---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-310516"
form_type: "8-K"
ticker: "DYN"
cik: "0001818794"
company_name: "Dyne Therapeutics, Inc."
filed_at: "2025-12-08T23:59:59+00:00"
generated_at: "2026-05-16T14:03:24.358478+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Dyne Therapeutics: DELIVER trial meets primary endpoint; dystrophin 5.46% of normal; BLA submission Q2 2026

## Summary
- Primary endpoint met: muscle content-adjusted dystrophin expression 5.46% of normal (p<0.0001), replicating 7-fold increase from MAD portion.
- Functional improvement across all six prespecified endpoints; two (TTR Velocity, 10MWR) nominal p<0.05; lung function preserved vs placebo decline.
- Long-term data up to 24 months show sustained functional improvement across all assessed endpoints (TTR Velocity, 10MWR, NSAA, SV95C, PUL2.0, FVC%p).
- Safety favorable: 1,441 doses administered; 113 patient-years; no related serious TEAEs in REC; two related serious TEAEs in OLE/LTE resolved.
- BLA for U.S. Accelerated Approval planned Q2 2026; global Phase 3 initiation Q2 2026; potential U.S. launch Q1 2027 assuming Priority Review.

## SEC filing metadata
- accession: 0001193125-25-310516
- form_type: 8-K
- ticker: DYN
- cik: 0001818794
- company_name: Dyne Therapeutics, Inc.
- filed_at: 2025-12-08T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1818794/000119312525310516/0001193125-25-310516-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1818794/000119312525310516/d16518d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-310516
- JSON: https://secwatch.observer/filing/0001193125-25-310516.json
- Plain text: https://secwatch.observer/filing/0001193125-25-310516.txt

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