Regenxbio reported that its Duchenne muscular dystrophy gene therapy RGX-202 met a pivotal clinical bar, setting the stage for an FDA submission and accelerating the company’s path toward commercialization. The update comes after prior regulatory and clinical setbacks that had weighed on the stock and investor confidence. In the pivotal portion of the Phase I/II/III Affinity Duchenne program, Regenxbio said the study met its primary endpoint with high statistical significance, with 93% of participants reaching at least 10% microdystrophin expression at week 12. The company also pointed to interim functional findings supporting continued development. Separately, the company’s CEO highlighted a near-term regulatory timeline, framing the result as compatible with accelerated approval expectations in the rare-disease setting.