---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-308343"
form_type: "8-K"
ticker: "DYN"
cik: "0001818794"
company_name: "Dyne Therapeutics, Inc."
filed_at: "2026-07-20T11:35:14+00:00"
generated_at: "2026-07-20T11:40:04.732217+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Dyne's BLA for DYNE-251 in DMD exon 51 skipping; Priority Review granted

## Summary
- FDA accepted BLA for z-rostudirsen (DYNE-251) to treat Duchenne muscular dystrophy amenable to exon 51 skipping.
- Priority Review assigned; PDUFA target action date is January 21, 2027.
- Company expects potential U.S. launch in Q1 2027 if approved on anticipated timeline.

## SEC filing metadata
- accession: 0001193125-26-308343
- form_type: 8-K
- ticker: DYN
- cik: 0001818794
- company_name: Dyne Therapeutics, Inc.
- filed_at: 2026-07-20T11:35:14+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1818794/000119312526308343/0001193125-26-308343-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1818794/000119312526308343/dyn-20260720.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-308343
- JSON: https://secwatch.observer/filing/0001193125-26-308343.json
- Plain text: https://secwatch.observer/filing/0001193125-26-308343.txt

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