Regeneron Gets FDA Approval for Genetic Hearing Loss Treatment

Published: 2026-04-23 13:30:33 ET REGN

Published on 04/23/2026 at 01:30 pm EDT

By Kelly Cloonan

Regeneron Pharmaceuticals received accelerated approval from the Food and Drug Administration for a gene therapy to treat genetic hearing loss.

The biotechnology company said Thursday its Otarmeni treatment was approved under the FDA Commissioner's National Priority Voucher program. The therapy is indicated to treat pediatric and adult patients with severe-to-profound and profound sensorineural hearing loss associated with molecularly confirmed biallelic variants in the OTOF gene.

Otarmeni is the first in vivo gene therapy for OTOF-related hearing loss, which affects about 50 newborns per year in the U.S., Regeneron said. Genetic OTOF-related hearing loss has historically been considered permanent and managed with life-long use of devices.

The company plans to make the treatment available for free in the U.S. to clinically eligible individuals.

Write to Kelly Cloonan at [email protected]

(END) Dow Jones Newswires

04-23-26 1329ET