Regeneron Pharmaceuticals ((REGN)) announced an update on their ongoing clinical study.
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Regeneron Pharmaceuticals is conducting a study titled A Two-Part Open-Label Study of REGV131-LNP1265, A CRISPR/Cas9 Based Coagulation Factor IX Gene Insertion Therapy in Participants With Hemophilia B. The study aims to evaluate the safety and effectiveness of a novel gene insertion therapy, REGV131-LNP1265, designed to enable long-term production of clotting factor in patients with hemophilia B, potentially reducing the need for regular factor replacement therapy.
The intervention involves two drugs, REGV131 and LNP1265, administered via intravenous infusion. This therapy uses CRISPR/Cas9 technology to insert a functional gene into the patient’s DNA, aiming to improve blood clotting without frequent treatments.
This interventional study is non-randomized with a sequential intervention model and no masking. Its primary purpose is treatment, focusing on determining a safe and effective dose of the therapy.
The study began on April 18, 2024, with the latest update submitted on August 21, 2025. These dates are crucial as they indicate the study’s progression and ongoing recruitment status.
Market implications of this study could be significant for Regeneron, potentially boosting investor confidence if successful. The collaboration with Intellia Therapeutics highlights the competitive landscape in gene therapy, where advancements could influence stock performance and industry dynamics.
The study is currently recruiting, with further details available on the ClinicalTrials portal.