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.