FDA Priority Review Accepted for Intellia's HAE Gene-Editing BLA
Intellia Therapeutics said the FDA has accepted its biologics license application for lonvoguran ziclumeran (lonvo-z) to treat hereditary angioedema. The FDA also told the company it does not plan to hold an advisory committee meeting for the application. Intellia began a rolling submission in April 2026 and reported additional positive HAELO study data in June, reinforcing lonvo-z’s potential as a one-time in vivo CRISPR therapy.