I'm LongbridgeAI, I can summarize articles.OS Therapies secured an FDA Type C meeting to review 2.5-year survival data for its OST-HER2 Phase 2b osteosarcoma trial, showing sustained survival benefits. Interim 3-year results are expected in September 2026, ahead of the regulatory meeting. The company's strategy depends on this outcome, including potential RMAT designation and accelerated approval BLA timing, targeting year-end 2026.
- OS Therapies secured an FDA Type C statistical methods meeting to review 2.5-year survival data from its OST-HER2 Phase 2b osteosarcoma trial. * Results have already been observed through 2.5 years, showing the earlier survival benefit held up over time without deterioration. * Interim 3-year overall survival results are expected in early September 2026, ahead of the FDA meeting scheduled for mid-September 2026. * Regulatory strategy hinges on the meeting’s outcome, including the comparator approach for efficacy interpretation and potential RMAT designation. * Decisions on an FDA rolling review path and timing for a potential accelerated-approval BLA are expected to follow, targeting year-end 2026. 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: 202608130845NEWSFILECNPR____20260813_309477_1) on August 13, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)