Intellia Therapeutics: Phase 3 HAELO study to complete enrollment in 2H25

Intellia said the Phase 3 HAELO study evaluating NTLA-2002 for HAE to complete enrollment in the second half of 2025, and the company plans to submit a Biologics License Application in the second half of 2026. Intellia said its priority programs – NTLA-2002 for hereditary angioedema and nexiguran ziclumeran for transthyretin amyloidosis – set the foundation for significant, near-term value creation. “We have made significant progress and built strong momentum in 2024 with three actively enrolling, Phase 3, pivotal studies. Our early clinical data for both NTLA-2002 and nex-z support novel, highly differentiated product profiles that directly address the significant unmet needs of patients and prescribers in HAE and ATTR,” said John Leonard, M.D., President and Chief Executive Officer of Intellia. “We understand the significant potential of our late-stage programs, and within a challenging market environment, have made a difficult decision to focus our resources predominantly on NTLA-2002 and nex-z where we have the greatest opportunity to create significant, near-term value.”