---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-385194"
form_type: "8-K"
ticker: "NTLA"
cik: "0001652130"
company_name: "Intellia Therapeutics, Inc."
filed_at: "2026-09-08T20:05:15+00:00"
generated_at: "2026-09-08T20:06:59.653969+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Intellia's lonvo-z BLA accepted by FDA with Priority Review for HAE; PDUFA March 10, 2027

## Summary
- FDA accepted BLA for lonvo-z (formerly NTLA-2002) for HAE with Priority Review; PDUFA target date March 10, 2027.
- No advisory committee currently planned; if approved, lonvo-z would be first in vivo CRISPR therapy and only one-time HAE treatment.
- Phase 3 HAELO (80 patients): 87% reduction in mean monthly attacks vs placebo (p<0.0001) during weeks 5-28.
- 62% of lonvo-z patients attack-free and therapy-free for 6 months vs 11% placebo (p<0.0001).
- No serious adverse events in lonvo-z arm; most common TEAEs were infusion-related reactions, headache, fatigue, back pain.

## SEC filing metadata
- accession: 0001193125-26-385194
- form_type: 8-K
- ticker: NTLA
- cik: 0001652130
- company_name: Intellia Therapeutics, Inc.
- filed_at: 2026-09-08T20:05:15+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1652130/000119312526385194/0001193125-26-385194-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1652130/000119312526385194/ntla-20260908.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-385194
- JSON: https://secwatch.observer/filing/0001193125-26-385194.json
- Plain text: https://secwatch.observer/filing/0001193125-26-385194.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.