Regeneron
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Regeneron’s Factor XI Antibodies Show Antithrombotic Promise in Phase 2 Trials; Results Presented at AHA and Published in *The Lancet*
Regeneron (REGN) announced positive Phase 2 data for REGN7508Cat and REGN9933A2, two factor XI antibodies, in preventing postoperative venous thromboembolism (VTE) after total knee replacement. REGN7508Cat showed a 7.1% VTE rate, outperforming enoxaparin. REGN9933A2 had a 17.2% VTE rate. Importantly, no major bleeding events occurred. Phase 3 trials are underway. An investor roundtable is scheduled for November 10, 2025.
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DB-OTO Shows Dramatic, Sustained Hearing and Speech Gains in Children with Profound Genetic Hearing Loss (NEJM)
Regeneron’s DB-OTO gene therapy showed significant hearing improvements in children with OTOF-related hearing loss in the CHORD trial. 11 of 12 participants demonstrated clinically meaningful hearing gains, with 3 achieving normal hearing. The trial met its primary endpoint, and improvements were durable up to 72 weeks. DB-OTO was generally well-tolerated. Regeneron plans to file for U.S. regulatory approval later in 2025, pending FDA discussions. DB-OTO holds Orphan Drug and other FDA designations.
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Itepekimab Meets Primary Endpoint in COPD Phase 3 Trial
Regeneron and Sanofi announced mixed results from their Phase 3 AERIFY trials of itepekimab for COPD. AERIFY-1 met its primary endpoint by reducing moderate or severe exacerbations in former smokers, while AERIFY-2 failed. The trials evaluated itepekimab’s impact on exacerbation frequency. Safety profiles appeared consistent across both trials. The companies are reviewing the full data.
