Regeneron Pharmaceuticals ((REGN)), Intellia Therapeutics Inc ((NTLA)) announced an update on their ongoing clinical study.
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Regeneron Pharmaceuticals and Intellia Therapeutics have launched a Phase 3 clinical study titled ‘MAGNITUDE-2’ to assess the efficacy and safety of NTLA-2001 in treating hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN). This study is crucial as it explores a potential breakthrough treatment for a debilitating genetic disorder.
The study tests a biological intervention called nexiguran ziclumeran (NTLA-2001), administered as a single intravenous infusion. This treatment aims to offer a new therapeutic option for patients suffering from ATTRv-PN.
The study follows a randomized, double-blind, placebo-controlled design with a parallel intervention model. Participants are randomly assigned to receive either NTLA-2001 or a placebo, with the option to switch treatments after 12 or 18 months. The primary goal is to evaluate treatment efficacy.
The study began on November 22, 2024, with an initial submission date of November 1, 2024. The latest update was submitted on August 11, 2025. These dates are significant as they mark the study’s progression and regulatory milestones.
This clinical update could positively influence the stock performance of Regeneron and Intellia by boosting investor confidence in their innovative treatment pipeline. As the biotech industry is highly competitive, successful trial outcomes could position these companies as leaders in genetic disorder therapies.
The study is currently recruiting, and further details can be accessed on the ClinicalTrials portal.