Precision Biosciences received FDA clearance of an Investigational New Drug application for PBGENE‑DMD, enabling site activation for a Phase I/II trial (FUNCTION‑DMD) in ambulatory patients with Duchenne muscular dystrophy. The company said the first U.S. clinical site will be activated in the first half of the year and that the IND clearance clears the path to initial human testing of its gene‑editing/gene‑replacement approach. Precision’s move is notable for the DMD field, where therapeutic options remain limited and regulatory scrutiny on gene‑based approaches is high. The clearance positions the company to begin patient dosing and gather early safety and biomarker data to inform further development.