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OS Therapies Provides Global Regulatory Update for OST-HER2 in Recurrent, Fully Resected, Pulmonary Metstatic Osteosarcoma
Additional forthcoming biomarker data from human trial expected to further characterize immune pathway activation and its relationship to clinical outcomesU.S., U.K. and European osteosarcoma key opinion leaders assembling to review clinical & biomarker trial data, and comment on proposed confirmatory trial designAyala Pharmaceuticals announces dissolution following liquidation of assetsNew York, New York--(Newsfile Corp. - February 17, 2026) - OS Therapies Inc. (NYSE American: OSTX) ("OS...
About this update from Os Therapies Incorporated
[{"type":"list","items":[{"val":[{"type":"text","content":"Additional forthcoming biomarker data from human trial expected to further characterize immune pathway activation and its relationship to clinical outcomes","length":155,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"U.S., U.K. and European osteosarcoma key opinion leaders assembling to review clinical & biomarker trial data, and comment on proposed confirmatory trial design","length":164,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Ayala Pharmaceuticals announces dissolution following liquidation of assets","length":75,"tagName":"p","attribs":{}}]}],"tagName":"ul","bulletedList":true,"length":394,"olType":false},{"type":"text","content":"New York, New York--(Newsfile Corp. - February 17, 2026) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today provided a global regulatory update for OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma (the "Human Metastatic Osteosarcoma Program").","length":415,"tagName":"p"},{"type":"text","content":"Following the submission of the Non-Clinical and Chemistry, Manufacturing & Controls (CMC) modules of its Biologics License Application (BLA) to U.S. Food & Drug Administration (FDA) at the end of January 2026, the Company anticipates releasing additional biomarker data from its Human Metastatic Osteosarcoma Program in the first quarter of 2026. These analyses are intended to further characterize immune pathway activation and evaluate the relationship between biomarker expression and observed clinical outcomes.","length":524,"tagName":"p"},{"type":"text","content":"The Company expects to complete conditional Marketing Authorisation Application (MAA) submissions to both the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) by the end of the first quarter of 2026. The Company remains on track to submit the Clinical BLA module to the FDA following an anticipated Type D meeting expected to occur in March 2026.","length":407,"tagName":"p"},{"type":"text","content":""We continue to advance our global regulatory strategy following previously reported pre-specified biomarker analyses demonstrating ...