Intellia Therapeutics announced the FDA accepted its Biologics License Application (BLA) for lonvoguran ziclumeran (lonvo-z). The agency granted Priority Review to accelerate the timeline for this one-time Hereditary Angioedema (HAE) treatment.
The FDA set a Prescription Drug User Fee Act (PDUFA) target action date of March 10, 2027. If approved, lonvo-z would become the first in vivo CRISPR-based therapy to edit genes directly inside the human body.
The agency currently does not plan to convene an advisory committee meeting to discuss the application. This decision signals confidence in the submitted data package for the investigational therapy.