OS Therapies Granted FDA End of Phase 2 Meeting for OST-HER2 Osteosarcoma Treatment

OS Therapies has been granted an End of Phase 2 Meeting by the US FDA for its OST-HER2 program in the prevention or delay of recurrent osteosarcoma. The meeting is expected to occur in Q3 2025 and marks a significant milestone in the drug development process. The company intends to seek alignment with FDA to begin a Rolling Review process for the forthcoming Biologics Licensing Application submission. OST-HER2 has received FDA Orphan Disease Designation, Fast Track, and Rare Pediatric Disease Designations.