Intellia shares surge 17.85% premarket as FDA lifts hold on MAGNITUDE-2 trial for ATTRv-PN.

Intellia Therapeutics (NTLA) surged 17.85% in premarket trading following the U.S. Food and Drug Administration’s decision to lift the clinical hold on its MAGNITUDE-2 Phase 3 trial for nexiguran ziclumeran (nex-z) in patients with hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN). The FDA’s action allows the company to resume patient enrollment and dosing in the trial, which had been paused in October 2025 due to safety concerns, including severe liver toxicity in a trial participant. Intellia announced enhanced safety monitoring measures, including stricter liver test protocols, to address these issues. While the clinical hold on the MAGNITUDE trial for the ATTR-CM variant remains in place, the resumption of MAGNITUDE-2 trials marked a significant regulatory milestone, signaling progress in advancing its CRISPR-based gene-editing therapy toward potential commercialization. Analysts noted the move as a positive step for regulatory alignment and investor confidence in the program’s safety framework.