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                                    <figcaption>NouvNeu001 is intended for the treatment of Parkinson’s disease. Credit: meeboonstudio / Shutterstock.com.</figcaption>
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<p>iRegene Therapeutics has received regenerative medicine advanced therapy (RMAT) designation from the US Food and Drug Administration (FDA) for its lead product, NouvNeu001, aimed at treating Parkinson’s disease.</p>



<p>This marks the first instance of an allogeneic induced pluripotent stem cell (iPSC)-derived cell therapy receiving both fast track and RMAT designations from the FDA, with the former awarded in August 2025.</p><div>
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<p>The FDA introduced the RMAT designation, a regulatory pathway, under the 21st Century Cures Act. It is intended to expedite the development and evaluation of regenerative medicine therapies intended for serious or life-threatening diseases.</p>



<p>Therapies receiving this designation may have earlier engagement with the agency and could qualify for accelerated approval and priority review.</p>



<p>NouvNeu001 is designed to address neuronal loss and support the restoration of natural dopamine production by targeting neuronal degeneration at its root.</p>



<p>Phase I data showed significant clinical efficacy, including improvements in movement disorder society-unified Parkinson’s disease rating scale (MDS-UPDRS) Part III motor scores.</p><div> 
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<p>iRegene chief medical officer Dr Meng Cai said: “The RMAT designation is a pivotal regulatory advancement for NouvNeu001 and a strong endorsement of its clinical value. </p>



<p>“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.</p>



<p>“We are committed to leveraging this opportunity to accelerate our global clinical development programme and bring this transformative therapy to patients as early as possible.”</p>



<p><em>Cell &amp; Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva</em>.</p>



<p><em>Editorial content is independently produced and follows the </em>highest standards <em>of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.</em></p>

      
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<p>iRegene Therapeutics has received RMAT designation from the US FDA for its lead product, NouvNeu001, aimed at treating Parkinson’s disease. This is the first allogeneic iPSC-derived cell therapy to receive both fast track and RMAT designations. The RMAT designation is intended to expedite the development of therapies for serious diseases, allowing for earlier engagement with the FDA and potential accelerated approval. NouvNeu001 targets neuronal degeneration and has shown significant clinical efficacy in Phase I trials, according to iRegene's chief medical officer, Dr. Meng Cai.</p>

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iRegene receives FDA RMAT designation for NouvNeu001 to treat Parkinson’s