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OS Therapies Completes Submission of Biomarker & Clinical Data for U.S. FDA Pre-BLA Meeting, Reports Full Year 2025 Financial Results and Provides Business Update
December 2025 Type C Meeting confirmed immune biomarkers suitability to establish surrogate clinical efficacy that could support BLA under Accelerated Approval PathwayPre-specified clinical outcomes data correlates with Immune biomarker signatureCompany positioned to review completed Phase 2b clinical & biomarker data and confirmatory Phase 3 trial protocol with U.S. FDA, EMA and U.K. MHRA in 2Q/26Company expects to initiate confirmatory Phase 3 trial in Australia in 3Q/26Company anticipates...
About this update from Os Therapies Incorporated
[{"type":"list","items":[{"val":[{"type":"text","content":"December 2025 Type C Meeting confirmed immune biomarkers suitability to establish surrogate clinical efficacy that could support BLA under Accelerated Approval Pathway","length":167,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Pre-specified clinical outcomes data correlates with Immune biomarker signature","length":79,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Company positioned to review completed Phase 2b clinical & biomarker data and confirmatory Phase 3 trial protocol with U.S. FDA, EMA and U.K. MHRA in 2Q/26","length":159,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Company expects to initiate confirmatory Phase 3 trial in Australia in 3Q/26","length":76,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Company anticipates receiving a BLA under Accelerated Approval Program in the U.S. and Conditional Marketing Authorizations in Europe and in the U.K. in 2H/26","length":158,"tagName":"p","attribs":{}}]}],"tagName":"ul","bulletedList":true,"length":639,"olType":false},{"type":"text","content":"New York, New York--(Newsfile Corp. - March 31, 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 completed the submission on clinical and biomarker data from the Company's Phase 2b clinical trial of OST-HER2 in the prevention of delay of recurrent, fully resected, pulmonary metastatic osteosarcoma to the U.S. Food & Drug Administration in preparation for the Company's upcoming Pre-BLA Meeting, reported full-year 2025 financial results for the period ended December 31, 2025 and provided a business update. The Company expects the Pre-BLA Meeting to occur in May 2026.","length":725,"tagName":"p"},{"type":"text","content":""The biomarker and clinical data packages are now with FDA as we begin preparations for our upcoming Pre-BLA Meeting with FDA," said Robert Petit, PhD, Chief Medical & Scientific Officer of OS Therapies. "In December 2025, FDA agreed that OST-HER2 had a strong safety profile and further aligned with the Company around pre-specified immune biomarker strategies being suitable to serve as surrogate clinical efficacy endpoints based upon well-establ...