---
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"
generated_at: "2026-06-08T02:33:48.795995+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Solid Biosciences gets FDA IND clearance for Duchenne gene therapy SGT-003; Phase 1/2 trial planned

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-277552
- JSON: https://secwatch.observer/filing/0001193125-23-277552.json
- Plain text: https://secwatch.observer/filing/0001193125-23-277552.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.