Regeneron said it will provide its FDA-accelerated gene therapy Otarmeni (lunsotogene parvec) for genetic hearing loss free of charge to eligible U.S. patients. The company said the decision was made possible by success across its broader portfolio, and it framed the move around increasing access for infants and children treated under the accelerated approval pathway. Otarmeni is an AAV-delivered in vivo therapy targeting variants in the OTOF gene and was approved for patients aged 10 months through 16 years, based on the open-label CHORD Phase I/II trial. Regeneron reported that 80% of patients showed improved hearing after a single dose in the trial. While the pricing decision is expected to reduce barriers to uptake, it also drew ethical scrutiny from parts of the deaf community. Gallaudet University said it has established a gene editing think tank to discuss the implications of gene therapy availability and commercialization. For the biotech sector, the move is likely to sharpen debate on pricing, access and ethical frameworks for rare-disease gene therapies—particularly those cleared under accelerated pathways and supported by orphan designations.