---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-256378"
form_type: "8-K"
ticker: "NTLA"
cik: "0001652130"
company_name: "Intellia Therapeutics, Inc."
filed_at: "2025-10-29T23:59:59+00:00"
generated_at: "2026-05-17T01:40:10.025545+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA places clinical hold on NTLA's Phase 3 nex-z trials after Grade 4 liver event

## Summary
- FDA verbally informed Intellia of clinical hold on MAGNITUDE and MAGNITUDE-2 Phase 3 trials for nex-z (nexiguran ziclumeran).
- Hold follows Grade 4 liver transaminases and increased total bilirubin in a MAGNITUDE patient dosed with nex-z.
- Company had temporarily paused dosing/screening on Oct 27 per protocol-defined pausing criteria.
- FDA will issue a formal Clinical Hold Letter within 30 days; Intellia plans to work with FDA to resolve.
- NTLA (Nasdaq) stock expected to react to this regulatory setback.

## SEC filing metadata
- accession: 0001193125-25-256378
- form_type: 8-K
- ticker: NTLA
- cik: 0001652130
- company_name: Intellia Therapeutics, Inc.
- filed_at: 2025-10-29T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1652130/000119312525256378/0001193125-25-256378-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1652130/000119312525256378/d98865d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-256378
- JSON: https://secwatch.observer/filing/0001193125-25-256378.json
- Plain text: https://secwatch.observer/filing/0001193125-25-256378.txt

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