Regenxbio completes enrollment in Duchenne trial, begins RGX-202 production

Regenxbio (RGNX) announced the completion of enrollment in the AFFINITY DUCHENNE pivotal trial of RGX-202, an investigational gene therapy for the treatment of Duchenne muscular dystrophy, as well as the successful production of the first batches intended for commercial supply. The pivotal portion of the Phase I/II/III AFFINITY DUCHENNE trial completed enrollment of 30 participants in October 2025In the Phase I/II portion of the trial, microdystrophin levels ranged from 20% to 122% in participants who received the pivotal dose. As of May 7, RGX-202 was well tolerated, with no serious adverse events or adverse events of special interest reported in the Phase I/II trial. Pivotal dose participants exceeded baseline-matched external natural history controls on all functional measures. Regenxbio has manufactured the first batches of RGX-202 intended for commercial supply, supporting the company’s expected approval and commercial launch in 2027, when the vast majority of the prevalent market is expected to be available. The company has also manufactured full supply of RGX-202 for the confirmatory trial. RGX-202 is manufactured at the company’s headquarters in Rockville, Md..