{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-266979","form_type":"8-K","ticker":"DYN","cik":"0001818794","company_name":"Dyne Therapeutics, Inc.","filed_at":"2025-11-05T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.584298+00:00","generated_at":"2026-05-17T00:23:03.299536+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Dyne Therapeutics Q3 net loss $108M; DMD topline data expected Dec 2025; DM1 enrollment delayed to early Q2 2026","bullets":["Net loss $108.0M ($0.76/share) vs $97.1M ($0.96/share) in Q3 2024; R&D $97.2M, G&A $16.7M.","Cash $791.9M; reaffirms runway into Q3 2027 covering first commercial launch and BLA submissions.","Topline data from DELIVER REC (z-rostudirsen in DMD) on track for Dec 2025; BLA submission Q2 2026, launch Q1 2027.","ACHIEVE REC enrollment (z-basivarsen in DM1) now expected early Q2 2026 (shift from Q4 2025) due to US site activation.","FDA granted Breakthrough Therapy Designation for z-rostudirsen in Aug 2025; one-year DM1 data presented at WMS."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-266979","json":"https://secwatch.observer/filing/0001193125-25-266979.json","markdown":"https://secwatch.observer/filing/0001193125-25-266979.md","text":"https://secwatch.observer/filing/0001193125-25-266979.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1818794/000119312525266979/0001193125-25-266979-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1818794/000119312525266979/dyn-20251105.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T00:23:03.299536+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"}