OS Therapies Inc Advances OST HER2 Toward Conditional EMA Approval Following Positive Regulatory Review

Reuters
2025/10/09
<a href="https://laohu8.com/S/OSTX">OS Therapies</a> Inc Advances OST HER2 Toward Conditional EMA Approval Following Positive Regulatory Review

OS Therapies Inc. has announced a positive regulatory update following a meeting with the European Medicines Agency $(EMA)$ rapporteur, the Dutch Medicines Evaluation Board. The discussions confirmed alignment on key safety, non-clinical, and manufacturing data for the company's OST-HER2 immunotherapy, currently in a Phase 2b trial for recurrent, fully-resected, pulmonary metastatic osteosarcoma. The EMA rapporteur acknowledged overall survival as a key efficacy endpoint and indicated that positive two-year survival data could support a conditional marketing authorization. Additionally, OS Therapies recently began the Marketing Authorisation Application process with the UK MHRA, which granted the company an expedited Market Access Scientific Advice Meeting to accelerate patient access. The regulatory pathway also includes plans for a post-market confirmatory trial that may expand the use of OST-HER2 to other osteosarcoma settings. No new grant or funding announcement involving OS Therapies Inc. or multiple organizations was included.

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: 269769) on October 09, 2025, and is solely responsible for the information contained therein.

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