The FDA will reconsider Regenxbio’s childhood gene therapy for Hunter syndrome after a recent rejection, according to Regenxbio. The company said the agency now acknowledges its existing Navsunli (RGX-121) clinical data are sufficient for an accelerated approval pathway, and it does not need to enroll additional patients or run new studies. Regenxbio said the agency previously flagged uncertainty around eligibility criteria and the company’s use of external controls, recommending an untreated control. In the latest “walk-back,” Regenxbio reported alignment with the next steps for submission and expects a Type A meeting in July followed by an expedited review after resubmission. The update adds to a sequence of rare-disease regulatory reversals that industry has linked to changes in FDA leadership. For Regenxbio, resubmission is expected in the third quarter, with labeling discussions to follow soon after. Clinically, the therapy targets a brain-penetration challenge in MPS II, where enzyme replacement therapies do not address neurological decline, keeping the accelerated pathway central to whether the company can restart its path to approval.