OS Therapies achieves incremental FDA alignment for OST-HER2
OS Therapies says it has achieved incremental alignment with the FDA and accepted an MHRA Project Orbis invitation for its OST-HER2 metastatic osteosarcoma program.
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10:01:47 AM UTC
SquawkNews
OS Therapies aligned with FDA on the adaptive Phase 3 design for OST-HER2 in metastatic osteosarcoma and accepted MHRA representation under Project Orbis. A Type B Pre-BLA meeting is expected in Q4 2026 after submission of 3-year OS data.Material DetailsContext by AI AnalystThis is a mid-cycle regu…
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