{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-22-012442","form_type":"8-K","ticker":"DYN","cik":"0001818794","company_name":"Dyne Therapeutics, Inc.","filed_at":"2022-07-05T23:59:59+00:00","discovered_at":"2026-05-14T18:03:57.192598+00:00","generated_at":"2026-06-24T21:25:43.527530+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"FDA lifts clinical hold on Dyne's IND for DYNE-251 in Duchenne muscular dystrophy","bullets":["FDA cleared IND and lifted clinical hold for DYNE-251, targeting exon 51 skipping in DMD.","Dyne expects to begin dosing patients in a Phase 1/2 trial in mid-2022.","Trial will enroll 30–50 males ages 4–16, both ambulant and non-ambulant.","Endpoints include safety, dystrophin expression by Western blot, PK/PD, and muscle function.","Company will release trial design details and data timing upon first dosing."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-22-012442","json":"https://secwatch.observer/filing/0000950170-22-012442.json","markdown":"https://secwatch.observer/filing/0000950170-22-012442.md","text":"https://secwatch.observer/filing/0000950170-22-012442.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1818794/000095017022012442/0000950170-22-012442-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1818794/000095017022012442/dyn-20220705.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-24T21:25:43.527530+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"}