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FDA Priority Review Accepted for Intellia's HAE Gene-Editing BLA

Intellia Therapeutics logoIntellia Therapeutics
Sig3.60Sen+6.40Env0.00Soc+3.40Gov+0.60

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.

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