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

Kathryn Williams

Juris Doctor Law Deakin University

Tuesday 3rd February 2026

The Use of TauPET & Blood GFAP in Clinical Trials & Practice to Enable Earlier Change Detection & Smaller Alzheimer’s Trials

10:30 am

Leveraging biomarker stratification and early change detection through integrated analysis of cognitive and functional scores to reduce trial duration and enhance patient engagement.
How close are Tau PET and blood GFAP being accepted as primary end‑points to enable smaller sample sizes once validated?