secwatch.observer — SEC 8-K summary
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Issuer:     Tenaya Therapeutics, Inc. (TNYA)
CIK:        0001858848
Form:       8-K
Filed at:   2025-12-11T23:59:59+00:00
Accession:  0001193125-25-315951
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1858848/000119312525315951/0001193125-25-315951-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1858848/000119312525315951/d68368d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-315951

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer