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.
Relay Therapeutics wins FDA breakthrough status for zovegalisib in breast cancer treatment
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Valneva and Instituto Butantan launch pilot chikungunya vaccination campaign in Brazil
Lupin launches Dasatinib tablets in US market
WuXi Biologics enters into licence and research service agreement with Vertex Pharmaceuticals
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
AstraZeneca agrees obesity and type 2 diabetes collaboration with CSPC
Ascletis Pharma Inc reports topline results from Phase III open-label study of denifanstat
Innovative Molecules GmbH completes Phase 1 clinical development programme for adibelivir
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA