{"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","discovered_at":"2026-05-14T18:02:40.846426+00:00","generated_at":"2026-05-16T23:08:46.614779+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"FDA places clinical hold on Tenaya's Phase 1b/2a TN-201 trial due to protocol amendment request","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-272423","json":"https://secwatch.observer/filing/0001193125-25-272423.json","markdown":"https://secwatch.observer/filing/0001193125-25-272423.md","text":"https://secwatch.observer/filing/0001193125-25-272423.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T23:08:46.614779+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"}