EMA accepts Regeneron Otarmeni gene therapy filing for OTOF-related hearing loss review

PUBT·05/22/2026 11:04:00

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Regeneron won EMA acceptance for accelerated review of its marketing application for Otarmeni, a gene therapy for biallelic OTOF variant-associated hearing loss.
The filing is backed by data from the pivotal CHORD trial in 24 patients aged 10 months to 16 years.
Otarmeni received FDA accelerated approval in April 2026; a positive EU decision would make it the first gene therapy for OTOF-related hearing loss in the bloc.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Regeneron Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202605220700PRIMZONEFULLFEED9725059) on May 22, 2026, and is solely responsible for the information contained therein.

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