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8-K//Current report

Entrada Therapeutics, Inc. 8-K

Accession 0001689375-26-000003

$TRDACIK 0001689375operating

Filed

Jan 7, 7:00 PM ET

Accepted

Jan 8, 7:25 AM ET

Size

212.8 KB

Accession

0001689375-26-000003

Research Summary

AI-generated summary of this filing

Updated

Entrada Therapeutics Reports Cash Position and Clinical Progress

What Happened

  • Entrada Therapeutics (TRDA) filed an 8-K on Jan 8, 2026 reporting an estimated $296 million in cash, cash equivalents and marketable securities as of Dec 31, 2025, and issued a press release summarizing progress across its RNA-based therapeutics portfolio.
  • The company completed dosing of Cohort 1 in the Phase 1/2 multiple ascending dose (MAD) study of ENTR-601-44 (for Duchenne muscular dystrophy amenable to exon 44 skipping) and moved into the open‑label Phase 2 portion. It expects ELEVATE-44-201 Cohort 1 data in Q2 2026 and ELEVATE-45-201 Cohort 1 data in mid-2026.
  • Regulatory and program updates include FDA Rare Pediatric Disease designation for ENTR-601-44 (Dec 2025), MHRA and Research Ethics Committee authorization to start a Phase 1/2 MAD study of ENTR-601-50 (exon 50 skipping) in the U.K., plans to initiate global ENTR-601-50 MAD study by end of 2026, planned global filings for ENTR-601-51 in 2026, and selection of ENTR-801 as the first ocular clinical candidate (Usher syndrome type 2A) with a second ocular candidate expected to be nominated in 2026.
  • The company also noted progress on the partnered VX-670 program with Vertex and will present at the 44th Annual J.P. Morgan Healthcare Conference on Jan 14, 2026.

Key Details

  • Estimated cash, cash equivalents and marketable securities: ~$296 million (as of 12/31/2025).
  • Clinical milestones: Cohort 1 dosing complete for ENTR-601-44; ELEVATE-44-201 Cohort 1 data expected Q2 2026; ELEVATE-45-201 Cohort 1 data expected mid-2026.
  • Regulatory: FDA Rare Pediatric Disease designation for ENTR-601-44 (Dec 2025); MHRA/REC authorization to start ENTR-601-50 Phase 1/2 MAD in the U.K.
  • Pipeline expansion: ENTR-801 nominated as first ocular clinical candidate (Usher syndrome type 2A); second ocular candidate expected in 2026.

Why It Matters

  • The cash balance (~$296M) and the company’s statement that resources are sufficient into the third quarter of 2027 (preliminary estimate) provide context on funding for near-term operations and clinical readouts.
  • Upcoming Phase 1/2 data (Q2 and mid-2026) and regulatory progress are potential near-term clinical and regulatory milestones that investors typically view as catalysts.
  • FDA designation and MHRA approvals reduce certain regulatory hurdles and may help enrollment and development timelines, but the filing includes standard forward‑looking statement caution: outcomes and timing are uncertain and subject to risks described in the company’s SEC filings.