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# FDA Lifts Clinical Hold on Intellia’s Phase 3 Trial
- URL: https://www.fdaweb.com/fda-lifts-clinical-hold-on-intellias-phase-3-trial/
- Published: 2026-01-27T12:00:00.000Z
- Updated: 2026-09-14T15:31:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160551

FDA has lifted a clinical hold on Intellia Therapeutics’ MAGNITUDE-2 Phase 3 trial evaluating nexiguran ziclumeran, or nex-z, for patients with hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN), clearing the way for the company to resume patient enrollment and dosing. The gene editing company says FDA removed the hold on the IND application for MAGNITUDE-2 following a review of additional data and agreed-upon study modifications, including enhanced monitoring of liver safety laboratory tests.

The agency placed clinical holds on the MAGNITUDE and MAGNITUDE-2 trials in late October after a patient in the MAGNITUDE Phase 3 trial for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) experienced Grade 4 elevations in liver transaminases along with increased total bilirubin that met protocol-defined pausing criteria, according to the company.

While the hold on MAGNITUDE-2 has been lifted, Intellia says discussions with FDA are continuing regarding the MAGNITUDE Phase 3 trial. The company said it will provide an update once there is alignment on a path forward for that program.

MAGNITUDE-2 is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of a single infusion of nex-z in patients with ATTRv-PN. As part of a protocol amendment agreed to with regulators, Intellia increased the trial’s target enrollment to about 60 patients from approximately 50\. Participants are randomized 1:1 to receive either a single 55-mg infusion of nex-z or placebo. The study’s primary endpoints include changes in modified neuropathy impairment score and serum transthyretin (TTR) levels.

Nex-z is described as an in vivo CRISPR/Cas9 gene editing therapy designed to inactivate the TTR gene, which encodes the transthyretin protein that misfolds and accumulates in ATTR amyloidosis.