Coya Therapeutics Inc. Re-Submits IND to FDA for Phase 2 ALS Study Following Request for Additional Data

Reuters

07-01

Coya <a href="https://laohu8.com/S/LENZ">Therapeutics</a> Inc. Re-Submits IND to FDA for Phase 2 ALS Study Following Request for Additional Data

Coya Therapeutics Inc. has made significant progress in its regulatory journey with the U.S. Food and Drug Administration (FDA) regarding its investigational treatment for Amyotrophic Lateral Sclerosis (ALS), COYA 302. Initially, the FDA had requested additional non-clinical data to support the initiation of a planned Phase 2 clinical study. In response, Coya Therapeutics re-submitted its Investigational New Drug $(IND.AU)$ Application on June 30, 2025, incorporating the requested data. The company is now awaiting acceptance of the IND, which will allow them to commence the Phase 2 study, aimed at evaluating the safety and efficacy of COYA 302. This development marks a crucial step forward in the company's efforts to advance potential treatment options for ALS.

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. Coya Therapeutics Inc. 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: 0001193125-25-153465), on July 01, 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/2548064220"},"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:\"2548064220\",edition:\"fundamental\",,,undefined,":{"share":"https://ttm.financial/m/news/2548064220?lang=zh_CN&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-07-01 20:01","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2548064220","market":"nz","top_or_hot":-1,"title":"Coya Therapeutics Inc. Re-Submits IND to FDA for Phase 2 ALS Study Following Request for Additional Data","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      Coya <a href=\"https://laohu8.com/S/LENZ\">Therapeutics</a> Inc. Re-Submits IND to FDA for Phase 2 ALS Study Following Request for Additional Data\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        Coya Therapeutics Inc. has made significant progress in its regulatory journey with the U.S. Food and Drug Administration (FDA) regarding its investigational treatment for Amyotrophic Lateral Sclerosis (ALS), COYA 302. Initially, the FDA had requested additional non-clinical data to support the initiation of a planned Phase 2 clinical study. In response, Coya Therapeutics re-submitted its Investigational New Drug <a href=\"https://laohu8.com/S/IND.AU\">$(IND.AU)$</a> Application on June 30, 2025, incorporating the requested data. The company is now awaiting acceptance of the IND, which will allow them to commence the Phase 2 study, aimed at evaluating the safety and efficacy of COYA 302. This development marks a crucial step forward in the company's efforts to advance potential treatment options for ALS.\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. Coya Therapeutics Inc. 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: 0001193125-25-153465), on July 01, 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>Coya Therapeutics Inc. Re-Submits IND to FDA for Phase 2 ALS Study Following Request for Additional Data</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\">\nCoya Therapeutics Inc. Re-Submits IND to FDA for Phase 2 ALS Study Following Request for Additional Data\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\">2025-07-01 20:01</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      Coya <a href=\"https://laohu8.com/S/LENZ\">Therapeutics</a> Inc. Re-Submits IND to FDA for Phase 2 ALS Study Following Request for Additional Data\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        Coya Therapeutics Inc. has made significant progress in its regulatory journey with the U.S. Food and Drug Administration (FDA) regarding its investigational treatment for Amyotrophic Lateral Sclerosis (ALS), COYA 302. Initially, the FDA had requested additional non-clinical data to support the initiation of a planned Phase 2 clinical study. In response, Coya Therapeutics re-submitted its Investigational New Drug <a href=\"https://laohu8.com/S/IND.AU\">$(IND.AU)$</a> Application on June 30, 2025, incorporating the requested data. The company is now awaiting acceptance of the IND, which will allow them to commence the Phase 2 study, aimed at evaluating the safety and efficacy of COYA 302. This development marks a crucial step forward in the company's efforts to advance potential treatment options for ALS.\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. Coya Therapeutics Inc. 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: 0001193125-25-153465), on July 01, 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":"BK4139","symbol_name":"生物科技","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250701:nNDL3V4QJq:1","article_id":"2548064220","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2548064220","pubTimestamp":1751371284,"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":"Coya Therapeutics Inc. has made significant progress in its regulatory journey with the U.S. Food and Drug Administration  regarding its investigational treatment for Amyotrophic Lateral Sclerosis , COYA 302. Initially, the FDA had requested additional non-clinical data to support the initiation of a planned Phase 2 clinical study. In response, Coya Therapeutics re-submitted its Investigational New Drug  Application on June 30, 2025, incorporating the requested data. The company is now awaiting acceptance of the IND, which will allow them to commence the Phase 2 study, aimed at evaluating the safety and efficacy of COYA 302. This development marks a crucial step forward in the company's efforts to advance potential treatment options for ALS.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 i","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4139":"生物科技","COYA":"COYA THERAPEUTICS INC"},"translate_title":"Coya Therapeutics Inc.在要求提供更多数据后，向FDA重新提交了2期ALS研究的IND","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"COYA":0.9},"content_text":"Coya Therapeutics Inc. Re-Submits IND to FDA for Phase 2 ALS Study Following Request for Additional Data\n    \n\n        Coya Therapeutics Inc. has made significant progress in its regulatory journey with the U.S. Food and Drug Administration (FDA) regarding its investigational treatment for Amyotrophic Lateral Sclerosis (ALS), COYA 302. Initially, the FDA had requested additional non-clinical data to support the initiation of a planned Phase 2 clinical study. In response, Coya Therapeutics re-submitted its Investigational New Drug $(IND.AU)$ Application on June 30, 2025, incorporating the requested data. The company is now awaiting acceptance of the IND, which will allow them to commence the Phase 2 study, aimed at evaluating the safety and efficacy of COYA 302. This development marks a crucial step forward in the company's efforts to advance potential treatment options for ALS.\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. Coya Therapeutics Inc. 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: 0001193125-25-153465), on July 01, 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":"","news_rank":0,"symbols":[],"gpt_button":0,"code":"91000000","status":"200"}}}