NRX Pharmaceuticals Advances NRX-100 Toward FDA Approval for Suicidal Depression

Reuters

Feb 17

NRX Pharmaceuticals Advances NRX-100 Toward FDA Approval for Suicidal Depression

NRX Pharmaceuticals Inc. announced completion of an in-person Type C guidance meeting with the US Food and Drug Administration regarding its preservative-free intravenous ketamine product, NRX-100, for the treatment of suicidal ideation in depression, including bipolar depression. Based on FDA guidance, NRx plans to use existing clinical trial data along with Real World Evidence from over 65,000 patients to support its New Drug Application. The company will work with the FDA to finalize the statistical analysis protocol for the Real World Evidence dataset. Study results have not yet been presented.

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. NRX Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202602170700PRIMZONEFULLFEED9655641) on February 17, 2026, and is solely responsible for the information contained therein.

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ID: 202602170700PRIMZONEFULLFEED9655641) on February 17, 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":"IE00B64PRP62.GBP","symbol_name":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (GBP) ACC","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260217:nNDL9Y5TCN:1","article_id":"2612451678","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2612451678","pubTimestamp":1771329784,"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":"NRX Pharmaceuticals Inc. announced completion of an in-person Type C guidance meeting with the US Food and Drug Administration regarding its preservative-free intravenous ketamine product, NRX-100, for the treatment of suicidal ideation in depression, including bipolar depression. 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Based on FDA guidance, NRx plans to use existing clinical trial data along with Real World Evidence from over 65,000 patients to support its New Drug Application. The company will work with the FDA to finalize the statistical analysis protocol for the Real World Evidence dataset. Study results have not yet been presented.\n      \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. NRX Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202602170700PRIMZONEFULLFEED9655641) on February 17, 2026, 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":"dataReport","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"}}}