07:38 AM EDT, 05/22/2026 (MT Newswires) -- Regeneron Pharmaceuticals ( REGN ) said Friday the European Medicines Agency has accepted for accelerated assessment its marketing authorization application for Otarmeni to treat OTOF-related hearing loss.

The gene therapy, previously known as DB-OTO, targets biallelic OTOF variant-associated hearing loss, the company said.

The therapy received accelerated approval in the US in April, Regeneron said, adding it plans regulatory submissions in other markets, including Japan.