secwatch.observer — SEC 8-K summary
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Issuer:     Entrada Therapeutics, Inc. (TRDA)
CIK:        0001689375
Form:       8-K
Filed at:   2026-10-14T11:52:00+00:00
Accession:  0001689375-26-000057
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

Entrada's ENTR-601-45 shows safe 5 mg/kg profile, 0.10% dystrophin rise in DMD Cohort 1
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- Cohort 1 of Phase 1/2 ELEVATE-45-201 enrolled 8 ambulatory DMD patients (exon 45 skipping), randomized 3:1 to IV ENTR-601-45 5 mg/kg or placebo on days 1, 43 and 85.
- Dystrophin rose a mean 0.10% from baseline in treated patients (n=6, nominal p=0.03) vs a 0.02% mean decrease on placebo; exon skipping rose 0.15% (n=5) vs -0.04% on placebo.
- Favorable safety: headache most common TEAE (5 events in 2 participants); 1 participant had 2 serious TEAEs (vomiting, pyrexia) that resolved; no discontinuations; no hypomagnesemia or renal concerns.
- No functional benefit seen after three doses, as expected given patient age and baseline function; Q6W dosing equals about nine infusions a year vs 50+ for weekly regimens.
- Cohort 2 (10 mg/kg) enrollment complete and dosing ongoing, with data due H1 2027; Cohort 3 up to 15 mg/kg to follow, targeting higher exposure and dystrophin.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1689375/000168937526000057/0001689375-26-000057-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1689375/000168937526000057/trda-20261014.htm
  HTML page:      https://secwatch.observer/filing/0001689375-26-000057

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