(RTTNews) - Intellia Therapeutics (NTLA) announced that the FDA has removed the clinical hold on the Investigational New Drug application for the MAGNITUDE-2 Phase 3 clinical trial of nexiguran ziclumeran, or nex-z, for patients with hereditary transthyretin amyloidosis with polyneuropathy. The clinical holds on the INDs for MAGNITUDE and MAGNITUDE-2 were imposed on October 29, 2025, following the observation of Grade 4 liver transaminases and increased total bilirubin in a patient.
"With the clinical hold for MAGNITUDE-2 lifted, our team is focused on resuming patient enrollment as quickly as possible as we seek to advance this potential one-time treatment option for people living with ATTRv-PN," said Intellia CEO John Leonard.
Intellia noted that its engagement with FDA is ongoing regarding the clinical hold on the IND for the MAGNITUDE Phase 3 clinical trial of nex-z for patients with transthyretin amyloidosis with cardiomyopathy. The company plans to provide an update once alignment has been achieved on the path forward.
In pre-market trading on NasdaqGM, Intellia shares are up 20.6 percent to $16.82.
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