EMA rolling review for OST-HER2; ATGA aligns on 3-year OS endpoint; peak EU sales >$300M

OS Therapies Inc

EMA initiated rolling review of OST-HER2 CMA for preventing recurrence in resected pulmonary metastatic osteosarcoma.
EMA and Australia TGA agreed 3-year overall survival as approvable endpoint; seroconversion data supports CMA.
UK MHRA granted Advanced Therapy Medicinal Product (ATMP) designation to OST-HER2.
Company forecasts peak European osteosarcoma sales exceeding $300M, with over $50M expected in 2027.
Confirmatory Phase 3 trial initiation planned for Q3 2026 in Australia; FDA and MHRA meetings in Q2 2026.

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