Tessera Therapeutics received FDA clearance of an IND and Australian HREC approval to initiate a Phase I/II study of TSRA‑196, its in‑vivo gene‑editing candidate for α‑1 antitrypsin deficiency (AATD). The green light allows Tessera to begin first‑in‑human dosing in the US and Australia, marking a key translational milestone for delivery‑focused genome editing approaches. TSRA‑196 uses Tessera’s gene‑writing platform designed to install corrective sequences in vivo rather than rely on ex vivo cell modification. Regulatory clearance at this stage will focus attention on safety, biodistribution and durable expression; outcomes from early cohorts will be watched closely by gene‑editing investors and platform developers.