OS Therapies granted End of Phase 2 Meeting by FDA to review OST-HER2 program
OS Therapies announced it was granted an End of Phase 2 Meeting by the United States Food & Drug Administration, FDA, to review the OST-HER2 program in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma. The Company expects the meeting to occur in the third quarter of 2025. The End of Phase 2 Meeting marks a pivotal point in the drug development process, and a significant milestone towards market access. The Company intends to seek alignment with FDA to begin a Rolling Review process for the forthcoming Biologics Licensing Application submission for OST-HER2. The Rolling Review process means that a company can submit completed sections of its Biologic License Application for review by FDA, rather than waiting until every section of the BLA is completed before the entire application can be reviewed. This can contribute to augmented interactions with FDA and potentially an expedited BLA approval timeline.
