OS Therapies Achieves Global Regulatory Alignment on Design of Phase 3 Trial of OST-HER2 in Fully Resected, Pulmonary Metastatic Osteosarcoma
OS Therapies secured full regulatory alignment with the FDA, EMA, MHRA, and TGA on the design of its Phase 3 trial for OST-HER2 in pulmonary metastatic osteosarcoma. The confirmatory trial is expected to commence in late Q3 2026 in Australia, utilizing existing Phase 2b drug product to minimize costs and accelerate timelines. This alignment positions the company for potential regulatory decisions in Q4 2026 and patient access in 2027, with a BLA filing already underway in the U.S.
Key figures
- Drug Name
- OST-HER2
- Phase Of Trial
- Phase 3
- Trial start region
- Australia
- Trial start timing
- late Q3 2026
- Patient access window
- 2027
- Regulatory decision window
- Q4 2026
AI analysis
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