Intellia Therapeutics Stock Rises After Completing Phase 3 HAELO Trial Enrollment

Intellia Therapeutics shares are up 24.28% after completing enrollment in its Phase 3 HAELO trial within nine months of dosing the first patient. The company expects Phase 3 topline data in H1 2026 and plans to file a biologics license application in H2 2026, with a U.S. launch planned in H1 2027.

Intellia Therapeutics, Inc. (NASDAQ: NTLA) has achieved a significant milestone by completing enrollment in its global Phase 3 HAELO study for lonvoguran ziclumeran (lonvo-z), a CRISPR-based therapy for hereditary angioedema (HAE). The study enrolled over 60 patients within nine months, with nearly half from the U.S. Intellia Therapeutics, Inc. Completes Enrollment in the Global Phase 3 HAELO Study of Lonvoguran Ziclumeran (lonvo-z) for Hereditary Angioedema^[1] The company expects to report topline data in H1 2026, followed by a biologics license application (BLA) submission in H2 2026, targeting a U.S. launch in H1 2027. Intellia Therapeutics Completes Enrollment in the Global Phase 3 HAELO Study of Lonvoguran Ziclumeran (lonvo-z) for Hereditary Angioedema^[2]

The HAELO study is a randomized, double-blind, placebo-controlled trial evaluating lonvo-z's efficacy in patients aged 16 and older with Type I or II HAE. The primary endpoints focus on HAE attack frequency and attack-free status from weeks 5-28, aligning with FDA requirements for this indication. Intellia Therapeutics Completes Enrollment in the Global Phase 3 HAELO Study of Lonvoguran Ziclumeran (lonvo-z) for Hereditary Angioedema^[2]

Intellia's rapid Phase 3 enrollment, faster than typical timelines for rare disease trials, signals high patient and physician interest in lonvo-z. The company has outlined a clear regulatory pathway, providing investors with transparent expectations regarding the development trajectory. Intellia Therapeutics Completes Enrollment in the Global Phase 3 HAELO Study of Lonvoguran Ziclumeran (lonvo-z) for Hereditary Angioedema^[2]

Lonvo-z, based on Nobel Prize-winning CRISPR/Cas9 technology, has the potential to become the first one-time treatment for HAE. Interim Phase 1/2 clinical data showed dramatic reductions in attack rate and kallikrein levels. Lonvo-z has received five notable regulatory designations, including Orphan Drug and RMAT Designation by the FDA, the Innovation Passport by the MHRA, Priority Medicines (PRIME) Designation by the EMA, and Orphan Drug Designation (ODD) by the European Commission. Intellia Therapeutics, Inc. Completes Enrollment in the Global Phase 3 HAELO Study of Lonvoguran Ziclumeran (lonvo-z) for Hereditary Angioedema^[1]

Intellia Therapeutics, a leading clinical-stage gene editing company, is focused on revolutionizing medicine with CRISPR-based therapies. The company's progress in the HAELO study reflects its commitment to addressing unmet medical needs and advancing the treatment paradigm for patients. Intellia Therapeutics, Inc. Completes Enrollment in the Global Phase 3 HAELO Study of Lonvoguran Ziclumeran (lonvo-z) for Hereditary Angioedema^[1]