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# Clinical Hold on 2 Intellia Gene Therapy Trials
- URL: https://www.fdaweb.com/clinical-hold-on-2-intellia-gene-therapy-trials/
- Published: 2025-10-30T12:00:00.000Z
- Updated: 2026-09-14T15:25:27.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5160133

FDA has issued a clinical hold on Intellia Therapeutics’ MAGNITUDE and MAGNITUDE-2 Phase 3 trials for nexiguran ziclumeran (nex-z) after the company disclosed Grade 4 liver transaminases and increased total bilirubin in a patient who was dosed with nex-z in the MAGNITUDE trial. The company earlier this week said it had temporarily paused dosing and screening in both trials based on the MAGNITUDE trial’s protocol-defined pausing criteria.

The hold follows a 10/24 report about the patient’s liver monitoring levels, the company says, adding that the patient was hospitalized and is receiving medical care. The company says it is consulting with external experts, exploring potential risk mitigation strategies, and engaging with regulatory authorities globally to determine a safe path to resume enrollment.

The MAGNITUDE trial currently has over 650 patients enrolled, and MAGNITUDE-2 has 47 patients enrolled, with more than 450 patients estimated to have received nex-z.

Nex-z, based on CRISPR/Cas9 gene editing, is designed to inactivate the TTR gene to reduce the production of transthyretin protein, according to Intellia. Interim Phase 1 data previously showed consistent, deep, and long-lasting TTR reduction, it says.