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OS Therapies Provides Positive EMA Regulatory Update Following Positive Rapporteur Meeting
Overall survival recognized as key efficacy endpoint in osteosarcoma, where no standard of care existsRapporteur highlights potential broader benefits of OST-HER2 in pulmonary and primary osteosarcoma settings, supported by translational canine data from the University of PennsylvaniaNew York, New York--(Newsfile Corp. - October 9, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology...
About this update from Os Therapies Incorporated
[{"type":"list","items":[{"val":[{"type":"text","content":"Overall survival recognized as key efficacy endpoint in osteosarcoma, where no standard of care exists","length":102,"tagName":"p"}]},{"val":[{"type":"text","content":"Rapporteur highlights potential broader benefits of OST-HER2 in pulmonary and primary osteosarcoma settings, supported by translational canine data from the University of Pennsylvania","length":183,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":285,"olType":false},{"type":"text","content":"New York, New York--(Newsfile Corp. - October 9, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced a positive regulatory update following an October 6, 2025 meeting with its European Medicines Agency (EMA) rapporteur, the Dutch Medicines Evaluation Board (MEB).","length":419,"tagName":"p"},{"type":"text","content":"During the meeting, OS Therapies and the Dutch Rapporteur aligned on key areas, including safety, non-clinical and chemistry, manufacturing, and controls (CMC) data in support of the Company's ongoing OST-HER2 Phase 2b clinical trial in the prevention or delay of recurrent, fully-resected, pulmonary metastatic osteosarcoma. The Rapporteur advised that the overall survival results, demonstrating statistically significant, final two-year data, may serve as an appropriate primary endpoint for consideration of conditional marketing authorization (CMA).","length":558,"tagName":"p"},{"type":"text","content":"The meeting represented an important milestone toward formal EMA Scientific Advice, anticipated in December 2025. A potential pathway was also established to support a confirmatory, randomized clinical development program, which could explore additional osteosarcoma settings and potentially expand the product label upon full marketing authorization.","length":351,"tagName":"p"},{"type":"text","content":"Meeting outcomes","length":16,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"The safety profile from the Fully Resected Osteosarcoma clinical study was confirmed as positive. In addition, data from other Listeria monocytogenes candidates, representing more than 500 patients treated across four other therapeutic indications, may be sufficien...