The U.S. Food and Drug Administration has removed a clinical hold on one of two Phase 3 trials testing Intellia Therapeutics’ CRISPR-based therapy for transthyretin amyloidosis (ATTR). The action follows a grade 4 liver event and a fatality reported in the sister study; the agency allowed a non-cardiac ATTR study to resume while the cardiac ATTR trial remains paused. Intellia and regulators will need to reconcile safety signals from the halted study with data collection plans for the resumed program. The FDA’s selective clearance preserves a pivotal pathway for Intellia’s lead asset but maintains heightened oversight of dosing and hepatic risk assessments. Clinical sites and investigators will now restart enrollment under revised monitoring protocols.