On April 2, 2025, Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to BIIB080, an investigational antisense oligonucleotide (ASO) therapy targeting tau, for the treatment of Alzheimer’s disease. This designation is intended to facilitate the development and expedite the review of drugs that address serious conditions and unmet medical needs.
BIIB080 is the first tau-targeting ASO to enter clinical development for Alzheimer’s disease and is currently being evaluated in the global Phase 2 CELIA study in individuals with early-stage disease. Results from the Phase 1b study previously showed dose-dependent reductions in soluble tau protein in cerebrospinal fluid, decreases in aggregated tau pathology in the brain, and favorable trends in exploratory clinical outcomes, supporting its potential clinical benefit.
The Fast Track designation underscores the urgent need for innovative treatments targeting tau pathology, which is strongly correlated with disease severity in Alzheimer's. Biogen is advancing this program with urgency, recognizing that a multi-modal approach, including tau-targeting therapies, will likely be necessary to address the diverse pathologies of this complex and fatal disease. The Phase 2 CELIA study is now fully enrolled, with a data readout expected in 2026.
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