OS Therapies Inc. announced today (October 10, 2025) a positive regulatory update following an October 6, 2025 meeting with its European Medicines Agency (EMA) rapporteur, the Dutch Medicines Evaluation Board (MEB). The meeting aligned on safety, non‑clinical, and chemistry, manufacturing, and controls (CMC) data supporting the company’s OST‑HER2 Phase 2b trial in recurrent, fully resected, pulmonary metastatic osteosarcoma.
The EMA rapporteur indicated that the overall survival results, demonstrating statistically significant two‑year data, may serve as an appropriate primary endpoint for a conditional marketing authorization. This represents a key milestone toward formal EMA Scientific Advice, anticipated in December 2025, and provides a clear regulatory pathway for the company’s lead asset.
In addition, OS Therapies reported that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted an expedited Market Access Scientific Advice Meeting, aligning UK, EU, and US regulatory expectations. The alignment across these agencies supports a coordinated strategy for conditional approval and a potential confirmatory randomized program to expand the product label upon full marketing authorization.
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