NTLA News & Events

Intellia Therapeutics announced that the U.S. Food and Drug Administration has removed the clinical hold on the Investigational New Drug application for the MAGNITUDE Phase 3 clinical trial of nexiguran ziclumeran for patients with transthyretin amyloidosis with cardiomyopathy. The clinical holds on the INDs for MAGNITUDE and MAGNITUDE-2 were imposed by the FDA on October 29, 2025, following the observation of Grade 4 liver transaminases and increased total bilirubin in a patient who was dosed with nex-z in MAGNITUDE that met the trial's protocol-defined pausing criteria. The company has aligned with the FDA on mitigation measures for MAGNITUDE and MAGNITUDE-2 that include enhanced monitoring of liver laboratory tests, guidance for short-term steroid treatment if elevated liver transaminases are observed in the initial period following dosing and the exclusion of patients with certain liver abnormalities. For MAGNITUDE, additional exclusion criteria are being incorporated for patients with a recent history of cardiovascular instability and those with ejection fraction less than25% at the time of screening. Intellia is engaged with clinical trial investigators, ethics committees, international regulatory authorities and other stakeholders to resume enrollment activities in MAGNITUDE and MAGNITUDE-2. MAGNITUDE is a randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of nex-z in approximately 1,200 patients with ATTR-CM. The primary endpoint of the trial is based on a composite measure of cardiovascular-related events, including mortality. Adult patients with ATTR-CM are randomized 2:1 to receive a single 55 mg infusion of nex-z or placebo

Reports Q4 revenue $23.017M, consensus $12.17M. "2025 was a time of accomplishment and resiliency for Intellia as we presented encouraging longer term Phase 1/2 clinical data for both lonvo-z and nex-z, rapidly enrolled patients in our three Phase 3 trials, commenced activities to prepare for a potential lonvo-z launch in HAE and responded to the clinical holds on our nex-z Phase 3 trials late in the year," said Intellia President and Chief Executive Officer John Leonard, M.D. "We expect the year ahead to be a pivotal one, highlighted by our topline Phase 3 data and planned BLA submission for lonvo-z, which has the potential to transform the HAE treatment paradigm by freeing most patients from both their attacks and chronic therapy. Additionally, we are focused on resuming our forward momentum with nex-z by completing patient enrollment in MAGNITUDE-2 and resolving the clinical hold on MAGNITUDE."

Intellia Therapeutics announced that on February 1, 2026, it awarded inducement grants to six new employees under Intellia's 2024 Inducement Plan as a material inducement to employment. The inducement grants consisted of time-based restricted stock units for an aggregate of 30,600 shares of Intellia's common stock, with one-third of such RSUs vesting annually over three years. All equity vesting is subject to each employee's continued service as an employee of, or other service provider to, Intellia through the applicable vesting dates.