---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-272423"
form_type: "8-K"
ticker: "TNYA"
cik: "0001858848"
company_name: "Tenaya Therapeutics, Inc."
filed_at: "2025-11-07T23:59:59+00:00"
generated_at: "2026-05-16T23:08:46.614779+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# FDA places clinical hold on Tenaya's Phase 1b/2a TN-201 trial due to protocol amendment request

## Summary
- FDA requests protocol amendment to standardize patient monitoring and immunosuppression management across trial sites.
- Clinical hold based on data previously reviewed by DSMB in summer 2025; DSMB found acceptable safety profile for expansion cohorts.
- TN-201 generally well tolerated; no new meaningful safety events since DSMB review.
- Tenaya working collaboratively with FDA to resolve hold; expects no impact on data milestones or development timelines.
- Company intends to resume dosing once protocol changes are implemented at trial sites.

## SEC filing metadata
- accession: 0001193125-25-272423
- form_type: 8-K
- ticker: TNYA
- cik: 0001858848
- company_name: Tenaya Therapeutics, Inc.
- filed_at: 2025-11-07T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1858848/000119312525272423/0001193125-25-272423-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1858848/000119312525272423/tnya-20251107.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-272423
- JSON: https://secwatch.observer/filing/0001193125-25-272423.json
- Plain text: https://secwatch.observer/filing/0001193125-25-272423.txt

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