OS Therapies gains regulatory clarity with EMA review and key 2026 milestones for OST-HER2 cancer drug

OS Therapies Inc. advanced its OST-HER2 drug toward global approval for pulmonary metastatic osteosarcoma, with the EMA initiating a rolling review and aligning on a 3-year survival endpoint alongside Australia's TGA. Key upcoming milestones include survival data releases in mid-2026, regulatory meetings with FDA and MHRA, Phase 3 trial start in Australia, and a potential EMA conditional marketing authorization decision by late 2026. The company also secured $5.25M funding plus $4M non-dilutive support to fuel these catalysts, with a potential priority review voucher adding valuation upside. This regulatory progress shifts the investment focus from early proof-of-concept to execution of a clear approval pathway.