NicOx SA Announces Successful Phase 3 Trials and Upcoming NDA Submissions for NCX 470 in U.S. and China

Reuters

09/04

NicOx SA Announces Successful Phase 3 Trials and Upcoming NDA Submissions for NCX 470 in U.S. and China

NicOx SA, a biotech company specializing in ophthalmology, has announced the completion of the second pivotal Phase 3 clinical trial, Denali, for its lead product candidate, NCX 470, in the U.S. and China. This development follows the global licensing of NCX 470 to Kowa and Ocumension Therapeutics. The company has stated that the trial results have met the requirements for New Drug Application (NDA) submissions in both the U.S. and China. An NDA filing in the United States is expected in the first half of 2026, with the submission in China to follow subsequently. The company anticipates that these submissions will lead to milestone payments in 2026 and 2027, with recurrent revenue from royalties on net sales expected from 2027. The costs associated with the NDA submissions will be covered by NicOx's partners, Kowa and Ocumension.

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. NicOx SA published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW1001126201-en) on September 04, 2025, and is solely responsible for the information contained therein.

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This development follows the global licensing of NCX 470 to Kowa and <a href=\"https://laohu8.com/S/OCUTF\">Ocumension Therapeutics</a>. The company has stated that the trial results have met the requirements for New Drug Application (NDA) submissions in both the U.S. and China. An NDA filing in the United States is expected in the first half of 2026, with the submission in China to follow subsequently. The company anticipates that these submissions will lead to milestone payments in 2026 and 2027, with recurrent revenue from royalties on net sales expected from 2027. The costs associated with the NDA submissions will be covered by NicOx's partners, Kowa and Ocumension.\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. NicOx SA published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW1001126201-en) on September 04, 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":"NDAQ","symbol_name":"纳斯达克OMX交易所","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250904:nNDL1L12kY:1","article_id":"2564328513","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2564328513","pubTimestamp":1756963830,"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":"NicOx SA, a biotech company specializing in ophthalmology, has announced the completion of the second pivotal Phase 3 clinical trial, Denali, for its lead product candidate, NCX 470, in the U.S. and China. 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This development follows the global licensing of NCX 470 to Kowa and Ocumension Therapeutics. The company has stated that the trial results have met the requirements for New Drug Application (NDA) submissions in both the U.S. and China. An NDA filing in the United States is expected in the first half of 2026, with the submission in China to follow subsequently. The company anticipates that these submissions will lead to milestone payments in 2026 and 2027, with recurrent revenue from royalties on net sales expected from 2027. The costs associated with the NDA submissions will be covered by NicOx's partners, Kowa and Ocumension.\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. 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