REGENXBIO Completes Enrollment In AFFINITY DUCHENNE Pivotal Trial Of RGX-202; Initiates Commercial Production Duchenne Gene Therapy Program

Author: Benzinga Newsdesk | October 30, 2025 06:13am

• Patients treated with RGX-202 demonstrate consistent, robust microdystrophin expression and functional improvement compared to natural history in Phase I/II portion of AFFINITY DUCHENNE® trial supporting potential approval via the accelerated approval pathway
• REGENXBIO continues to enroll patients in the confirmatory trial
• First batches intended for commercial supply manufactured at in-house Manufacturing Innovation Center
  • Capacity to produce up to 2,500 RGX-202 doses per year
• Topline pivotal data now expected in early Q2 2026 and BLA submission in mid-2026

ROCKVILLE, Md., Oct. 30, 2025 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced the completion of enrollment in the AFFINITY DUCHENNE® pivotal trial of RGX-202, an investigational gene therapy for the treatment of Duchenne muscular dystrophy, as well as the successful production of the first batches intended for commercial supply.

REGENXBIO continues enrolling ambulatory participants aged 1 year and above in the confirmatory trial.

Posted In: RGNX