Also known as: OS Therapies
OS Therapies is a clinical-stage biopharmaceutical company focused on treatments for osteosarcoma and other solid tumors. Its pipeline includes OST-HER2 immunotherapy and an antibody-drug conjugate platform (OST-tADC). The company was incorporated in 2018, is based in Maryland, and trades on NYSE American as OSTX.
OS Therapies achieved FDA, MHRA, EMA and TGA alignment on the Phase 3 design for OST-HER2 in osteosarcoma. The confirmatory trial must start before BLA grant and is expected in Q3 2026.
EMA has initiated a rolling review of OS Therapies' OST-HER2 for preventing recurrence in fully resected pulmonary metastatic osteosarcoma. A potential conditional marketing authorization decision is expected in Q4 2026, with a confirmatory Phase 3 trial planned for Q3 2026 in Australia.
Recent developments in breast cancer treatment include new clinical trials for advanced disease, findings on CDK4/6 inhibitor sequencing, and discovery of genetic markers explaining drug resistance in HER2-positive breast cancer.
FDA elevated OS Therapies' Type D meeting to Type B pre-BLA meeting for OST-HER2 in osteosarcoma, signaling transition to Accelerated Approval discussions. Clinical data submission targeted for end of Q1 2026.
OS Therapies progresses toward Accelerated Approval for OST-HER2 in osteosarcoma, with FDA elevating meeting status and global regulatory submissions on track for Q1 2026.
OS Therapies progresses toward Accelerated Approval for OST-HER2 in osteosarcoma, with FDA elevating meeting status and global regulatory submissions on track for Q1 2026.
