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.

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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. 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Re-Submits IND to FDA for Phase 2 ALS Study Following Request for Additional Data\n</h2>\n<h4 class=\"meta\">\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1032215980\">\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 smaller\">2025-07-01 20:01</p>\n</div>\n</a>\n</h4>\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</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. 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