OS Therapies Provided an Update on Global Early Market Access Regulatory Coordination Efforts By UK's MHRA For OST-HER2 For Pulmonary Metastatic Osteosarcoma Under Project Orbis

OS Therapies announced alignment with the UK's MHRA to initiate a confirmatory Phase 3 trial for OST-HER2 in pulmonary metastatic osteosarcoma, with a Conditional Marketing Authorisation Application (CMAA) expected in the coming weeks and trial initiation planned for mid Q4 2026. The MHRA's recommendations include leading global regulatory efforts alongside the U.S. FDA and EMA, and access to the UK Clinical Practice Research Datalink to enhance data comparability. The company is also engaging with the U.S. FDA on alternative approval routes, while awaiting decisions on various regulatory designations ahead of its ongoing BLA filing completion in Q4 2026.