05:42 PM EST, 11/11/2025 (MT Newswires) -- Metagenomi ( MGX ) plans to advance its MGX-001 gene therapy for Hemophilia A into clinical development after preclinical data showed curative levels of clotting factor activity in non-human primates.

A single-dose treatment restored therapeutically relevant levels of factor VIII, a protein essential for blood clotting, with activity ranging from 17% to 81% across six dose cohorts, the company said Tuesday in a statement.

The study involved 24 animals receiving a B-domain deleted human FVIII gene, followed by a dose of MG29-1 nuclease mRNA and guide RNA to enable genome editing, the company said. The results are expected to inform dosing strategy ahead of a planned investigational new drug submission, targeted for late 2026

The findings support MGX-001's potential as a best-in-class therapy and mark a key step toward human trials, the company said.

Metagenomi ( MGX ) shares fell 7.3% in after-hours trading. On Tuesday, the company also reported a wider Q3 loss, reduced its workforce by 25%, and named a new chief executive officer.