The FDA approved Regeneron’s Otarmeni (lunsotogene parvec), the first gene therapy cleared under the agency’s National Priority Voucher program. The treatment is authorized for hearing loss due to variants in the otoferlin gene, a rare inherited condition estimated to affect about 50 newborns annually in the U.S. Regeneron said the company plans to offer Otarmeni at no cost to eligible patients. The approval follows earlier FDA accelerated approval for the therapy’s pathway and positions Regeneron to monetize the accompanying rare pediatric disease priority review voucher. Industry impact: Otarmeni’s approval is the clearest signal yet that the voucher program can translate into tangible authorizations for one-time-use AAV gene therapies—potentially influencing how sponsors prioritize manufacturing scale, confirmatory plans, and lifecycle strategies.