REGENXBIO Completes Dosing in Confirmatory Study of RGX-202, Marking Completion of Registrational Development Program and Supporting Planned BLA Submission in Q3 2026
Summary
REGENXBIO completed dosing in the confirmatory study for RGX-202 ahead of schedule and now plans to file a BLA in Q3 2026. The company says the program remains on track for potential FDA approval in the second half of 2027 under the accelerated approval pathway. The release highlights supportive pivotal data, including strong microdystrophin expression, functional improvement signals, and a favorable safety profile. REGENXBIO is also preparing for launch with commercial manufacturing already underway. The news reinforces the company’s late-stage pipeline and its readiness for a potential commercial transition.
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