UniXell Biotechnology announced that on 23 June 2026 it secured Investigational New Drug clearance from the U.S. Food and Drug Administration for UX-DA003, an allogeneic induced pluripotent stem cell-derived midbrain dopaminergic progenitor therapy for Parkinson’s disease.
The filing follows prior IND approval from China’s National Medical Products Administration on 3 June 2026 and will enable concurrent clinical development in both countries.
According to the company, UX-DA003 is built on UniXell’s SISBAR lineage tracing platform and a directed differentiation system and is supported by a GMP-compliant iPSC seed cell bank with verified genetic stability.
The company claims preclinical data show functional dopaminergic neuron purity of 50 to 60 percent in grafts, a reduction in required clinical dose by 50 to 80 percent, and a six-month post-transplant cell proliferation rate of 0.23 percent, results the company says support improved safety and manufacturability.
UniXell also noted a dual-pathway Parkinson’s portfolio that includes UX-DA001, an autologous iPSC therapy in a Phase I trial at Ruijin Hospital, whose first enrolled patient completed one year of follow-up.
