By: IPP Bureau
Last updated : January 21, 2026 7:33 am
The RMAT designation accelerates the development of regenerative medicine therapies for serious or life-threatening diseases
iRegene Therapeutics Co, a biotech innovator in chemically induced allogeneic cell therapy, has announced that its lead product, NouvNeu001, has received Regenerative Medicine Advanced Therapy (RMAT) designation from the US FDA for the treatment of Parkinson’s disease (PD).
This milestone positions NouvNeu001 as the first allogeneic iPSC-derived cell therapy worldwide to hold both FDA Fast Track Designation (FTD)—granted in August 2025—and RMAT status, cementing its potential as a disease-modifying therapy. iRegene’s chemical induction platform and the therapy’s promising clinical data were central to this regulatory recognition.
The RMAT designation, established under the 21st Century Cures Act, accelerates the development of regenerative medicine therapies for serious or life-threatening diseases.
“The RMAT designation is a pivotal regulatory advancement for NouvNeu001 and a strong endorsement of its clinical value,” said Dr Meng Cai, Chief Medical Officer of iRegene Therapeutics.
“This designation reflects the FDA's recognition of NouvNeu001's potential to address a serious unmet medical need in Parkinson's disease and provides a structured framework for deep, efficient collaboration with the agency. We are committed to leveraging this opportunity to accelerate our global clinical development program and bring this transformative therapy to patients as early as possible.”
Parkinson’s disease is the second most common neurodegenerative disorder globally, yet current therapies primarily target symptoms rather than halting disease progression. NouvNeu001 aims to fill this critical gap.
As an iPSC-derived, allogeneic dopaminergic progenitor cell therapy, NouvNeu001 is designed to replace lost neurons, restore neural circuits, and reestablish endogenous dopamine production. By targeting the root cause of neuronal degeneration, the therapy represents a first-in-class, disease-modifying approach with the potential to redefine PD treatment standards.