Regulatory Hurdle Cleared for Intellia’s Gene Therapy Trial

Intellia Therapeutics has received authorization from the U.S. Food and Drug Administration (FDA) to resume its MAGNITUDE-2 Phase 3 clinical trial. The clearance, granted on January 27, allows the biotechnology firm to continue testing its CRISPR-based gene therapy, Nexiguran Ziclumeran, in patients suffering from hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN). This decision enables the company to restart patient enrollment and dosing for this specific study.

The regulatory action follows a clinical hold the FDA placed on the trial in October 2025. That suspension was triggered by a serious adverse liver event observed in a participant enrolled in a separate but related study, named MAGNITUDE. That sister trial is evaluating the identical therapeutic candidate for a different manifestation of the disease: transthyretin amyloidosis with cardiomyopathy (ATTR-CM).

To address the agency's safety concerns, Intellia has agreed to implement modifications to the MAGNITUDE-2 trial protocol. These revisions include enhanced monitoring procedures for liver function. It is important to note that the FDA's recent green light applies solely to the MAGNITUDE-2 study for ATTRv-PN.

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Ongoing Discussions for Related Clinical Program

The clinical hold on the original MAGNITUDE study for ATTR-CM patients remains in effect at this time. According to company statements, Intellia remains engaged in continuous dialogue with regulators to chart a path toward resuming that trial. Lifting both clinical holds had been identified by the company's leadership as a critical near-term priority for the new year.

The broader CRISPR technology sector continues to be viewed as a cornerstone of advancing precision medicine. This field maintains robust growth momentum as firms like Intellia work to transition their experimental treatments from clinical development to potential commercialization.