The FDA has fully lifted a clinical hold on Intellia’s Magnitude Phase 3 trial of CRISPR gene editing candidate nexiguran ziclumeran (nex‑z) for ATTR‑CM, allowing enrollment to resume under tightened safety measures. Intellia said the agency agreed to a path forward that excludes patients with certain liver or cardiac risk factors and adds enhanced liver‑enzyme monitoring and steroid guidance. Company leadership framed the alignment as enabling completion of enrollment; analysts noted lingering uncertainty about the cause of a prior fatal liver event but called the regulatory fix modest and manageable for timelines.
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