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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April 24, 2026 15:15 ET Economics news flow was relatively light this week even as the conflict in the Middle East continued, raising concerns for policymakers. In the U.S., spending data, initial jobless claims and pending home sales were the highlights. Business confidence in the biggest euro area economy was in focus in Europe. Inflation data from Japan gained attention in Asia.