FDA Lifts Clinical Hold on GH Research's GH001, Allowing U.S. Trials

Reuters

Jan 05

FDA Lifts Clinical Hold on GH Research's GH001, Allowing U.S. Trials

GH Research plc announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on its Investigational New Drug Application for GH001, clearing the way for U.S. subject enrollment. This regulatory clearance enables the company to progress toward a global Phase 3 program for GH001 as a potential ultra-rapid and durable treatment for treatment-resistant depression, with Phase 3 initiation targeted for 2026. The company plans to seek FDA alignment on the global Phase 3 program design, aiming to replicate the successful Phase 2b trial results.

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. GH Research plc published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9619641-en) on January 05, 2026, and is solely responsible for the information contained therein.

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ID: GNW9619641-en) on January 05, 2026, and is solely responsible for the information contained therein.</span></i>\n</p>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4585","symbol_name":"ETF&股票定投概念","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260105:nNDLc1wmYx:1","article_id":"2601764885","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2601764885","pubTimestamp":1767614429,"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":"GH Research plc announced that the U.S. Food and Drug Administration  has lifted the clinical hold on its Investigational New Drug Application for GH001, clearing the way for U.S. subject enrollment. 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