Regeneron Pharmaceuticals ((REGN)) announced an update on their ongoing clinical study.
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Study Overview: Regeneron Pharmaceuticals is conducting a Phase 3 study titled ‘A Phase 3, Multicenter, Randomized, Open-Label, Sponsor-Blinded, Study to Evaluate REGN7508, A Factor XI Monoclonal Antibody, Versus Apixaban and Enoxaparin for Prophylaxis of Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-APEX)’. The study aims to assess the efficacy of REGN7508 in preventing venous thromboembolism (VTE) in adults undergoing total knee replacement surgery, along with evaluating potential side effects, drug levels in the blood, and antibody development against the drug.
Intervention/Treatment: The study tests REGN7508, an experimental Factor XI monoclonal antibody, against standard treatments Apixaban and Enoxaparin. REGN7508 is designed to prevent VTE following knee surgery.
Study Design: This is an interventional study with a randomized, parallel assignment. The study is double-masked, meaning both the investigator and outcomes assessor are unaware of the treatment allocation. The primary purpose is treatment-focused.
Study Timeline: The study began on June 3, 2025, with the latest update submitted on August 28, 2025. These dates are crucial as they mark the study’s progression and the most recent information available.
Market Implications: The ongoing study could significantly impact Regeneron’s stock performance, as successful results may enhance investor confidence and market position. Competing with established drugs like Apixaban and Enoxaparin, REGN7508’s success could disrupt the current market dynamics in thromboprophylaxis.
The study is currently recruiting, with further details available on the ClinicalTrials portal.