Intellia Therapeutics, Inc. has just announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the investigational new drug application (IND) for the magnitude-2 phase 3 clinical trial of Nexiguran Ziclumeran (Nex-Z) for patients with hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN). This comes after the FDA had imposed a clinical hold on the INDs for magnitude and magnitude-2 on October 29, 2025, due to observations of grade 4 liver transaminases and increased total bilirubin in a patient who was dosed with Nex-Z in magnitude.
The company has stated that they have aligned with the FDA on certain study modifications and mitigation measures related to magnitude-2, including enhanced safety monitoring of liver laboratory tests. As a result, Intellia plans to resume patient enrollment and dosing for the magnitude-2 trial as quickly as possible.
As part of the protocol amendment, Intellia has increased the trial's target enrollment from approximately 50 patients to approximately 60 patients with ATTRv-PN. The primary endpoints of the study are a change in modified neuropathy impairment score and a change in serum TTR levels. Adult patients with ATTRv-PN are randomized 1:1 to receive a single 55 mg infusion of Nex-Z or placebo.
Intellia also mentioned that their engagement with the FDA is ongoing regarding the clinical hold on the IND for the magnitude phase 3 clinical trial of Nex-Z for patients with transthyretin amyloidosis with cardiomyopathy (ATTR-CM), and the company plans to provide an update once alignment has been achieved on the path forward for this program.
As a result of these announcements, the company's shares have moved 5.31% on the market, and are now trading at a price of $12.50. For more information, read the company's full 8-K submission here.
