Intellia reports positive Phase 3 HAELO data for lonvo-z, resumes nex-z enrollment

Intellia Therapeutics reported second quarter 2026 results and business updates on August 6, 2026. In April, the company announced positive topline results from the global Phase 3 HAELO trial of lonvo-z in hereditary angioedema, with additional data presented in June at the European Academy of Allergy & Clinical Immunology Congress and published in the New England Journal of Medicine.¹

The trial met its primary endpoint: over a six-month efficacy evaluation window from week 5 to week 28, a single infusion of lonvo-z cut attack rates by 87% compared with placebo, with a monthly attack rate of 0.26 in the treated group versus 2.10 in the placebo group (p<0.0001).¹ All key secondary endpoints were also met with statistical significance, including 62% of lonvo-z patients being completely free of attacks and rescue therapy during that period, versus 11% on placebo.¹ Safety data were described as favorable, with the most common adverse events being infusion-related reactions, headache, fatigue, back pain, and upper respiratory infection, all mild or moderate, and no serious adverse events in the lonvo-z arm.¹

Intellia said it expects the FDA to accept its BLA for lonvo-z in the second half of 2026, with a planned U.S. commercial launch in the first half of 2027 if approved.¹

On the ATTR amyloidosis program, a genomic analysis of more than 600 patient samples across nex-z trials, conducted with Regeneron and outside experts, found that the highest liver transaminase elevations occurred in patients carrying one specific HLA allele; Intellia is discussing the finding with the FDA and other regulators and will provide HLA genotyping results to trial participants.¹ Enrollment has advanced in the MAGNITUDE and MAGNITUDE-2 Phase 3 trials, with MAGNITUDE-2 enrollment expected to complete in the second half of 2026.¹

In April 2026, Intellia raised approximately $195 million in net proceeds through an underwritten stock offering.¹ Cash and marketable securities totaled $628.4 million as of June 30, 2026, up from $605.1 million at year-end 2025, which the company said should fund operations into 2028 and beyond the planned lonvo-z launch.¹