OS Therapies Inc., a clinical-stage immunotherapy and Antibody Drug Conjugate biopharmaceutical company, has been granted an End of Phase 2 Meeting by the United States Food & Drug Administration (FDA) for its OST-HER2 program. This program focuses on the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma. The meeting, anticipated for the third quarter of 2025, marks a significant milestone in the drug's development process. OS Therapies plans to seek FDA alignment to initiate a Rolling Review process for the Biologics Licensing Application $(BLA.AU)$ submission of OST-HER2. This approach allows for submission of completed sections of the BLA for FDA review, potentially expediting the approval timeline. The OST-HER2 program has already received FDA Orphan Disease Designation, Fast Track, and Rare Pediatric Disease Designation. If the company secures Accelerated Approval by September 30, 2026, it may receive a Priority Review Voucher, which it intends to sell.
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