OS Therapies Advances OST‑HER2 Toward BLA; FDA Elevates Meeting To Type B Pre‑BLA

FDA's elevated meeting status signals transition from biomarker data discussions to Accelerated Approval discussions

OS Therapies on track to complete clinical data submission by the end of Q1 2026

New York, New York--(Newsfile Corp. - March 9, 2026) - OS Therapies Inc. (NYSE:OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today provided an update regarding ongoing conversations with the United States Food & Drug Administration (FDA) with regards to its ongoing Biologics License Application (BLA) submission under the Accelerated Approval Program (Accelerated Approval) for OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma. FDA elevated OS Therapies' Type D Biomarker Meeting to a Type B pre-BLA Meeting, expected to occur shortly after the Company completes submission of its clinical data package to the agency, targeted for the end of the first quarter of 2026.