Kolon TissueGene’s cell-based gene therapy failed to meet co-primary endpoints in a Phase 3 osteoarthritis trial. The company said it will hold off on determining next steps while a second late-stage study is scheduled to report data in October. The setback adds uncertainty around the timing and structure of the program’s clinical development in a category where dosing durability and functional outcomes are pivotal for regulatory and reimbursement. The Phase 3 readout cadence will likely define whether Kolon shifts strategy, refines endpoints, or pivots to other indications as the October results come into view.