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Decision-gradeTopline results

Intellia reports positive Phase 3 HAELO results for lonvo-z in HAE

The HAELO Phase 3 trial met its primary endpoint with an 87% reduction in mean monthly HAE attacks and showed 62% of patients attack-free and therapy-free for six months. Additional key secondary endpoints demonstrated 89-91% reductions in on-demand treatment and moderate/severe attacks plus clinically meaningful quality-of-life gains. These data support the ongoing rolling BLA submission initiated in April and the company’s guidance for potential U.S. approval and launch in the first half of 2027.

Key facts

Filed
Jun 15, 2026, 12:52 PM
Event
Topline results
Direction
Positive
Company
NTLAIntellia
Asset
lonvoguran ziclumeran
Source
SEC 8-K
Confidence
Sourced
Calendar
FDA decision (PDUFA) · Mar 10, 2027 · Positive
attack free
62% vs 11% (p<0.0001)
attack reduction
87% (p<0.0001)
AE qol improvement
-17.04 points (p<0.0001)
on demand reduction
89% (79%, 94%)
moderate severe reduction
91% (81%, 96%)

Source excerpt

EX-99.1 2 ntla-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Intellia Therapeutics Reports Additional Positive Phase 3 Results for Lonvoguran Ziclumeran (lonvo-z) in Patients with Hereditary Angioedema • Data from HAELO Phase 3 clinical trial presented today in a late-breaking oral session at European Academy of Allergy & Clinical Immunology Annual Congress 2026 • HAELO manuscript simultaneously published in the New England Journal of Medicine CAMBRIDGE, Mass., June 13, 2026 – Intellia Therapeutics, Inc. (Nasdaq: NTLA), a leading biopharmaceutical company focused on revolutionizing medicine leveraging CRISPR gene editing and other core technologies, today presented additional positive results from the global Phase 3 HAELO clinical trial of lonvo-z (formerly NTLA-2002) for hereditary angioedema (HAE) in a late-breaking oral presentation at the European Academy of Allergy & Clinical Immunology (EAACI) Annual Congress 2026 in Istanbul, Türkiye. Results from the trial were simultaneously published in the New England Journal of Medicine . The presentation and publication can be accessed from the Scientific Publications and Presentations section o f intelliatx.com. As previously announced, HAE LO met its primary endpoint with an 87% reduction (p<0.0001) in mean monthly attacks in the lonvo-z arm vs. the placebo arm during the efficacy evaluation period (weeks 5 to 28). In addition, 62% of patients in the lonvo-z arm were entirely attack free and therapy free for the six-month effic

SEC 8-K

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