{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-277552","form_type":"8-K","ticker":"SLDB","cik":"0001707502","company_name":"Solid Biosciences Inc.","filed_at":"2023-11-15T23:59:59+00:00","discovered_at":"2026-05-14T18:03:30.120763+00:00","generated_at":"2026-06-08T02:33:48.795995+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Solid Biosciences gets FDA IND clearance for Duchenne gene therapy SGT-003; Phase 1/2 trial planned","bullets":["FDA clears IND for SGT-003, a next-generation microdystrophin gene therapy for Duchenne muscular dystrophy.","Phase 1/2 trial (SGT-003-101) will be first-in-human, open-label, multicenter; dose 1E14vg/kg as single IV infusion.","Cohort 1 enrolls patients aged 4 to <6 years; minimum 3 patients per cohort with potential expansion; 5-year follow-up.","SGT-003 uses capsid AAV-SLB101 with R16/R17 nNOS-binding domains; preclinical data showed improved biodistribution vs AAV9.","Company expects to submit for IRB approval and commence patient screening shortly."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-277552","json":"https://secwatch.observer/filing/0001193125-23-277552.json","markdown":"https://secwatch.observer/filing/0001193125-23-277552.md","text":"https://secwatch.observer/filing/0001193125-23-277552.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1707502/000119312523277552/0001193125-23-277552-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1707502/000119312523277552/d852507d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-08T02:33:48.795995+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"}