Intellia Therapeutics, Inc. — Form 8-K

Intellia announced FDA acceptance of its Biologics License Application (BLA) for lonvo-z (lonvoguran ziclumeran), a CRISPR gene-editing therapy for hereditary angioedema (HAE), with Priority Review and a PDUFA target action date of March 10, 2027. The BLA is supported by Phase 3 HAELO trial data showing 87% reduction in mean monthly attacks versus placebo (p<0.0001) and 62% of patients attack-free during the 6-month efficacy evaluation period. If approved, lonvo-z would be the world's first in vivo CRISPR-based therapy and the only one-time HAE treatment; no advisory committee is planned.