REGENXBIO Announces Positive Long-Term Functional Outcomes in Duchenne Gene Therapy Program

REGENXBIO announced new, positive 18-month functional data from patients treated with the pivotal dose in the Phase I/II portion of the AFFINITY DUCHENNE® trial. They expect to share pivotal topline data in early Q2 2026 and submit a Biologics License Application (BLA) under the accelerated approval pathway in mid-2026. 

Link to press release: https://www.prnewswire.com/news-releases/regenxbio-highlights-key-2026-catalysts-and-announces-positive-long-term-functional-outcomes-in-lead-duchenne-gene-therapy-program-302657988.html