The U.S. FDA approved Regeneron Pharmaceuticals’ gene therapy Otarmeni (lunsotogene parvec) for a rare, inherited form of hearing loss caused by otoferlin gene variants, marking the first gene therapy cleared under the agency’s National Priority Voucher program. Regeneron said it will offer the treatment at no cost to eligible U.S. patients. The approval follows earlier trial evidence showing hearing improvements that Regeneron characterized as modest, and it comes amid scrutiny from parts of the Deaf community. Otarmeni’s clearance under the voucher framework also underscores how FDA’s priority tools are being used to accelerate approvals for ultra-rare indications. Separate reporting in STAT+ tied the decision to the timing of a broader U.S. drug pricing package involving Regeneron, with the company also signaling future development commitments tied to the program.