The FDA approved Regeneron’s Otarmeni (lunsotogene parvec), a gene therapy for a rare inherited form of hearing loss linked to otoferlin variants. The approval marks the first gene therapy cleared under the agency’s National Priority Voucher program, a mechanism designed to accelerate review and enable expanded access. Regeneron said it will offer the treatment at no cost to eligible patients in the US, positioning the voucher framework as a practical path for paying for and scaling one-time curative options. The decision also adds to a growing wave of single-dose genetic medicines reaching patients beyond oncology. Separately, Regeneron received FDA clearance alongside a hearing-loss-related voucher policy momentum, underscoring how the regulatory and payment incentives around vouchers are being operationalized in real-world approvals.