{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-105008","form_type":"8-K","ticker":"DSGN","cik":"0001807120","company_name":"Design Therapeutics, Inc.","filed_at":"2025-08-07T23:59:59+00:00","discovered_at":"2026-05-14T18:02:45.061391+00:00","generated_at":"2026-05-17T18:06:15.446275+00:00","sec_items":["2.02","7.01","9.01"],"event_type":"earnings","sentiment":"neutral","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Design Therapeutics Q2 net loss $19.1M; FDA clinical hold on DT-216P2 US IND; cash $216.3M","bullets":["Net loss of $19.1M for Q2 2025; R&D expense $15.7M, G&A $5.8M; cash and securities $216.3M as of June 30, 2025.","Early human PK data for DT-216P2 shows favorable translation from NHPs; improved AUC and sustained plasma levels vs DT-216P1.","FDA placed clinical hold on DT-216P2 US IND over starting dose; company plans to address with clinical/nonclinical data; RESTORE-FA trial continues outside US.","Phase 2 biomarker trial of DT-168 in Fuchs Endothelial Corneal Dystrophy patients has been initiated.","Preclinical DM1 program on track for development candidate selection in H2 2025; Huntington's disease preclinical characterization ongoing."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-105008","json":"https://secwatch.observer/filing/0000950170-25-105008.json","markdown":"https://secwatch.observer/filing/0000950170-25-105008.md","text":"https://secwatch.observer/filing/0000950170-25-105008.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1807120/000095017025105008/0000950170-25-105008-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1807120/000095017025105008/dsgn-20250807.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T18:06:15.446275+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"}