The FDA granted accelerated approval to Regeneron’s Otarmeni (lunsotogene parvec-cwha), positioning the therapy as the first gene treatment designed to restore neurosensory function in severe-to-profound OTOF-related sensorineural hearing loss. The approval covers children and adults with molecularly confirmed biallelic OTOF variants, preserved outer hair cell function, and no prior cochlear implant in the same ear. The decision was based on hearing sensitivity improvement measured by average pure tone audiometry at week 24 in the Phase I/II CHORD trial (NCT05788536). Regeneron reported that 80% of participants (16 of 20) achieved hearing improvements at ≤70 dB HL by week 24, with additional confirmatory signals from auditory brainstem response endpoints and durability through 48 weeks. Regeneron said it will make Otarmeni available for free in the U.S. The FDA’s accelerated approval framework hinges on verification and characterization of clinical benefit in the confirmatory portion of CHORD.