Intellia Therapeutics Receives Regulatory Clearance to Resume Key Trial

The U.S. Food and Drug Administration (FDA) has granted Intellia Therapeutics permission to restart a significant portion of its clinical program. The regulatory agency has lifted a clinical hold on the Phase 3 MAGNITUDE-2 study, which is evaluating the gene-editing candidate nexiguran ziclumeran (nex-z). This decision allows the company to resume patient recruitment and dosing for this trial. However, a separate but related study, MAGNITUDE, remains on hold, presenting a critical near-term focus for the biotech firm.

The FDA initially imposed a clinical hold on both the MAGNITUDE and MAGNITUDE-2 studies on October 29, 2025. This action followed a serious adverse event reported in the MAGNITUDE trial, where a participant exhibited markedly elevated liver enzymes.

Following a review, Intellia has now reached an agreement with regulators to modify the study's design. The updated protocol for MAGNITUDE-2 includes enhanced liver function monitoring for patient safety. Furthermore, the trial's target enrollment has been increased from approximately 50 to 60 patients. The study focuses on treating hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN).

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A Split Decision on the Clinical Program

With this clearance, Intellia can reactivate a core component of its development plan for nex-z. Company leadership has indicated it will move swiftly to restart patient enrollment.

The path forward for the broader program, however, is only partially clear. The clinical hold on the MAGNITUDE study continues. This trial is investigating nex-z for a different condition, transthyretin amyloidosis with cardiomyopathy (ATTR-CM). Intellia states it remains in active discussions with the FDA, aiming to secure a similar resumption for this equally important arm of its research.

Upcoming Catalysts Beyond Current Headlines

Looking ahead, the company's pipeline offers additional near-term milestones. Intellia anticipates reporting topline data in the first half of 2026 from its Phase 3 HAELO study. This trial assesses a different drug candidate, lonvo-z, for hereditary angioedema (HAE). Should the results be positive, the firm plans to submit a Biologics License Application (BLA) to the FDA during the second half of 2026.