FDA Places Clinical Hold on Intellia Therapeutics' Phase 3 Trials for Nex-Z

On October 29, 2025, Intellia Therapeutics, Inc. reported that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the Investigational New Drug applications for the MAGNITUDE and MAGNITUDE-2 Phase 3 clinical trials for nexiguran ziclumeran (nex-z). The FDA verbally informed the company of the hold and indicated that a formal Clinical Hold Letter would be provided within 30 days. This action follows a previously disclosed report of Grade 4 liver transaminases and increased total bilirubin in a patient dosed with nex-z in the MAGNITUDE trial. The company had temporarily paused dosing and screening in these trials on October 27, 2025, based on protocol-defined pausing criteria. Intellia Therapeutics intends to work with the FDA to address the clinical hold as expeditiously as possible. The company also highlighted forward-looking statements regarding the safety, efficacy, and advancement of its clinical programs, including the potential risks and uncertainties associated with resolving the clinical hold and resuming the trials.