The U.S. Food and Drug Administration has lifted a clinical hold on one of Intellia Therapeutics’ two Phase 3 trials of its CRISPR/Cas9 candidate nexiguran ziclumeran (nex‑z) after a regulatory safety review. The agency permitted Magnitude‑2—the study focused on transthyretin amyloidosis with polyneuropathy (ATTR‑PN)—to restart while the related Magnitude trial for cardiomyopathy remains suspended pending further data. Intellia said it will implement additional safety safeguards and continue discussions with the FDA on the broader program. The action follows a fatality and a prior grade‑4 liver transaminase event reported in the sister ATTR‑CM study, which triggered the original holds. Regulators’ selective reopening underscores continued caution around systemic in vivo gene editing, particularly concerning off‑target and hepatic risks. The partial clearance removes a regulatory obstacle for Intellia’s neuropathy indication but keeps scrutiny on safety signals that could shape trial design and monitoring across the gene‑editing field.