Posted by Michael Wonder on 20 Jan 2026
FDA grants regenerative medicine advanced therapy designation to iRegene's NouvNeu001, making it the world's first iPSC therapy with both FTD and RMAT recognitions
19 January 2026 - iRegene Therapeutics today announced that its lead product, NouvNeu001, has been granted regenerative medicine advanced therapy designation by the US FDA for the treatment of Parkinson's disease.
This milestone makes NouvNeu001 the first allogeneic iPSC-derived cell therapy globally to hold both FDA fast track designation and regenerative medicine advanced therapy designations, following the fast track designation granted in August 2025.
