8-K filing — Entrada Therapeutics, Inc. (TRDA)
Filed: 2026-10-14 AccNo: 0001689375-26-000057 Size: 501 KB Item 7.01: Regulation FD Disclosure Item 8.01: Other Events Item 9.01: Financial Statements and Exhibits
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TRDA stock fell over 15% after Entrada Therapeutics announced initial Phase 1/2 ELEVATE-45-201 study results for ENTR-601-45.
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Filed: 2026-10-14 AccNo: 0001689375-26-000057 Size: 501 KB Item 7.01: Regulation FD Disclosure Item 8.01: Other Events Item 9.01: Financial Statements and Exhibits
Entrada Therapeutics announced positive topline data from Cohort 1 of the Phase 1/2 ELEVATE-45-201 study of ENTR-601-45 for DMD patients amenable to exon 45 skipping. The trial met primary safety and tolerability objectives at the 5 mg/kg dose with favorable safety profile and demonstrated a 0.10% mean increase in dystrophin production. The company expects significant increases in dystrophin production at higher doses in future cohorts and plans to report Cohort 2 data (10 mg/kg) in the first half of 2027.
Entrada Therapeutics announced that an independent Data Monitoring Committee has recommended advancing to Cohort 3 at the top dose of 18 mg/kg in the ELEVATE-44-201 Phase 1/2 clinical study of ENTR-601-44 for Duchenne muscular dystrophy. The dose escalation marks progress in understanding the drug's safety and efficacy profile. Cohort 1 data is expected by year-end 2026, with Cohort 2 data anticipated in Q1 2027.