iRegene Therapeutics' iPSC-Derived Therapy NouvNeu001 Receives FDA RMAT Designation, First in Neurological Disorders with Dual FTD and RMAT Status

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On December 22, iRegene's independently developed NouvNeu001 injection received RMAT designation from the FDA.NouvNeu001BecomeThe world's first inNervous System DiseasesField ApprovedRMAT'siPSCChemical InductionUniversal Cell Therapy Products。The full name of FDA's RMAT is Regenerative Medicine Advanced Therapy (RMAT).，YesAccelerated Approval Pathway Established by the 21st Century Cures Act of 2016，Specifically targeting regenerative medicine therapies,Guided by significant clinical value,Help it quickly reach the market，To address unmet medical needs。

NouvNeu001In2025Year8Monthly CoverFDAGrantFTDLater, quickly obtainedRMATRecognition,Becoming the world's first to obtainFDA FTDAndRMATDual Qualification CertificationIPSC Product,ReflectFDACorrectNouvNeu001Clinical DataHighly Affirmative。iRegeneNouvNeu001 Shows Promising Data in Phase I Clinical Trial for Parkinson's DiseaseThe completeness, the rigor of clinical trials, and superior safety and efficacy data were obtained.FDAHighly appreciated.

RMATQualification certification indicates the product's significant potential in the international Parkinson's disease market.Therapeutic Value。FDAWillFurtherClosely with iRegeneCommunication, providing subsequent clinical developmentCustomizationGuidance, including close dialogue on trial design, selection of clinical endpoints, and accelerated approval pathways.，Thereby shortening the time from clinical to market.RMATThe acquisition, alsoMarks a milestone for iRegene iniPSCFieldInnovative StrengthPipelineClinical value highly recognized by international authoritative regulatory agencies,Fully reflectiRegene Team iniPSCField"Important Breakthrough from 0 to 1 and Continuous Leadership"International Status。

Dr. Cai Meng, Chief Medical Officer of iRegene, stated that receiving the RMAT designation represents a significant regulatory milestone in the development of NouvNeu001, fully demonstrating its clinical value and innovation. This not only signifies the FDA’s recognition of the product’s therapeutic potential for addressing serious unmet medical needs but also provides us with a structured pathway for in-depth and efficient collaboration with regulatory authorities. We will make full use of this qualification to accelerate global multi-center clinical trials, striving to bring this revolutionary therapy to patients worldwide as soon as possible.

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