• OS Therapies outlined plans to seek early market access for OST-HER2 in metastatic osteosarcoma via a U.K. conditional filing in coming weeks.
• MHRA is set to lead the Project Orbis review, positioning the program for coordinated decisions across major regulators.
• FDA alignment on an amended Phase 3 design supports a confirmatory trial start in the U.K. in mid-Q4 2026.
• Access to the U.K. national patient registry is expected to strengthen comparator evidence while the Phase 3 study runs.
• No new clinical results were presented; the update focused on trial timing and the regulatory pathway toward potential early launch.

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: 202609210630NEWSFILECNPR____20260921_315136_1) on September 21, 2026, and is solely responsible for the information contained therein.