FDA Lifts Clinical Hold on Intellia Therapeutics Trial for Nerve Disease Therapy

The FDA cleared Intellia Therapeutics to resume its late-stage nerve disease trial. While enrollment restarts for polyneuropathy, a heart trial remains held.

Insights:
On January 27, 2026, the U.S. Food and Drug Administration in the US USUSofficially lifted the clinical hold on a late-stage trial conducted by Intellia Therapeutics Inc for its nexiguran ziclumeran program. The regulatory decision enables the company to resume patient enrollment for the CRISPR-based gene therapy designed to treat hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN). Following the news, shares of Intellia Therapeutics Incrose 10 percent in morning trading as the market responded to the removal of a major developmental obstacle.
FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
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