Intellia Therapeutics Inc (NASDAQ:NTLA) shares are soaring on Thursday after the company completed enrollment in its crucial Phase 3 HAELO trial and laid out its key development milestones.
What Happened: Intellia announced that it concluded patient enrollment in the global Phase 3 HAELO study of lonvoguran ziclumeran (lonvo-z) within nine months of dosing the first subject.
Phase 3 topline data is expected in the first half of 2026, and the company remains on track to file a biologics license application (BLA) in the second half of 2026, ahead of a U.S. launch planned in the first half of 2027.
"Completing HAELO enrollment within nine months since dosing the first patient marks a pivotal moment for the company and reflects the degree of unmet need we are hearing from people living with HAE," said John Leonard, Intellia President and CEO.
"Our momentum remains strong for a planned biologics license application (BLA) submission in 2026 as we seek to make this potentially life-changing therapy available to HAE patients starting in the U.S.”
Under the randomized, double-blind and placebo-controlled trial, at least 60 or more adults and adolescents with Type I or II hereditary angioedema (HAE) were administered either a single 50 mg infusion of lonvo-z or a placebo at a two-to-one ratio. Participants had the option of a blinded crossover at week 28. Intellia said it intends to share more extensive data from its Phase 1/2 study in the fourth quarter of 2025.
NTLA Price Action: Intellia Therapeutics shares are up 24.28% at $15.41 at the time of publication on Thursday, per Benzinga Pro.
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