The FDA has approved Intellia Therapeutics’ in vivo CRISPR therapy lonvoguran ziclumeran (lonvo-z) following clearance of the company’s biologics license application, delivering a one-dose genome editing option for hereditary angioedema (HAE). The approval follows successful Phase 3 results from the HAELO trial (NCT06634420), with the treatment designed as an mRNA-lipid nanoparticle (LNP) regimen intended to provide durable disease control with reduced treatment burden compared with recurring therapies. Clinicians note that HAE attacks are unpredictable and can be disfiguring or life-threatening when they involve the upper airway. Patient-reported quality-of-life impact and the psychological burden of uncertainty are central to how the new modality may be adopted in care pathways.