Sentynl Resubmits CUTX-101 NDA to FDA for Menkes Disease Treatment

Reuters11-17

Sentynl Resubmits CUTX-101 NDA to FDA for Menkes Disease Treatment

Fortress Biotech Inc. announced that Sentynl Therapeutics, Inc., which assumed responsibility for the development and commercialization of CUTX-101 from Cyprium Therapeutics, has resubmitted the New Drug Application (NDA) for CUTX-101 to the U.S. Food and Drug Administration. The NDA seeks approval for the use of CUTX-101 (copper histidinate) to treat Menkes disease in pediatric patients. Cyprium will retain ownership of any Priority Review Voucher issued upon NDA approval and is eligible for royalties and milestone payments. Regulatory review of the application is ongoing.

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. Fortress Biotech 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: 0001104659-25-112945), on November 17, 2025, and is solely responsible for the information contained therein.

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ID: 0001104659-25-112945), on November 17, 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:20251117:nNDL1RmBjs:1","article_id":"2584233296","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2584233296","pubTimestamp":1763382807,"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":"Fortress Biotech Inc. announced that Sentynl Therapeutics, Inc., which assumed responsibility for the development and commercialization of CUTX-101 from Cyprium Therapeutics, has resubmitted the New Drug Application  for CUTX-101 to the U.S. Food and Drug Administration. 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Cyprium will retain ownership of any Priority Review Voucher issued upon NDA approval and is eligible for royalties and milestone payments. Regulatory review of the application is ongoing.\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. Fortress Biotech 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. 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