secwatch / observer

8-K filed June 1, 2026, 8:00 AM ET ticker VYGR CIK 0001640266

regulatory confidence high sentiment positive materiality 0.65

FDA clears IND for VY1706, Voyager's tau-silencing gene therapy for Alzheimer's

Voyager Therapeutics, Inc.

VY1706 targets intra- and extracellular tau; IND cleared by FDA on June 1, 2026.
Phase 1 open-label, dose-escalation trial expected to begin dosing in H2 2026.
Trial to enroll up to 18 early AD patients across 3 cohorts; highest dose 5 x 10^13 vg/kg.
Primary endpoint: safety/tolerability; secondary endpoints: CSF tau biomarkers and tau PET imaging.
Company plans to initiate multi-site study; VY1706 administered as one-time IV dose.

Machine-readable event card

schema_version: secwatch.filing_event.v1
accession: 0001104659-26-068591
form_type: 8-K
ticker: VYGR
cik: 0001640266
company_name: Voyager Therapeutics, Inc.
filed_at: 2026-06-01T12:00:26+00:00
discovered_at: 2026-06-01T12:05:00.309639+00:00
generated_at: 2026-06-01T12:07:02.711114+00:00
sec_items: ["8.01"]
event_type: regulatory
sentiment: positive
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: high
secwatch_canonical_url: https://secwatch.observer/filing/0001104659-26-068591
json_url: https://secwatch.observer/filing/0001104659-26-068591.json
markdown_url: https://secwatch.observer/filing/0001104659-26-068591.md
text_url: https://secwatch.observer/filing/0001104659-26-068591.txt
edgar_index_url: https://www.sec.gov/Archives/edgar/data/1640266/000110465926068591/0001104659-26-068591-index.htm
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review_status: machine_generated
human_reviewed: false
corrected: false
correction_note: null
correction_timestamp: null
superseded_by: null

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