OS Therapies requests meeting with FDA regarding OST-HER2

OS Therapies (OSTX) announced that it has submitted a request for a formal meeting with the Center for Biologics Evaluation and Research of the United States FDA to gain alignment on the clinical endpoints required to support Breakthrough Therapy Designation and Accelerated Approval via a conditional BLA of investigational off-the-shelf immunotherapy candidate OST-HER2 in the prevention or delay of recurrence of fully resected, lung metastatic osteosarcoma. The meeting is expected to occur in the second quarter of 2025, and thereafter the company intends to initiate a rolling BLA submission with the potential to receive Accelerated Approval as early as year-end 2025. The company has sufficient cash on hand to operate into mid-2026. “We are excited to meet with the FDA – and commence market access discussions – the goal of receiving Accelerated Approval for a Biologics License Application of OST-HER2 in the prevention or delay of recurrence lung metastatic osteosarcoma by year-end 2025,” said Dr. Robert Petit, Chief Medical & Scientific Officer of OS Therapies. “We believe that we have identified the comparator data necessary to address the comments from FDA regarding our prior BTD request. We expect this data will also be able support our application for Accelerated Approval. Our clinical and regulatory teams are diligently preparing for the meeting and the subsequent BLA submission that is targeted to begin after the public release of additional clinical trial data at MIB Factor in June.”