{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-101620","form_type":"8-K","ticker":"DYN","cik":"0001818794","company_name":"Dyne Therapeutics, Inc.","filed_at":"2025-08-04T23:59:59+00:00","discovered_at":"2026-05-14T18:02:45.112269+00:00","generated_at":"2026-05-17T21:33:15.396932+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-251 in Duchenne MD","bullets":["FDA granted Breakthrough Therapy Designation to DYNE-251 for DMD amenable to exon 51 skipping.","Designation based on DELIVER trial data showing sustained functional improvement over 18 months.","DYNE-251 now joins DYNE-101 (DM1) as Dyne's second compound to receive this designation.","Registrational expansion cohort data expected late 2025; BLA submission for accelerated approval anticipated early 2026.","Benefits include rolling review, Priority Review eligibility, and enhanced FDA support."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-101620","json":"https://secwatch.observer/filing/0000950170-25-101620.json","markdown":"https://secwatch.observer/filing/0000950170-25-101620.md","text":"https://secwatch.observer/filing/0000950170-25-101620.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1818794/000095017025101620/0000950170-25-101620-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1818794/000095017025101620/dyn-20250804.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T21:33:15.396932+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"}