Organogenesis Confirmed to Start FDA License Application for ReNu

Dow Jones

2025/12/16

By Katherine Hamilton

Organogenesis received confirmation to initiate a license application with the Food and Drug Administration for its knee condition treatment ReNu.

The regenerative tissue company said Monday it plans to initiate a rolling Biologics License Application for ReNu before the end of December.

Shares gained 9% to $5.28 in after-hours trading.

The plans come after a planned Type-B meeting with the FDA, which was completed Monday, Organogenesis said.

Organogenesis has done two large Phase 3 trials of ReNu, plus a separate randomized controlled trial.

ReNu is designed to treat people with symptomatic knee osteoarthritis, a degenerative condition that causes knee pain. It affects 31.1 million Americans and is ranked among the most common causes of disability and poor quality of life, Organogenesis said.

Write to Katherine Hamilton at katherine.hamilton@wsj.com

(END) Dow Jones Newswires

December 15, 2025 17:11 ET (22:11 GMT)

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It affects 31.1 million Americans and is ranked among the most common causes of disability and poor quality of life, Organogenesis said. \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  Write to Katherine Hamilton at katherine.hamilton@wsj.com \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  December 15, 2025 17:11 ET (22:11 GMT)\n</p>\n<p>\n  Copyright (c) 2025 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>Organogenesis Confirmed to Start FDA License Application for ReNu</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: 12.5px; color: #7E829C; margin: 0;}\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\">\nOrganogenesis Confirmed to Start FDA License Application for ReNu\n</h2>\n<h4 class=\"meta\">\n<div class=\"head\" \">\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 smaller\">2025-12-16 06:11</p>\n</div>\n</div>\n</h4>\n</header>\n<article>\n<font class=\"NormalMinus1\" face=\"Arial\">\n<p>\n  By Katherine Hamilton \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  Organogenesis received confirmation to initiate a license application with the Food and Drug Administration for its knee condition treatment ReNu. \n</p>\n<p>\n  The regenerative tissue company said Monday it plans to initiate a rolling Biologics License Application for ReNu before the end of December. \n</p>\n<p>\n  Shares gained 9% to $5.28 in after-hours trading. \n</p>\n<p>\n  The plans come after a planned Type-B meeting with the FDA, which was completed Monday, Organogenesis said. \n</p>\n<p>\n  Organogenesis has done two large Phase 3 trials of ReNu, plus a separate randomized controlled trial. \n</p>\n<p>\n  ReNu is designed to treat people with symptomatic knee osteoarthritis, a degenerative condition that causes knee pain. It affects 31.1 million Americans and is ranked among the most common causes of disability and poor quality of life, Organogenesis said. \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  Write to Katherine Hamilton at katherine.hamilton@wsj.com \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  December 15, 2025 17:11 ET (22:11 GMT)\n</p>\n<p>\n  Copyright (c) 2025 Dow Jones &amp; Company, Inc.\n</p>\n</font>\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4139","symbol_name":"生物科技","start_time":0,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","article_id":"2591227756","we_media_id":"106","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2591227756","pubTimestamp":1765836660,"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":"Organogenesis received confirmation to initiate a license application with the Food and Drug Administration for its knee condition treatment ReNu.The regenerative tissue company said Monday it plans to initiate a rolling Biologics License Application for ReNu before the end of December.Shares gained 9% to $5.28 in after-hours trading.The plans come after a planned Type-B meeting with the FDA, which was completed Monday, Organogenesis said.Organogenesis has done two large Phase 3 trials of ReNu, plus a separate randomized controlled trial.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4139":"生物科技","ORGO":"Organogenesis Holdings Inc"},"translate_title":"Organogenesis确认开始ReNu的FDA许可申请","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"ORGO":0.9},"content_text":"By Katherine Hamilton \n\n\n \n\n\n  Organogenesis received confirmation to initiate a license application with the Food and Drug Administration for its knee condition treatment ReNu. \n\n\n  The regenerative tissue company said Monday it plans to initiate a rolling Biologics License Application for ReNu before the end of December. \n\n\n  Shares gained 9% to $5.28 in after-hours trading. \n\n\n  The plans come after a planned Type-B meeting with the FDA, which was completed Monday, Organogenesis said. \n\n\n  Organogenesis has done two large Phase 3 trials of ReNu, plus a separate randomized controlled trial. \n\n\n  ReNu is designed to treat people with symptomatic knee osteoarthritis, a degenerative condition that causes knee pain. It affects 31.1 million Americans and is ranked among the most common causes of disability and poor quality of life, Organogenesis said. \n\n\n \n\n\n  Write to Katherine Hamilton at katherine.hamilton@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  December 15, 2025 17:11 ET (22:11 GMT)\n\n\n  Copyright (c) 2025 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":"1","news_tag":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":true,"code":"91000000","status":"200"}}}