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FDA accepts NDA for Intellia's lonvo-z, granting Priority Review with PDUFA date of March 10, 2027
NTLAIntellia Therapeutics, Inc.
On September 8, 2026, Intellia Therapeutics announced that the U.S. Food and Drug Administration accepted its Biologics License Application for lonvoguran ziclumeran (lonvo-z) to treat hereditary angioedema. The FDA granted Priority Review status with a PDUFA target action date of March 10, 2027, and indicated no advisory committee is currently planned. Lonvo-z is an in vivo CRISPR-based therapy designed as a one-time treatment for the rare genetic disease. Clinical data from the Phase 3 HAELO trial showed an 87% reduction in mean monthly attacks compared to placebo, with 62% of patients achieving complete attack freedom during the evaluation period. Intellia Therapeutics is a biopharmaceutical company focused on developing curative treatments using CRISPR gene editing technology.