OS Therapies Inc. has initiated the submission of a Biologics License Application (BLA) to the U.S. Food & Drug Administration (FDA) for OST-HER2, a listeria-based immunotherapy aimed at preventing or delaying recurrence of fully resected, pulmonary metastatic osteosarcoma. The company has submitted the Non-Clinical and Chemistry, Manufacturing, and Controls $(CMC)$ modules and requested a Rolling Review from the FDA. Following a recent Type C Meeting with the FDA, OS Therapies expects to participate in a Type D Meeting in March 2026 to review Comparative Oncology biomarker data from both human and canine trials. The final clinical module of the BLA is expected to be submitted by the end of March 2026. Additionally, OS Therapies has updated its Regenerative Medicine Advanced Therapy (RMAT) designation request with new biomarker data. OST-HER2 has received Orphan Disease Designation, Fast Track Designation, and Rare Pediatric Disease Designation from the FDA, and the company remains on track for potential approval by September 30, 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: 282344) on February 02, 2026, and is solely responsible for the information contained therein.