Intellia Therapeutics has received U.S. regulatory clearance to resume a key late-stage clinical trial for one of its genetic medicine programs. The Food and Drug Administration (FDA) has lifted a clinical hold on the company’s MAGNITUDE-2 Phase 3 study. However, the agency continues to maintain a separate hold on a related trial, creating a mixed regulatory picture for the biotech firm.
Details of the FDA’s Decision
The regulatory suspension on the MAGNITUDE-2 trial, which was initiated on October 29, 2025, has now been formally removed. This hold was originally placed following a serious liver-related safety event observed in a patient enrolled in a separate but related study. That study, named MAGNITUDE, is investigating a treatment for ATTR-CM (transthyretin amyloidosis with cardiomyopathy).
Although the patient populations in the two trials are distinct, the FDA initially required further safety clarifications before allowing MAGNITUDE-2 to proceed. The study in question evaluates the candidate nexiguran ziclumeran (also known as nex-z or NTLA-2001) for the treatment of ATTRv-PN, a form of hereditary transthyretin amyloidosis with polyneuropathy.
Revised Protocol for the Resumed Study
In response to the agency’s review, Intellia has agreed to implement specific protocol modifications for MAGNITUDE-2. A central component of these changes involves instituting more frequent laboratory monitoring of liver function tests to enhance patient safety oversight.
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Furthermore, the company plans to expand the trial’s enrollment. The revised protocol will aim to include approximately 60 participants, an increase from the originally planned cohort of around 50 patients. The study’s primary endpoints will focus on measuring changes in a modified neuropathy score and tracking serum TTR (transthyretin) levels.
Persistent Challenge with Cardiomyopathy Program
Despite the positive development for the neuropathy program, a significant obstacle remains. The FDA’s clinical hold on the Investigational New Drug (IND) application for the MAGNITUDE Phase 3 study in ATTR-CM patients is still in effect. Intellia has stated that discussions with the regulatory body regarding the path forward for this cardiomyopathy program are ongoing.
For investors, this creates a nuanced situation. The resumption of MAGNITUDE-2 is a clear step forward, but the more critical near-term catalyst will likely be concrete updates on the status of the stalled ATTR-CM trial. The market will be watching for details on whether, and under what specific conditions, the MAGNITUDE study can be restarted.
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