REGENXBIO completes dosing in Duchenne gene therapy confirmation study; planning BLA submission to FDA in Q3 2026

- Posted in Research
gene therapy REGENXBIO

REGENXBIO has completed dosing in the confirmatory study of RGX-202, an AAV-delivered microdystrophin gene therapy for the treatment of Duchenne.  The company is on track to initiate a Biologics License Application (BLA) under the accelerated approval pathway in Q3 2026, for a potential approval by the US FDA in the second half on 2027.

Press release:  REGENXBIO press release – RGX-202 – 24Jun2026
Community letter:

RGX-202 community letter – enrollment complete and BLA plans 24Jun2026 vFDownload

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