OS Therapies Inc., a clinical-stage biopharmaceutical company, announced an important regulatory update regarding their immunotherapy candidate OST-HER2. The company has submitted preliminary external control data and comprehensive plans to the US Food & Drug Administration (FDA) as part of their efforts to secure marketing authorization under the FDA's Accelerated Approval Program. This submission is in line with the prevailing guidance to industry, including ICH E10 and other FDA guidelines. The regulatory update follows recent positive clinical trial data showing statistically significant 1-year event-free survival for their Phase 2b trial in lung metastatic osteosarcoma. OS Therapies has also responded to follow-up questions from the FDA Type D Meeting, positioning them for an End of Phase 2 meeting, further advancing their regulatory review process.