Regeneron Pharmaceuticals ((REGN)) announced an update on their ongoing clinical study.
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Regeneron Pharmaceuticals is conducting a 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 study aims to assess the safety, tolerability, and effectiveness of REGN5381 in patients with heart failure, focusing on side effects, drug levels in the blood, and antibody development against the drug.
The intervention being tested is REGN5381, a monoclonal antibody agonist administered as a single dose intravenous infusion. It is designed to treat heart failure by improving heart function.
The study is interventional with a randomized, parallel assignment. It employs quadruple masking, meaning that the participant, care provider, investigator, and outcomes assessor are unaware of the treatment assignments. The primary purpose is treatment-focused.
The study began on January 23, 2024, and the latest update was submitted on August 28, 2025. These dates are crucial as they indicate the study’s progress and timeline, with the primary completion and estimated study completion dates yet to be announced.
This update may positively influence Regeneron’s stock performance and investor sentiment, as successful results could enhance their market position in treating heart failure. Competitors in the cardiovascular treatment space will be closely monitoring these developments.
The study is ongoing, with further details available on the ClinicalTrials portal.