---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-273230"
form_type: "8-K"
ticker: "TNYA"
cik: "0001858848"
company_name: "Tenaya Therapeutics, Inc."
filed_at: "2025-11-10T23:59:59+00:00"
generated_at: "2026-05-16T22:37:23.422732+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Tenaya reports Q3 net loss $20.3M; FDA places clinical hold on TN-201 MyPEAK-1 trial

## Summary
- Net loss $20.3M ($0.12/share) vs $25.6M ($0.30) in Q3 2024; cash $56.3M, sufficient into H2 2026.
- FDA placed clinical hold on MyPEAK-1 trial of TN-201 (MYBPC3 HCM) after proactive FDA outreach; company expects resolution without impacting timelines.
- New TN-201 data at AHA: Cohort 1 patients at ≥52 weeks showed durable reductions in hypertrophy and biomarkers; dose-dependent MyBP-C protein expression.
- TN-401 (PKP2 ARVC) completed dosing in Cohort 2 (6E13 vg/kg); DSMB positive for expansion; Cohort 1 data expected Q4 2025.
- DSMB recommended dose expansion for TN-201 after positive safety review; no new meaningful safety events since review.

## SEC filing metadata
- accession: 0001193125-25-273230
- form_type: 8-K
- ticker: TNYA
- cik: 0001858848
- company_name: Tenaya Therapeutics, Inc.
- filed_at: 2025-11-10T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1858848/000119312525273230/0001193125-25-273230-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1858848/000119312525273230/tnya-20251110.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-273230
- JSON: https://secwatch.observer/filing/0001193125-25-273230.json
- Plain text: https://secwatch.observer/filing/0001193125-25-273230.txt

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