The FDA lifted clinical holds on two Intellia Phase 3 trials of its CRISPR‑based gene editing therapies after a prior safety event, allowing enrollment to resume with added liver‑safety measures. Regulators required exclusion criteria for patients with specific liver issues and tighter monitoring of hepatic enzymes, plus steroid guidance for transient enzyme elevations. The holds followed a serious liver toxicity event that resulted in a patient death; Intellia and partner Regeneron worked with the agency to define safeguards that balance patient safety with trial continuity. Analysts called the conditions modest and noted timely resolution reduces disruption to development timelines. The outcome illustrates how agencies may permit trial continuation after serious adverse events when companies and regulators align on risk‑mitigation measures.