Regeneron plans FDA filing based on latest DB-OTO data

13 October 2025

US biotech Regeneron Pharmaceuticals (Nasdaq: REGN) has announced positive updated data for its investigational gene therapy DB-OTO for profound genetic hearing loss due to variants of the otoferlin (OTOF) gene and revealed plans to progress the product into regulatory filing.

The data were published in The New England Journal of Medicine and presented during an oral presentation at the annual American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNSF) meeting.

These latest results from the pivotal CHORD trial show 11 out of 12 participants have experienced clinically meaningful hearing improvements, including three who achieved normal hearing levels. Additionally, eight participants with longer follow-up showed stability or continued improvement in their hearing, and among three who completed speech assessments, all showed significant improvement.

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