Intellia Therapeutics Inc. (NASDAQ:NTLA) saw its stock climb 5.5% in premarket trading Thursday after the company announced the completion of enrollment in its Phase 3 HAELO trial of lonvoguran ziclumeran for hereditary angioedema (HAE).
The Cambridge, Massachusetts-based biotech completed enrollment in just nine months, with nearly 50% of participants coming from the U.S. Intellia aims to release topline results in the first half of 2026 and is on track to submit a biologics license application (BLA) in the second half of 2026, with a U.S. launch targeted for early 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 Intellia President and CEO John Leonard in a statement.
The HAELO trial is a randomized, double-blind, placebo-controlled study assessing the efficacy and safety of lonvo-z in at least 60 adults and adolescents aged 16 and older with Type I or II HAE. Participants are randomized 2:1 to receive a single 50 mg infusion of lonvo-z or placebo, with an optional blinded crossover at week 28.
Key endpoints include the number of HAE attacks and the proportion of patients achieving attack-free status from week 5 through week 28. Intellia also plans to present additional results from its Phase 1/2 study in the fourth quarter of 2025.
The company first dosed a patient in the HAELO study in January 2025, marking the start of this pivotal Phase 3 trial.
Intellia Therapeutics stock price
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