Intellia reports positive Phase 3 HAELO results for lonvo-z; BLA rolling submission initiated

Intellia Therapeutics, Inc.

89% reduction (p<0.0001) in monthly attacks requiring on-demand treatment vs placebo; 91% reduction in moderate/severe attacks.
62% of lonvo-z patients attack-free and therapy-free during weeks 5-28 vs 11% placebo (p<0.0001).
AE-QoL total score improved by -17.04 points vs placebo (p<0.0001); all TEAEs mild/moderate, no serious events in lonvo-z arm.
Rolling BLA submission started April 2026; company expects FDA approval and U.S. launch in first half 2027.
All patients in lonvo-z arm experienced attack-rate reductions; plasma kallikrein levels stable through Feb 2026 cutoff.

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