Intellia Therapeutics to Present lonvo-z Phase 3 HAELO Data in Late-Breaking Oral at EAACI 2026, Istanbul — Rolling BLA Advances Toward First In Vivo CRISPR Therapy Approval
Intellia Therapeutics announced on June 1, 2026 that additional Phase 3 data for lonvoguran ziclumeran (lonvo-z) — its wholly owned, in vivo CRISPR/Cas9 therapy for hereditary angioedema (HAE) — will be presented in a late-breaking oral session at the European Academy of Allergy & Clinical Immunology (EAACI) Annual Congress in Istanbul, Turkey. The late-breaking oral presentation is scheduled for June 13, 2026 at 8:45–9:45 a.m. TRT (Session LB07: Late Breaking Abstracts), with a companion poster on June 12. The EAACI presentation follows the pivotal April 27, 2026 Phase 3 HAELO topline readout: lonvo-z reduced HAE attack rates by 87% vs. placebo (primary endpoint, p<0.0001); 62% of treated patients were completely free from both attacks and ongoing HAE therapy vs. 11% in the placebo arm; all secondary endpoints met; no serious adverse events in the lonvo-z group. The Phase 3 data, simultaneously selected as a late-breaking oral at the EAACI Annual Congress — one of the world's leading allergy and immunology conferences — underscores the transformative potential of lonvo-z for HAE, a potentially life-threatening rare disease caused by mutations in the SERPING1 gene. Intellia initiated a rolling BLA submission to the FDA on April 27, 2026, holds RMAT designation enabling rolling review, and is participating in the FDA's CMC Development and Readiness Pilot program. BLA completion is targeted for H2 2026, with potential U.S. commercial launch in H1 2027. If approved, lonvo-z would become the world's first approved in vivo CRISPR gene editing therapy, complementing Casgevy (exagamglogene autotemcel) as the first approved ex vivo CRISPR therapy. Intellia's stock (NTLA) rose 14.4% on the April Phase 3 readout.
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- T3 GlobeNewswire — Intellia Therapeutics EAACI 2026 Late-Breaking Oral Announcement, June 1, 2026 Institutional western
- T3 GlobeNewswire — Intellia Phase 3 HAELO Topline Results, April 27, 2026 Institutional western
- T3 GlobeNewswire — Intellia Rolling BLA Submission Initiated, April 27, 2026 Institutional western