Regeneron

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.

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.