Intellia Therapeutics (NTLA) announced the FDA has removed the clinical hold on the Investigational New Drug application for the MAGNITUDE Phase 3 clinical trial of nexiguran ziclumeran for patients with transthyretin amyloidosis with cardiomyopathy. The clinical holds on the INDs for MAGNITUDE and MAGNITUDE-2 were imposed by the FDA on October 29, 2025, following the observation of Grade 4 liver transaminases and increased total bilirubin in a patient who was dosed with nex-z in MAGNITUDE that met the trials protocol-defined pausing criteria.
Intellia CEO John Leonard said: "With the resolution in January of the clinical hold on our MAGNITUDE-2 Phase 3 trial for patients with hereditary ATTR with polyneuropathy, our attention now turns to completing enrollment in both ongoing trials."
In pre-market trading on NasdaqGM, Intellia shares are up 3.56 percent to $14.27.
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