Regenxbio said the FDA has reversed course on parts of its rejection of the company’s Hunter syndrome gene therapy Navsunli (RGX-121). After earlier concerns over eligibility criteria and the need for an untreated control, Regenxbio said the agency acknowledged existing clinical data as sufficient for potential accelerated approval. Regenxbio plans to resubmit its biologics license application following a requested Type A meeting expected in July to review longer-term biomarker and clinical data. The company framed the pivot as aligned with regulators on the “next steps” and said the resubmission would be reviewed on an expedited basis. The development adds to a broader series of FDA “U-turns” affecting rare-disease gene therapy applicants after prior leadership-era decisions drew scrutiny.