iRegene Therapeutics’ NouvNeu001 Receives the US FDA RMAT Designation in Parkinson’s Disease
Shots:
- The US FDA has granted RMAT designation to NouvNeu001 for the treatment of Parkinson’s disease
- The P-I data showed marked improvements in MDS-UPDRS Part III motor scores, as low-dose pts achieved 30.6 (OFF; 52.82% improvement) & 12.9 (ON; 54.67% improvement) points at 12mos. & high-dose pts 23.3 (OFF) & 9.67 (ON) at 9mos., with benefits continuing through 15mos. post-treatment
- NouvNeu001 is an allogeneic iPSC-derived cell therapy that also received Fast Track Designation from the US FDA in Aug 2025
Ref: PRnewswire | Image: iRegene | Press Release
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