---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-023387"
form_type: "8-K"
ticker: "NTLA"
cik: "0001652130"
company_name: "Intellia Therapeutics, Inc."
filed_at: "2026-01-27T23:59:59+00:00"
generated_at: "2026-05-16T07:33:05.215831+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA lifts clinical hold on Intellia's MAGNITUDE-2 Phase 3 trial for ATTRv-PN; MAGNITUDE hold ongoing

## Summary
- FDA removed clinical hold on IND for MAGNITUDE-2 Phase 3 trial of nex-z for ATTRv-PN, imposed Oct 29, 2025 after Grade 4 liver event and patient death.
- Intellia to resume patient enrollment with enhanced liver safety monitoring; target enrollment increased from ~50 to ~60 patients.
- FDA engagement ongoing for clinical hold on MAGNITUDE Phase 3 trial for ATTR-CM; no update on path forward yet.

## SEC filing metadata
- accession: 0001193125-26-023387
- form_type: 8-K
- ticker: NTLA
- cik: 0001652130
- company_name: Intellia Therapeutics, Inc.
- filed_at: 2026-01-27T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1652130/000119312526023387/0001193125-26-023387-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1652130/000119312526023387/d29201d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-023387
- JSON: https://secwatch.observer/filing/0001193125-26-023387.json
- Plain text: https://secwatch.observer/filing/0001193125-26-023387.txt

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