---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-22-012442"
form_type: "8-K"
ticker: "DYN"
cik: "0001818794"
company_name: "Dyne Therapeutics, Inc."
filed_at: "2022-07-05T23:59:59+00:00"
generated_at: "2026-06-24T21:25:43.527530+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# FDA lifts clinical hold on Dyne's IND for DYNE-251 in Duchenne muscular dystrophy

## Summary
- FDA cleared IND and lifted clinical hold for DYNE-251, targeting exon 51 skipping in DMD.
- Dyne expects to begin dosing patients in a Phase 1/2 trial in mid-2022.
- Trial will enroll 30–50 males ages 4–16, both ambulant and non-ambulant.
- Endpoints include safety, dystrophin expression by Western blot, PK/PD, and muscle function.
- Company will release trial design details and data timing upon first dosing.

## SEC filing metadata
- accession: 0000950170-22-012442
- form_type: 8-K
- ticker: DYN
- cik: 0001818794
- company_name: Dyne Therapeutics, Inc.
- filed_at: 2022-07-05T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1818794/000095017022012442/0000950170-22-012442-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1818794/000095017022012442/dyn-20220705.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-22-012442
- JSON: https://secwatch.observer/filing/0000950170-22-012442.json
- Plain text: https://secwatch.observer/filing/0000950170-22-012442.txt

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