Regenxbio Expands DUCHENNE® Trial to Include a New Cohort of Younger Patients
- Company to begin enrollment of patients aged 1-3 years
- Expects data from younger cohort to be part of pivotal plans and BLA filing for broad label
- End-of-Phase II meeting with FDA scheduled for late July to finalize pivotal program design
- Based on recent commercial landscape, confirmed accelerated approval pathway remains available given ongoing unmet need and RGX-202 differentiated design
- Remains on track to initiate pivotal trial in late Q3 to early Q4 2024
- The next potential therapy to become available for Duchenne patients
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