{"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","discovered_at":"2026-05-14T18:02:40.846602+00:00","generated_at":"2026-05-16T22:37:23.422732+00:00","sec_items":["2.02","9.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Tenaya reports Q3 net loss $20.3M; FDA places clinical hold on TN-201 MyPEAK-1 trial","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-273230","json":"https://secwatch.observer/filing/0001193125-25-273230.json","markdown":"https://secwatch.observer/filing/0001193125-25-273230.md","text":"https://secwatch.observer/filing/0001193125-25-273230.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T22:37:23.422732+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"}