Intellia Therapeutics Initiates Rolling Submission of Biologics License Application to FDA for Lonvoguran Ziclumeran (lonvo-z) as a One-Time Treatment for Hereditary Angioedema

Intellia initiated a rolling BLA submission for lonvo-z, seeking FDA approval for the world's first in vivo CRISPR-based gene editing therapy for hereditary angioedema. The submission is backed by positive Phase 3 HAELO data where a one-time dose met primary and key secondary endpoints, freeing most patients from attacks and ongoing therapy.

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