Regeneron reported that nine of 12 children in a trial of its gene therapy for congenital deafness achieved hearing levels that could remove the need for cochlear implants, and the company said it will seek regulatory approval. The data—published in The New England Journal of Medicine—showed clinically meaningful gains in auditory function in a small pediatric cohort. Regeneron plans to engage the FDA on an approval pathway; the program’s outcomes will be scrutinized for durability of effect, safety in developing ears and how regulators weigh small‑cohort pediatric efficacy when setting approval standards for rare congenital indications.