{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-211534","form_type":"8-K","ticker":"DYN","cik":"0001818794","company_name":"Dyne Therapeutics, Inc.","filed_at":"2024-09-03T23:59:59+00:00","discovered_at":"2026-05-14T18:03:14.650265+00:00","generated_at":"2026-05-31T06:40:05.747693+00:00","sec_items":["5.02","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 initiates registrational cohorts after positive Phase 1/2 DELIVER data; leadership changes","bullets":["DYNE-251 (20 mg/kg Q4W) showed mean absolute dystrophin 3.71% of normal (unadjusted), >10x eteplirsen's 0.3% (cross-trial caution).","Functional improvement in NSAA, SV95C (met EMA MCID), 10-MWR, Time to Rise from Floor; 10 mg/kg cohort improved from 6 to 12 months.","Safety: favorable profile; no related SAEs except two at 40 mg/kg (resolved); >675 doses, >50 patient-years follow-up.","Leadership: CMO Wildon Farwell resigned; hired Doug Kerr as CMO, Johanna Friedl-Naderer as CCO, Lucia Celona as CHRO; CBO and COO also resigning.","Plans to update path to registration for DYNE-251 and DYNE-101 by end of 2024; ACHIEVE trial safety favorable up to 6.8 mg/kg Q8W."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-211534","json":"https://secwatch.observer/filing/0001193125-24-211534.json","markdown":"https://secwatch.observer/filing/0001193125-24-211534.md","text":"https://secwatch.observer/filing/0001193125-24-211534.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1818794/000119312524211534/0001193125-24-211534-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1818794/000119312524211534/d786894d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T06:40:05.747693+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":[{"claim_id":"5d6aa0d16b","claim":"Jonathan McNeill, M.D. resigned as Chief Business Officer at Dyne Therapeutics, Inc..","evidence_excerpt":"Jonathan McNeill, M.D., the Company’s Chief Business Officer, and Susanna High, the Company’s Chief Operating Officer, each notified the Company of their intention to resign their employment.","evidence_source":"SEC 8-K Item 5.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1818794/000119312524211534/0001193125-24-211534-index.htm","confidence":1.0,"family_label":"Executive change","details":[{"label":"Action","value":"resigned"},{"label":"Role","value":"Chief Business Officer"}],"fact_type":"executive_change"},{"claim_id":"6a1edbe088","claim":"Susanna High resigned as Chief Operating Officer at Dyne Therapeutics, Inc..","evidence_excerpt":"Jonathan McNeill, M.D., the Company’s Chief Business Officer, and Susanna High, the Company’s Chief Operating Officer, each notified the Company of their intention to resign their employment.","evidence_source":"SEC 8-K Item 5.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1818794/000119312524211534/0001193125-24-211534-index.htm","confidence":1.0,"family_label":"Executive change","details":[{"label":"Action","value":"resigned"},{"label":"Role","value":"Chief Operating Officer"}],"fact_type":"executive_change"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}