Bristol Myers Squibb (BMY) announced Wednesday that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to BMS-986446, a potential best-in-class anti-microtubule binding region-tau (anti-MTBR-tau) antibody currently in Phase 2 development for the treatment of early Alzheimer's disease.
The FDA's Fast Track Designation for BMS-986446 underscores the urgent need for innovative therapies for Alzheimer's disease and recognizes the potential of this investigational anti-MTBR-tau antibody to meaningfully alter the trajectory of disease progression
Alzheimer's disease, the most common type of dementia in adults, is a progressive, multifaceted and devastating neurodegenerative disease in which significant changes occur in the brain that cause neurons to die over time.
BMS-986446 aims to modify the underlying course of the disease with the ultimate goal of slowing or delaying disease progression.
In preclinical models, BMS-986446 demonstrated significant reductions in tau uptake and spread, protection against behavioral deficits and was localized with tau pathology in Alzheimer's brain tissue.
BMS-986446 was also shown to be safe and well tolerated across three dose cohorts in a Phase 1 study of healthy participants.
The ongoing Phase 2 study is fully enrolled and includes several biomarkers of tau and amyloid-beta biology, as well as clinical outcome measures, to evaluate the impact of BMS-986446 on disease progression.
For comments and feedback contact: editorial@rttnews.com
Business News
June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.