(RTTNews) - NKGen Biotech, Inc. (NKGN) on Wednesday announced that its investigational therapy, troculeucel, has been granted Fast Track Designation by the U.S. Food and Drug Administration or FDA for the treatment of moderate Alzheimer's disease or AD.
Troculeucel, an ex vivo expanded autologous NK cell therapy, has shown promising results in Phase 1 trials, with early clinical benefits for patients with moderate AD.
The Fast Track designation will expedite the development process and allow for more frequent interactions with the FDA. This could also pave the way for accelerated approval, Priority Review, and Rolling Review of the drug.
Currently enrolling patients in its Phase 2a trial, NKGen expects to release updated clinical data by the end of 2025.
The Fast Track designation highlights the urgent need for new treatments for moderate AD, a group that represents about 30% of all Alzheimer's cases, and provides hope for faster access to a potentially transformative therapy for these patients.
NKGN is currently trading at $0.47 up by 25.65%.
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