Intellia Therapeutics stock jumps on FDA priority review

Shares of Intellia Therapeutics (NASDAQ:NTLA) climbed 8% on Tuesday following the company's announcement that the U.S. Food and Drug Administration had accepted its Biologics License Application and granted Priority Review for lonvoguran ziclumeran (lonvo-z), an investigational therapy for hereditary angioedema.

The FDA has assigned a Prescription Drug User Fee Act target action date of March 10, 2027. The agency also informed Intellia that it does not currently anticipate convening an advisory committee to review the application. Should approval be granted, lonvo-z would become the world's first in vivo CRISPR-based therapy and the sole one-time treatment for HAE.

The Biologics License Application is backed by results from Intellia's Phase 3 HAELO trial, which enrolled 80 participants over a nine-month period. The study assessed the efficacy and safety of a single 50-milligram dose of lonvo-z in adults and adolescents age 16 and older with Type 1 or Type 2 hereditary angioedema.

HAELO achieved its primary endpoint and all key secondary endpoints, showing an 87% decrease in mean monthly attack rates for lonvo-z relative to placebo during the efficacy evaluation window spanning weeks 5 through 28. Furthermore, 62% of patients receiving lonvo-z remained free from attacks and did not require HAE therapy during the six-month assessment period, versus 11% in the placebo group.

As of the data cutoff date of February 10, 2026, every patient who received lonvo-z either at baseline or via crossover following week 28 remained without the need for long-term prophylactic treatment.

During the primary observation period, the most frequent treatment-emergent adverse events seen more often with lonvo-z than with placebo included infusion-related reactions, headache, fatigue, back pain, and upper respiratory tract infection. All treatment-emergent adverse events reported were mild or moderate in severity, and no serious adverse events occurred among patients given lonvo-z.

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