Bristol Myers Squibb’s Alzheimer’s Candidate BMS-986446 Receives FDA Fast Track Designation
Friday, October 03, 2025
Bristol Myers Squibb has announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation to BMS-986446, an investigational antibody targeting the microtubule binding region of tau (MTBR-tau).
Alzheimer’s disease, the most common form of dementia, is a progressive neurodegenerative disorder characterised by memory loss, behavioural changes and cognitive decline. A major feature of the disease is the abnormal build-up and spread of tau proteins in the brain. MTBR-tau fragments are thought to play a central role in the development of neurofibrillary tangles, which contribute to nerve cell death.
BMS-986446 is a humanised monoclonal antibody designed to block tau spread, prevent cellular uptake and stimulate microglia, the brain’s immune cells, to clear tau deposits. By targeting tau pathology, the therapy aims to slow or delay disease progression.
The therapy is currently in Phase 2 development for the treatment of early Alzheimer’s disease.
Fast Track Designation is intended to accelerate the development and review of medicines that address serious conditions with limited treatment options.
Preclinical studies showed that BMS-986446 reduced tau spread, protected against behavioural decline and localised with tau pathology in Alzheimer’s brain tissue. A Phase 1 trial confirmed the treatment was safe and well tolerated in healthy volunteers.
The fully enrolled Phase 2 TargetTau-1 trial is now evaluating multiple doses of BMS-986446 in patients with early Alzheimer’s disease, measuring both clinical outcomes and biomarkers of tau and amyloid-beta biology to assess its potential to modify disease progression.
Source: bms.com
