Regeneron Pharmaceuticals ((REGN)) announced an update on their ongoing clinical study.
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Study Overview: The MAGNITUDE study, officially titled MAGNITUDE: A Phase 3, Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM), aims to assess the efficacy and safety of NTLA-2001. This study is significant as it targets Transthyretin Amyloidosis with Cardiomyopathy (ATTR-CM), a condition that affects the heart and can lead to severe health issues.
Intervention/Treatment: The study tests NTLA-2001, a biological treatment administered as a single intravenous infusion. This experimental treatment is compared to a placebo, which is a normal saline solution, to evaluate its effectiveness in treating ATTR-CM.
Study Design: This Phase 3 interventional study uses a randomized, parallel assignment model. Participants are allocated in a 2:1 ratio to receive either NTLA-2001 or a placebo. The study employs quadruple masking, meaning the participant, care provider, investigator, and outcomes assessor are blinded to the treatment assignments. The primary purpose of the study is treatment.
Study Timeline: The study began on November 8, 2023, with its primary completion and estimated overall completion dates yet to be announced. The latest update was submitted on August 22, 2025. These dates are crucial for tracking the study’s progress and anticipating results.
Market Implications: This study update could influence Regeneron Pharmaceuticals’ stock performance and investor sentiment, as successful results may enhance their market position in the ATTR-CM treatment space. The collaboration with Intellia Therapeutics highlights a strategic partnership in the competitive biopharmaceutical industry, potentially impacting competitors focusing on similar conditions.
The study is ongoing, with further details available on the ClinicalTrials portal.