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

Reuters
Oct 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.

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