REGENXBIO reached an agreement with the FDA on a path to resubmit its Biologics License Application (BLA) for NAVSUNLI™. This one-time gene therapy targets Hunter syndrome, a rare neurodegenerative disease also known as MPS II. The company seeks accelerated approval for the treatment.
The FDA confirmed that REGENXBIO requires no additional clinical studies for the resubmission. This follows a Complete Response Letter issued by the agency in February 2026. The FDA will instead conduct an expedited review of existing longer-term study data.
REGENXBIO plans to request a Type A meeting in July. The company expects to resubmit the BLA in the third quarter of 2026. This development removes a significant regulatory overhang for the company. The FDA's flexibility signals positive momentum for biotech ETFs like IYH and VHT.