":false,"isTTM":true,"region":"SGP","license":"TBSG","edition":"fundamental"},"__swrFallback__":{"@#url:\"https://stock-news.skytigris.cn/v3/news\",params:#id:\"2487661025\",edition:\"fundamental\",,,undefined,":{"share":"https://ttm.financial/m/news/2487661025?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2024-11-29 23:48","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2487661025","market":"us","top_or_hot":-1,"title":"Applied Therapeutics Stock Plummets 73%. The FDA Delivers This Crushing Blow. -- Barrons.com","media":"Dow Jones","content":"<font class=\"NormalMinus1\" face=\"Arial\">\n<p>\n  By George Glover \n</p>\n<p>\n  Applied <a href=\"https://laohu8.com/S/LENZ\">Therapeutics</a> stock was tanking Friday after regulators said they were unable to green light a drug to treat a rare genetic disease. \n</p>\n<p>\n     Shares in the biotech company plunged 73% to $2.33, wiping out $730 million in valuation. The small-cap Russell 2000 index was up 0.6%. \n</p>\n<p>\n     The massive losses came after Applied Therapeutics said it had received a letter from the Food and Drug Administration in which the agency declined to approve a drug to treat the metabolic disorder Classic Galactosemia. The company said the FDA had cited \"deficiencies in the clinical application\" of the drug, which it's marketing as govorestat. \n</p>\n<p>\n     Founder and CEO Shoshana Shendelman said she was \"disappointed by the FDA's decision,\" adding that Applied Therapeutics would \"work with the FDA to address the concerns\" raised in its letter. \n</p>\n<p>\n     It looks like a crushing blow for the stock. As of Wednesday's close, shares in Applied Therapeutics were up 135% in 2024, but Friday's losses mean they're now trading in the red for the year. \n</p>\n<p>\n     Write to George Glover at george.glover@dowjones.com \n</p>\n<p>\n     This content was created by Barron's, which is operated by Dow Jones &amp; Co. Barron's is published independently from Dow Jones Newswires and The Wall Street Journal. \n</p>\n<pre>\n \n</pre>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  November 29, 2024 10:48 ET (15:48 GMT)\n</p>\n<p>\n  Copyright (c) 2024 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>Applied Therapeutics Stock Plummets 73%. The FDA Delivers This Crushing Blow. -- Barrons.com</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\">\nApplied Therapeutics Stock Plummets 73%. The FDA Delivers This Crushing Blow. -- Barrons.com\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\">2024-11-29 23:48</p>\n</div>\n\n</div>\n\n\n</h4>\n\n</header>\n<article>\n<font class=\"NormalMinus1\" face=\"Arial\">\n<p>\n  By George Glover \n</p>\n<p>\n  Applied <a href=\"https://laohu8.com/S/LENZ\">Therapeutics</a> stock was tanking Friday after regulators said they were unable to green light a drug to treat a rare genetic disease. \n</p>\n<p>\n     Shares in the biotech company plunged 73% to $2.33, wiping out $730 million in valuation. The small-cap Russell 2000 index was up 0.6%. \n</p>\n<p>\n     The massive losses came after Applied Therapeutics said it had received a letter from the Food and Drug Administration in which the agency declined to approve a drug to treat the metabolic disorder Classic Galactosemia. The company said the FDA had cited \"deficiencies in the clinical application\" of the drug, which it's marketing as govorestat. \n</p>\n<p>\n     Founder and CEO Shoshana Shendelman said she was \"disappointed by the FDA's decision,\" adding that Applied Therapeutics would \"work with the FDA to address the concerns\" raised in its letter. \n</p>\n<p>\n     It looks like a crushing blow for the stock. As of Wednesday's close, shares in Applied Therapeutics were up 135% in 2024, but Friday's losses mean they're now trading in the red for the year. \n</p>\n<p>\n     Write to George Glover at george.glover@dowjones.com \n</p>\n<p>\n     This content was created by Barron's, which is operated by Dow Jones &amp; Co. Barron's is published independently from Dow Jones Newswires and The Wall Street Journal. \n</p>\n<pre>\n \n</pre>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  November 29, 2024 10:48 ET (15:48 GMT)\n</p>\n<p>\n  Copyright (c) 2024 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":null,"symbol_name":null,"start_time":0,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","article_id":"2487661025","we_media_id":"106","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2487661025","pubTimestamp":1732895280,"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":"Applied Therapeutics stock was tanking Friday after regulators said they were unable to green light a drug to treat a rare genetic disease.Shares in the biotech company plunged 73% to $2.33, wiping out $730 million in valuation. The small-cap Russell 2000 index was up 0.6%.The massive losses came after Applied Therapeutics said it had received a letter from the Food and Drug Administration in which the agency declined to approve a drug to treat the metabolic disorder Classic Galactosemia. The company said the FDA had cited \"deficiencies in the clinical application\" of the drug, which it's marketing as govorestat.Founder and CEO Shoshana Shendelman said she was \"disappointed by the FDA's decision,\" adding that Applied Therapeutics would \"work with the FDA to address the concerns\" raised in its letter.It looks like a crushing blow for the stock. As of Wednesday's close, shares in Applied Therapeutics were up 135% in 2024, but Friday's losses mean they're now trading in the red for the ye","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{},"translate_title":"Applied Therapeutics股价暴跌73%。食品和药物管理局提供了这一毁灭性的打击。——Barrons.com","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"APLT":0.9,"LENZ":1,"MMAT":0.6},"content_text":"By George Glover \n\n\n  Applied Therapeutics stock was tanking Friday after regulators said they were unable to green light a drug to treat a rare genetic disease. \n\n\n     Shares in the biotech company plunged 73% to $2.33, wiping out $730 million in valuation. The small-cap Russell 2000 index was up 0.6%. \n\n\n     The massive losses came after Applied Therapeutics said it had received a letter from the Food and Drug Administration in which the agency declined to approve a drug to treat the metabolic disorder Classic Galactosemia. The company said the FDA had cited \"deficiencies in the clinical application\" of the drug, which it's marketing as govorestat. \n\n\n     Founder and CEO Shoshana Shendelman said she was \"disappointed by the FDA's decision,\" adding that Applied Therapeutics would \"work with the FDA to address the concerns\" raised in its letter. \n\n\n     It looks like a crushing blow for the stock. As of Wednesday's close, shares in Applied Therapeutics were up 135% in 2024, but Friday's losses mean they're now trading in the red for the year. \n\n\n     Write to George Glover at george.glover@dowjones.com \n\n\n     This content was created by Barron's, which is operated by Dow Jones & Co. Barron's is published independently from Dow Jones Newswires and The Wall Street Journal. \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  November 29, 2024 10:48 ET (15:48 GMT)\n\n\n  Copyright (c) 2024 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":"-2","news_tag":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":0}}}