OS Therapies Inc. announced positive biomarker data from its Phase 2b clinical trial of OST-HER2, aimed at preventing or delaying recurrent, fully resected, pulmonary metastatic osteosarcoma. The results, which have already been presented, indicate that activation of immune blood biomarkers in the interferon gamma pathway distinguished long-term survivors (≥2 years) from short-term survivors (<1 year). The company utilized a pre-specified pathway analysis strategy based on data from a 118-patient canine metastatic osteosarcoma study published in February 2025. OS Therapies is preparing its Biologics License Application (BLA) and Marketing Authorisation Application submissions, targeting regulatory approval for OST-HER2 in the UK by the end of the second quarter of 2026, in the US by the end of the third quarter of 2026, and in Europe by year end 2026. OST-HER2 has received FDA Orphan Disease Designation, Fast Track Designation from FDA and EMA, and Rare Pediatric Disease Designation from the FDA.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. OS Therapies Inc. published the original content used to generate this news brief via Newsfile (Ref. ID: 280482) on January 15, 2026, and is solely responsible for the information contained therein.