{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-310516","form_type":"8-K","ticker":"DYN","cik":"0001818794","company_name":"Dyne Therapeutics, Inc.","filed_at":"2025-12-08T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.584492+00:00","generated_at":"2026-05-16T14:03:24.358478+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Dyne Therapeutics: DELIVER trial meets primary endpoint; dystrophin 5.46% of normal; BLA submission Q2 2026","bullets":["Primary endpoint met: muscle content-adjusted dystrophin expression 5.46% of normal (p<0.0001), replicating 7-fold increase from MAD portion.","Functional improvement across all six prespecified endpoints; two (TTR Velocity, 10MWR) nominal p<0.05; lung function preserved vs placebo decline.","Long-term data up to 24 months show sustained functional improvement across all assessed endpoints (TTR Velocity, 10MWR, NSAA, SV95C, PUL2.0, FVC%p).","Safety favorable: 1,441 doses administered; 113 patient-years; no related serious TEAEs in REC; two related serious TEAEs in OLE/LTE resolved.","BLA for U.S. Accelerated Approval planned Q2 2026; global Phase 3 initiation Q2 2026; potential U.S. launch Q1 2027 assuming Priority Review."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-310516","json":"https://secwatch.observer/filing/0001193125-25-310516.json","markdown":"https://secwatch.observer/filing/0001193125-25-310516.md","text":"https://secwatch.observer/filing/0001193125-25-310516.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1818794/000119312525310516/0001193125-25-310516-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1818794/000119312525310516/d16518d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T14:03:24.358478+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"}