OS Therapies targets mid-Q4 2026 start for UK Phase 3 OST-HER2 trial in metastatic osteosarcoma

• OS Therapies outlined plans to seek early market access for OST-HER2 in metastatic osteosarcoma via a U.K. conditional filing in coming weeks.
• MHRA is set to lead the Project Orbis review, positioning the program for coordinated decisions across major regulators.
• FDA alignment on an amended Phase 3 design supports a confirmatory trial start in the U.K. in mid-Q4 2026.
• Access to the U.K. national patient registry is expected to strengthen comparator evidence while the Phase 3 study runs.
• No new clinical results were presented; the update focused on trial timing and the regulatory pathway toward potential early launch.

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