FDA accepts Intellia's BLA for lonvo-z in hereditary angioedema, grants priority review
The agency set a PDUFA date of March 10, 2027, and does not currently plan an advisory committee meeting.
SEC filing
Latest
3 stories
Tuesday, September 8
Friday, September 4
Intellia secures up to $400 million credit facility from OrbiMed
The gene-editing company drew $75 million upfront and can access further tranches tied to lonvo-z regulatory and revenue milestones.
SEC filing
Thursday, August 6
Intellia reports positive Phase 3 HAELO data for lonvo-z, resumes nex-z enrollment
Intellia expects FDA to accept its BLA for lonvo-z in the second half of 2026 and plans a U.S. launch in the first half of 2027, while nex-z Phase 3 enrollment has restarted.
SEC filing