{"schema_version":"secwatch.filing_event.v1","accession":"0001818794-26-000009","form_type":"8-K","ticker":"DYN","cik":"0001818794","company_name":"Dyne Therapeutics, Inc.","filed_at":"2026-09-29T20:10:18+00:00","discovered_at":"2026-09-29T20:11:00.402429+00:00","generated_at":"2026-10-12T13:48:54.142763+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Dyne ACHIEVE 1-year data: vHOT fell 3.2 sec vs placebo's 0.4 sec rise; REC topline due Q1 2027","bullets":["Pooled dose group (N=25-26) drawn from 3.4 mg/kg Q4W, 5.4 mg/kg Q8W and 6.8 mg/kg Q8W MAD cohorts; mean baseline vHOT 8.2 sec fell 3.2 sec at 6 months vs a 0.4 sec rise on placebo (N=14).","At 12 months the pooled group improved 5xSTS by 1.2 sec and 10MWR by 0.3 sec; QMT total and hand grip each rose 4.8% predicted, diverging from the matched natural history cohort on 10MWR and QMT.","MDHI patient-reported total score improved 25.2% from baseline at 12 months vs an unmatched END-DM1 cohort (N=410); safety data as of April 20, 2026 showed no related serious TEAEs.","ACHIEVE REC (71 participants) mean baseline vHOT is 8.3 sec and remains blinded; topline expected Q1 2027 to support a BLA for U.S. Accelerated Approval in Q3 2027.","Phase 3 HARMONIA, with 12-month change in 5xSTS as the primary confirmatory endpoint, is recruiting at over 35 active global sites."],"urls":{"canonical":"https://secwatch.observer/filing/0001818794-26-000009","json":"https://secwatch.observer/filing/0001818794-26-000009.json","markdown":"https://secwatch.observer/filing/0001818794-26-000009.md","text":"https://secwatch.observer/filing/0001818794-26-000009.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1818794/000181879426000009/0001818794-26-000009-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1818794/000181879426000009/dyn-20260929.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-12T13:48:54.142763+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"}