Intellia Therapeutics advanced its hereditary angioedema (HAE) program after delivering a second set of positive Phase III readouts for lonvoguran ziclumeran (lonvo-z). The company said the therapy met the primary endpoint in the HAELO trial and, in additional analyses presented at the European Academy of Allergy & Clinical Immunology (EAACI) Annual Congress 2026 and published in The New England Journal of Medicine, hit three key secondary endpoints over weeks 5–28. Across endpoints, Intellia reported improvements in the monthly rate of attacks requiring on-demand treatment (0.19 vs. 1.79), monthly rate of moderate/severe attacks (0.11 vs. 1.23), and change in AE-QoL total score by week 28 (-23.51 vs. -6.47). Company commentary highlighted that patients receiving lonvo-z were off long-term prophylaxis and that outcomes were consistent across subgroups. The data supported Intellia’s rolling Biologics License Application (BLA) submission, which began in April, with the company expecting to complete filing by year-end. Intellia is targeting an FDA decision and potential first-half 2027 launch for lonvo-z, contingent on regulatory review.
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