Intellia rises after FDA grants fast-track status to its treatment for rare disease
BUZZ-Intellia rises after FDA grants fast-track status to its treatment for rare disease ** Shares of Intellia Therapeutics NTLA.O rise 6.4% to $13.55 premarket
** Co says the U.S. FDA accepted its application seeking approval of lonvoguran ziclumeran, or lonvo-z, as an experimental treatment for hereditary angioedema (HAE), and granted it priority review
** HAE is a rare genetic disorder that causes recurrent and potentially life-threatening swelling attacks
** The health regulator set a target action date of March 10 next year for its review of the therapy
** 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 - NTLA
** 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
** NTLA says the FDA does not currently plan to convene an advisory committee meeting to discuss the application
** As of last close, stock down 41.7% YTD
(Reporting by Siddhi Mahatole)
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Intellia rises after FDA grants fast-track status to its treatment for rare disease
Brief: Intellia Therapeutics Announces FDA Acceptance Of Biologics License Application With Priority Review For Lonvoguran Ziclumeran (Lonvo-Z) For Hereditary Angioedema (Hae)