OS Therapies Inc. announced progress in its research and development of OST-HER2, a listeria-based cancer immunotherapy aimed at preventing or delaying recurrent, fully resected, pulmonary metastatic osteosarcoma. Following a successful Type C meeting with the FDA, the company reported that data from their ongoing Phase 2b clinical trial, including immune activation biomarker results, may support a Biologics License Application (BLA) under the FDA's Accelerated Approval Program. The FDA confirmed that single-arm studies in rare diseases could be considered for this pathway and suggested a confirmatory, randomized study in additional osteosarcoma settings. OS Therapies plans to present new biomarker data from both human and canine studies to the FDA in a forthcoming meeting, with the intent to file BLA documents by the end of January 2026.