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StocksMedium•25 March 2026•

1 min read

OS Therapies Receives EMA ATMP Designation for OST-HER2 Immunotherapy

Key Facts

1The EMA's Committee for Advanced Therapies (CAT) granted ATMP designation for OST-HER2.

2The treatment targets pulmonary recurrence in resected osteosarcoma.

3The designation provides an accelerated Conditional Marketing Authorisation (CMA) pathway and reduced fees for SMEs.

OS Therapies (OSTX) announced that its immunotherapy candidate, OST-HER2, has been granted the Advanced Therapy Medicinal Product (ATMP) designation by the European Medicines Agency (EMA). The designation, recommended by the Committee for Advanced Therapies (CAT), is specifically aimed at treating pulmonary recurrence in patients with resected osteosarcoma. This regulatory milestone provides the company with an accelerated pathway toward Conditional Marketing Authorisation (CMA) within the European Union. Additionally, as a small and medium-sized enterprise (SME), OS Therapies will benefit from reduced regulatory fees and enhanced scientific guidance. This development is a significant step forward for the biotech firm, potentially shortening the timeline and lowering the costs for market entry. While this designation is not a final approval, it validates the therapeutic potential of OST-HER2 in addressing rare and aggressive bone cancers.

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