---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-315951"
form_type: "8-K"
ticker: "TNYA"
cik: "0001858848"
company_name: "Tenaya Therapeutics, Inc."
filed_at: "2025-12-11T23:59:59+00:00"
generated_at: "2026-05-16T13:32:40.928131+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA lifts clinical hold on TN-201; TN-401 shows positive interim data in ARVC patients

## Summary
- FDA removed clinical hold on MyPEAK-1 trial for TN-201 gene therapy; protocol amendments implemented, dosing to resume.
- TN-401 well tolerated at 3E13 vg/kg; no dose-limiting toxicities or thrombotic microangiopathy observed.
- Robust transduction and PKP2 protein increase in 2 of 3 patients; vector copy numbers 3.4 and 5.0 per genome.
- Clinically meaningful arrhythmia reduction: Patient 1 PVCs -46%, Patient 2 PVCs -89% and NSVT from 78 to 0.
- One-year Cohort 1 and early Cohort 2 data for TN-201 and TN-401 expected in first half of 2026.

## SEC filing metadata
- accession: 0001193125-25-315951
- form_type: 8-K
- ticker: TNYA
- cik: 0001858848
- company_name: Tenaya Therapeutics, Inc.
- filed_at: 2025-12-11T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1858848/000119312525315951/0001193125-25-315951-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1858848/000119312525315951/d68368d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-315951
- JSON: https://secwatch.observer/filing/0001193125-25-315951.json
- Plain text: https://secwatch.observer/filing/0001193125-25-315951.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.