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

Regeneron Pharmaceuticals, Inc.

Regeneron Pharmaceuticals, Inc.

REGN

0.00
  • 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.

This page is machine-translated. Sahm tries to improve but does not guarantee the accuracy and reliability of the translation, and will not be liable for any loss or damage caused by any inaccuracy or omission of the translation. *Disclaimer: The above content only represents the author's personal position and opinion and does not represent any position of Sahm Capital Financial Company and Sahm cannot confirm the authenticity, accuracy, and originality of the above content. Investors should consider the risks of investment products in light of their circumstances before making any investment decisions. When necessary, please consult a professional investment advisor. Sahm does not provide any investment advice, nor does it make any commitments and guarantees.