Denali Therapeutics fell 14% premarket on clinical hold for Alzheimer’s candidate

Tiger Newspress2022-01-13

Denali Therapeutics fell 14% in the pre-market after announcing a clinical hold imposed by the FDA for the company’s experimental therapy for Alzheimer’s disease, DNL919.

On Wednesday after the close, the regulator has informed the company via email that the DNL919 (ATV:TREM2) Investigational New Drug (IND) application had been placed on clinical hold.

An official clinical hold letter will be issued to Denali (DNLI) in this regard in about 30 days, the federal agency has added. The company plans to announce further updates on this development subject to its ongoing discussions with the regulator.

According to the therapeutic pipeline of the company, DNL919 (ATV:TREM2) is part of its Alzheimer’s program. Early this week, Denali (DNLI) said that subject to the FDA acceptance of its IND application, the company would begin first-in-human clinical trials for DNL919 in H1 2022.

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

Phie
2022-01-14
Phie
Good.
Pluto891
2022-01-13
Pluto891
oop
KYBoo
2022-01-13
KYBoo
Goof

Leave a comment

{"i18n":{"language":"en_US"},"isChannel":false,"data":{"share":"https://ttm.financial/m/news/1182371720?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2022-01-13 21:28","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"1182371720","market":"us","top_or_hot":-1,"title":"Denali Therapeutics fell 14% premarket on clinical hold for Alzheimer’s candidate","media":"Tiger Newspress","content":"<html><head></head><body><p><a href=\"https://laohu8.com/S/DNLI\">Denali Therapeutics </a> fell 14% in the pre-market after announcing a clinical hold imposed by the FDA for the company’s experimental therapy for Alzheimer’s disease, DNL919.</p><p><img src=\"https://static.tigerbbs.com/e3a70235a688890f0fbb57a5beb7e535\" tg-width=\"1033\" tg-height=\"634\" referrerpolicy=\"no-referrer\"/></p><p>On Wednesday after the close, the regulator has informed the company via email that the DNL919 (ATV:TREM2) Investigational New Drug (IND) application had been placed on clinical hold.</p><p>An official clinical hold letter will be issued to Denali (DNLI) in this regard in about 30 days, the federal agency has added. The company plans to announce further updates on this development subject to its ongoing discussions with the regulator.</p><p>According to the therapeutic pipeline of the company, DNL919 (ATV:TREM2) is part of its Alzheimer’s program. Early this week, Denali (DNLI) said that subject to the FDA acceptance of its IND application, the company would begin first-in-human clinical trials for DNL919 in H1 2022.</p></body></html>","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>Denali Therapeutics fell 14% premarket on clinical hold for Alzheimer’s candidate</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\">\nDenali Therapeutics fell 14% premarket on clinical hold for Alzheimer’s candidate\n</h2>\n\n<h4 class=\"meta\">\n\n2022-01-13 21:28 北京时间&nbsp;&nbsp;&nbsp;<strong>Tiger Newspress</strong>\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Denali Therapeutics  fell 14% in the pre-market after announcing a clinical hold imposed by the FDA for the company’s experimental therapy for Alzheimer’s disease, DNL919.On Wednesday after the close,...</p>\n\n<a href=\"\">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":"DNLI","symbol_name":"Denali Therapeutics Inc.","start_time":0,"source_url":"","article_id":"1182371720","we_media_id":"1079075236","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=1182371720","pubTimestamp":1642080538,"sourceInfo":null,"weMediaInfo":{"media_name":"Tiger Newspress","introduction":"Providing stock market headlines, business news, financials and earnings ","home_visible":1,"id":"1079075236","head_image":"https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba"},"summary":"Denali Therapeutics  fell 14% in the pre-market after announcing a clinical hold imposed by the FDA ","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"DNLI":"Denali Therapeutics Inc."},"translate_title":"Denali Therapeutics在阿尔茨海默病候选患者的临床暂停上市前下跌14%","themeId":"","isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"DNLI":0.9},"content_text":"Denali Therapeutics  fell 14% in the pre-market after announcing a clinical hold imposed by the FDA for the company’s experimental therapy for Alzheimer’s disease, DNL919.On Wednesday after the close, the regulator has informed the company via email that the DNL919 (ATV:TREM2) Investigational New Drug (IND) application had been placed on clinical hold.An official clinical hold letter will be issued to Denali (DNLI) in this regard in about 30 days, the federal agency has added. The company plans to announce further updates on this development subject to its ongoing discussions with the regulator.According to the therapeutic pipeline of the company, DNL919 (ATV:TREM2) is part of its Alzheimer’s program. Early this week, Denali (DNLI) said that subject to the FDA acceptance of its IND application, the company would begin first-in-human clinical trials for DNL919 in H1 2022.","kind":"news","is_publish_news":true,"is_publish_highlight":true,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[{"id":9002758629,"gmtCreate":1642113684220,"gmtModify":1676533681399,"author":{"id":"4101375719331580","authorId":"4101375719331580","name":"Phie","avatar":"https://static.tigerbbs.com/6a07886258370a0cc2aa5f412320f532","vip":1,"crmLevel":2,"crmLevelSwitch":0,"idStr":"4101375719331580","authorIdStr":"4101375719331580"},"htmlText":"Good.&nbsp;","listText":"Good.&nbsp;","text":"Good.","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":2,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/9002758629","repostId":1182371720,"repostType":4,"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"langContent":"EN"},{"id":9002478272,"gmtCreate":1642084492594,"gmtModify":1676533679198,"author":{"id":"3581937910767045","authorId":"3581937910767045","name":"Pluto891","avatar":"https://static.tigerbbs.com/c9963f2ef3d3ad2aff28340461d3d6d0","vip":1,"crmLevel":2,"crmLevelSwitch":1,"idStr":"3581937910767045","authorIdStr":"3581937910767045"},"htmlText":"oop","listText":"oop","text":"oop","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/9002478272","repostId":1182371720,"repostType":4,"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"langContent":"EN"},{"id":9002449414,"gmtCreate":1642081764282,"gmtModify":1676533678729,"author":{"id":"3581501341719005","authorId":"3581501341719005","name":"KYBoo","avatar":"https://static.tigerbbs.com/43072e3bdf1be8a6c0fb9e0d7c8a0558","vip":1,"crmLevel":3,"crmLevelSwitch":0,"idStr":"3581501341719005","authorIdStr":"3581501341719005"},"htmlText":"Goof","listText":"Goof","text":"Goof","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":2,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/9002449414","repostId":1182371720,"repostType":4,"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"langContent":"EN"}],"isCommentEnd":false,"newsSizeData":{"likeSize":37,"commentSize":3,"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":"4.29.3","shortVersion":"4.29.3","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/1182371720"}