---
schema_version: "secwatch.filing_event.v1"
accession: "0001689375-25-000004"
form_type: "8-K"
ticker: "TRDA"
cik: "0001689375"
company_name: "Entrada Therapeutics, Inc."
filed_at: "2025-02-24T23:59:59+00:00"
generated_at: "2026-05-26T06:00:33.064016+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA lifts clinical hold on Entrada's ENTR-601-44 for DMD Phase 1b study

## Summary
- FDA authorized ELEVATE-44-102, a Phase 1b multiple ascending dose study of ENTR-601-44 in adults with DMD amenable to exon 44 skipping.
- Study targets ~32 non-ambulatory and ambulatory patients; doses from 0.16 to 1.28 mg/kg every six weeks.
- Company also received UK MHRA authorization for ELEVATE-44-201; global program now covers pediatric and adult patients.
- Plans to initiate enrollment in first half of 2026 with seamless transition to open-label extension.
- CEO cites strength of Phase 1 safety/target engagement data and unmet need in adults living with Duchenne.

## SEC filing metadata
- accession: 0001689375-25-000004
- form_type: 8-K
- ticker: TRDA
- cik: 0001689375
- company_name: Entrada Therapeutics, Inc.
- filed_at: 2025-02-24T23:59:59+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/1689375/000168937525000004/0001689375-25-000004-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1689375/000168937525000004/trda-20250224.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001689375-25-000004
- JSON: https://secwatch.observer/filing/0001689375-25-000004.json
- Plain text: https://secwatch.observer/filing/0001689375-25-000004.txt

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