Biogen Says Investigational Alzheimer's Drug Receives FDA Fast Track Designation

MT Newswires Live

2025/04/02

Biogen (BIIB) said Wednesday that the US Food and Drug Administration has granted fast track designation to its investigational antisense oligonucleotide therapy BIIB080 aimed at treating Alzheimer's disease.

The company said BIIB080 is the first tau-targeting ASO therapy to enter clinical development for Alzheimer's and is currently being evaluated in a global phase 2 study in individuals with early-stage disease.

Biogen said the phase 2 trial is fully enrolled and a data readout is expected in 2026.

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