The U.S. FDA cleared Tessera’s IND for TSRA‑196, its in vivo gene‑editing candidate for alpha‑1 antitrypsin deficiency, and Australia’s HREC approved the phase I/II study there. The green light allows Tessera to initiate first‑in‑human dosing of an in‑body editing platform aimed at correcting AATD at the genomic level. The dual regulatory approvals mark another step for systemic in vivo genome editing approaches and will test Tessera’s delivery and editing safety in humans. Early clinical readouts will be watched closely for editing efficiency, off‑target profiles, and durable biomarker changes relevant to a monogenic liver disorder.