VY1706 / Voyager - LARVOL DELTA

Anticipated Upcoming Milestones (GlobeNewswire) - "(i) 2025-2026: Potentially informative data read-outs expected for tau-targeting agents from multiple third parties; (ii) 2026: U.S. IND/Canadian CTA submissions + clinical trial initiation anticipated for VY1706 in AD; (iii) 2026: Neurocrine indicates potential clinical trial initiations for FA and GBA1 programs; (iv) H2 2026: Initial tau PET imaging data expected in MAD clinical trial of VY7523 in AD."

Clinical data • New trial • Alzheimer's Disease • Friedreich ataxia

Second Quarter 2025 and Recent Highlights (GlobeNewswire) - "VY7523 (anti-tau antibody): initial tau positron emission tomography (PET) data from clinical trial in Alzheimer’s disease (AD) patients expected in the second half of 2026...Potential for data from multiple gene therapy programs: Neurocrine-partnered FA and GBA1 programs anticipated to enter clinical trials in 2026; VY1706 tau silencing gene therapy anticipated to enter a clinical trial in 2026; Critical third-party data from large Phase 2 studies of an anti-tau antibody and tau knockdown program expected in 2026, which have the potential to further validate tau as a target....VY1706 (tau silencing gene therapy): IND-enabling work is underway to support an IND and clinical trial initiation expected in 2026."

Clinical data • IND • New trial • Alzheimer's Disease • Friedreich ataxia

Cross-Species BBB-Penetrant IV-Delivered AAV Gene Therapy Provides Broad and Robust CNS Tau Lowering in Tauopathy Mouse Models and Non-Human Primate (ASGCT 2025) - "In the present study, we utilized a second-generation, cross-species BBB-penetrant TRACER™-derived capsid to intravenously deliver a vectorized primary artificial microRNA (pri-amiRNA) containing a potent tau siRNA, VY-1706, in tauopathy mouse models as well as non-human primates (NHP)...These findings demonstrate that the combination of a potent and well-tolerated tau targeting pri-amiRNA with a novel cross-species BBB-penetrant capsid holds promise as a one-time, IV treatment option for AD and other tauopathies. Disease Focus of Abstract:Central Nervous System Disorders"

Gene therapy • Preclinical • Alzheimer's Disease • CNS Disorders • Gene Therapies

Intravenous Delivery of VY1706, a CNS penetrant AAV gene therapy for Alzheimer's Disease, Provides Broad Tau Lowering in NHP (ASGCT 2025) - "Supported by the Neurologic and Opthalmic Committee"

Gene therapy • Alzheimer's Disease • CNS Disorders • Gene Therapies

Voyager Reports First Quarter 2025 Financial and Operating Results (GlobeNewswire) - "Advanced tau silencing gene therapy VY1706 for AD: Completed a pre-IND interaction with the U.S. Food and Drug Administration (FDA). IND-enabling work is ongoing to support U.S. IND and Canadian clinical trial application (CTA) submissions expected in 2026."

FDA event • IND • New trial • Alzheimer's Disease

Voyager Reports Fourth Quarter and Full Year 2024 Financial and Operating Results (GlobeNewswire) - "Development candidate selected for tau silencing gene therapy program VY1706: In a three-month non-human primate (NHP) study, a single 1.3E13 vg/kg dose of VY1706 delivered intravenously (IV) resulted in reductions in tau mRNA levels of 50% to 73% across the cerebral cortex, including in areas of the brain where tau accumulates during progression of Alzheimer’s disease (AD). Voyager expects to present additional data from the NHP study of VY1706 at the International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders (ADPD) April 1-5, 2025....Anticipated Upcoming Milestones:...2026: U.S. IND and Canadian clinical trial application (CTA) filings anticipated with tau silencing gene therapy VY1706 for AD."

IND • New trial • Preclinical • Alzheimer's Disease

Voyager Provides Update on SOD1 ALS Gene Therapy Program (GlobeNewswire) - "Voyager Therapeutics... today announced it has decided to assess alternate payloads related to its gene therapy program for superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS)....Voyager no longer anticipates filing an investigational new drug (IND) application for VY9323 in mid-2025. Voyager’s cash runway is now expected to extend into mid-2027...We continue to expect IND filings in 2025 for our gene therapy candidates for GBA1 and FA, and in 2026 for VY1706."

IND • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • CNS Disorders