NTLA Completes Enrollment in Pivotal Study on HAE Candidate, Stock Up

Core Insights - Intellia Therapeutics' shares increased by 29.8% following the completion of enrollment in the phase III HAELO study for its investigational candidate lonvoguran ziclumeran (lonvo-z) aimed at treating hereditary angioedema (HAE) [1][8] - Top-line data from the pivotal HAELO study is anticipated in the first half of 2026, with a potential biologics license application submission planned for the second half of 2026 [2][8] - The company aims to launch lonvo-z in the U.S. in the first half of 2027 [2] Company Developments - Intellia began dosing the first patient in the phase III HAELO study in January 2025, with full enrollment completed within nine months [6][7][8] - The study focuses on the safety and efficacy of lonvo-z in adults with type I or type II HAE, measuring the number of HAE attacks and the number of patients achieving attack-free status [6][8] - Lonvo-z is designed to prevent HAE attacks by suppressing plasma kallikrein activity, addressing the limitations of current chronic treatment options [9] Additional Candidate Development - Intellia is also developing nexiguran ziclumeran (nex-z) in collaboration with Regeneron Pharmaceuticals, targeting ATTR amyloidosis with polyneuropathy (ATTRv-PN) and ATTR amyloidosis with cardiomyopathy (ATTR-CM) [10][11] - The phase III MAGNITUDE study for nex-z in treating ATTR-CM is currently enrolling patients, with the first patient in the MAGNITUDE-2 study for ATTRv-PN dosed in April 2025 [11] - Positive data from the MAGNITUDE-2 study could lead to global regulatory filings for nex-z [12] Stock Performance - Year-to-date, Intellia's shares have risen by 38.2%, significantly outperforming the industry average increase of 3.3% [5]