Regenxbio Reports Positive Long-Term Results in Duchenne Gene Therapy and Plans 2026 BLA Filing

Reuters01-12

Regenxbio Reports Positive Long-Term Results in Duchenne Gene Therapy and Plans 2026 BLA Filing

Regenxbio Inc. has announced new long-term functional data from its Phase I/II clinical trial of RGX-202, a gene therapy for Duchenne Muscular Dystrophy. The data demonstrate a durable treatment effect at 18 months at the pivotal dose. The company continues robust patient enrollment in a confirmatory trial and expects the majority of patients to be dosed by the planned Biologics License Application (BLA) filing in mid-2026. Regenxbio also anticipates sharing pivotal topline data in early Q2 2026 and plans to submit the BLA under the accelerated approval pathway in mid-2026. Results were highlighted in a presentation at the 44th Annual J.P. Morgan Healthcare Conference, with a webcast available on the company’s website.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Regenxbio Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: PH60568) on January 11, 2026, and is solely responsible for the information contained therein.

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