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

Intellia Therapeutics, Inc.

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.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.