Benzinga | Apr 13, 2021 08:31AM EDT

Akouos Receives FDA Orphan Drug And Rare Pediatric Disease Designations For AK-OTOF For The Treatment Of Otoferlin Gene-Mediated Hearing Loss

Akouos, Inc. (NASDAQ:AKUS), a precision genetic medicine company dedicated to developing potential gene therapies for individuals living with disabling hearing loss worldwide, today announced that the U.S. Food and Drug Administration (FDA) has granted both Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) for AK-OTOF, a gene therapy intended for the treatment of otoferlin gene-mediated hearing loss. Akouos anticipates that it will submit an investigational new drug application (IND) for AK-OTOF in the first half of 2022.