Ultragenyx Setrusumab Fails to Meet Primary Fracture Reduction Endpoint in Phase 3 Osteogenesis Imperfecta Trials

Reuters

Dec 29, 2025

Ultragenyx Setrusumab Fails to Meet Primary Fracture Reduction Endpoint in Phase 3 Osteogenesis Imperfecta Trials

Ultragenyx Pharmaceutical Inc. announced results from the Phase 3 Orbit and Cosmic studies evaluating setrusumab (UX143) in patients with Osteogenesis Imperfecta $(OI)$. Both studies did not achieve their primary endpoints of reducing annualized clinical fracture rates compared to placebo (Orbit) or bisphosphonates (Cosmic). However, both studies met their secondary endpoints, showing statistically significant improvements in bone mineral density. No changes were observed in the safety profile of setrusumab. The company stated it will implement significant expense reductions following these results and continues to build commercial revenue from its approved products. The results from these studies have already 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. Ultragenyx Pharmaceutical Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9617641-en) on December 29, 2025, and is solely responsible for the information contained therein.

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Both studies did not achieve their primary endpoints of reducing annualized clinical fracture rates compared to placebo (Orbit) or bisphosphonates (Cosmic). However, both studies met their secondary endpoints, showing statistically significant improvements in bone mineral density. No changes were observed in the safety profile of setrusumab. The company stated it will implement significant expense reductions following these results and continues to build commercial revenue from its approved products. The results from these studies have already been presented.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>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. Ultragenyx Pharmaceutical Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9617641-en) on December 29, 2025, 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":"SG9999014021.USD","symbol_name":"UNITED GLOBAL DURABLE EQUITIES (USDHDG) ACC","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20251229:nNDL5qlM9s:1","article_id":"2595381527","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2595381527","pubTimestamp":1767015014,"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":"Ultragenyx Pharmaceutical Inc. announced results from the Phase 3 Orbit and Cosmic studies evaluating setrusumab  in patients with Osteogenesis Imperfecta . Both studies did not achieve their primary endpoints of reducing annualized clinical fracture rates compared to placebo  or bisphosphonates . However, both studies met their secondary endpoints, showing statistically significant improvements in bone mineral density. No changes were observed in the safety profile of setrusumab. The company stated it will implement significant expense reductions following these results and continues to build commercial revenue from its approved products. The results from these studies have already been presented.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. 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Both studies did not achieve their primary endpoints of reducing annualized clinical fracture rates compared to placebo (Orbit) or bisphosphonates (Cosmic). However, both studies met their secondary endpoints, showing statistically significant improvements in bone mineral density. No changes were observed in the safety profile of setrusumab. The company stated it will implement significant expense reductions following these results and continues to build commercial revenue from its approved products. The results from these studies have already 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. Ultragenyx Pharmaceutical Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9617641-en) on December 29, 2025, 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":"-2","news_tag":"dataReport","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":true,"code":"91000000","status":"200"}}}