OS Therapies lands FDA fee waiver and wins EMA green light for OST‑HER2

OS Therapies Inc. — the biotech firm developing immunotherapies against bone cancer — announced on December 5, 2025 that it has secured two important regulatory milestones. First, the U.S. Food and Drug Administration (FDA) granted a waiver of the application fee for its Biologics License Application (BLA 125867) for its lead candidate, OST-HER2. Second, the European Medicines Agency (EMA) — via its Committee for Medicinal Products for Human Use (CHMP) — awarded “Union Marketing Authorisation eligibility” for OST‑HER2 under the Company’s metastatic osteosarcoma programme. This paves the way for a centralized Marketing Authorisation Application (MAA) that, if approved, would enable OST‑HER2 to be marketed across all EU member states. EMA has requested that this MAA be submitted by February 28, 2026. In addition, OS Therapies has already submitted pre‑meeting materials to the UK Medicines and Healthcare products Regulatory Agency (MHRA) in advance of a pre‑MAA meeting scheduled for December 8, 2025, and will hold a “Type C” meeting with FDA on December 11, 2025. The company plans to review its final commercial CMC (chemistry, manufacturing, controls) data and non-clinical information, and to propose a global confirmatory study design — aiming for conditional approval via MHRA in the UK and accelerated approval via FDA in the U.S. If all goes according to plan, OST‑HER2 could become one of the few immunotherapies for metastatic osteosarcoma available — a big step forward in a field with limited treatment options. #OSTHER2 #OSTherapies #cancerimmunotherapy #osteosarcoma #SlimScan #GrowthStocks #CANSLIM