Regeneron Pharmaceuticals ((REGN)) announced an update on their ongoing clinical study.
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Regeneron Pharmaceuticals is conducting a Phase 2 clinical study titled A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of a Single Dose of REGN5381, an NPR1 Monoclonal Antibody Agonist, in Patients With Chronic Heart Failure With Reduced Ejection Fraction. The primary goal is to assess the safety, tolerability, and effectiveness of REGN5381 in treating heart failure with reduced ejection fraction, a condition where the heart does not pump efficiently.
The study is testing REGN5381, an experimental monoclonal antibody designed to improve heart function. It is administered as a single dose intravenous infusion, with the aim of determining its safety and pharmacokinetic profile.
This interventional study is randomized and follows a parallel assignment model. It employs a quadruple masking approach, meaning that the participant, care provider, investigator, and outcomes assessor are all blinded to the treatment allocation. The primary purpose of the study is treatment-focused.
The study began on April 11, 2024, with the primary completion and estimated completion dates yet to be announced. The latest update was submitted on June 24, 2025, indicating ongoing recruitment and progress.
For investors, this study represents a significant development in Regeneron’s cardiovascular portfolio. Positive results could enhance Regeneron’s market position and potentially influence its stock performance favorably. The study’s progress is crucial for maintaining investor confidence, especially in the competitive pharmaceutical landscape.
The study is ongoing, with further details available on the ClinicalTrials portal.