Kolon’s cell-based gene therapy program suffered a late-stage setback after failing to meet co-primary endpoints in a Phase 3 osteoarthritis trial. In an update tied to Kolon TissueGene’s osteoarthritis candidate, the biotech said the first late-stage study missed its primary goals. It indicated a second Phase 3 study is scheduled to report data in October and that it will not immediately determine next steps until that readout. The result adds pressure to a field that has seen mixed durability and efficacy outcomes for regenerative approaches in joint disease, where endpoints can vary and patient populations are heterogeneous. For investors and collaborators, the clinical milestone shifts near-term development planning and may influence regulatory and partnership discussions ahead of the October data.