REGENXBIO (RGNX) Rises as FDA Waives New Studies for NAVSUNLI BLA Resubmission

REGENXBIO (RGNX) shares gained in premarket trading on June 22, 2026, after the U.S. Food and Drug Administration (FDA) informed the company that no new clinical studies are required for the resubmission of its Biologics License Application (BLA) for NAVSUNLI (RGX-314). This decision significantly streamlines the regulatory pathway for NAVSUNLI, an investigational gene therapy for wet age-related macular degeneration (wet AMD). The company plans to resubmit the BLA in the third quarter of 2026. The original BLA for NAVSUNLI was withdrawn in October 2023 due to a Chemistry, Manufacturing, and Controls (CMC) issue, which the company has since addressed. The FDA's latest guidance removes a key uncertainty regarding the resubmission timeline and requirements.