REGENXBIO Completes Dosing in Confirmatory Study of RGX-202, Marking Completion of Registrational Development Program and Supporting Planned BLA Submission in Q3 2026
REGENXBIO completed dosing in the confirmatory study of RGX-202 for Duchenne muscular dystrophy, marking the end of the registrational development program ahead of schedule. The company plans to submit a Biologics License Application (BLA) in Q3 2026 under the accelerated approval pathway, targeting potential FDA approval in the second half of 2027.
Key figures
- Drug Name
- RGX-202
- Bla submission timing
- Q3 2026
- Pivotal expression rate
- >93% at Week 12
- Potential approval timing
- 2H 2027
- Pivotal study participants
- 30
- Confirmatory study participants
- 63
AI analysis
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