OS Therapies Advances OST-HER2 Osteosarcoma Trial After Positive FDA Meeting

Reuters12-15

<a href="https://laohu8.com/S/OSTX">OS Therapies</a> Advances OST-HER2 Osteosarcoma Trial After Positive FDA Meeting

OS Therapies Inc. announced progress in its research and development of OST-HER2, a listeria-based cancer immunotherapy aimed at preventing or delaying recurrent, fully resected, pulmonary metastatic osteosarcoma. Following a successful Type C meeting with the FDA, the company reported that data from their ongoing Phase 2b clinical trial, including immune activation biomarker results, may support a Biologics License Application (BLA) under the FDA's Accelerated Approval Program. The FDA confirmed that single-arm studies in rare diseases could be considered for this pathway and suggested a confirmatory, randomized study in additional osteosarcoma settings. OS Therapies plans to present new biomarker data from both human and canine studies to the FDA in a forthcoming meeting, with the intent to file BLA documents by the end of January 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: 278027) on December 15, 2025, and is solely responsible for the information contained therein.

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