Chinese biotechnology company iRegene Therapeutics Co Ltd announced on Monday that its lead product, NouvNeu001, has received Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration (FDA) for the treatment of Parkinson's disease (PD).

The company says that this milestone makes NouvNeu001 the first allogeneic iPSC-derived cell therapy globally to hold both FDA Fast Track Designation (FTD) and RMAT designations, following the FTD granted in August 2025. These regulatory recognitions validate the promising clinical data, innovative chemical induction platform, and the therapy's potential to modify the course of Parkinson's disease.

RMAT designation is designed to accelerate the development and review of regenerative medicine therapies intended to treat, modify, reverse, or cure serious or life-threatening diseases. Products granted RMAT designation may receive benefits including early, frequent, and close interaction with the FDA, and potential eligibility for accelerated approval pathways and priority review. This collaborative regulatory framework is expected to further shorten the timeline from clinical development to market.