secwatch.observer — SEC 8-K summary
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Issuer:     Entrada Therapeutics, Inc. (TRDA)
CIK:        0001689375
Form:       8-K
Filed at:   2025-03-24T23:59:59+00:00
Accession:  0001689375-25-000018
Event type: regulatory
Sentiment:  positive
Materiality: 0.55
Item codes: 7.01, 8.01, 9.01, 2.02
LLM model:  deepseek-v4-flash:cloud@v2

Entrada receives UK authorization for Phase 1/2 trial of ENTR-601-45 in DMD exon 45 skipping
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- UK MHRA and Research Ethics Committee clearance to start ELEVATE-45-201, a Phase 1/2 MAD study of ENTR-601-45.
- On track to initiate the trial in Q3 2025; Part A will evaluate doses 5–15 mg/kg every 6 weeks in ~24 patients.
- Second Duchenne program (after ELEVATE-44); regulatory filings also submitted in the EU with review ongoing.
- Study is randomized, double-blind, placebo-controlled with a Part B for optimal dose evaluation and an OLE.
- CEO states strategy to run UK/EU studies first, then share data with FDA to enable U.S. registrational studies.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1689375/000168937525000018/0001689375-25-000018-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1689375/000168937525000018/trda-20250324.htm
  HTML page:      https://secwatch.observer/filing/0001689375-25-000018

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer