Regenxbio reported that its Duchenne muscular dystrophy gene therapy RGX-202 met the primary endpoint in a pivotal trial, with the company targeting an FDA submission path in 2027. The update follows the company’s recent pressure from prior clinical setbacks and regulatory scrutiny. Regenxbio’s announcement described high rates of achieving at least 10% microdystrophin expression at Week 12, establishing a key functional readout tied to its accelerated approval strategy. The company framed the milestone as paving a clearer path toward commercialization planning after years of development and safety evaluation. The update keeps gene therapy demand high among Duchenne stakeholders and raises the probability of accelerated regulatory engagement in the next review cycle.