Voyager Receives FDA IND Clearance for VY1706, First Gene Therapy Approach to Reducing Tau Production in the Brain for Alzheimer’s Disease

About this update from Voyager Therapeutics, Inc.

- Dosing of adults with early Alzheimer’s disease in clinical trial expected H2 2026 - - Comprehensive preclinical program showed compelling pharmacology and safety profile for VY1706 - - VY1706 uses an IV-delivered, brain-targeted capsid to reduce intracellular and extracellular tau - LEXINGTON, Mass., June 01, 2026 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to leveraging genetics to treat neurological diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for VY1706, the Company’s investigational gene therapy targeting intracellular and extracellular tau for Alzheimer’s disease (AD). The IND clearance enables initiation of a clinical trial of VY1706 in adults with early AD; dosing is expected to begin in the second half of the year. “The IND clearance for VY1706 is the first for a tau-targeted gene therapy and follows a comprehensive preclinical program demonstrating a compelling pharmacology and safety profile,” said Alfred W. Sandrock, Jr., M.D., Ph.D., Chief Executive Officer of Voyager. “Recent third-party data continue to suggest that tau is the next critical target in Alzheimer’s disease, and that reducing tau production holds promise. We view VY1706 as leading the next generation of tau targeting treatments; it is designed to durably reduce tau protein levels in key brain regions following a single IV administration.” The core of VY1706 is a potent, vectorized siRNA that targets MAPT mRNA to decrease levels of both intracellular and extracellular tau in the brain. This core is encapsulated in a Voyager TRACER™ AAV capsid that leverages ALPL, a well-conserved, novel receptor identified by Voyager, to deliver the siRNA into the brain following a one-time, intravenous (IV) dose. The efficacy and safety of VY1706 have been assessed in a comprehensive preclinical program spanning multiple species. VY1706 has been demonstrated to reduce tau protein up to 75% in key brain regions relevant to AD and to de-target the liver, a source of adverse events associated with other systemically administered gene therapies. Clinical Trial Design Voyager is initiating a multi-site, open-label, dose-escalation clinical trial of VY1706 administered as a one-time IV dose to adult participants with early AD who have evidence of tau patholog...

View stock analysis, news, and events for Voyager Therapeutics, Inc.