Intellia Therapeutics, Inc. (NTLA) on Monday reported positive topline results from its Phase 3 HAELO trial of lonvo-z, a CRISPR-based gene editing therapy for Hereditary angioedema (HAE). The study met its primary goal.
HAE is a rare genetic condition in which patients experience recurrent and potentially life-threatening swelling attacks in various parts of their body.
Results showed a one-time infusion of lonvo-z cut attack rates by 87% versus placebo over six months, with monthly attacks averaging 0.26 compared with 2.10 in the placebo group. The company said a significantly higher proportion of patients remained attack-free during the study period versus placebo.
Lonvo-z demonstrated a favorable safety profile, with all reported adverse events being mild to moderate.
Intellia said it has begun a rolling biologics license application submission with the U.S. Food and Drug Administration and expects a potential U.S. launch in the first half of 2027, if approved.
Shares rose more than 4% in pre-market trading after closing at $13.63 on Friday.
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