Intellia Therapeutics Shares Rise as FDA Grants Priority Review to Lonvo-z

Intellia Therapeutics (NASDAQ:NTLA) shares rose 8% on Tuesday after the U.S. Food and Drug Administration accepted the company’s Biologics License Application for lonvoguran ziclumeran, or lonvo-z, for hereditary angioedema and granted it Priority Review.

The FDA set a Prescription Drug User Fee Act target action date of March 10, 2027. The agency also advised Intellia that it does not currently plan to convene an advisory committee to discuss the application.

If approved, the company said lonvo-z would become the world’s first in vivo CRISPR-based therapy and the only one-time treatment for hereditary angioedema, or HAE.

Phase 3 HAELO Trial Supports Application

The Biologics License Application is supported by results from Intellia’s Phase 3 HAELO clinical trial, which enrolled 80 patients over nine months.

The study evaluated the efficacy and safety of a single 50 milligram dose of lonvo-z in adults and adolescents aged 16 and older with Type 1 or Type 2 HAE.

HAELO met its primary endpoint and all key secondary endpoints. During the efficacy evaluation period covering weeks five through 28, patients receiving lonvo-z recorded an 87% reduction in mean monthly HAE attacks compared with placebo.

The company also reported that 62% of patients receiving lonvo-z remained free from both HAE attacks and HAE therapy throughout the six-month efficacy evaluation period, compared with 11% of patients receiving placebo.

Patients Remained Free From Long-Term Prophylaxis at Data Cutoff

As of the February 10, 2026 data cutoff, all patients who received lonvo-z either at baseline or after crossing over from placebo following week 28 remained free from long-term prophylaxis therapy, according to the supplied information.

The most common treatment-emergent adverse events reported more frequently in the lonvo-z group than the placebo group during the primary observation period were infusion-related reactions, headache, fatigue, back pain and upper respiratory tract infection.

All reported treatment-emergent adverse events were classified as mild or moderate, and no serious adverse events were observed in the lonvo-z arm during that period.

FDA Decision Targeted for March 2027

Priority Review shortens the FDA’s review timetable but does not indicate whether the application will ultimately be approved.

The regulatory process will now continue towards the March 10, 2027 PDUFA target action date.

Intellia’s 8% share-price increase followed confirmation that the application had been accepted for Priority Review as investors assessed the Phase 3 HAELO results and the timetable for the FDA’s decision on lonvo-z.

Intellia Therapeutics stock price