Nuravax Receives FDA Fast Track Designation for AV‑1959R, an Investigational Vaccine Designed to Help Prevent Alzheimer's Disease Before Symptoms Begin
- 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
IRVINE, Calif., Oct. 20, 2026 /PRNewswire/ -- Nuravax, Inc., a clinical-stage biotechnology company developing vaccines for neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AV-1959R, its lead investigational amyloid-beta (Aβ) vaccine, for the prevention of Alzheimer's disease in cognitively unimpaired individuals with biomarker evidence of amyloid pathology.
Fast Track is intended to speed the development and review of therapies for serious conditions with unmet medical need. Nuravax, a spin-out of the non-profit Institute for Molecular Medicine (IMM), plans to evaluate AV-1959R in AREVIA, a Phase 2 study in amyloid-positive, cognitively unimpaired adults.
"Alzheimer's therapeutics are shifting from slowing disease in people with symptoms toward stopping it before it starts," said Michael G. Agadjanyan, Ph.D., President of Nuravax and Head of Molecular Immunology at IMM. "Our request was supported by published preclinical results and Phase 1 data demonstrating the safety and strong immunogenicity of AV-1959R. Our goal is to stop amyloid buildup in people who are at risk but have no symptoms, and ultimately to delay or even prevent dementia."
"This designation is an important milestone for Nuravax," said Roman Kniazev, CEO of Nuravax. "Amyloid-beta builds up silently in the brain for up to two decades before symptoms appear, triggering the spread of tau that drives the disease. That silent window is precisely what a preventive vaccine is designed to address."
"Fast Track enables more frequent interaction with the FDA, which could help streamline development," said Lon S. Schneider, M.D., professor of psychiatry, neurology and gerontology at the Keck School of Medicine of USC and a medical consultant to Nuravax. "It also supports early dialogue on Phase 3 design, eligibility for rolling review and, if criteria are met, Accelerated Approval and Priority Review."
About the AREVIA Phase 2 Study
AREVIA (NCT07827768) is a planned Phase 2 study expected to enroll 160 cognitively unimpaired adults with biomarker-confirmed amyloid pathology. Participants will receive two priming immunizations of AV-1959R followed by a booster at Week 44. The study will assess safety, including MRI monitoring for amyloid-related imaging abnormalities (ARIA), as well as immunogenicity and changes in amyloid and tau biomarkers in blood and brain. The study will be conducted under Nuravax's Investigational New Drug (IND) application 30925.
About AV-1959R
AV-1959R is an investigational vaccine based on the MultiTEP platform, designed to elicit antibodies against pathological forms of Aβ. It is not approved for any use, and its safety and efficacy have not been established.
About Nuravax, Inc.
Nuravax, Inc. is a clinical-stage biotechnology company in Irvine, Calif., developing vaccines for neurodegenerative diseases. A spin-out of the non-profit Institute for Molecular Medicine, Nuravax licenses the MultiTEP platform, which combines self-antigen B-cell epitopes with foreign T-helper epitopes to generate antibodies against disease proteins including amyloid beta, tau and alpha-synuclein.
About the Institute for Molecular Medicine
The Institute for Molecular Medicine is a non-profit biomedical research organization in Huntington Beach, Calif. IMM developed the MultiTEP platform and supplied the AV-1959R drug product.
Forward-Looking Statements
This press release contains forward-looking statements, including statements about the potential benefits of Fast Track designation and the planned development of AV-1959R. These statements are subject to risks and uncertainties that could cause actual results to differ materially. Fast Track designation does not guarantee faster development, review, or approval, and early-stage results may not predict later outcomes. Nuravax undertakes no obligation to update these statements except as required by law.
SOURCE Nuravax, Inc.
Share this article