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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...
About this update from Os Therapies Incorporated
[{"type":"list","items":[{"val":[{"type":"text","content":"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","length":297,"tagName":"p","attribs":{}}]}],"tagName":"ul","bulletedList":true,"length":297,"olType":false},{"type":"text","content":"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.","length":518,"tagName":"p"},{"type":"text","content":"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. The Company is finalizing the preparation of a CMA submission to EMA for OST-HER2 in the prevention or delay of recurrent, fully-resected, pulmonary metastatic osteosarcoma. ATMP designation is the European equivalent of the Regenerative Medicine Advanced Therapy (RMAT) designation with the U.S. Food & Drug Administration.","length":669,"tagName":"p"},{"type":"text","content":""ATMP designation marks a significant milestone along OST-HER2's path toward becoming the standard of care in Europe," said Paul Romness, MPH, Chairman & CEO of OS Therapies. "We believe this increases the likelihood that we will receive conditional marketing authorisation later this year, which would help us establish a significant revenue stream for the Company projected to begin in 2027. We look forward to continued engagement with the EMA in the months ahead and are pleased that EMA has begun coordinating with the U.K. Medicines and Healthcare products Regulatory Agency (M...