Outlook Therapeutics Says FDA Issued Complete Response Letter to ONS-5010 BLA Resubmission

MT Newswires Live

01/01

Outlook Therapeutics (OTLK) said Wednesday the US Food and Drug Administration has issued a complete response letter to the ONS-5010 biologics license application resubmission.

The move indicates the regulator cannot approve the application in its present form for the treatment of wet age-related macular degeneration, the company said.

Outlook Therapeutics said it is exploring "all available pathways" for potential clearance in the US and it also plans to continue its efforts to expand into more markets in Europe and other regions.

Trading in shares of Outlook Therapeutics were halted.

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/2600701922"},"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:\"2600701922\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2600701922?lang=zh_CN&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2026-01-01 05:33","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2600701922","market":"hk","top_or_hot":-1,"title":"Outlook Therapeutics Says FDA Issued Complete Response Letter to ONS-5010 BLA Resubmission","media":"MT Newswires Live","content":"<html><body><p> Outlook <a href=\"https://laohu8.com/S/LENZ\">Therapeutics</a> (OTLK) said Wednesday the US Food and Drug Administration has issued a complete response letter to the ONS-5010 biologics license application resubmission.</p><p>The move indicates the regulator cannot approve the application in its present form for the treatment of wet age-related macular degeneration, the company said.</p><p>Outlook Therapeutics said it is exploring \"all available pathways\" for potential clearance in the US and it also plans to continue its efforts to expand into more markets in Europe and other regions.</p><p>Trading in shares of Outlook Therapeutics were halted.</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>Outlook Therapeutics Says FDA Issued Complete Response Letter to ONS-5010 BLA Resubmission</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\">\nOutlook Therapeutics Says FDA Issued Complete Response Letter to ONS-5010 BLA Resubmission\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\">2026-01-01 05:33</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html><body><p> Outlook <a href=\"https://laohu8.com/S/LENZ\">Therapeutics</a> (OTLK) said Wednesday the US Food and Drug Administration has issued a complete response letter to the ONS-5010 biologics license application resubmission.</p><p>The move indicates the regulator cannot approve the application in its present form for the treatment of wet age-related macular degeneration, the company said.</p><p>Outlook Therapeutics said it is exploring \"all available pathways\" for potential clearance in the US and it also plans to continue its efforts to expand into more markets in Europe and other regions.</p><p>Trading in shares of Outlook Therapeutics were halted.</p></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4007","symbol_name":"制药","start_time":0,"source_url":"https://www.mtnewswires.com/","article_id":"2600701922","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2600701922","pubTimestamp":1767216792,"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":"Outlook Therapeutics  said Wednesday the US Food and Drug Administration has issued a complete response letter to the ONS-5010 biologics license application resubmission.The move indicates the regulator cannot approve the application in its present form for the treatment of wet age-related macular degeneration, the company said.Outlook Therapeutics said it is exploring \"all available pathways\" for potential clearance in the US and it also plans to continue its efforts to expand into more markets in Europe and other regions.Trading in shares of Outlook Therapeutics were halted.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4007":"制药","OTLK":"Outlook Therapeutics, Inc.","BK4539":"次新股","BK4139":"生物科技","LENZ":"Therapeutics"},"translate_title":"Outlook Therapeutics表示FDA发布了对ONS-5010 BLA重新提交的完整回复信","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"OTLK":1,"LENZ":1.5},"content_text":"Outlook Therapeutics (OTLK) said Wednesday the US Food and Drug Administration has issued a complete response letter to the ONS-5010 biologics license application resubmission.The move indicates the regulator cannot approve the application in its present form for the treatment of wet age-related macular degeneration, the company said.Outlook Therapeutics said it is exploring \"all available pathways\" for potential clearance in the US and it also plans to continue its efforts to expand into more markets in Europe and other regions.Trading in shares of Outlook Therapeutics were halted.","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":1,"need_auth":false,"code":"91000000","status":"200"}}}