FDA places clinical hold on Intellia’s gene-editing treatment trials

 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.

https://kfgo.com/2025/10/29/us-fda-places-clinical-hold-on-intellias-gene-editing-treatment-trials-shares-fall/