Intellia rises after FDA grants fast-track status to its treatment for rare disease
NTLA•Trial data and regulatory outlook
The application was supported by late-stage trial data in which a single dose of lonvo-z reduced mean monthly attacks by 87% compared with placebo during the primary evaluation period from weeks 5 to 28.
Intellia said the FDA does not currently plan to convene an advisory committee meeting to discuss the application.
As of the last close, the stock was down 41.7% year to date.
Potential first-in-class gene-editing treatment
HAE is a rare genetic disorder that causes recurrent and potentially life-threatening swelling attacks.
If approved, lonvo-z would become the first in vivo CRISPR-based gene-editing therapy to reach the market and the first one-time treatment for HAE, Intellia said.
Shares rise after FDA accepts and prioritizes application
Shares of Intellia Therapeutics NTLA.O rose 6.4% to $13.55 in premarket trading after the company said the U.S. Food and Drug Administration accepted its application seeking approval of lonvoguran ziclumeran, or lonvo-z, as an experimental treatment for hereditary angioedema (HAE), and granted it priority review.
The health regulator set a target action date of March 10 next year for its review of the therapy.
