# Otarmeni™ (lunsotogene parvec-cwha) Approved by FDA as First and Only Gene Therapy for Genetic Hearing Loss; Regeneron to Provide Otarmeni for Free in the U.S.
Canonical URL: https://biopharmsignal.com/news/REGN/otarmenitm-lunsotogene-parvec-cwha-approved-by-fda-as-first-and-only-gene-therapy-for-genetic-hearing-loss-regeneron-to-provide-otarmeni-for-free-in-the-u-s
Ticker: REGN
Company: Regeneron Pharmaceuticals
Source: Regeneron Pharmaceuticals
Published: 2026-04-23 16:40 EST
Original Source URL: https://investor.regeneron.com
## Summary

Approval in severe-to-profound and profound  OTOF -related hearing loss is based on pivotal results of the CHORD trial demonstrating 80% of participants achieved or surpassed a hearing level meeting the primary endpoint, and with longer follow-up, 42% achieved normal hearing that included whispers

## Article Body
Approval in severe-to-profound and profound  OTOF -related hearing loss is based on pivotal results of the CHORD trial demonstrating 80% of participants achieved or surpassed a hearing level meeting the primary endpoint, and with longer follow-up, 42% achieved normal hearing that included whispers
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