{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-141739","form_type":"8-K","ticker":"DYN","cik":"0001818794","company_name":"Dyne Therapeutics, Inc.","filed_at":"2025-06-17T23:59:59+00:00","discovered_at":"2026-05-14T18:02:49.868396+00:00","generated_at":"2026-05-19T05:01:39.646110+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA Breakthrough Therapy Designation for DYNE-101 in DM1; revised Accelerated Approval path","bullets":["FDA granted Breakthrough Therapy Designation to DYNE-101 for myotonic dystrophy type 1 (DM1).","Revised ACHIEVE trial protocol submitted with vHOT as primary endpoint (60 patients, 3:1 randomization).","Enrollment in Registrational Expansion Cohort expected to complete Q4 2025; data mid-2026, submission late 2026.","New 12-month data: sustained vHOT improvement of 3.3 sec at 6 months; QMT strength improved 10% at 6 mo, 20% at 12 mo.","Cash $677.5M as of March 31, 2025; runway extended into Q4 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-141739","json":"https://secwatch.observer/filing/0001193125-25-141739.json","markdown":"https://secwatch.observer/filing/0001193125-25-141739.md","text":"https://secwatch.observer/filing/0001193125-25-141739.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1818794/000119312525141739/0001193125-25-141739-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1818794/000119312525141739/d47489d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-19T05:01:39.646110+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"}