Core Viewpoint - OS Therapies Inc. is advancing its Biologics License Application (BLA) for OST-HER2, a listeria-based cancer immunotherapy, aimed at preventing or delaying recurrent pulmonary metastatic osteosarcoma, with an expected submission of clinical data by the end of Q1 2026 [1][2]. Group 1: FDA Engagement and Designations - The FDA has elevated OS Therapies' Type D Biomarker Meeting to a Type B pre-BLA Meeting, indicating progress in discussions regarding Accelerated Approval for OST-HER2 [1]. - OST-HER2 has received multiple designations from the FDA, including Orphan Drug Designation (ODD), Fast Track Designation, and Rare Pediatric Disease Designation (RPDD) [2][3]. - If OST-HER2 receives Accelerated Approval, the company will be eligible for a Priority Review Voucher (PRV), which could be sold; the last reported PRV transaction was valued at $205 million [2]. Group 2: Clinical Trials and Efficacy - The company reported positive results from its Phase 2b clinical trial of OST-HER2, showing statistically significant benefits in the 12-month event-free survival (EFS) primary endpoint [3]. - A confirmatory randomized Phase 3 trial is planned to commence before the company can be granted Accelerated Approval in the U.S. [2]. Group 3: Future Developments - OS Therapies is also working on next-generation Antibody Drug Conjugates (ADC) and Drug Conjugates (DC), utilizing proprietary technology for tailored treatment options [4]. - The company anticipates reading out data from a Phase 1b study of OST-504 in castration-resistant prostate cancer in the first half of 2026 [3].