Regeneron said it will pursue regulatory approval after an NEJM‑published study showed its gene therapy restored usable hearing in most treated children with a congenital form of deafness. The company reported that nine of 12 treated children reached hearing thresholds that could remove the need for cochlear implants, prompting a filing plan with the FDA. The data were presented in The New England Journal of Medicine and include objective audiologic endpoints reported by Regeneron. Separately, Moderna disclosed phase 1/2 melanoma responses that informed its decision to prioritize an IDO‑targeted cancer candidate. The company reported tumor responses in patients who had failed checkpoint inhibitors, data that drove an internal shift toward advancing the asset. Moderna’s update reassesses its oncology allocation and signals renewed interest in combination immunotherapy approaches.