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OS Therapies Granted Meetings with U.S. FDA, U.K. MHRA, EMA and Australian Therapeutic Goods Administration to Review Global Confirmatory Phase 3 Trial for OST-HER2 in Metastatic Osteosarcoma

Meetings with all four regulatory agencies scheduled to occur in the second quarter of 2026, with expected Phase 3 commencement in the third quarter of 2026 initially in Australia Commencing the Phase 3 confirmatory study is a pre-requisite to being granted a Biologics License Application (BLA) under the Accelerated Approval Program in the U.S. and Conditional Marketing Authorisations (CMAs) in the U.K. & Europe New York, New York--(Newsfile Corp. - March 27, 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 been granted meetings with the U.S. Food & Drug Administration (FDA), the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), the European Medicines Agency (EMA) and the Australian Therapeutic Goods Administration (TGA) to review the design of the proposed global confirmatory Phase 3 trial for OST-HER2 in metastatic osteosarcoma. Meetings with each of these four regulatory agencies are expected to occur in the second quarter of 2026, with trial enrollment expected to begin in the third quarter of 2026 initially in Australia.

OS Therapies Granted EMA's Advanced Therapy Medicinal Product (ATMP) Designation for OST-HER2 in the Treatment of Pulmonary Recurrence in Resected Osteosarcoma

ATMP benefits include access to the Conditional Marketing Authorisation accelerated market access pathway in Europe, significantly reduced user fees for small and medium-sized enterprises (SMEs), tailored regulatory assessment via Committee for Advanced Therapies (CAT) and increased pricing power New York, New York--(Newsfile Corp. - March 25, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced that the European Medicines Agency's (EMA) Committee for Advanced Therapies (CAT) granted OST-HER2 Advanced Therapy Medicinal Product designation (ATMP) for the treatment of pulmonary recurrence in resected osteosarcoma in the European Union (EU) at CAT's 18-20th March 2026 meeting. ATMP benefits include opening of the Conditional Marketing Authorisation (CMA) accelerated market access pathway in Europe, significantly reduced user fees for small and medium-sized enterprises (SMEs), tailored regulatory assessment via Committee for Advanced Therapies (CAT) and increased reimbursement pathways & reimbursement codes.

OS Therapies Announces FDA OST-HER2 Type D Meeting Elevated to Type B Pre-BLA Meeting

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 American: 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.

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 outcomes U.S., U.K. and European osteosarcoma key opinion leaders assembling to review clinical & biomarker trial data, and comment on proposed confirmatory trial design Ayala Pharmaceuticals announces dissolution following liquidation of assets 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"). 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.