#NouvNeu001
iRegene announces first U.S. patient dosed in their Phase 2a trial of NouvNeu001 (allogeneic iPSC-derived dopaminergic progenitor cell therapy) in #Parkinsons (NCT07102342) & the 1st enrollment in their Chinaese randomized clinical trial for NouvNeu004
www.fiercebiotech.com/sponsored/ir...
iRegene Hits Dual Global Firsts: U.S. Patient Dosed in Phase IIa for NouvNeu001 in Parkinson’s and First Enrollment in China’s Randomized MSA Trial for NouvNeu004
The global race to treat neurodegenerative diseases has reached a new tempo as iRegene Therapeutics pushes its cell therapy pipeline into key clinical stages in the U.S. and China. | Breaking ground: ...
www.fiercebiotech.com
February 23, 2026 at 9:40 AM
[FDA Grants Regenerative Medicine Advanced Therapy (RMAT) Designation to iRegene's NouvNeu001, Making It the World's First iPSC Therapy with Both FTD and RMAT Recognitions]

www.prnewswire.com/news-release...
FDA Grants Regenerative Medicine Advanced Therapy (RMAT) Designation to iRegene's NouvNeu001, Making It the World's First iPSC Therapy with Both FTD and RMAT Recognitions
/PRNewswire/ -- iRegene Therapeutics Co., Ltd. ("iRegene" or the "Company"), a biotechnology company pioneering chemically induced allogeneic cell therapy,...
www.prnewswire.com
January 23, 2026 at 7:40 AM
iRegene's NouvNeu001 Becomes the First iPSC Therapy with Dual FDA Designations#NouvNeu001#FDA_Designation#iRegene_Therapeutics
iRegene's NouvNeu001 Becomes the First iPSC Therapy with Dual FDA Designations
iRegene Therapeutics has received dual FDA recognitions for NouvNeu001—highlighting its potential to transform Parkinson's treatment with innovative cell therapy.
third-news.com
January 19, 2026 at 1:10 PM
iRegene Therapeutics Unveils Promising Data from Phase I NouvNeu001 Trials Targeting Parkinson's Disease#China#Chengdu#Therapeutics#NouvNeu001#iRegene
iRegene Therapeutics Unveils Promising Data from Phase I NouvNeu001 Trials Targeting Parkinson's Disease
iRegene Therapeutics announces encouraging Phase I clinical data for NouvNeu001, a new therapy aiming to treat Parkinson's disease.
third-news.com
October 13, 2025 at 1:46 PM
New clinical trial registered: Phase I clinical testing of NouvNeu001 (a dopamine neuron transplantation product) in 10 individuals with #Parkinsons who have previously undergone Deep Brain Stimulation (DBS) or deep brain nucleus lesioning surgery
clinicaltrials.gov/study/NCT075...
ClinicalTrials.gov
clinicaltrials.gov
April 27, 2026 at 7:54 PM
New clinical trial registered: iRegene Therapeutics have initiated a phase 1 clinical study to evaluate the safety, tolerability, feasibility, & preliminary efficacy of NouvNeu001 (human dopaminergic progenitor cells) in 5 people with advanced #Parkinsons
clinicaltrials.gov/study/NCT071...
August 28, 2025 at 9:35 PM
FDA Grants RMAT to iRegene’s NouvNeu001, Making It World’s First iPSC Therapy with FTD and RMAT Recognitions - bioinformant.com/fda-grants-r...
FDA Grants RMAT to iRegene's NouvNeu001, Making It World's First iPSC Therapy with FTD and RMAT Recognitions | BioInformant
Designation underscores potential of chemically induced, off-the-shelf cell therapy to address high unmet need in Parkinson’s disease, following compelling Phase I clinical data CHENGDU, China, Jan. 1...
bioinformant.com
February 13, 2026 at 1:19 PM
Signal or noise? > FDA Grants RMAT Designation to iRegene’s NouvNeu001,
Cementing its Lead as the World’s First iPSC Therapy with Both FTD
and RMAT Recognitions >> Comment below! #strategy #competitiveintelligence #marketing #healthcare #pharma #biotech #pharmaceutical #competitivemarketing
FDA Grants RMAT Designation to iRegene’s NouvNeu001, Cementing its Lead as the World’s First iPSC Therapy with Both FTD and RMAT Recognitions
iRegene’s NouvNeu001 earns dual FTD/RMAT status, a first for iPSC therapies. Strong Phase I data in PD validates its scalable chemical induction platform.
dlvr.it
January 20, 2026 at 1:00 AM