FDA lifts hold on Intellia trial

Ella Jeffries / beckershospitalreview - The FDA has lifted a clinical hold on Intellia Therapeutics’ phase 3 Magnitude trial of nexiguran ziclumeran, or nex-z. The trial was paused Oct. 29 after a patient developed grade 4 liver transaminase elevations and elevated bilirubin following a Sept. 3…

AI Summary: The FDA has lifted clinical holds on Intellia Therapeutics’ Phase 3 gene‑editing trials, allowing the company to resume patient enrollment and advance its nexiguran (nex‑z) development program. Regulators appear satisfied with submitted safety updates, clearing a major regulatory hurdle and moving the gene-editing program back toward its clinical milestones.

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