22 May 2026 - Regeneron Pharmaceuticals today announced the EMA has accepted for review under accelerated assessment the marketing authorisation application for Otarmeni (lunsotogene parvec), an in vivo adeno-associated virus vector-based gene therapy for the treatment of biallelic OTOF variant-associated hearing loss. 

Otarmeni, formerly known as DB-OTO, previously received orphan designation from the EMA. 

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