Intellia Therapeutics’ in vivo CRISPR therapy for hereditary angioedema cleared Phase III and received an FDA biologics license application approval. The one-dose treatment, lonvoguran ziclumeran (lonvo-z), uses an mRNA-lipid nanoparticle platform intended to address unpredictable and life-threatening swelling attacks. The report ties the BLA decision to a successful Phase III HAELO clinical trial, with results published in the New England Journal of Medicine. Clinicians highlighted the burden of HAE beyond the attacks themselves, including psychological stress and disruption to work and travel. The approval marks another step in genome editing’s shift from clinical promise toward regulated, commercial delivery—where questions about durability, safety monitoring, and real-world uptake will intensify for the field.