---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-008307"
form_type: "8-K"
ticker: "NTLA"
cik: "0001652130"
company_name: "Intellia Therapeutics, Inc."
filed_at: "2026-01-09T23:59:59+00:00"
generated_at: "2026-05-16T11:04:14.638815+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Intellia provides update on FDA clinical hold for nex-z after patient death in MAGNITUDE trial

## Summary
- Patient in MAGNITUDE Phase 3 trial for ATTR-CM died from septic shock secondary to perforated duodenal ulcer; autopsy supports clinical diagnoses.
- Grade 4 liver transaminase elevations reported in <1% of >650 enrolled MAGNITUDE patients; all other cases resolved within weeks.
- FDA clinical hold continues on MAGNITUDE (ATTR-CM) and MAGNITUDE-2 (ATTRv-PN) Phase 3 trials of nex-z.
- No Grade 4 liver events reported in MAGNITUDE-2 (47 patients enrolled with ATTRv-PN).
- Company plans to provide update after finalizing path forward with regulators.

## SEC filing metadata
- accession: 0001193125-26-008307
- form_type: 8-K
- ticker: NTLA
- cik: 0001652130
- company_name: Intellia Therapeutics, Inc.
- filed_at: 2026-01-09T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1652130/000119312526008307/0001193125-26-008307-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1652130/000119312526008307/d15047d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-008307
- JSON: https://secwatch.observer/filing/0001193125-26-008307.json
- Plain text: https://secwatch.observer/filing/0001193125-26-008307.txt

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