Designation covers AV-1959R for people with amyloid buildup in the brain but no symptoms, a population for whom no preventive therapy is approved
Fast Track allows more frequent FDA interaction and potential eligibility for rolling review, Accelerated Approval and Priority Review
Nuravax plans to evaluate AV-1959R in AREVIA, a 160-participant Phase 2 prevention study
Oct. 20, 2026 -- Nuravax, Inc., a clinical-stage biotechnology company developing vaccines for neurodegenerative diseases, today