Core Points - NKGen Biotech has received Fast Track designation from the U.S. FDA for its NK cell therapy, troculeucel, aimed at treating moderate Alzheimer's disease [2][3] - The Fast Track designation is designed to expedite the development and review process for therapies addressing serious health conditions and unmet medical needs [4] - NKGen is currently enrolling patients in a Phase 2a trial for troculeucel and anticipates sharing updated clinical data by the end of 2025 [3] Company Overview - NKGen Biotech is a clinical-stage biotechnology company focused on developing and commercializing innovative autologous and allogeneic natural killer cell therapeutics [6] - The company is headquartered in Santa Ana, California, and aims to address neurodegenerative disorders and various cancers with its therapies [6][5] Product Information - Troculeucel is an ex vivo expanded autologous NK cell immunotherapeutic drug candidate, with the International Nonproprietary Name (INN) SNK01 assigned by the WHO [5] - The therapy targets the moderate stage of Alzheimer's disease, which constitutes about 30% of all Alzheimer's cases, addressing a significant unmet need in the market [3]
NKGen Biotech Receives U.S. FDA Fast Track Designation for Troculeucel for the Treatment of Moderate Alzheimer’s Disease