iRegene Therapeutics said the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to its allogeneic iPSC‑derived product NouvNeu001 for Parkinson’s disease, adding to an existing Fast Track label and signaling expedited regulatory engagement. The designation follows Phase 1 data the company reported showing substantial motor score improvements and sustained benefit up to 15 months in treated patients. RMAT status affords sponsors more frequent interactions with FDA and potential acceleration routes to approval, contingent on confirmatory data. For clinicians and developers: iPSC‑derived allogeneic cell therapies aim to offer off‑the‑shelf neuronal replacement without patient‑specific manufacturing; RMAT recognition formalizes regulatory interest and may shape investor and partner attention.