FDA Accepts Intellia's BLA for Lonvo-z with Priority Review; PDUFA Date Set for March 10, 2027

summarizeSummary

FDA accepted Intellia's BLA for lonvo-z with Priority Review and set a PDUFA date of March 10, 2027. No advisory committee is currently planned. If approved, lonvo-z would be the first in vivo CRISPR-based therapy and the only one-time HAE treatment.

check_boxKey Events · Product Development and Regulatory · NTLA

• FDA Accepts BLA with Priority Review

  The FDA accepted the BLA for lonvo-z and granted Priority Review, setting a PDUFA target action date of March 10, 2027.

• No Advisory Committee Planned

  The FDA advised Intellia it is not currently planning to hold an advisory committee to discuss the application, reducing a common source of delay and uncertainty.

• First-in-Class Potential

  If approved, lonvo-z would be the world's first in vivo CRISPR-based therapy and the only one-time treatment for hereditary angioedema.

• Phase 3 Data Support Filing

  The BLA is supported by the Phase 3 HAELO trial, which showed an 87% reduction in mean monthly attacks and 62% of patients attack-free and therapy-free over six months.

auto_awesomeAnalysis · NTLA · Life Sciences

The FDA has 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 the company on a defined path to a potential first-in-class approval — the world's first in vivo CRISPR-based therapy and the only one-time HAE treatment. The specific PDUFA date and the absence of an advisory committee are new details beyond the earlier same-day news report, and they materially de-risk the approval timeline.