$NTLA (INTELLIA THERAPEUTICS) — 8-K: FDA grants Priority Review to Intellia’s lonvo-z with PDUFA date of March 10, 2027

The FDA accepted the BLA for lonvo-z and set a PDUFA target action date of March 10, 2027. If approved, lonvo-z would be the world’s first in vivo CRISPR-based therapy and the only one-time treatment for hereditary angioedema. The Phase 3 HAELO trial met its primary endpoint, showing an 87% reduction in mean monthly attacks versus placebo, and 62% of treated patients were attack free and HAE therapy free for six months compared with 11% on placebo.

The FDA accepted the BLA for lonvo-z and set a PDUFA target action date of March 10, 2027. If approved, lonvo-z would be the world’s first in vivo CRISPR-based therapy and the only one-time treatment