The U.S. Food and Drug Administration placed a clinical hold on two late‑stage Intellia Therapeutics trials testing a CRISPR-based in vivo gene-editing therapy after a serious liver injury in a treated patient. Intellia reported the adverse event and temporarily paused dosing and screening prior to the FDA’s hold; the company’s shares fell sharply on the news. The company and regulators will review the safety signal and underlying data to determine whether the program can resume and under what conditions. The case adds to an ongoing industry debate about on‑target toxicities in systemic gene‑editing approaches and is likely to prompt closer safety monitoring in similar programs. The hold affects late‑stage development timelines and highlights regulatory scrutiny of novel in vivo editing platforms where off‑target and organ‑specific toxicities remain critical uncertainties.