FDA Accepts Intellia's BLA for Lonvo-z with Priority Review, PDUFA Date March 10, 2027
NTLA sits 72% above its 52-week low of $7.95.
Summary
The FDA accepted Intellia's BLA for lonvo-z, its in vivo CRISPR gene-editing therapy for hereditary angioedema, and granted Priority Review with a PDUFA target action date of March 10, 2027. The agency also indicated it is not currently planning an advisory committee meeting. This is a major regulatory milestone that puts lonvo-z on track for potential approval as the world's first in vivo CRISPR-based therapy and the first one-time treatment for HAE. The BLA is supported by Phase 3 HAELO data showing an 87% reduction in monthly attacks and 62% of patients attack-free. The news follows positive Phase 3 results reported in June and a $400M non-dilutive term loan secured last week, strengthening the company's commercial readiness. Approval would open a significant market opportunity in HAE, where current treatments require chronic administration.
At the time of this announcement, NTLA was trading at $13.69 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.8B. The 52-week trading range was $7.95 to $28.25. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.