Intellia Reports Q2 2026 Results: Lonvo-Z BLA Submission on Track for Second Half of 2026

Intellia Therapeutics announced second-quarter 2026 financial results confirming its rolling Biologics License Application for lonvoguran ziclumeran (lonvo-z) — an in vivo CRISPR therapy for hereditary angioedema — remains on track for completion in the second half of 2026, with FDA acceptance anticipated in H2 2026 and a targeted US launch in H1 2027. The Phase 3 HAELO data (87% attack reduction, 62% of patients fully attack-free vs. 11% on placebo, all treatment-emergent adverse events mild-to-moderate with no serious adverse events in the lonvo-z arm) was published in the New England Journal of Medicine after being presented at EAACI in June. The RMAT designation allows Intellia to submit BLA sections on a rolling basis for expedited FDA review, positioning lonvo-z to become the world's first approved in vivo CRISPR gene-editing therapy.