The U.S. FDA has approved Regeneron’s Otarmeni (lunsotogene parvec), an AAV-mediated gene therapy for hearing loss caused by otoferlin (OTOF) variants, clearing the first gene therapy under the agency’s national priority voucher program. The approval is tied to a rare pediatric disease priority review voucher Regeneron can monetize. Regeneron said it will offer Otarmeni at no cost to eligible patients in the U.S., positioning the launch as both a clinical and access milestone. Early trials reported modest hearing gains, and the development drew scrutiny from parts of the Deaf community during the review process. In a related report, FDA clearance is described as an accelerated step for real-world gene therapy access, with the company framing the voucher-linked program as a path to bring the therapy to patients faster. For the biotech market, the decision underscores the continuing shift toward gene therapy programs with explicit access models and regulatory pathways designed to reduce time to market.