Regeneron’s hearing loss gene therapy Otarmeni (lunsotogene parvec) won FDA approval for a rare inherited type of hearing loss caused by otoferlin variants, becoming the first gene therapy cleared under the agency’s national priority voucher program. The approval positions Otarmeni for eligible patients at no cost, while also adding a rare pediatric disease priority review voucher that the company can sell for substantial value. Separate coverage highlighted Regeneron’s Otarmeni as the flagship real-world outcome from the voucher framework—an approach intended to increase speed-to-patient for selected breakthrough therapies, though it has already drawn scrutiny from advocacy groups. The clearance marks a milestone for AAV-mediated gene therapy commercialization and reinforces how the voucher program is being used to concentrate regulatory attention on select modalities and targets.