PolyPid Ltd. Announces Plans to Submit NDA to FDA for D-PLEX100 in Early 2026 Following Positive Phase 3 Trial Results

Reuters

06-09

<a href="https://laohu8.com/S/PYPD">PolyPid Ltd.</a> Announces Plans to Submit NDA to FDA for D-PLEX100 in Early 2026 Following Positive Phase 3 Trial Results

PolyPid Ltd., a late-stage biopharma company based in Israel, announced that it plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in early 2026 for its product D-PLEX100, following positive topline results from its Phase 3 SHIELD II trial. The trial demonstrated a significant reduction in surgical site infections in patients undergoing abdominal colorectal surgery. The product has received Fast Track designation from the FDA, indicating an expedited review process. A Marketing Authorization Application $(MAA)$ for the European Union is expected to follow shortly after the NDA submission.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. PolyPid Ltd. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001213900-25-052320), on June 09, 2025, and is solely responsible for the information contained therein.

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

1
2
3
4
5
6
7
8
9
10

{"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/2542890733"},"companyName":"老虎证券"},"pageData":{"isMobile":false,"isTiger":false,"isTTM":true,"region":"SGP","license":"TBSG","edition":"fundamental"},"__swrFallback__":{"@#url:\"https://stock-news.skytigris.cn/v3/news\",params:#id:\"2542890733\",edition:\"fundamental\",,,undefined,":{"share":"https://ttm.financial/m/news/2542890733?lang=zh_CN&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-06-09 19:36","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2542890733","market":"nz","top_or_hot":-1,"title":"PolyPid Ltd. Announces Plans to Submit NDA to FDA for D-PLEX100 in Early 2026 Following Positive Phase 3 Trial Results","media":"Reuters","content":"<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      <a href=\"https://laohu8.com/S/PYPD\">PolyPid Ltd.</a> Announces Plans to Submit NDA to FDA for D-PLEX100 in Early 2026 Following Positive Phase 3 Trial Results\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        PolyPid Ltd., a late-stage biopharma company based in Israel, announced that it plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in early 2026 for its product D-PLEX100, following positive topline results from its Phase 3 SHIELD II trial. The trial demonstrated a significant reduction in surgical site infections in patients undergoing abdominal colorectal surgery. The product has received Fast Track designation from the FDA, indicating an expedited review process. A Marketing Authorization Application <a href=\"https://laohu8.com/S/MAA\">$(MAA)$</a> for the European Union is expected to follow shortly after the NDA submission.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. PolyPid Ltd. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001213900-25-052320), on June 09, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></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>PolyPid Ltd. Announces Plans to Submit NDA to FDA for D-PLEX100 in Early 2026 Following Positive Phase 3 Trial Results</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\">\nPolyPid Ltd. Announces Plans to Submit NDA to FDA for D-PLEX100 in Early 2026 Following Positive Phase 3 Trial Results\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1032215980\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Reuters </p>\n<p class=\"h-time\">2025-06-09 19:36</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      <a href=\"https://laohu8.com/S/PYPD\">PolyPid Ltd.</a> Announces Plans to Submit NDA to FDA for D-PLEX100 in Early 2026 Following Positive Phase 3 Trial Results\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        PolyPid Ltd., a late-stage biopharma company based in Israel, announced that it plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in early 2026 for its product D-PLEX100, following positive topline results from its Phase 3 SHIELD II trial. The trial demonstrated a significant reduction in surgical site infections in patients undergoing abdominal colorectal surgery. The product has received Fast Track designation from the FDA, indicating an expedited review process. A Marketing Authorization Application <a href=\"https://laohu8.com/S/MAA\">$(MAA)$</a> for the European Union is expected to follow shortly after the NDA submission.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. PolyPid Ltd. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001213900-25-052320), on June 09, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></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://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250609:nNDL37bjW0:1","article_id":"2542890733","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2542890733","pubTimestamp":1749468979,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"PolyPid Ltd., a late-stage biopharma company based in Israel, announced that it plans to submit a New Drug Application  to the U.S. Food and Drug Administration  in early 2026 for its product D-PLEX100, following positive topline results from its Phase 3 SHIELD II trial. The trial demonstrated a significant reduction in surgical site infections in patients undergoing abdominal colorectal surgery. The product has received Fast Track designation from the FDA, indicating an expedited review process. A Marketing Authorization Application  for the European Union is expected to follow shortly after the NDA submission.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. PolyPid Ltd. published the original content used to generate this news brief v","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4007":"制药","PYPD":"PolyPid Ltd."},"translate_title":"PolyPid Ltd.宣布计划在3期试验结果积极后于2026年初向FDA提交D-PLEX100的NDA","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"PYPD":0.9},"content_text":"PolyPid Ltd. Announces Plans to Submit NDA to FDA for D-PLEX100 in Early 2026 Following Positive Phase 3 Trial Results\n    \n\n        PolyPid Ltd., a late-stage biopharma company based in Israel, announced that it plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in early 2026 for its product D-PLEX100, following positive topline results from its Phase 3 SHIELD II trial. The trial demonstrated a significant reduction in surgical site infections in patients undergoing abdominal colorectal surgery. The product has received Fast Track designation from the FDA, indicating an expedited review process. A Marketing Authorization Application $(MAA)$ for the European Union is expected to follow shortly after the NDA submission.\n      \n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. PolyPid Ltd. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001213900-25-052320), on June 09, 2025, and is solely responsible for the information contained therein.","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":"productRelease","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"}}}