FDA clears Alzheimer’s blood test: a game changer for biomarker-driven trials

AbbVie submitted an NDA to the FDA following Ph3 data of Tavapadon targeting Parkinson’s

BMS granted FDA Fast Track Designation for BMS-986446 - an anti-microtubule binding region tau antibody currently in Ph2 targeting Alzheimer’s

C2N Diagnostics submitted regulatory filing to the FDA for their Alzheimer’s blood test

Herantis Pharma announced positive topline Ph1b data evaluation HER-096 targeting PD

Precision Medicine in Alzheimer’s Disease: Leveraging Deep Disease Insights and Biomarker-Guided Therapeutics

By | 5 December 2025

Characterizing Alzheimer’s Disease into biologically meaningful subtypes based on underlying pathophysiology (e.g., amyloid, tau, neuroinflammation, synaptic dysfunction)
Integrating multi-modal biomarkers (fluid, imaging, genetics) to define patient subgroups and align therapeutic mechanisms with disease biology
Using validated biomarkers for patient selection, enrichment, and response monitoring to accelerate development of disease-modifying therapies
Matching therapeutic interventions to molecular and clinical subtypes to maximize efficacy and minimize unnecessary exposure
Combining precision diagnostics with adaptive trial designs to transform Alzheimer’s treatment into a personalized care paradigm