other material
confidence high
sentiment positive
materiality 0.95
Intellia announces positive Phase 3 HAELO results: 87% attack reduction, 62% attack-free; starts BLA for lonvo-z
Intellia Therapeutics, Inc.
- Single dose of lonvo-z reduced HAE attacks by 87% vs placebo (mean monthly rate 0.26 vs 2.10, p<0.0001) over 6 months.
- 62% of lonvo-z patients were entirely attack-free and therapy-free vs 11% on placebo (p<0.0001); all key secondary endpoints met.
- No serious adverse events; all TEAEs mild/moderate; most common: infusion-related reactions, headache, fatigue.
- Rolling BLA submission to FDA initiated; potential U.S. launch in first half of 2027 if approved.
- Median follow-up 7.5 months; all lonvo-z patients remained long-term prophylaxis-free as of Feb 10, 2026 cutoff.