Regeneron published trial results showing a gene therapy substantially improved hearing in children born with a specific genetic form of deafness and plans to file for regulatory approval. Published data indicate nine of 12 treated children reached hearing levels that could remove the need for cochlear implants, prompting the company to head to the FDA. The New England Journal of Medicine report underpins Regeneron’s submission plans and marks a high‑profile push for pediatric gene therapy approvals. The data will be evaluated for durability, safety and broader applicability as regulators consider labeling and patient selection.