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OS Therapies Initiates US FDA BLA Filing for OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma
Request for FDA Rolling Review submitted to FDA on January 30, 2026Non-Clinical and CMC BLA modules submitted to FDAAt FDA's request, Type D Meeting expected in March 2026 to review Comparative Oncology biomarker data from patients treated in OST-HER2 Phase 2b human clinical trial and OST-HER2 trial in spontaneous osteosarcoma in caninesFinal BLA clinical module expected to be submitted to FDA by end of March 2026 after Type D Meeting Regenerative Medicine Advanced Therapy (RMAT) designation...
About this update from Os Therapies Incorporated
[{"type":"list","items":[{"val":[{"type":"text","content":"Request for FDA Rolling Review submitted to FDA on January 30, 2026","length":67,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Non-Clinical and CMC BLA modules submitted to FDA","length":49,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"At FDA's request, Type D Meeting expected in March 2026 to review Comparative Oncology biomarker data from patients treated in OST-HER2 Phase 2b human clinical trial and OST-HER2 trial in spontaneous osteosarcoma in canines","length":227,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Final BLA clinical module expected to be submitted to FDA by end of March 2026 after Type D Meeting","length":99,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Regenerative Medicine Advanced Therapy (RMAT) designation requests update submitted to FDA with recent biomarker data","length":117,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Company remains on track to be eligible to receive Priority Review Voucher under Rare Pediatric Disease Designation (RPDD) with approval anticipated by September 30, 2026","length":170,"tagName":"p","attribs":{}}]}],"tagName":"ul","bulletedList":true,"length":729,"olType":false},{"type":"text","content":"New York, New York--(Newsfile Corp. - February 2, 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 formally initiated a Biologics License Application (BLA) submission to the U.S. Food & Drug Administration (FDA) for OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma ("Human Metastatic Osteosarcoma"). The Company has submitted the Non-Clinical and the Chemistry, Manufacturing, and Controls (CMC) modules of the BLA to FDA, along with a request for Rolling Review. At FDA's invitation following a December 2025 Type C Meeting, the Company has requested a Type D Meeting to review new Comparative Oncology OST-HER2 biomarker data generated from the Company's Phase 2b human clinical trial in Human Metastatic Osteosarcoma and a similar trial of OST-HER2 in spontaneous osteosarcoma in canines (the "OST-HER2 Comparative Oncology Data"). The Company expects to...