Core Insights - OS Therapies Inc. is positioned to enhance the standard of care for metastatic osteosarcoma with its lead candidate OST-HER2, with significant regulatory submissions planned for 2026 [3][4][5] Regulatory Submissions - The company plans to submit a Biologics License Application (BLA) to the U.S. FDA by the end of January 2026 under the Accelerated Approval Program [4] - Marketing Authorization Applications (MAA) for conditional approval are expected to be submitted to the U.K. MHRA and the European EMA by the end of February 2026 and March 2026, respectively [4][5] Clinical Data and Milestones - Phase 2b biomarker data from the Metastatic Osteosarcoma Program is anticipated to be released during the week of the J.P. Morgan Healthcare Conference in January 2026 [2][12] - The company expects to engage in multiple meetings with regulatory authorities in the first half of 2026 to discuss clinical efficacy endpoints and trial designs [5] Designations and Incentives - OST-HER2 has received Orphan Disease Designation (ODD), Fast Track Designation, and Rare Pediatric Disease Designation (RPDD) from the FDA, making it eligible for a Priority Review Voucher (PRV) if approved before September 30, 2026 [6][9] Future Developments - The company is advancing its OS Animal Health subsidiary towards a go-public transaction, with a confidential SEC filing expected in early January 2026 [7][12] - Additional oncology programs, including OST-503 and OST-504, are also in development, with key meetings with the FDA planned for 2026 [8][12]