Core Viewpoint - OS Therapies Inc. has initiated a Biologics License Application (BLA) submission to the FDA for OST-HER2, targeting the prevention or delay of recurrent pulmonary metastatic osteosarcoma, with expectations for approval by September 30, 2026 [1][5]. Company Developments - The company has submitted the Non-Clinical and Chemistry, Manufacturing, and Controls (CMC) modules of the BLA to the FDA and requested a Rolling Review [1][5]. - A Type D Meeting is anticipated in March 2026 to discuss new Comparative Oncology biomarker data from the Phase 2b clinical trial in humans and a similar trial in canines [1][5]. - The final clinical BLA module is expected to be submitted by the end of March 2026 [5]. Designations and Approvals - OST-HER2 has received Orphan Disease Designation (ODD), Fast Track Designation from the FDA and EMA, and Rare Pediatric Disease Designation (RPDD) from the FDA [3][4]. - If Accelerated Approval is granted before September 30, 2026, the company will be eligible for a Priority Review Voucher (PRV), which it intends to sell [3][4]. Clinical Trial Results - Positive data from the Phase 2b clinical trial of OST-HER2 demonstrated statistically significant benefits in the 12-month event-free survival (EFS) primary endpoint [4]. Future Developments - OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), utilizing proprietary technology for enhanced delivery of therapeutic payloads [6].