The U.S. Food and Drug Administration has lifted a clinical hold on Intellia Therapeutics’ Magnitude-2 Phase 3 trial of its CRISPR/Cas9 therapy nexiguran ziclumeran (nex‑z) for transthyretin amyloidosis with polyneuropathy (ATTR‑PN). The agency left the sister trial for ATTR‑CM (cardiomyopathy) suspended after a severe liver transaminase event and a patient death in the related study. Intellia disclosed the lift for Magnitude‑2 on Jan. 27 and said it is in ongoing discussions with FDA about the Magnitude (cardiac) trial. The company reported a sharp rise in its shares after the regulatory update; analysts characterized the move as cautious validation of the program while safety questions remain. Regulators cited repeated grade‑4 liver toxicity signals when pausing the broader program, underscoring continued agency scrutiny of in vivo gene editing. The decision lets Intellia proceed with the neuropathy study while the company and FDA work through additional safety mitigation and monitoring steps. The case highlights the balance regulators are demanding between accelerated development of CRISPR therapeutics and new safety signals that can stall multi‑indication programs.