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AC Immune Gets FDA Fast-Track Designation for Neurodegenerative Diagnostic Scan
AC Immune's partner, Life Molecular Imaging (LMI), has received Fast Track Designation from the FDA for the Tau-PET diagnostic [18F]PI-2620 in three neurodegenerative conditions: Alzheimer's disease (AD), progressive supranuclear palsy (PSP), and corticobasal degeneration (CBD). PI-2620, currently in Phase 3 clinical development for detecting Tau pathology in AD, is a next-generation PET imaging agent. This designation aims to accelerate development and review, highlighting the importance of early and accurate diagnoses in neurodegenerative diseases.
The Fast Track status for PI-2620 follows similar designations for AC Immune's active immunotherapies ACI-35.030 and ACI-24.060, both in Phase 2. This recognition underscores AC Immune's leadership in developing precision therapeutics for neurodegenerative diseases and its commitment to improving patient care through early diagnosis and treatment.
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