On October 17, 2025 OS Therapies announced that the U.S. Food & Drug Administration granted a second Type C meeting for its lead candidate OST‑HER2, following a successful End of Phase 2 meeting. The meeting will focus on aligning clinical efficacy endpoints to support a Biologics Licensing Application under the Accelerated Approval Program and is scheduled for December 11, 2025.
In parallel, the UK Medicines and Healthcare products Regulatory Agency granted a pre‑Marketing Authorization Application meeting for OST‑HER2, enabling the company to coordinate U.S. and U.K. submission timing under Project Orbis. OS Therapies plans to begin a rolling review process in November 2025, aligning BLA and MAA submissions to accelerate market access in both regions.
The meeting underscores OS Therapies’ progress toward accelerated approval, with OST‑HER2 already holding Regenerative Medicine Advanced Therapy, Fast‑Track, and Orphan Drug designations. Successful alignment on endpoints could enable a 2025 BLA submission and potential eligibility for a Priority Review Voucher, representing a significant step toward bringing a first‑in‑class osteosarcoma therapy to patients.
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