Omeros Shares Hit 52-Week High on Plan to Resubmit Narsoplimab Application

Dow Jones11-15

By Stephen Nakrosis

Shares of Omeros touched a 52-week high, a day after the company said it could resubmit its biologics license application for narsoplimab to the Food and Drug Administration.

In Thursday afternoon trading, the stock had gained 47%, to $6.20. Earlier in the session, shares hit a high of $7.51.

Omeros said it held a presubmission meeting with FDA for its biologics license application for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy. The National Institutes of Health said the disorder, also known as TA-TMA, can be triggered by several mechanisms during transplants.

Following the meeting, the company said, it revised and resubmitted its statistical analysis plan, and now expects to receive a reply imminently. If the results support resubmission, the company said, it plans to finalize and resubmit the BLA as soon as possible.

The biopharmaceutical company also said preparations are underway for a European marketing authorization application for narsoplimab in TA-TMA, which it expects to submit in the first half of next year.

Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

(END) Dow Jones Newswires

November 14, 2024 13:33 ET (18:33 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.

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/2483733857?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2024-11-15 02:33","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2483733857","market":"hk","top_or_hot":-1,"title":"Omeros Shares Hit 52-Week High on Plan to Resubmit Narsoplimab Application","media":"Dow Jones","content":"<font class=\"NormalMinus1\" face=\"Arial\">\n<pre>\n \n</pre>\n<p>\n  By Stephen Nakrosis \n</p>\n<pre>\n \n</pre>\n<p>\n  Shares of Omeros touched a 52-week high, a day after the company said it could resubmit its biologics license application for narsoplimab to the Food and Drug Administration. \n</p>\n<p>\n  In Thursday afternoon trading, the stock had gained 47%, to $6.20. Earlier in the session, shares hit a high of $7.51. \n</p>\n<p>\n  Omeros said it held a presubmission meeting with FDA for its biologics license application for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy. The National Institutes of Health said the disorder, also known as TA-TMA, can be triggered by several mechanisms during transplants. \n</p>\n<p>\n  Following the meeting, the company said, it revised and resubmitted its statistical analysis plan, and now expects to receive a reply imminently. If the results support resubmission, the company said, it plans to finalize and resubmit the BLA as soon as possible. \n</p>\n<p>\n  The biopharmaceutical company also said preparations are underway for a European marketing authorization application for narsoplimab in TA-TMA, which it expects to submit in the first half of next year. \n</p>\n<pre>\n \n</pre>\n<p>\n  Write to Stephen Nakrosis at stephen.nakrosis@wsj.com \n</p>\n<pre>\n \n</pre>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  November 14, 2024 13:33 ET (18:33 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>Omeros Shares Hit 52-Week High on Plan to Resubmit Narsoplimab Application</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\">\nOmeros Shares Hit 52-Week High on Plan to Resubmit Narsoplimab Application\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-11-15 02:33 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://dowjonesnews.com/newdjn/logon.aspx?AL=N><strong>Dow Jones</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>By Stephen Nakrosis \n\n\n \n\n\n  Shares of Omeros touched a 52-week high, a day after the company said it could resubmit its biologics license application for narsoplimab to the Food and Drug ...</p>\n\n<a href=\"https://dowjonesnews.com/newdjn/logon.aspx?AL=N\">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":"BK6045","symbol_name":"建筑与工程","start_time":0,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","article_id":"2483733857","we_media_id":"106","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2483733857","pubTimestamp":1731609180,"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":"Shares of Omeros touched a 52-week high, a day after the company said it could resubmit its biologics license application for narsoplimab to the Food and Drug Administration.In Thursday afternoon trading, the stock had gained 47%, to $6.20. Earlier in the session, shares hit a high of $7.51.Omeros said it held a presubmission meeting with FDA for its biologics license application for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy. The National Institutes of Health said the disorder, also known as TA-TMA, can be triggered by several mechanisms during transplants.Following the meeting, the company said, it revised and resubmitted its statistical analysis plan, and now expects to receive a reply imminently. If the results support resubmission, the company said, it plans to finalize and resubmit the BLA as soon as possible.The biopharmaceutical company also said preparations are underway for a European marketing authorization application for narsopl","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK6045":"建筑与工程","BK6512":"房地产股","PA3.SI":"长益","OMER":"奥麦罗制药","BK4007":"制药"},"translate_title":"Omeros计划重新提交Narsoplimab申请，股价创52周新高","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"OMER":1,"PA3.SI":0.63},"content_text":"By Stephen Nakrosis \n\n\n \n\n\n  Shares of Omeros touched a 52-week high, a day after the company said it could resubmit its biologics license application for narsoplimab to the Food and Drug Administration. \n\n\n  In Thursday afternoon trading, the stock had gained 47%, to $6.20. Earlier in the session, shares hit a high of $7.51. \n\n\n  Omeros said it held a presubmission meeting with FDA for its biologics license application for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy. The National Institutes of Health said the disorder, also known as TA-TMA, can be triggered by several mechanisms during transplants. \n\n\n  Following the meeting, the company said, it revised and resubmitted its statistical analysis plan, and now expects to receive a reply imminently. If the results support resubmission, the company said, it plans to finalize and resubmit the BLA as soon as possible. \n\n\n  The biopharmaceutical company also said preparations are underway for a European marketing authorization application for narsoplimab in TA-TMA, which it expects to submit in the first half of next year. \n\n\n \n\n\n  Write to Stephen Nakrosis at stephen.nakrosis@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  November 14, 2024 13:33 ET (18:33 GMT)\n\n\n  Copyright (c) 2024 Dow Jones & Company, Inc.","kind":null,"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":1},"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":"4.29.2","shortVersion":"4.29.2","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/2483733857"}