Genascence's GNSC-001 gene therapy received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. The therapy uses a recombinant adeno-associated viral vector to deliver an optimized interleukin-1 receptor antagonist aimed at sustained inhibition of IL-1, a key driver of knee osteoarthritis pathology including inflammation and cartilage damage. GNSC-001 showed promising results in Phase I and DONATELLO Phase Ib trials evaluating safety, tolerability, and pharmacodynamics. The RMAT status provides expedited regulatory pathways to accelerate late-stage clinical development and potential approval for this novel osteoarthritis treatment.