• OS Therapies requested an FDA Type B meeting to confirm 3-year overall survival as an approvable endpoint for an accelerated BLA for OST-HER2.
• FDA alignment would match MHRA and EMA positions, potentially supporting earlier U.S. market access for the metastatic osteosarcoma program.
• Biomarker data was submitted to the FDA BEST program to support use as a surrogate for clinical efficacy in the accelerated approval pathway.
• OST-400 natural history data may be used as a synthetic control arm, a key element in the proposed statistical approach for the BLA.
• Rolling Review, RMAT, and Breakthrough Therapy designation requests remain under FDA discussion, with outcomes likely to affect review speed and regulatory risk.

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 on June 30, 2026, and is solely responsible for the information contained therein.