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OS Therapies Granted Meetings with U.S. FDA, U.K. MHRA, EMA and Australian Therapeutic Goods Administration to Review Global Confirmatory Phase 3 Trial for OST-HER2 in Metastatic Osteosarcoma
Meetings with all four regulatory agencies scheduled to occur in the second quarter of 2026, with expected Phase 3 commencement in the third quarter of 2026 initially in Australia Commencing the Phase 3 confirmatory study is a pre-requisite to being granted a Biologics License Application (BLA) under the Accelerated Approval Program in the U.S. and Conditional Marketing Authorisations (CMAs) in the U.K. & EuropeNew York, New York--(Newsfile Corp. - March 27, 2026) - OS Therapies, Inc. (NYSE...
About this update from Os Therapies Incorporated
[{"type":"list","items":[{"val":[{"type":"text","content":"Meetings with all four regulatory agencies scheduled to occur in the second quarter of 2026, with expected Phase 3 commencement in the third quarter of 2026 initially in Australia ","length":179,"tagName":"p"}]},{"val":[{"type":"text","content":"Commencing the Phase 3 confirmatory study is a pre-requisite to being granted a Biologics License Application (BLA) under the Accelerated Approval Program in the U.S. and Conditional Marketing Authorisations (CMAs) in the U.K. & Europe","length":239,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":418,"olType":false},{"type":"text","content":"New York, New York--(Newsfile Corp. - March 27, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced that it has been granted meetings with the U.S. Food & Drug Administration (FDA), the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), the European Medicines Agency (EMA) and the Australian Therapeutic Goods Administration (TGA) to review the design of the proposed global confirmatory Phase 3 trial for OST-HER2 in metastatic osteosarcoma. Meetings with each of these four regulatory agencies are expected to occur in the second quarter of 2026, with trial enrollment expected to begin in the third quarter of 2026 initially in Australia.","length":786,"tagName":"p"},{"type":"text","content":"Commencing the Phase 3 trial is a requirement to be granted a Biologics License Application (BLA) under the Accelerated Approval Program in the U.S. and Conditional Marketing Authorisation (CMA) in the U.K. and in Europe. The Company is seeking to receive a BLA in the U.S. and CMAs in the U.K. & in Europe in the second half of 2026. The Company remains on track to deliver to FDA the clinical and biomarker data it requested in preparation for the Company's upcoming Type B Pre-BLA Meeting by the end of the first quarter of 2026. The company has also commenced preparatory market access activities in Europe, including the Health Technology Assessment (HTA) process.","length":677,"tagName":"p"},{"type":"text","content":""We are very pleased to see coordination between these global regulatory agencies as it relates to the proposed design of our planned global confirmat...