{"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","discovered_at":"2026-05-14T18:02:40.846776+00:00","generated_at":"2026-05-16T13:32:40.928131+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA lifts clinical hold on TN-201; TN-401 shows positive interim data in ARVC patients","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-315951","json":"https://secwatch.observer/filing/0001193125-25-315951.json","markdown":"https://secwatch.observer/filing/0001193125-25-315951.md","text":"https://secwatch.observer/filing/0001193125-25-315951.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T13:32:40.928131+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}