Otarmeni™ (lunsotogene parvec) Receives EMA Filing Acceptance for Genetic Hearing Loss

Otarmeni™ (lunsotogene parvec) Receives EMA Filing Acceptance for Genetic Hearing Loss

TARRYTOWN, N.Y., May 22, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the European Medicines Agency (EMA) has accepted for review under Accelerated Assessment the Marketing Authorization Application (MAA) for Otarmeni™ (lunsotogene parvec), an in vivo adeno-associated…

EMA Accepts Otarmeni Gene Therapy for OTOF-Related Hearing Loss for Review

If approved, Regeneron’s Otarmeni will be the first gene therapy for OTOF-related hearing loss in the European Union. Regeneron Pharmaceuticals announced the European Medicines Agency (EMA) has accepted for review its marketing authorization application (MAA) for Otarmeni (lunsotogene parvec). The application for the gene therapy, which treats biallelic OTOF variant-associated hearing loss, is being reviewed under the EMA’s Accelerated Assessmen…