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US FDA places clinical hold on Intellia’s gene-editing treatment trials; shares fall

By Thomson Reuters Oct 29, 2025 | 4:11 PM

(Reuters) -Intellia Therapeutics said on Wednesday that the U.S. Food and Drug Administration has placed a clinical hold on its two late-stage trials testing an experimental gene-editing therapy for a rare disease that can damage the heart and nerves.

Shares of the company fell about 14% in extended trading.

Earlier this week, the company said that in one of its gene-editing trials a patient who received the therapy, called nexiguran ziclumeran (nex-z), developed a serious liver injury, prompting a temporary pause in dosing and patient screening.

The FDA verbally informed the company of the decision on October 29 and said it would issue a formal letter within 30 days.

(Reporting by Kamal Choudhury in Bengaluru; Editing by Alan Barona)