OS Therapies Prepares FDA Submission for OST-HER2 in Metastatic Osteosarcoma

Reuters

Jan 05

<a href="https://laohu8.com/S/OSTX">OS Therapies</a> Prepares FDA Submission for OST-HER2 in Metastatic Osteosarcoma

OS Therapies Inc. announced it is finalizing preparations for a U.S. FDA Biologics License Application (BLA) submission for its lead candidate, OST-HER2, targeting the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma. The company expects to submit the BLA under the FDA's Accelerated Approval Program by the end of January 2026. Additionally, OS Therapies plans to submit Marketing Authorisation Applications $(MAA)$ for conditional approval of OST-HER2 in the U.K. and Europe by the end of February and March 2026, respectively. The company anticipates multiple meetings with the U.S. FDA, U.K. MHRA, and Europe's EMA in the first half of 2026 as part of the regulatory review process.

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. OS Therapies Inc. published the original content used to generate this news brief via Newsfile (Ref. ID: 279451) on January 05, 2026, and is solely responsible for the information contained therein.

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The company expects to submit the BLA under the FDA's Accelerated Approval Program by the end of January 2026. Additionally, OS Therapies plans to submit Marketing Authorisation Applications <a href=\"https://laohu8.com/S/MAA\">$(MAA)$</a> for conditional approval of OST-HER2 in the U.<a href=\"https://laohu8.com/S/TKKD.SI\">K</a>. and Europe by the end of February and March 2026, respectively. The company anticipates multiple meetings with the U.S. FDA, U.K. MHRA, and Europe's EMA in the first half of 2026 as part of the regulatory review process.\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. OS Therapies Inc. published the original content used to generate this news brief via Newsfile (Ref. ID: 279451) 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":"BK4139","symbol_name":"生物科技","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260105:nNDL39mfrw:1","article_id":"2601889635","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2601889635","pubTimestamp":1767616881,"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":"OS Therapies Inc. announced it is finalizing preparations for a U.S. FDA Biologics License Application  submission for its lead candidate, OST-HER2, targeting the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma. 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