OS Therapies to Meet Global Regulators for Phase 3 OST-HER2 Trial Design

OS Therapies, Inc. (OSTX) announced it has secured meetings with four major global regulatory agencies, including the U.S. FDA and European EMA, scheduled for the second quarter of 2026. These discussions will focus on finalizing the design of the global confirmatory Phase 3 trial for OST-HER2, a treatment targeting metastatic osteosarcoma. The engagement with the U.K. MHRA and Australian TGA alongside major regulators underscores a coordinated international approach to clinical development. This step is crucial for the company as it seeks to secure Biologics License Application (BLA) in the U.S. and Conditional Marketing Authorisations in Europe. Enrollment for the Phase 3 study is projected to commence in the third quarter of 2026, with initial patient recruitment starting in Australia. While the news signals significant clinical progress, the timeline for these milestones reflects a long-term path toward potential commercialization.

Sources:newsfilecorp.comcure51.comcurexbio.comprorelixresearch.comdctd.cancer.govcelegence.comhoncology.comjamanetwork.commondaq.comiqvia.comabpi.org.uk