NKGen Biotech Inc (Nasdaq:NKGN), a developer of autologous and allogeneic natural killer (NK) cell therapeutics, announced on Wednesday that it has been granted Fast Track designation by the US Food and Drug Administration (FDA) for its autologous NK cell therapy, troculeucel, for moderate Alzheimer's disease (AD).

This designation accelerates the development and review process for therapies addressing serious health conditions and unmet medical needs.

With Fast Track status, NKGen benefits from increased FDA interactions and enhanced visibility, potentially qualifying for Accelerated Approval, Priority Review and Rolling Review, streamlining the path to market.

NKGen is currently enrolling patients in a Phase 2a trial for moderate AD and plans to release updated clinical data by the end of 2025.